[Federal Register Volume 61, Number 3 (Thursday, January 4, 1996)]
[Proposed Rules]
[Pages 295-337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 95P-0197]
RIN 0910-AA19
Food Labeling: Health Claims; Oats and Coronary Heart Disease
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to
authorize the use, on food labels and in food labeling, of health
claims on the association between oat products, i.e., oat bran and
oatmeal, and reduced risk of coronary heart disease (CHD). FDA is
proposing this action in response to a petition filed by the Quaker
Oats Co. (the petitioner). The agency has tentatively concluded that,
based on the totality of publicly available scientific evidence, diets
high in oatmeal and oat bran and low in saturated fat and cholesterol
may reduce the risk of CHD.
DATES: Written comments by April 3, 1996. The agency is proposing that
any final rule that may issue based upon this proposal become effective
upon its publication in the Federal Register.
ADDRESSES: Written comments to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT:
Joyce J. Saltsman, Center for Food Safety and Applied Nutrition (HFS-
165), Food and Drug Administration, 200 C St. SW., Washington, DC
20204, 202-205-5916.
SUPPLEMENTARY INFORMATION:
I. Background
A. The Nutrition Labeling and Education Act of 1990
On November 8, 1990, the President signed into law the Nutrition
Labeling and Education Act of 1990 (the 1990 amendments) (Pub. L. 101-
535). This new law amended the Federal Food, Drug, and Cosmetic Act
(the act) in a number of important ways. One of the most notable
aspects of the 1990 amendments was that they confirmed FDA's authority
to regulate health claims on food labels and in food labeling. As
amended by the 1990 amendments, section 403(r)(1)(B) of the act (21
U.S.C. 343(r)(1)(B)) provides that a product is misbranded if it bears
a claim that characterizes the relationship of a nutrient to a disease
or health-related condition, unless the claim is made in accordance
with the procedures and standards contained in regulations adopted by
FDA.
Under section 403(r)(3)(B)(i) of the act, the Secretary of Health
and Human Services (and, by delegation, FDA) shall issue regulations
authorizing such claims only if he or she determines, based on the
totality of publicly available scientific evidence (including evidence
from well-designed studies conducted in a manner which is consistent
with generally recognized scientific procedures and principles), that
there is significant scientific agreement, among experts qualified by
scientific training and experience to evaluate such claims, that the
claim is supported by such evidence.
Sections 403(r)(3)(B)(ii) and (r)(3)(B)(iii) of the act describe
the information that must be included in any claim authorized under the
act. The act provides that the claim shall be an accurate
representation of the significance of the substance in affecting the
disease or health-related condition, and that it shall enable the
public to comprehend the information and understand its significance in
the context of the total daily diet. Finally, section 403(r)(4)(A)(i)
of the act provides that any person may petition FDA to issue a
regulation authorizing a health claim.
The 1990 amendments, in addition to amending the act, directed FDA
to consider 10 substance-disease relationships as possible subjects of
health claims. One of the 10 substance- disease relationships was the
relationship between dietary fiber and cardiovascular disease (CVD) (58
FR 2552, January 6, 1993) (hereinafter referred to as the 1993 dietary
fiber and CVD final rule).
B. FDA's Response
In the Federal Register of January 6, 1993 (58 FR 2478), FDA
adopted a final rule that implemented the health claim provisions of
the act (hereinafter referred to as the 1993 health claims final rule).
In that final rule, FDA adopted Sec. 101.14 (21 CFR 101.14), which sets
out the circumstances in which a substance is eligible to be the
subject of a health claim (Sec. 101.14(b)), adopts the standard in
section 403(r)(3)(B)(i) of the act as the standard that the agency will
apply in deciding whether to authorize a claim about a substance-
disease relationship (Sec. 101.14(c)), sets forth general rules on how
authorized claims are to be made in food labeling (Sec. 101.14(d)), and
establishes limitations on the circumstances in which claims can be
made (Sec. 101.14(e)). The agency also adopted Sec. 101.70 (21 CFR
101.70), which establishes a process for petitioning the agency to
authorize health claims about a substance-disease relationship
(Sec. 101.70(a)) and sets out the types of information that any such
petition must include (Sec. 101.70(d)). These regulations became
effective on May 8, 1993.
In addition, FDA conducted an extensive review of the evidence on
the 10 substance-disease relationships listed in the 1990 amendments.
As a result of its review, FDA has authorized claims that relate to 8
of these 10 relationships. While the agency denied the use on food
labeling of health claims relating dietary fiber to reduced risk of CVD
(58 FR 2552), it authorized a health claim relating diets low in
saturated fat and cholesterol and high in fruits, vegetables, and grain
products that contain dietary fiber (particularly soluble fiber) to a
reduced risk of CHD, the most common, most frequently reported, and
most serious form of CVD.
In denying the dietary fiber and CVD health claim, the agency
stated that a problem in determining whether there is a relationship
between dietary fiber and heart disease is presented by the fact that
dietary fiber is a diverse group of chemical substances that may be
associated with different physiological functions (58 FR 2552 at 2572).
Chemically and physiologically, cellulose, lignin, hemicellulose,
pectin, and alginate (all relatively purified fiber types) behave
differently. Wheat bran, oat bran, and rice bran (all heterogeneous
mixtures of fibers) are not similar in composition. The agency also
noted that it is very difficult to chemically analyze dietary fiber
components, and that it is consequently hard to correlate the role of
specific fiber components to health effects.
Based on its review of numerous authoritative documents, including
Federal government reports and recent research on dietary fiber and
CHD, and on its consideration of comments received in response to its
``Health Claims; Dietary Fiber and Cardiovascular Disease'' proposed
rule (56 FR 60582, November 27, 1991) (hereinafter referred to as the
1991 dietary fiber and CVD proposal), FDA concluded that the publicly
available scientific evidence supports an association between diets low
in saturated fat and cholesterol and high in fruits, vegetables, and
grain products, foods that are low in saturated fat and cholesterol and
that are good sources of dietary fiber, and reduced risk of heart
disease (58 FR 2552 at 2572). The
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agency further stated that, although the specific roles of the numerous
potentially protective substances in such plant foods are not yet
understood, populations with diets rich in these foods experience many
health advantages, including lower rates of heart disease. The agency
noted, however, that there was no scientific agreement as to whether
the observed protective effects against heart disease are the result of
a combination of nutrient components of the foods, including soluble
fiber; of the other components of soluble fiber-rich diets (for
example, potassium and magnesium); of the displacement of saturated fat
and cholesterol from the diet; or of non-nutritive substances in these
foods. For all these reasons, the agency stated that the fact that
these foods contain dietary fiber, particularly soluble fiber, can
serve as a useful marker for identifying those fruits, vegetables, and
grain products that, when added to diets low in saturated fat and
cholesterol, may help in reducing blood LDL-cholesterol levels (58 FR
2552 at 2572). Thus, the agency authorized a health claim in
Sec. 101.77 (21 CFR 101.77) on the association between diets low in
saturated fat and cholesterol and high in vegetables, fruit, and grain
products that contain soluble fiber and a reduced risk of heart
disease.
In the 1993 dietary fiber and CVD final rule, in response to a
comment regarding the apparent hypocholesterolemic properties of
specific food fibers, e.g., oats, FDA agreed that the effectiveness of
naturally occurring fibers in foods may be documented for specific food
products (e.g., oat brans meeting specified parameters) (58 FR 2552 at
2567). Further, the agency stated that if manufacturers can document,
through appropriate studies, that dietary consumption of the soluble
fiber in their particular food has the effect of lowering low density
lipoprotein cholesterol (LDL)-cholesterol, and has no adverse effects
on other heart disease risk factors (e.g., high density lipoprotein
(HDL)-cholesterol), they should petition for a health claim for their
particular product.
The present rulemaking is in response to a manufacturer's health
claim petition on the relationship between a specific fiber-containing
food, oats, and heart disease.
II. Petition for Oat Products and Reduced Risk of CHD
A. Background
On March 22, 1995, the Quaker Oats Co. submitted a health claim
petition to FDA requesting that the agency authorize a health claim on
the relationship between consumption of oat products and the risk of
CHD (Ref. 1). On June 29, 1995, the agency sent the petitioners a
letter stating that it had completed its initial review of the
petition, and that the petition would be filed in accordance with
section 403(r)(4) of the act (Ref. 2). In this document, the agency
will consider whether a health claim on this food-disease relationship
is justified under the standard in section 403(r)(3)(B)(i) of the act
and Sec. 101.14(c) of FDA's regulations. The following is a review of
the health claim petition.
B. Preliminary Requirements
1. The Substances Are Associated With a Disease for Which the U.S.
Population Is at Risk
CHD remains a major public health problem and the number one cause
of death in the United States. Despite the decline in deaths from CHD
over the past 30 years, this disease is still exacting a tremendous
toll in morbidity and mortality (Refs. 3 and 4). There are more than
500,000 deaths each year for which CHD is an underlying cause, and
another 250,000 deaths for which CHD is a contributing cause. About 20
percent of adults (male and female; black and white) ages 20 to 74
years have blood total cholesterol (or serum cholesterol) levels in the
``high risk'' category (total cholesterol greater than (>) 240
milligrams (mg) per (/) deciliter (dL) and LDL-cholesterol greater than
160 mg/dL) (Ref. 47). Another 31 percent have ``borderline high''
cholesterol levels (total cholesterol between 200 and 239 mg/dL and
LDL-cholesterol between 130 and 159 mg/dL) in combination with two or
more risk factors.
CHD has a significant effect on health-care costs. In 1985, total
direct costs related to CHD were estimated at $13 billion, and indirect
costs from loss of productivity due to illness, disability, and
premature deaths from this disease were an estimated $36 billion (Ref.
3).
Based on these facts, FDA concludes that, as required in
Sec. 101.14(b)(1), CHD is a disease for which the U.S. population is at
risk.
2. The Substances Are Food
Oatmeal and oat bran are foods and are used as ingredients in other
foods. These oat products contribute taste, aroma, or nutritive value
that are retained when consumed at levels necessary to justify the
petitioned claim.
Therefore, FDA tentatively concludes that these substances satisfy
the preliminary requirements of Sec. 101.14(b)(3)(i).
3. The Substances Are Safe
Oatmeal and oat bran are safe and lawful under the act. Both
substances have a long history of use as food and food ingredients and
are generally recognized as safe under Sec. 170.30(d) (21 CFR
170.30(d)).
Thus, FDA tentatively concludes that the petitioner has satisfied
the requirement of Sec. 101.14(b)(3)(ii).
III. Review of Scientific Evidence
A. Basis for Evaluating the Relationship Between Oats and CHD
In the 1991 dietary fiber and CVD proposal, the agency set forth
the basis of the relationship between dietary fiber and CVD (56 FR
60582 at 60583). In that document, the agency stated that there are
many risk factors that contribute to the development of CVD, and
specifically CHD, the most serious form of CVD and the leading cause of
disability. The agency also stated that there is general agreement that
elevated blood cholesterol levels are one of the major ``modifiable''
risk factors in the development of CVD and, more specifically, CHD. The
Federal government and other reviews have concluded that there is
substantial epidemiologic and clinical evidence that high blood levels
of total cholesterol and LDL-cholesterol are a cause of atherosclerosis
(inadequate circulation of blood to the heart due to narrowing of the
arteries) and represent major contributors to CHD (56 FR 60727 at
60728, November 27, 1991; Refs. 3 through 6). Factors that decrease
total cholesterol and LDL-cholesterol will also tend to decrease the
risk of CHD. High intakes of saturated fat and, to a lesser degree, of
dietary cholesterol are associated with elevated blood total and LDL-
cholesterol levels (56 FR 60727 at 60728). Thus, it is generally
accepted that total cholesterol and LDL-cholesterol levels can predict
the risk of developing CHD, and that dietary factors affecting blood
total cholesterol levels affect the risk of CHD (Refs. 3 through 6).
When considering the effect that the diet or components of the diet
have on blood (or serum) lipids, it is also important to consider the
effect that these factors may have on blood levels of HDL-cholesterol.
Evidence from epidemiologic studies show that elevated levels of HDL-
cholesterol are inversely related to the incidence of atherosclerosis
and thus CHD (Ref. 3). HDL- cholesterol is involved in the regulation
of cholesterol transport out of
[[Page 298]]
cells and to the liver from which it is ultimately excreted (Refs. 3
and 48). Therefore, HDL-cholesterol has a protective effect in the body
by helping to lower total cholesterol. Dietary factors that help to
significantly lower total cholesterol should, themselves, not have an
adverse affect on the level of HDL-cholesterol.
For these reasons, FDA limited its review of the relationship
between oatmeal and oat bran and CHD to effects of these food
components on blood lipid levels and on the risk of developing CHD. The
agency based its evaluation of this relationship on changes in total
blood and LDL-cholesterol from dietary intervention with oatmeal and
oat bran and with oat- containing products. This focus is consistent
with that used by the agency in response to the 1990 amendments in
deciding on the dietary saturated fat and cholesterol and CHD health
claim (Sec. 101.75) (56 FR 60727 and 58 FR 2739, January 6, 1993) and
the fruits, vegetables, and grain products and CHD claim (Sec. 101.77)
(56 FR 60582 and 58 FR 2552).
B. Review of Scientific Evidence
1. Evidence Considered in Reaching the Decision
The petitioner submitted scientific studies evaluating the
relationship between oat bran and oatmeal, consumed as foods and as
ingredients in foods, and serum lipid levels (Ref. 1). These studies
were conducted between 1980 and 1995. The petition included a review of
these studies and a summary of the evidence. Most of the studies that
were published before 1993 had been reviewed by the agency in the
proposed and final rules on dietary fiber and CVD (56 FR 60582 at 60596
and 58 FR 2552 at 2581). A review of the studies evaluating the effect
of oat products on blood lipids submitted by the petitioner, including
those previously reviewed by the agency, is provided in Table 1. In
addition, in its review of the petition, the agency considered the
conclusions of the Life Sciences Research Office (LSRO) of the
Federation of American Societies for Experimental Biology (FASEB) (Ref.
7) relative to studies involving oats.
2. Criteria for Selection of Human Studies
The criteria that the agency used to select pertinent studies were
that the studies: (1) Present data and adequate descriptions of the
study design and methods; (2) be available in English; (3) include
estimates, or enough information to estimate, soluble dietary fiber
intakes; (4) include direct measurement of blood total cholesterol and
other blood lipids related to CHD; and (5) be conducted in persons who
represent the general U.S. population (adults with blood total
cholesterol levels less than (<) 300="" mg/dl).="" in="" selecting="" human="" for="" review,="" the="" agency="" excluded="" studies="" that="" were="" published="" in="" abstract="" form="" because="" they="" lacked="" sufficient="" detail="" on="" study="" design="" and="" methodologies,="" and="" because="" they="" lacked="" necessary="" primary="" data.="" studies="" using="" special="" population="" groups,="" such="" as="" insulin-="" dependent="" diabetics,="" individuals="" with="" very="" high="" serum="" cholesterol="" (mean="" greater="" than="" 300="" mg/dl),="" children="" with="" hypercholesterolemia,="" and="" persons="" who="" had="" already="" experienced="" a="" myocardial="" infarction,="" were="" also="" generally="" not="" weighed="" heavily="" because="" of="" questions="" about="" their="" relevance="" to="" the="" general="" healthy="" u.s.="" population.="" 3.="" criteria="" for="" evaluating="" the="" relationship="" between="" oat="" products="" and="" chd="" fda="" applied="" the="" same="" criteria="" in="" evaluating="" the="" relationship="" between="" oat="" products="" and="" chd="" that="" it="" did="" in="" evaluating="" the="" relationship="" between="" dietary="" fiber="" and="" cvd="" in="" the="" 1991="" dietary="" fiber="" and="" cardiovascular="" disease="" proposal="" (56="" fr="" 60582="" at="" 60587).="" the="" criteria="" that="" the="" agency="" used="" in="" evaluating="" these="" studies="" included:="" (1)="" reliability="" and="" accuracy="" of="" the="" methods="" used="" in="" nutrient="" intake="" analysis,="" including="" measurements="" of="" total="" dietary="" soluble="" fiber="" and="" total="" dietary="" fiber;="" (2)="" available="" information="" on="" the="" soluble="" fiber="" or="" beta-glucan="">-glucan, the predominant soluble fiber in oats)
content of the oat products and control food; (3) measurement of study
endpoints (i.e., total cholesterol, LDL-cholesterol, and HDL-
cholesterol); and (4) general study design characteristics. The
characteristics of general study design included randomization of
subjects, appropriateness of controls, selection criteria for subjects,
attrition rates (including reasons for attrition), potential for
misclassification of individuals with regard to dietary intakes,
presence of recall bias and interviewer bias, recognition and control
of confounding factors (for example, intake of saturated fat and other
nutrients, monitoring body weight, and control of weight loss),
appropriateness of statistical tests and comparisons, and statistical
power of the studies. The agency considered whether the intervention
studies that it evaluated had been of long enough duration to
reasonably ensure stabilization of blood lipids (greater than or equal
to 3 weeks duration). Finally, the agency considered it highly
desirable if the available information on a study included information
on the total dietary fiber and total dietary soluble fiber content of
baseline, treatment, and control diets and on the nutrient intakes of
the subjects during the course of the study.
As stated above, dietary saturated fat and cholesterol affect blood
lipid levels (Refs. 4 through 6). Previous reviewers have generally
concluded that, in persons with relatively higher baseline levels of
blood cholesterol, responses to treatment tend to be of a larger
magnitude than is seen in persons with more normal blood cholesterol
levels (56 FR 60582 at 60587 and Refs. 4 through 6). To take into
account these factors, FDA separately evaluated studies on mildly to
moderately hypercholesterolemic individuals (persons with elevated
blood total cholesterol levels of 200 to 300 mg/dL) and studies on
normocholesterolemic individuals (persons with normal blood total
cholesterol levels (< 200="" mg/dl)).="" fda="" also="" separately="" evaluated="" studies="" in="" which="" oat="" products'="" effects="" were="" evaluated="" as="" part="" of="" a="" ``typical''="" american="" diet="" (approximately="" 37="" percent="" of="" calories="" from="" fat,="" 13="" percent="" of="" calories="" from="" saturated="" fat,="" and="" more="" than="" 300="" mg="" of="" cholesterol="" daily)="" and="" studies="" in="" which="" the="" test="" protocols="" incorporated="" a="" step="" i="" or="" similar="" (e.g.,="" american="" heart="" association="" (aha))="" dietary="" regimen="" (less="" than="" 30="" percent="" of="" calories="" from="" fat,="" less="" than="" 10="" percent="" of="" calories="" from="" saturated="" fat,="" and="" less="" than="" 300="" mg="" of="" cholesterol="" daily).="" moreover,="" to="" ensure="" that="" results="" were="" not="" reflective="" of="" transient="" changes,="" such="" as="" failure="" of="" blood="" cholesterol="" levels="" to="" stabilize="" to="" the="" dramatic="" changes="" in="" dietary="" patterns="" that="" occur="" with="" the="" introduction="" of="" large="" amounts="" of="" test="" substances,="" fda="" gave="" less="" weight="" to="" studies="" with="" treatment="" periods="" of="" less="" than="" 3="" weeks="" than="" it="" gave="" to="" studies="" of="" longer="" duration.="" c.="" summary="" of="" human="" studies="" fda's="" review="" of="" the="" 37="" human="" studies="" on="" oat="" bran="" and="" oatmeal="" and="" serum="" cholesterol="" (refs.="" 8="" through="" 32,="" 34="" through="" 39,="" and="" 41="" through="" 46)="" that="" were="" submitted="" with="" the="" petition="" is="" summarized="" in="" detail="" in="" table="" 1.="" the="" results="" of="" a="" metaanalysis="" (ref.="" 33)="" that="" included="" a="" number="" of="" the="" oat="" studies="" is="" discussed="" in="" section="" iii.c.5.="" of="" this="" document.="" 1.="" hypercholesterolemics:="" ``typical''="" or="" ``usual''="" diets="" eight="" of="" the="" studies="" (refs.="" 8,="" 12,="" 20,="" 21,="" 25,="" 35,="" 44,="" and="" 45)="" show="" a="" relationship="" between="" consumption="" of="" oat="" products="" and="" reduced="" serum="" [[page="" 299]]="" cholesterol="" in="" hypercholesterolemic="" subjects="" consuming="" a="" typical="" american="" diet.="" anderson="" et="" al.="" (ref.="" 8)="" in="" a="" metabolic="" ward="" study="" reported="" significantly="" lower="" total="" (12.8="" percent)="" and="" ldl-cholesterol="" (12.1="" percent)="" in="" male="" subjects="" consuming="" 110="" grams="" (g)="" (7.6="" g="" soluble="" fiber,="" 13.4="" g="" total="" dietary="" soluble="" fiber)="" oat="" bran="" for="" 21="" days="" (d).="" a="" wheat="" group,="" which="" consumed="" 40="" g="" of="" wheat="" bran="" (1.3="" g="" soluble="" fiber,="" 7.8="" g="" total="" dietary="" soluble="" fiber),="" experienced="" nonsignificant="" decreases="" in="" total="" (4.4="" percent)="" and="" ldl-cholesterol="" (5.5="" percent).="" there="" was="" no="" significant="" change="" in="" hdl-cholesterol="" in="" either="" group.="" both="" groups="" experienced="" a="" significant="" decrease="" in="" weight="" (1="" kilogram="" (kg))="" compared="" to="" their="" mean="" baseline="" weight="" values.="" there="" was="" no="" difference="" in="" weight="" loss="" between="" the="" oat="" and="" wheat="" groups.="" braaten="" et="" al.="" (ref.="" 12)="" evaluated="" the="" effects="" on="" blood="" cholesterol="" levels="" of="" instant="" oat="" gum="" (7.2="" g;="" 5.8="" g="">-glucan), an extract
of oat bran comprised of almost entirely -glucan soluble fiber
plus some trace elements, or a placebo (maltodextrin) when mixed with a
noncarbonated diet fruit drink (250 milliliters (mL)) and consumed
twice a day at each main meal for 4 weeks by hypercholesterolemic
subjects. Results showed significantly lower total cholesterol by 9.2
percent (p<0.0001) and="" ldl-cholesterol="" by="" 10="" percent=""><0.001) in="" the="" oat="" gum="" group="" compared="" to="" baseline.="" hegsted="" et="" al.="" (ref.="" 20)="" evaluated="" the="" hypocholesterolemic="" properties="" of="" rice="" bran="" and="" oat="" bran="" in="" hypercholesterolemic="" subjects.="" using="" a="" cross-over="" design,="" subjects="" consumed="" treatment="" diets="" providing="" 100="" g/d="" of="" rice="" bran="" and="" oat="" bran="" for="" 3-week="" periods="" each.="" a="" control="" diet,="" which="" consisted="" of="" the="" treatment="" diet="" but="" with="" wheat="" flour="" and="" no="" bran,="" was="" consumed="" for="" 2="" weeks="" before="" each="" bran="" period.="" the="" results="" showed="" significant="" reductions="" in="" total="" cholesterol="" with="" both="" the="" rice="" and="" oat="" bran="" diets="" compared="" to="" the="" control="" diet=""><0.001). during="" the="" two="" oat="" test="" periods,="" serum="" cholesterol="" was="" reduced="" about="" 10="" percent="" (phase="" 1)="" and="" 4="" percent="" (phase="" 2)="" compared="" to="" serum="" cholesterol="" values="" during="" the="" control="" period.="" oat="" bran="" intervention="" also="" resulted="" in="" significant="" reductions="" (about="" 13="" percent="" in="" phase="" 1="" and="" about="" 7="" percent="" in="" phase="" 2)="" in="" ldl-cholesterol.="" rice="" bran="" was="" as="" effective="" in="" lowering="" serum="" cholesterol="" as="" oat="" bran.="" kahn="" et="" al.="" (ref.="" 21)="" evaluated="" the="" hypocholesterolemic="" properties="" of="" four="" oat="" bran="" muffins/d="" (80="" g="" total="" daily="" oat="" bran)="" in="" hypercholesterolemic="" subjects="" randomized="" into="" immediate="" oat="" bran="" intervention="" and="" delayed="" oat="" bran="" intervention="" groups.="" the="" delayed="" oat="" bran="" intervention="" group="" served="" as="" the="" control="" group.="" after="" correcting="" for="" the="" time="" delay="" of="" the="" study,="" the="" results="" showed="" that="" oat="" bran="" dietary="" intervention="" significantly="" reduced="" total="" cholesterol="" by="" almost="" 8="" percent=""><0.02), ldl-cholesterol="" by="" about="" 10="" percent=""><0.02), and="" hdl-cholesterol="" by="" almost="" 1="" percent=""><0.03) from="" baseline.="" kestin="" et="" al.="" (ref.="" 25)="" reported="" decreased="" levels="" of="" total="" cholesterol="" (4.9="" percent)="" and="" ldl-cholesterol="" (6.8="" percent)="" in="" hypercholesterolemic="" subjects="" consuming="" 95="" g/d="" (5.8="" g="" soluble="" fiber)="" oat="" bran.="" these="" values="" were="" significantly="" lower="" than="" those="" observed="" in="" subjects="" consuming="" rice="" bran=""><0.01) and="" wheat="" bran=""><0.001). hdl-="" cholesterol="" increased="" in="" all="" groups.="" the="" oat="" bran="" was="" incorporated="" into="" bread="" and="" muffins.="" spiller="" et="" al.="" (ref.="" 35)="" reported="" significantly="" lower="" total="" cholesterol="" (3.7="" percent)="" and="" ldl-cholesterol="" (6.6="" percent),="" and="" a="" nonsignificant="" increase="" in="" hdl-cholesterol="" (1="" percent),="" in="" hypercholesterolemic="" subjects="" consuming="" 77="" g/d="" (5="" g="" soluble="" fiber)="" oat="" bran.="" changes="" in="" total="" cholesterol="" were="" experienced="" within="" the="" first="" 14="" days="" with="" no="" significant="" changes="" occurring="" between="" days="" 14="" and="" 21="" of="" the="" study.="" the="" oat="" bran="" was="" mixed="" with="" water="" and="" consumed="" before="" meals.="" the="" calories="" provided="" by="" the="" oat="" bran="" replaced="" about="" an="" equal="" amount="" of="" carbohydrate="" calories="" in="" the="" subjects'="" diets.="" whyte="" et="" al.="" (ref.="" 45)="" reported="" decreases="" in="" total="" cholesterol="" of="" 3.1="" percent=""><0.01) and="" ldl-cholesterol="" of="" 5.7="" percent=""><0.01) compared="" to="" baseline="" values="" after="" hypercholesterolemic="" subjects="" consumed="" 123="" g="" (10.3="" g="" soluble="" fiber)="" oat="" bran/day="" for="" 4="" weeks.="" the="" oat="" bran="" was="" consumed="" as="" a="" breakfast="" cereal.="" consumption="" of="" total="" fat="" and="" saturated="" fat="" remained="" the="" same="" during="" the="" test="" period.="" van="" horn="" et="" al.="" (ref.="" 44)="" reported="" reductions="" in="" total="" cholesterol="" (about="" 6.2="" percent)="" and="" ldl-cholesterol="" (9.2="" percent)="" levels,="" compared="" to="" a="" control="" group,="" in="" subjects="" consuming="" 57="" g="" of="" instant="" oats="" daily="" for="" 8="" weeks.="" the="" control="" group="" experienced="" decreases="" in="" total="" cholesterol="" and="" ldl-cholesterol="" of="" 1.4="" percent="" and="" 3.7="" percent,="" respectively.="" the="" differences="" between="" the="" oat="" and="" control="" groups="" were="" significant=""><0.05). the="" authors="" reported="" greater="" reductions="" in="" total="" cholesterol="" in="" those="" individuals="" who="" had="" a="" baseline="" cholesterol="" level="" above="" the="" baseline="" median="" cholesterol="" level="" of="" 243="" mg/dl.="" the="" authors="" also="" reported="" significantly="" different="" dietary="" intakes="" after="" 4="" weeks="" of="" intervention="" for="" a="" number="" of="" nutrients="" in="" the="" oat="" group's="" diet="" compared="" to="" that="" of="" the="" control="" group.="" after="" 4="" weeks="" of="" intervention,="" the="" oat="" group="" had="" higher="" intakes="" of="" soluble="" and="" total="" fiber="" and="" lower="" intakes="" of="" saturated="" fat="" and="" cholesterol.="" a="" metaanalysis="" conducted="" by="" ripsin="" et="" al.="" (ref.="" 33),="" which="" is="" discussed="" in="" section="" iii.c.5.="" of="" this="" document,="" evidences="" that="" the="" changes="" in="" dietary="" fats="" and="" cholesterol="" intake="" in="" this="" study="" did="" not="" appear="" to="" be="" responsible="" for="" the="" drop="" in="" serum="" cholesterol="" levels,="" thus="" suggesting="" that="" oat="" bran="" and="" oatmeal="" were="" responsible="" for="" the="" observed="" effect.="" results="" of="" four="" studies="" (refs.="" 18,="" 26,="" 34,="" and="" 38)="" were="" inconclusive="" regarding="" the="" relationship="" between="" oat="" bran="" or="" oatmeal="" consumption="" and="" reduced="" serum="" lipids.="" gormley="" et="" al.="" (ref.="" 18)="" reported="" no="" effect="" of="" oatmeal="" porridge="" on="" serum="" cholesterol="" or="" hdl-cholesterol="" in="" hypercholesterolemic="" men="" and="" normocholesterolemic="" women.="" the="" authors="" stated="" that="" dietary="" intakes="" were="" monitored,="" but="" the="" subjects'="" dietary="" intakes="" were="" not="" reported.="" the="" amount="" of="" total="" dietary="" fiber="" and="" soluble="" fiber="" in="" the="" total="" diet="" and="" oatmeal="" porridge="" were="" not="" provided.="" insufficient="" dietary="" controls="" make="" the="" results="" of="" this="" study="" difficult="" to="" interpret.="" leadbetter="" et="" al.="" (ref.="" 26)="" reported="" no="" significant="" effect="" of="" increasing="" intakes="" of="">-glucan from oat bran on serum
cholesterol in 40 hypercholesterolemic men and women. Subjects consumed
0, 30, 60, or 90 g oat bran/day for 1-month intervals. The authors
stated that the New Zealand oats used in this study were lower in
soluble fiber (3.7 to 4.2 percent -glucan) than oat bran used
in studies that showed a significant lowering of serum cholesterol with
oat bran supplementation.
Saudia et al. (Ref. 34) reported no significant difference in serum
cholesterol levels in hypercholesterolemic subjects consuming oat bran
daily for 93 days. The subjects consumed 3 ounces (oz) (about 84 g) of
oat bran daily with their usual diet for 3 months. The subjects' total
dietary intake, including their intake of total and saturated fat and
cholesterol, before and during the trial were not reported. The authors
stated that the subjects may have changed their diets during the test
period because the study took place over summer months and because of
an increased awareness by the subjects of risk-reducing behavior and
lifestyles. The study also lacked a control group, thus making the
results of this study difficult to interpret.
Torronen et al. (Ref. 38) showed small reductions in serum
cholesterol, LDL-, and HDL-cholesterol in an oat bran
[[Page 300]]
group compared to baseline, but these reductions were not statistically
significant. An oat bran concentrate was prepared and incorporated into
a loaf of bread (11.2 g -glucan per loaf). A control bread was
made with wheat flour. The use of oat bran concentrate in this study
does not provide evidence for an effect of oat bran per se on serum
cholesterol because the authors state that the method of concentrating
and processing the oat bran and -glucan may have affected the
effectiveness of the -glucan in lowering serum cholesterol.
Animal studies by these authors confirmed that the method of producing
the oat bran concentrate produced significantly weaker
hypocholesterolemic responses than untreated oat bran or concentrates
with higher viscosities.
One study (Ref. 32) showed equivocal results in reducing total
cholesterol. Poulter and coworkers reported small but significant
reductions in serum cholesterol and LDL-cholesterol in
hypercholesterolemic subjects consuming 50 g of oat cereal compared to
subjects consuming the same amount of cereal without oats. Subjects
with baseline cholesterol values greater than 231 mg/dL experienced the
most significant reduction in serum cholesterol. However, the results
of this study are difficult to interpret because some subjects made
changes in their diets after starting the trial. There was a
significant reduction in total energy from fat compared to baseline
intakes. Similarly, the ratio of polyunsaturated fat to saturated fat
in the subjects' diet also fell significantly during the oat period.
2. Hypercholesterolemics: Low Fat Diets
Results of six studies (Refs. 11, 15, 23, 24, 39, and 43) showed a
cholesterol reducing effect of oatmeal or oat bran in
hypercholesterolemic subjects who consumed the oat products as part of
a low fat diet. Beling et al. (Ref. 11) divided the subjects into 3
groups. Group 1 consumed their regular (not fat modified) diet. Groups
2 and 3 consumed an AHA fat modified diet. There were significantly
lower total and LDL-cholesterol levels after 4 weeks in groups 2 and 3.
In groups 2 and 3, total cholesterol decreased by 10 percent and 11.8
percent, and LDL-cholesterol decreased by 11.5 percent and 11.8
percent, respectively. From weeks 5 to 8, group 2 continued on the AHA
diet, while group 3 consumed the AHA diet plus 56 g oat bran cereal/
day. At the end of week 8, total cholesterol had decreased by 2.3
percent, 8.4 percent, and 12.2 percent from baseline levels for groups
1, 2, and 3, respectively. The mean total cholesterol level of the oat
group was significantly different from the control group and the group
that consumed only the AHA diet (p<0.05). at="" week="" 8,="" ldl-cholesterol="" levels="" were="" 10.1="" percent="" below="" baseline="" for="" group="" 2="" and="" 14.9="" percent="" below="" baseline="" for="" group="" 3=""><0.05). hdl-cholesterol="" decreased="" 1="" percent,="" 3="" percent,="" and="" 8="" percent="" in="" groups="" 1,="" 2,="" and="" 3,="" respectively,="" at="" 8="" weeks.="" the="" differences="" in="" hdl-cholesterol="" between="" the="" 3="" groups="" were="" not="" significant.="" the="" differences="" in="" hdl-cholesterol="" in="" groups="" 2="" and="" 3="" were="" significantly="" different="" from="" the="" control=""><.05). groups="" 2="" and="" 3="" experienced="" weight="" loss,="" but="" the="" differences="" between="" these="" groups="" were="" not="" significant.="" davidson="" et="" al.="" (ref.="" 15)="" evaluated="" the="" hypocholesterolemic="" effects="" of="" increasing="" amounts="" of="">-glucan from oat bran and oatmeal in
hypercholesterolemic subjects consuming a Step 1 diet. The results
showed that groups consuming diets containing 3 g/d or more of
-glucan experienced significant declines in blood total
cholesterol (7 to 10 percent) and LDL-cholesterol (10 to 16 percent)
compared to baseline. Blood total cholesterol levels of groups
consuming diets containing 1 to 2.4 g daily of -glucan did not
differ significantly from baseline.
Turnbull and Leeds (Ref. 39) evaluated the effects of oats and
wheat on total cholesterol in hypercholesterolemic subjects consuming a
low fat diet. During a 1-month run-in period (baseline), the subjects
consumed the low fat diet alone and experienced a 7.6 percent (not
significant) reduction in total cholesterol. The subjects were then
randomized to receive 150 g/d of oats or wheat while consuming the low
fat diet for another month. At the end of the month, subjects crossed
over to the other grain supplement. The results of this study showed
that during the oat period, subjects experienced significant reductions
in total cholesterol (p<0.03) and="" ldl-cholesterol=""><0.002) compared="" to="" baseline="" despite="" an="" increase="" in="" energy="" and="" total="" fat="" intake.="" there="" were="" no="" significant="" changes="" in="" total="" cholesterol="" and="" ldl-cholesterol="" when="" subjects="" consumed="" the="" wheat="" diet.="" hdl-cholesterol="" showed="" a="" nonsignificant="" increase="" from="" baseline="" during="" the="" oat="" period="" and="" no="" change="" during="" the="" wheat="" period.="" in="" a="" large,="" controlled="" clinical="" trial,="" van="" horn="" et="" al.="" (ref.="" 43)="" instructed="" moderately="" hypercholesterolemic="" subjects="" (mean="" total="" cholesterol="" of="" 208="" mg/dl)="" on="" the="" aha="" low="" fat="" diet.="" the="" subjects="" consumed="" the="" aha="" diet="" alone="" for="" 6="" weeks,="" during="" which="" time="" they="" experienced="" significantly="" reduced="" total="" cholesterol="" compared="" to="" baseline.="" the="" subjects="" were="" then="" randomized="" to="" one="" of="" 3="" groups:="" two="" oat="" groups="" (2="" oz="" of="" oat="" bran="" or="" oatmeal="" daily)="" or="" the="" control="" group="" (aha="" diet="" only)="" for="" another="" 6="" weeks.="" at="" the="" end="" of="" the="" intervention="" period,="" subjects="" consuming="" 56="" g="" of="" oat="" bran="" and="" oatmeal="" had="" total="" cholesterol="" values="" 8="" percent="" and="" 9.3="" percent="" lower="" than="" baseline,="" respectively.="" the="" control="" group="" experienced="" a="" 4.5="" percent="" reduction="" in="" serum="" cholesterol.="" at="" the="" end="" of="" the="" study,="" the="" differences="" in="" total="" cholesterol="" levels="" for="" all="" three="" groups="" compared="" to="" baseline="" levels="" were="" statistically="" significant=""><0.05), but="" there="" was="" no="" significant="" difference="" between="" the="" oat="" groups="" and="" the="" control.="" both="" the="" oat="" bran="" and="" the="" oatmeal="" groups="" experienced="" a="" modest="" (3="" percent)="" reduction="" in="" serum="" cholesterol="" beyond="" that="" achieved="" by="" the="" low="" fat="" diet="" alone.="" the="" modest="" effect="" of="" oat="" bran="" and="" oatmeal="" on="" serum="" cholesterol="" in="" this="" study="" may="" have="" been="" affected="" by="" the="" subjects'="" cholesterol="" levels="" before="" dietary="" intervention.="" the="" subjects'="" mean="" cholesterol="" level="" was="" 208.4="" mg/dl.="" after="" dietary="" intervention,="" the="" mean="" cholesterol="" levels="" were="" 201="" mg/dl="" (control),="" 196.4="" mg/dl="" (oat="" bran="" group),="" and="" 195.2="" mg/dl="" (oatmeal="" group).="" studies="" have="" shown="" that="" subjects="" with="" higher="" initial="" blood="" cholesterol="" levels="" usually="" experience="" the="" most="" reduction="" in="" total="" cholesterol="" from="" oat="" intervention="" (refs.="" 6="" and="" 33).="" thus,="" because="" of="" the="" subjects'="" relatively="" low="" cholesterol="" levels="" at="" the="" initiation="" of="" the="" oats="" intervention="" period,="" the="" differences="" among="" the="" groups="" may="" have="" been="" minimized.="" keenan="" et="" al.="" (ref.="" 23)="" reported="" variable="" responses="" in="" serum="" lipids="" depending="" on="" the="" order="" of="" feeding="" of="" the="" diets="" supplemented="" with="" 56="" g="" of="" oat="" bran="" or="" wheat="" cereal="" during="" an="" 18-week="" double-blind="" study="" with="" crossover.="" subjects="" consumed="" a="" step="" 1="" diet="" during="" the="" first="" period="" (6="" weeks)="" and="" then="" were="" randomized="" to="" 1="" of="" 3="" groups.="" the="" control="" group="" consumed="" a="" step="" 1="" diet="" for="" another="" 12="" weeks.="" the="" two="" test="" groups="" consumed="" wheat="" cereal="" or="" oat="" cereal="" for="" 6="" weeks="" before="" crossover="" to="" the="" other="" test="" cereal="" for="" another="" 6="" weeks.="" interpretation="" of="" results="" was="" complicated="" by="" the="" fact="" that="" the="" control="" group="" showed="" an="" initial="" decline="" in="" blood="" cholesterol="" levels="" followed="" by="" a="" return="" to="" baseline="" at="" the="" end="" of="" the="" study.="" only="" the="" oat="" groups="" maintained="" reduced="" serum="" cholesterol="" and="" ldl-cholesterol="" throughout="" the="" test="" periods.="" when="" compared="" to="" the="" control="" and="" wheat="" groups,="" these="" reductions="" were="" significant=""><.01). [[page="" 301]]="" kelley="" et="" al.="" (ref.="" 24)="" reported="" significantly="" reduced="" serum="" cholesterol=""><0.04) and="" ldl-cholesterol=""><0.05) at="" the="" end="" of="" 4="" weeks="" in="" subjects="" who="" were="" participating="" in="" a="" program="" of="" supervised="" aerobic="" exercises.="" the="" subjects="" consumed="" about="" 94="" g="" of="" oat="" bran="" daily="" as="" part="" of="" their="" usual="" low="" fat,="" low="" saturated="" fat="" diets.="" this="" study="" lacked="" an="" appropriate="" placebo="" control.="" six="" studies="" (refs.="" 13,="" 16,="" 27,="" 28,="" 36,="" and="" 41)="" gave="" inconclusive="" results="" regarding="" the="" relationship="" between="" oat="" consumption="" and="" reduced="" serum="" lipids="" in="" hypercholesterolemic="" subjects="" consuming="" low="" fat="" diets.="" in="" a="" study="" by="" bremer="" et="" al.="" (ref.="" 13),="" subjects="" consumed="" either="" oat="" or="" wheat="" bread="" (about="" 8="" slices/day)="" in="" place="" of="" other="" carbohydrate="" foods="" as="" part="" of="" their="" aha="" phase="" ii="" diet="" (total="" fat="" 25="" to="" 30="" percent="" of="" energy,="" saturated="" fat=""><8 percent="" of="" energy,="" polyunsaturated="" fat="" 5="" to="" 10="" percent="" of="" energy,="" cholesterol=""><250 mg/day).="" subjects="" had="" a="" mean="" intake="" of="" 44.6="" g/day="" of="" oat="" bran="" (range="" of="" 34.2="" to="" 68.4="" g/day).="" the="" study="" showed="" no="" significant="" differences="" in="" total="" serum="" cholesterol="" or="" ldl-="" cholesterol="" between="" the="" period="" in="" which="" the="" subjects="" consumed="" oat="" bread="" and="" the="" period="" in="" which="" they="" consumed="" wheat="" bread.="" however,="" the="" lack="" of="" an="" observed="" effect="" on="" serum="" cholesterol="" from="" oat="" bran="" could="" be="" attributable="" to="" the="" lower="" soluble="" fiber="" content="" of="" the="" new="" zealand="" oat="" bran="" used="" in="" this="" study="" compared="" to="" oat="" bran="" used="" in="" other="" studies.="" demark-wahnefried="" et="" al.="" (ref.="" 16)="" evaluated="" the="" hypocholesterolemic="" properties="" of="" oat="" bran="" in="" hypercholesterolemic="" subjects="" following="" one="" of="" four="" dietary="" protocols="" for="" 12="" weeks:="" step="" 1="" diet="" alone,="" step="" 1="" diet="" plus="" added="" soluble="" fiber="" from="" 50="" g="" of="" oat="" bran,="" regular="" diet="" plus="" 50="" g="" of="" oat="" bran,="" and="" regular="" diet="" plus="" 42="" g="" of="" processed="" oat="" bran.="" the="" results="" of="" this="" study="" showed="" significant="" reductions=""><0.05) in="" serum="" cholesterol="" in="" all="" diet="" groups.="" the="" serum="" cholesterol="" levels="" of="" groups="" consuming="" diets="" containing="" the="" higher="" soluble="" fiber="" (approximately="" 4="" g="" added="" soluble="" fiber="" daily)="" did="" not="" differ="" from="" groups="" on="" a="" dietary="" regimen="" modified="" only="" in="" fat="" and="" cholesterol="" content.="" variable="" weight="" loss="" was="" reported="" among="" the="" groups,="" and="" dietary="" changes="" in="" all="" groups="" confound="" the="" results="" of="" this="" study.="" in="" a="" study="" by="" lepre="" and="" crane="" (ref.="" 27),="" subjects="" received="" a="" prescribed="" low="" fat="" diet="" for="" 8="" weeks="" before="" being="" randomly="" assigned="" to="" either="" the="" oat="" or="" wheat="" group.="" subjects="" consumed="" 2="" oat="" bran="" muffins="" (60="" g="" of="" oat="" bran,="" 3.2="" g="" soluble="" fiber)="" or="" 2="" wheat="" bran="" muffins="" (60="" g="" wheat="" bran)="" daily="" for="" 8="" weeks.="" at="" the="" end="" of="" the="" first="" 8-week="" test="" period,="" subjects="" crossed="" over="" to="" the="" other="" test="" group="" for="" another="" 8="" weeks.="" the="" results="" showed="" small,="" nonsignificant="" reductions="" in="" serum="" cholesterol="" (2.2="" percent)="" and="" ldl-cholesterol="" (3.1="" percent)="" and="" a="" nonsignificant="" increase="" in="" hdl-cholesterol="" (3.0="" percent)="" during="" the="" oat="" bran="" period="" compared="" to="" diet="" only="" period.="" during="" the="" wheat="" bran="" period,="" there="" was="" a="" nonsignificant="" increase="" in="" total="" cholesterol,="" ldl-cholesterol,="" and="" the="" ratio="" of="" ldl-="" to="" hdl-cholesterol="" (ldl:hdl)="" and="" a="" nonsignificant="" decrease="" in="" hdl-cholesterol.="" the="" results="" of="" this="" study="" were="" confounded="" because="" subjects="" made="" significant="" dietary="" changes="" during="" the="" diet="" only="" and="" the="" oat="" bran="" periods.="" the="" subjects="" were="" aware="" of="" their="" hyperlipidemias="" and="" were="" already="" on="" a="" low="" fat="" diet="" before="" the="" start="" of="" this="" study.="" they="" also="" knew="" in="" advance="" which="" days="" they="" were="" required="" to="" record="" their="" dietary="" intake.="" the="" intakes="" of="" dietary="" cholesterol="" and="" saturated="" fat="" were="" significantly="" less,="" and="" dietary="" fiber="" intake="" was="" significantly="" more,="" during="" the="" oat="" bran="" period="" compared="" to="" the="" diet="" only="" period.="" the="" results="" of="" this="" study,="" therefore,="" are="" inconclusive="" for="" an="" effect="" of="" oat="" bran="" on="" serum="" cholesterol.="" mackay="" and="" ball="" (ref.="" 28)="" evaluated="" the="" hypocholesterolemic="" properties="" of="" 55="" g="" each="" of="" low-fiber="" and="" high-fiber="" oat="" bran="" (new="" zealand="" cultivars)="" and="" of="" beans="" in="" hypercholesterolemic="" subjects="" consuming="" a="" moderately="" low="" fat="" diet.="" the="" oat="" bran="" used="" in="" this="" study="" was="" specially="" formulated="" to="" provide="" specific="" amounts="" of="">-
glucan. The low-fiber oat bran provided 1.9 g -glucan, and the
high-fiber oat bran provided about 3 g -glucan. The results of
this study showed no significant changes in serum cholesterol or LDL-
cholesterol from any of the test substances. HDL-cholesterol, however,
increased in all groups compared to baseline values, and these
increases were statistically significant (p<0.05). the="" energy="" intake="" on="" the="" high-fiber="" oat="" bran="" diet="" was="" significantly="" higher="" than="" that="" of="" the="" low-fat="" diet="" alone;="" however,="" there="" was="" no="" reported="" change="" in="" body="" weights.="" this="" study="" lacked="" a="" placebo="" control="" which="" makes="" the="" study="" difficult="" to="" interpret.="" also,="" the="" source="" of="" this="" oat="" bran,="" a="" new="" zealand="" cultivar,="" may="" have="" contributed="" to="" the="" lack="" of="" a="" hypocholesterolemic="" response="" to="" oat="" bran="" in="" this="" study="" (see="" refs.="" 13="" and="" 26).="" stewart="" et="" al.="" (ref.="" 36)="" reported="" no="" significant="" differences="" in="" serum="" cholesterol,="" ldl-,="" or="" hdl-cholesterol="" in="" subjects="" consuming="" an="" oat-free,="" low="" fat="" diet="" or="" a="" low="" fat="" diet="" with="" 50="" g/d="" of="" oat="" bran="" for="" 6="" weeks="" each.="" however,="" the="" subjects'="" compliance="" with="" the="" required="" dietary="" protocol="" in="" this="" study="" was="" poor.="" the="" authors="" reported="" a="" wide="" variability="" among="" the="" subjects'="" diets="" at="" baseline="" as="" well="" as="" a="" variability="" in="" the="" intake="" of="" oat="" bran.="" moreover,="" both="" processed="" and="" unprocessed="" new="" zealand="" oat="" brans="" were="" used="" in="" this="" study.="" as="" stated="" in="" the="" previous="" paragraph,="" the="" type="" of="" oat="" bran="" cultivar="" used,="" and="" the="" method="" of="" processing="" the="" oat="" bran,="" may="" have="" affected="" the="" results="" of="" this="" study.="" uusitupa="" et="" al.="" (ref.="" 41)="" evaluated="" the="" hypocholesterolemic="" effects="" of="" a="">-glucan-enriched oat bran and regular wheat bran in
hypercholesterolemic subjects consuming an AHA Step 1 diet. Baseline
serum cholesterol values were determined during a 4-week run-in period
when the subjects consumed the AHA Step 1 diet with no bran. The
subjects were then randomized into two groups to receive the -
glucan-enriched oat bran or regular wheat bran for an 8-week test
period. The brans were provided in sachets (62 g/sachet), and the
subjects instructed to increase their daily consumption of bran in a
step-wise approach until they consumed the entire contents of the
sachet or until they reached the highest tolerable amount. The mean
intake of oat bran during the test period was 50 g. At the end of 4
weeks of bran intervention, there was a significant reduction in serum
cholesterol in the oat bran group compared to baseline. By the end of 8
weeks, however, the differences were no longer significant. There was
no change in LDL-cholesterol in the oat bran group after 4 weeks, but a
small, nonsignificant reduction (about 3 percent) after 8 weeks. There
was a small, nonsignificant increase in serum cholesterol in the wheat
bran group. The results of this study were difficult to interpret
because subjects did not adhere to the reduced fat diet and failed to
consume the required amount of bran.
Two studies (Refs. 10 and 46) showed equivocal results in reducing
total cholesterol. Bartram et al. (Ref. 10) evaluated the effect of oat
bran muesli cereal on serum cholesterol in 13 men and women who had
been on a low cholesterol diet for 6 months. The subjects consumed 60 g
of oat muesli (made with lowfat milk and 120 g of bananas, grapes, and
apples) for 3 weeks. The results of this study showed a significant
reduction in serum cholesterol (8-10 percent) (p<0.01) and="" ldl-="" cholesterol=""><0.05) during="" the="" oat="" cereal="" period.="" however,="" the="" results="" are="" difficult="" to="" interpret="" because="" the="" fruits="" consumed="" with="" the="" muesli="" cereal="" may="" have="" contributed="" to="" the="" observed="" reduction="" in="" serum="" cholesterol.="" zhang="" et="" al.="" (ref.="" 46)="" compared="" the="" hypocholesterolemic="" properties="" of="" oat="" [[page="" 302]]="" bran="" (118="" g)="" with="" wheat="" flour="" using="" a="" crossover="" design.="" the="" subjects="" consumed="" one="" of="" the="" test="" substances="" as="" part="" of="" a="" low="" fiber="" base="" diet="" for="" 3="" weeks="" before="" crossover="" to="" the="" other="" test="" substance.="" during="" the="" oat="" period,="" serum="" cholesterol="" was="" significantly="" lower="" than="" during="" the="" wheat="" flour="" period.="" the="" results="" of="" this="" study="" are="" difficult="" to="" interpret="" because="" all="" subjects="" had="" ileostomies="" (i.e.,="" an="" opening="" from="" the="" ileum="" through="" the="" abdominal="" wall,="" permitting="" drainage="" of="" the="" contents="" of="" the="" small="" intestine)="" and="" the="" mechanism="" by="" which="" oat="" bran="" lowers="" serum="" lipids="" in="" this="" group="" may="" not="" apply="" to="" the="" general="" population.="" 3.="" normocholesterolemics:="" ``typical''="" or="" ``usual''="" diets="" the="" results="" of="" two="" studies="" (refs.="" 17="" and="" 29)="" support="" a="" cholesterol="" lowering="" effect="" of="" oat="" bran="" or="" oatmeal="" in="" subjects="" with="" normal="" serum="" cholesterol="" values.="" a="" third="" study="" (ref.="" 14)="" showed="" evidence="" of="" the="" cholesterol-lowering="" effects="" of="" oat="" bran="" postprandially.="" gold="" and="" davidson="" (ref.="" 17)="" reported="" a="" significant=""><0.05) reduction="" in="" total="" cholesterol="" (5.3="" percent)="" and="" ldl-cholesterol="" (8.7="" percent)="" compared="" to="" baseline="" measures="" in="" normocholesterolemic="" subjects="" consuming="" 2="" oat="" bran="" muffins/d="" for="" 4="" weeks.="" the="" oat="" bran="" muffins="" provided="" a="" total="" of="" 34="" g="" oat="" bran.="" there="" were="" no="" data="" given="" on="" the="" subjects'="" dietary="" intake="" before="" or="" during="" the="" test="" period.="" marlett="" et="" al.="" (ref.="" 29)="" studied="" the="" mechanism="" of="" serum="" cholesterol="" reduction="" by="" oat="" bran="" using="" a="" single="" isotope="" to="" determine="" bile="" acid="" kinetics.="" during="" the="" first="" month,="" normo-="" cholesterolemic="" subjects="" consumed="" a="" low="" fiber="" control="" diet="" provided="" in="" a="" metabolic="" unit.="" during="" the="" second="" month,="" this="" same="" diet="" was="" supplemented="" with="" 100="" g="" of="" oat="" bran.="" the="" results="" showed="" significantly="" lowered="" serum="" cholesterol="" compared="" to="" baseline="" values="" during="" both="" periods.="" serum="" cholesterol="" on="" the="" low="" fiber="" diet="" was="" reduced="" 14="" percent=""><0.01) and="" on="" the="" oat="" bran="" diet="" 22="" percent=""><0.01) compared="" to="" baseline="" values.="" serum="" cholesterol="" during="" the="" high="" fiber="" period="" was="" also="" significantly="" lower="" than="" that="" of="" the="" low="" fiber="" period="" (an="" additional="" decrease="" of="" 9="" percent).="" cara="" et="" al.="" (ref.="" 14)="" evaluated="" the="" effects="" of="" oat="" bran="" and="" other="" high="" fiber-containing="" foods="" on="" postprandial="" lipemia="" in="" 6="" normocholesterolemic="" men.="" the="" subjects="" consumed,="" on="" separate="" days,="" a="" low="" fiber="" (control)="" meal="" or="" a="" high="" fiber="" test="" meal="" enriched="" with="" 10="" g="" of="" oat="" bran,="" rice="" bran,="" wheat="" fiber,="" or="" wheat="" germ.="" the="" results="" of="" this="" study="" showed="" that="" the="" oat="" bran="" test="" meal="" produced="" the="" greatest="" reduction="" in="" serum="" cholesterol="" compared="" to="" the="" other="" fibers="" tested.="" the="" differences="" between="" serum="" cholesterol="" levels="" in="" the="" oat="" bran="" test="" and="" those="" in="" the="" control="" test="" remained="" significant=""><0.05) 7="" hours="" postprandial.="" the="" results="" of="" this="" study="" support="" a="" significant="" short="" term="" effect="" on="" serum="" cholesterol,="" but="" they="" do="" not="" address="" long="" term="" effectiveness="" of="" oat="" bran="" in="" maintaining="" reduced="" serum="" cholesterol="" levels.="" the="" results="" of="" one="" study="" (ref.="" 31)="" was="" inconclusive="" for="" an="" effect="" of="" oatmeal="" on="" serum="" cholesterol="" in="" normo-cholesterolemic="" subjects.="" o'kell="" and="" duston="" (ref.="" 31)="" reported="" no="" significant="" differences="" in="" serum="" cholesterol="" and="" hdl-cholesterol="" in="" subjects="" consuming="" 1/2="" to="" 3/4-="" cup="" of="" oatmeal="" daily="" for="" a="" series="" of="" 3-month="" test="" periods="" over="" the="" course="" of="" a="" year.="" after="" each="" 3-month="" oatmeal="" period,="" the="" subjects="" consumed="" their="" usual="" diets="" without="" oatmeal="" for="" 3="" months.="" the="" results="" of="" this="" study="" were="" difficult="" to="" interpret="" because="" the="" subjects'="" dietary="" intakes="" before="" and="" during="" the="" study="" were="" not="" reported,="" and="" subject="" compliance="" was="" not="" adequately="" addressed.="" one="" study="" (ref.="" 37)="" showed="" equivocal="" results="" in="" reducing="" total="" cholesterol.="" swain="" et="" al.="" evaluated="" the="" hypocholesterolemic="" effects="" of="" oat="" bran="" and="" wheat="" bran="" in="" a="" group="" of="" young="" females="" with="" normal="" serum="" cholesterol="" (mean="" total="" cholesterol="" of="" 185="" mg/dl)="" using="" a="" double-blind,="" cross-over="" study="" design.="" the="" subjects="" consumed="" an="" average="" of="" 87="" g="" oat="" bran="" and="" 93="" g="" wheat="" bran/day="" during="" each="" 6-week="" test="" period.="" the="" authors="" reported="" statistically="" significant="" reductions="" from="" baseline="" levels="" in="" total="" cholesterol=""><0.05) and="" ldl-cholesterol=""><0.05) in="" both="" bran="" test="" periods.="" the="" differences="" between="" the="" oat="" bran="" and="" wheat="" bran="" groups="" were="" not="" significant.="" the="" results="" of="" this="" study="" are="" difficult="" to="" interpret="" because="" of="" dietary="" changes="" during="" the="" oat="" bran="" period.="" the="" subjects="" significantly="" increased="" their="" intake="" of="" total="" calories="" from="" fat="" and="" saturated="" fat="" compared="" to="" the="" wheat="" period.="" mean="" body="" weight="" was="" unchanged="" over="" the="" short="" test="" period="" suggesting="" that="" there="" was="" a="" substitution="" effect="" with="" the="" diet.="" young="" premenopausal="" women="" with="" low="" serum="" cholesterol="" levels="" do="" not="" represent="" a="" population="" at="" risk="" for="" chd.="" therefore,="" the="" benefits="" of="" oat="" bran="" may="" not="" be="" reflected="" in="" this="" group.="" 4.="" normocholesterolemics:="" low="" fat="" diets="" one="" study="" (ref.="" 42)="" reported="" significantly="" lower="" total="" cholesterol,="" compared="" to="" a="" control="" group,="" after="" 4-weeks="" of="" oat="" intervention="" in="" subjects="" with="" normal="" to="" mildly="" elevated="" total="" cholesterol.="" the="" oat="" group="" consumed="" a="" phase="" ii="" aha="" diet="" (low="" fat,="" low="" saturated="" fat,="" low="" cholesterol)="" plus="" 56="" g="" of="" oatmeal="" daily="" compared="" to="" a="" control="" group="" that="" consumed="" only="" the="" phase="" ii="" diet.="" over="" the="" next="" 4="" weeks,="" however,="" serum="" cholesterol="" levels="" increased="" slightly="" in="" the="" oat="" group="" and="" decreased="" slightly="" in="" the="" control="" group.="" after="" 8="" weeks,="" serum="" cholesterol="" was="" reduced="" 3.1="" percent="" in="" the="" oat="" group="" and="" 1.4="" percent="" in="" the="" control="" group.="" there="" were="" no="" significant="" differences="" in="" total="" serum="" cholesterol="" levels="" between="" the="" groups.="" subgroup="" analysis="" of="" the="" data="" showed="" greater="" reductions="" in="" serum="" cholesterol="" among="" those="" subjects="" in="" the="" oat="" group="" who="" had="" the="" highest="" baseline="" cholesterol="" levels.="" the="" results="" of="" this="" study="" suggest="" a="" modest="" benefit="" of="" oatmeal="" in="" lowering="" serum="" cholesterol="" in="" subjects="" with="" normal="" cholesterol="" levels.="" one="" survey="" (ref.="" 19)="" showed="" equivocal="" results="" for="" an="" effect="" of="" oat="" bran="" or="" oatmeal="" on="" serum="" cholesterol.="" he="" et="" al.="" (ref.="" 19)="" evaluated="" the="" relationship="" between="" the="" intakes="" of="" oats="" and="" buckwheat="" and="" serum="" cholesterol="" in="" a="" population="" of="" chinese="" by="" conducting="" a="" survey="" of="" their="" dietary="" habits.="" this="" particular="" population="" group="" consumed="" a="" high="" energy,="" low="" fat,="" and="" high="" fiber="" diet,="" and="" had="" active="" working="" lifestyles.="" the="" results="" of="" this="" study="" showed="" that="" the="" groups="" consuming="" greater="" than="" 25="" g="" of="" oats="" a="" day="" had="" significantly="" lower="" serum="" cholesterol="" than="" those="" who="" ate="" less="" than="" 25="" g="" of="" oats="" a="" day="" or="" no="" oats.="" all="" baseline="" serum="" cholesterol="" values,="" however,="" were="" under="" 160="" mg/dl.="" the="" results="" of="" this="" study="" were="" difficult="" to="" interpret="" because="" this="" population="" group="" is="" one="" whose="" diets="" and="" lifestyles="" do="" not="" reflect="" that="" of="" the="" general="" american="" population.="" the="" results="" of="" this="" study="" are="" also="" confounded="" because="" of="" the="" questionable="" assessment="" of="" dietary="" intake="" of="" oat="" bran="" and="" oatmeal="" and="" the="" absence="" of="" any="" controls.="" 5.="" other="" studies="" evidence="" for="" the="" cholesterol-lowering="" effect="" of="" soluble="" fiber="" from="" oatmeal="" and="" oat="" bran="" was="" evaluated="" using="" a="" metaanalysis="" (ref.="" 33).="" in="" this="" study,="" after="" pooling="" the="" raw="" data="" from="" 13="" studies="" (refs.="" 11,="" 15="" through="" 17,="" 23,="" 25,="" 30,="" 37,="" 39,="" 40,="" and="" 42="" through="" 44)="" that="" reported="" on="" the="" effect="" of="" consumption="" of="" oatmeal="" and="" oat="" bran="" on="" total="" cholesterol,="" a="" modest="" reduction="" (average="" decrease="" of="" 5="" to="" 6="" mg/dl)="" on="" blood="" total="" cholesterol="" levels="" was="" found.="" to="" assess="" whether="" other="" dietary="" factors,="" i.e.,="" substitution="" of="" oats="" for="" dietary="" fats="" and="" cholesterol,="" might="" have="" been="" responsible="" for="" the="" drop="" in="" blood="" [[page="" 303]]="" total="" cholesterol="" levels,="" ripsin="" and="" coworkers="" used="" the="" experimentally="" derived,="" predictive="" equation="" of="" keys="" to="" see="" whether="" dietary="" changes="" in="" fat="" components="" of="" the="" test="" diets="" could="" account="" for="" the="" observed="" decreases="" in="" serum="" cholesterol="" (ref.="" 33).="" the="" results="" of="" their="" analysis="" showed="" that="" reduction="" in="" fat="" and="" cholesterol="" intake="" attributable="" to="" substituting="" oat="" bran="" or="" oatmeal="" for="" these="" food="" components="" did="" not="" account="" for="" all="" of="" the="" blood="" cholesterol="" reduction="" observed.="" oat="" bran="" and="" oatmeal="" apparently="" had="" some="" effect="" beyond="" that="" of="" simply="" replacing="" fat="" and="" cholesterol="" in="" the="" diet.="" the="" authors="" concluded,="" therefore,="" that="" incorporation="" of="" oat="" products="" into="" diets="" causes="" a="" modest="" decrease="" in="" average="" blood="" cholesterol.="" the="" authors="" also="" suggested="" that="" there="" was="" a="" dose-response="" relationship="" between="" the="" amount="" of="" soluble="" fiber="" from="" oat="" bran="" or="" oatmeal="" and="" the="" reduction="" in="" blood="" cholesterol="" levels,="" with="" intakes="" of="" soluble="" fiber="" from="" oats="" above="" 3="" g/day="" showing="" more="" effect="" than="" lower="" intakes.="" they="" stated="" that="" there="" is="" significant="" evidence="" of="" an="" interaction="" between="" dose="" and="" initial="" cholesterol="" levels.="" the="" trials="" that="" used="" subjects="" with="" initial="" serum="" cholesterol="" levels="" of="" 229="" mg/dl="" or="" higher="" demonstrated="" fivefold="" greater="" reductions="" in="" total="" cholesterol="" with="" 3="" g/d="" or="" more="" of="" soluble="" fiber="" from="" oat="" bran="" or="" oatmeal="" than="" trials="" whose="" subjects="" had="" lower="" initial="" cholesterol="" levels.="" additionally,="" the="" authors="" noted="" that="" other="" components="" in="" oats="" may="" play="" a="" role="" in="" the="" observed="" cholesterol="" reduction="" and="" suggested="" the="" need="" for="" long-term="" clinical="" trials="" (6="" months="" or="" more)="" with="" multiple="" doses="" to="" verify="" their="" conclusions="" from="" the="" metaanalysis.="" lsro,="" in="" its="" 1987="" report="" entitled="" ``physiological="" effects="" and="" health="" consequences="" of="" dietary="" fiber,''="" stated="" that="" oat="" bran="" has="" been="" shown="" to="" exert="" a="" substantial="" cholesterol-lowering="" effect="" in="" patients="" with="" hypercholesterolemia="" (ref.="" 7).="" it="" noted="" that="" the="" effects="" of="" oat="" bran="" are="" not="" as="" pronounced="" in="" subjects="" with="" normal="" serum="" cholesterol="" as="" they="" are="" in="" subjects="" with="" elevated="" serum="" lipid="" levels.="" 6.="" summary="" of="" the="" 37="" studies="" that="" fda="" reviewed,="" 4="" studies="" (refs.="" 9,="" 14,="" 22,="" and="" 30)="" had="" short="" test="" periods,="" ranging="" from="" 7="" hours="" to="" 18="" days="" and,="" thus,="" did="" not="" meet="" the="" agency's="" criteria="" for="" selecting="" pertinent="" studies="" with="" respect="" to="" study="" duration="" (i.e.,="" intervention="" test="" period="" of="" no="" less="" than="" 3="" weeks).="" seventeen="" studies="" (refs.="" 8,="" 11,="" 12,="" 15,="" 17,="" 20,="" 21,="" 23,="" 24,="" 25,="" 29,="" 35,="" 39,="" 42="" through="" 45)="" demonstrated="" a="" positive="" effect="" of="" oat="" bran="" or="" oatmeal="" on="" total="" and="" ldl-cholesterol.="" the="" majority="" of="" these="" studies="" showed="" statistically="" significant="" reductions="" in="" total="" and="" ldl-="" cholesterol="" in="" hypercholesterolemic="" subjects="" consuming="" either="" a="" typical="" american="" diet="" (refs.="" 8,="" 12,="" 20,="" 21,="" 25,="" 35,="" 44,="" and="" 45)="" or="" a="" low="" fat="" diet="" (refs.="" 11,="" 15,="" 23,="" 24,="" 39,="" 42,="" and="" 43).="" the="" results="" of="" three="" studies="" showed="" a="" statistically="" significant="" effect="" of="" oat="" bran="" or="" oatmeal="" in="" subjects="" with="" normal="" serum="" cholesterol="" consuming="" either="" a="" typical="" american="" diet="" (refs.="" 17="" and="" 29)="" or="" a="" low="" fat="" diet="" (ref.="" 42).="" the="" amount="" of="" oat="" bran="" or="" oatmeal="" consumed="" daily="" to="" lower="" total="" and="" ldl-cholesterol="" in="" the="" above="" studies="" ranged="" from="" 34="" g="" (2.5="" g="" soluble="" fiber)="" (ref.="" 17)="" to="" 123="" g="" (10.3="" g="" soluble="" fiber)="" (ref.="" 45).="" in="" those="" studies="" that="" evaluated="" hdl-cholesterol="" responses="" to="" oat="" intervention,="" three="" reported="" a="" slight,="" nonsignificant="" decrease="" in="" hdl-cholesterol="" (refs.="" 8,="" 11,="" and="" 21);="" four="" reported="" no="" change="" (refs.="" 12,="" 20,="" 23,="" and="" 35);="" and="" five="" reported="" a="" slight="" increase="" in="" hdl-="" cholesterol="" as="" a="" result="" of="" oat="" intervention="" (refs.="" 24,="" 25,="" 39,="" 42,="" and="" 45).="" five="" studies="" (refs.="" 10,="" 19,="" 32,="" 37,="" and="" 46)="" showed="" equivocal="" results="" in="" reducing="" serum="" cholesterol.="" the="" results="" by="" bartram="" et="" al.="" (ref.="" 10)="" were="" difficult="" to="" interpret="" because="" fruits="" were="" included="" in="" the="" oat="" bran="" cereal.="" the="" soluble="" fiber="" of="" the="" fruit="" may="" have="" had="" an="" independent="" effect="" on="" serum="" lipid="" levels.="" the="" questionable="" assessment="" of="" dietary="" intake="" and="" the="" lack="" of="" temporal="" sequence="" in="" an="" uncontrolled,="" cross-sectional="" survey="" conducted="" by="" he="" et="" al.="" (ref.="" 19)="" make="" the="" beneficial="" results="" of="" this="" study="" difficult="" to="" interpret.="" in="" addition,="" the="" population="" group="" used="" in="" this="" study="" (i.e.,="" chinese="" farmers="" and="" migrants)="" do="" not="" reflect="" the="" general="" population="" in="" the="" united="" states.="" the="" agency="" also="" questioned="" the="" appropriateness="" of="" the="" population="" groups="" used="" in="" two="" other="" studies="" (refs.="" 37="" and="" 46).="" zhang="" et="" al.="" (ref.="" 46)="" showed="" significant="" reductions="" in="" total="" cholesterol="" in="" subjects="" who="" had="" ileostomies.="" the="" mechanism="" by="" which="" oat="" bran="" or="" oatmeal="" help="" lower="" serum="" lipids="" in="" this="" population="" may="" not="" reflect="" the="" general="" population="" in="" the="" united="" states.="" swain="" and="" coworkers="" (ref.="" 37)="" evaluated="" the="" cholesterol-lowering="" properties="" of="" oat="" bran="" and="" wheat="" in="" a="" group="" of="" young="" pre-menopausal="" women="" with="" low="" serum="" cholesterol="" levels,="" a="" group="" who="" does="" not="" represent="" a="" population="" at="" risk="" for="" chd.="" dietary="" changes="" were="" reported="" during="" the="" oat="" period="" which="" also="" make="" interpretation="" of="" the="" results="" difficult.="" significant="" dietary="" changes="" during="" the="" oat="" intervention="" period="" made="" it="" difficult="" to="" interpret="" the="" results="" of="" another="" study="" (ref.="" 32).="" poulter="" et="" al.="" (ref.="" 32)="" reported="" significant="" reductions="" in="" total="" and="" ldl-cholesterol="" in="" subjects="" consuming="" 56="" g="" of="" oat="" cereal.="" there="" were="" no="" significant="" changes="" in="" total="" and="" ldl-cholesterol="" when="" the="" subjects="" consumed="" their="" usual="" (control)="" cereal.="" however,="" an="" analysis="" of="" the="" nutrient="" data="" revealed="" a="" significant="" reduction="" in="" total="" energy="" from="" fat="" and="" in="" the="" ratio="" of="" polyunsaturated="" to="" saturated="" fat="" (p:s)="" during="" the="" oat="" period.="" in="" the="" 11="" studies="" in="" which="" no="" effect="" on="" serum="" lipid="" levels="" were="" found="" (refs.="" 13,="" 16,="" 18,="" 26="" through="" 28,="" 31,="" 34,="" 36,="" 38,="" and="" 41),="" a="" number="" of="" reasons="" were="" advanced="" for="" the="" lack="" of="" a="" positive="" finding.="" a="" lack="" of="" compliance="" and="" changes="" in="" dietary="" intakes="" by="" the="" subjects="" plagued="" a="" number="" of="" these="" studies="" (refs.="" 18,="" 27,="" 31,="" 34,="" and="" 41).="" the="" source="" of="" the="" oat="" cultivars="" allegedly="" contributed="" to="" the="" lack="" of="" an="" effect="" of="" oat="" bran="" or="" oatmeal="" on="" serum="" lipids="" in="" four="" others="" (refs.="" 13,="" 26,="" 28,="" and="" 36).="" the="" authors="" of="" these="" studies="" noted="" that="" new="" zealand="" oat="" cultivars="" tend="" to="" have="" lower="" levels="" of="" soluble="" fiber="" than="" oat="" cultivars="" used="" in="" studies="" showing="" cholesterol-lowering="" properties.="" the="" processing="" of="" oats="" allegedly="" caused="" a="" loss="" of="" effectiveness="" in="" another="" study="" (ref.="" 38).="" torronen="" and="" coworkers="" found="" that="" wet="" milling="" finnish="" oats="" to="" produce="" an="" oat="" bran="" concentrate="" negatively="" affected="" the="" hypocholesterolemic="" properties="" of="" oat="">-glucan.
The results of the study by Demark-Wahnefried et al. (Ref. 16)
suffered from a lack of statistical power to detect changes between
groups, variable weight loss among the groups, and significant dietary
changes during the course of the study.
IV. Decision To Propose a Health Claim Relating Oat Products to
Reduction in Risk of CHD
The petition set out the conclusions reached by the Federal
government and other recognized scientific bodies, as well as those
reached in review articles and in pertinent human studies published
since 1987. FDA reviewed this information as well as those studies that
evaluated the effects on serum cholesterol and LDL-cholesterol levels
from dietary intervention with oat bran or oatmeal in subjects with
normal to elevated serum cholesterol levels.
FDA tentatively concludes that, based on the totality of publicly
available scientific evidence, there is significant scientific
agreement to support the relationship between consumption of oat bran
or oatmeal as foods, or as ingredients in foods, and the risk of CHD.
The strongest evidence for the effect of oat bran or oatmeal on the
risk of CHD is provided by studies that
[[Page 304]]
measured the effect of dietary oat consumption on the two major risk
factors for CHD, total and LDL-cholesterol. FDA is aware of five
studies of that effect in which problems associated with subject
compliance and weight loss were avoided and in which appropriate
controls were used (Refs. 12, 25, 29, 39, and 45). All of these studies
showed a significant relationship between oat consumption and lowered
serum total and LDL-cholesterol levels and no adverse effect on other
CHD risk factors, such as significantly lowering HDL-cholesterol. The
daily oat intake ranged from an estimated 70 g oat bran (Ref. 12) to
150 g oat bran (Ref. 39). Four of these studies (Refs. 12, 25, 39, and
45) were conducted in subjects with mild to moderately elevated levels
of serum cholesterol. One study (Ref. 29) used subjects with normal
serum cholesterol levels.
Braaten et al. (Ref. 12) showed that when subjects consumed an
amount of purified oat gum (containing 80 percent -glucan)
equivalent to consuming 70 g oat bran daily, total and LDL-cholesterol
were significantly reduced, and HDL-cholesterol remained unchanged. The
oat gum was consumed with a typical American diet.
Kestin et al. (Ref. 25) showed significant reductions in total and
LDL-cholesterol, compared to blood lipid levels during wheat and rice
bran periods, in subjects who consumed 95 g oat bran/day for 4 weeks
(Ref. 25). HDL-cholesterol showed slight, nonsignificant increases
compared to baseline in all diet periods. The subjects consumed the
test foods as part of their usual diet.
Subjects with moderate hypercholesterolemia showed significant
reductions in total and LDL-cholesterol after they consumed 150 g oats/
day for 4 weeks compared to baseline lipid levels (Ref. 39). These same
subjects experienced small increases in total and LDL-cholesterol (not
significant) after consuming wheat products. Blood levels of HDL-
cholesterol increased slightly (not significant) during the oat period
but remained the same during the wheat period. All subjects consumed a
low fat diet in this study.
Whyte et al. (Ref. 45) reported significant reductions in total and
LDL-cholesterol in subjects who consumed 123 g oat bran/day for 4 weeks
as part of their usual diets. The subjects experienced a slight
increase in total cholesterol and no change in LDL-cholesterol after
consuming wheat bran. HDL-cholesterol increased slightly (not
significant) during both bran periods.
In a study designed to assess the mechanism by which oat bran
lowers total cholesterol, Marlett et al. (Ref. 29) reported significant
reductions in total cholesterol in the period in which subjects
consumed oat bran compared to a wheat control period. The subjects
consumed 100 g oat bran/day for 4 weeks during the high fiber period
and wheat gluten during the low fiber, control period, with their usual
diets.
The results of 12 other studies (Refs. 8, 11, 15, 17, 20, 21, 23,
24, 35, and 42 through 44) also support the relationship between oat
consumption and reduction in total and LDL-cholesterol. Six studies
(Refs. 8, 17, 20, 21, 35, and 44) showed the benefits of oat
intervention in reducing serum total and LDL-cholesterol in subjects
consuming a typical American diet. HDL-cholesterol showed no
significant change in four of these studies (Refs. 8, 20, 21, and 35)
and a significant reduction in one study (Ref. 21). The amount of oat
bran or oatmeal consumed in these studies ranged from 34 g/day (Ref.
17) to 110 g/d (Ref. 8).
Three studies (Refs. 15, 23, and 24) showed a significant effect of
oat bran or oatmeal on total and LDL-cholesterol that was beyond that
of a Step 1 diet alone. The results of the three other studies (Refs.
11, 42, and 43) showed lower, nonsignificant, total and LDL-cholesterol
in subjects who consumed oat bran or oatmeal compared to the group who
consumed the Step 1 or Step 2 diets alone. In two of these studies
(Refs. 42 and 43), the subjects' lipid values after a run-in period on
the low fat diet ranged from a mean of 193 to 197 mg/dL. The lack of
significant difference between the diet only and the oat groups in
these studies may be overshadowed by the effect of the diet alone on
subjects who had initially low total and LDL-cholesterol levels. There
were no significant changes in HDL- cholesterol from the consumption of
a low fat diet plus oats. The range of oat intake in these studies
ranged from 35 g (Ref. 43) to 100 g/day (Ref. 24).
Two studies (Ref. 20 and 23) used wheat as a placebo control. The
results of these studies showed significantly lower total and LDL-
cholesterol in subjects who consumed oat bran compared to those who
consumed wheat.
A metaanalysis (Ref. 33) using pooled, raw data from a number of
oat studies (Refs. 11, 15 through 17, 23, 25, 30, 37, 39, 40, and 42
through 44) found that an intake of 3 g soluble fiber (used as a marker
for oat bran and oatmeal) or more produced modest reductions (average
decrease of 5 to 6 mg/dL) of serum total cholesterol levels. The
decrease in total cholesterol was largest in those trials with subjects
that initially had high total cholesterol levels.
As stated in section III.A. of this document, Federal government
and other reviews have concluded that there is substantial
epidemiologic and clinical evidence that high blood levels of total
cholesterol and LDL-cholesterol represent major contributors to CHD (56
FR 60727 at 60728, and Refs. 3 through 5). Dietary factors that
decrease total cholesterol and LDL-cholesterol will affect the risk of
CHD (Refs. 3 through 6). Based on the scientific evidence presented in
the petition, the agency tentatively concludes that there is
significant scientific evidence to show that oat bran and oatmeal will
help reduce serum lipids, and that such reductions may reduce the risk
of CHD. In the majority of clinical studies evaluating oat products,
total and LDL-cholesterol fractions were shown to be the most affected
by oat intervention. Regular consumption of oat bran or oatmeal, in an
amount to provide 3 g or more of oat -glucan soluble fiber,
resulted in reduced total and LDL-cholesterol levels in subjects with
normal and elevated serum cholesterol levels.
Changes in HDL-cholesterol levels as a result of oat intervention
were generally absent or not significant (Refs. 8, 11 through 13, 18,
20, 23 through 28, 32, 35 through 39, 41, 42, and 45). A tendency
toward an increase in HDL-cholesterol was shown in nine studies (Refs.
13, 24, 25, 27, 28, 32, 39, 42, and 45); no change was shown in nine
studies (Refs. 8, 12, 18, 20, 23, 24, 35, 36, and 41); and a
nonsignificant decrease in HDL-cholesterol was shown in three studies
(Ref. 11, 26, and 38). Although HDL-cholesterol was reduced 0.9 percent
(p<0.03) in="" the="" study="" by="" kahn="" et="" al.="" (ref.="" 21),="" the="" hdl:ldl="" and="" hdl:total="" cholesterol="" ratios="" were="" improved,="" compared="" to="" baseline,="" because="" of="" significant="" reductions="" in="" total="" cholesterol="" (8="" percent)="" and="" ldl-cholesterol="" (10="" percent).="" oat="" bran="" and="" oatmeal="" were="" tested="" in="" a="" variety="" of="" food="" forms="" but="" produced="" fairly="" consistent="" results,="" showing="" that="" the="" way="" in="" which="" these="" foods="" are="" consumed="" does="" not="" alter="" their="" effect="" on="" serum="" lipids.="" they="" were="" consumed="" as="" hot="" and="" cold="" cereals="" or="" used="" in="" a="" variety="" of="" other="" foods,="" such="" as="" muffins,="" breads,="" shakes,="" and="" entrees.="" the="" eleven="" studies="" that="" did="" not="" show="" reduced="" total="" and="" ldl-="" cholesterol="" from="" the="" consumption="" of="" oat="" bran="" or="" oatmeal="" (refs.="" 13,="" 16,="" 18,="" 26="" through="" 28,="" 31,="" 34,="" 36,="" 38,="" and="" 41)="" do="" not="" detract="" from="" the="" agency's="" tentative="" conclusion="" about="" this="" relationship="" or="" that="" the="" claim="" is="" valid.="" [[page="" 305]]="" the="" lack="" of="" result="" in="" five="" of="" these="" studies="" (refs.="" 13,="" 26,="" 28,="" 36,="" and="" 38)="" was="" apparently="" attributed="" to="" the="" oat="" source,="" i.e.,="" new="" zealand="" cultivars,="" or="" to="" the="" method="" of="" processing="" oat="" bran.="" the="" results="" of="" the="" remaining="" six="" studies="" were="" associated="" with="" a="" lack="" of="" subject="" compliance="" and="" significant="" changes="" in="" dietary="" intake="" during="" the="" test="" periods,="" or="" to="" problems="" in="" study="" design,="" i.e.,="" a="" lack="" of="" statistical="" power="" to="" detect="" changes="" between="" groups.="" given="" all="" of="" this="" evidence,="" the="" agency="" is="" proposing="" a="" health="" claim="" on="" the="" relationship="" between="" oat="" bran="" and="" oatmeal="" and="" reduced="" risk="" of="" chd.="" v.="" description="" and="" rationale="" for="" components="" of="" health="" claim="" a.="" relationship="" between="" oatmeal="" and="" oat="" bran="" and="" chd="" and="" the="" significance="" of="" the="" relationship="" proposed="" sec.="" 101.81(a)="" describes="" the="" relationship="" between="" diets="" high="" in="" oat="" bran="" or="" oatmeal="" and="" the="" risk="" of="" chd.="" in="" proposed="" sec.="" 101.81(a)(1),="" the="" agency="" recounts="" that="" chd="" is="" the="" most="" common="" and="" serious="" form="" of="" cvd,="" and="" that="" chd="" refers="" to="" diseases="" of="" the="" heart="" muscle="" and="" supporting="" blood="" vessels.="" the="" regulation="" also="" notes="" that="" high="" blood="" total="" and="" ldl-cholesterol="" levels="" are="" associated="" with="" increased="" risk="" of="" developing="" chd.="" the="" regulation="" identifies="" the="" levels="" of="" total="" cholesterol="" and="" ldl-cholesterol="" that="" would="" put="" an="" individual="" at="" high="" risk="" of="" developing="" chd="" and="" those="" serum="" lipid="" levels="" that="" are="" associated="" with="" borderline="" high="" risk.="" the="" intent="" is="" to="" provide="" consumers="" with="" information="" to="" help="" them="" understand="" the="" seriousness="" of="" chd.="" in="" proposed="" sec.="" 101.81(a)(2),="" the="" agency="" recounts="" that="" populations="" with="" a="" low="" incidence="" of="" chd="" tend="" to="" have="" low="" blood="" total="" and="" ldl-="" cholesterol="" levels.="" it="" states="" that="" these="" populations="" also="" tend="" to="" have="" dietary="" patterns="" that="" are="" low="" in="" total="" fat,="" saturated="" fat,="" and="" cholesterol="" and="" high="" in="" fruits,="" vegetables,="" and="" grain="" products,="" such="" as="" oatmeal="" and="" oat="" bran.="" this="" information="" is="" consistent="" with="" that="" provided="" in="" the="" authorized="" health="" claim="" for="" fruits,="" vegetables,="" and="" grain="" products="" and="" chd="" (sec.="" 101.77).="" the="" agency="" tentatively="" finds="" that="" this="" information="" provides="" a="" basis="" for="" a="" better="" understanding="" of="" the="" numerous="" factors="" that="" contribute="" to="" the="" risk="" of="" chd="" and="" the="" relationship="" between="" oat="" bran="" and="" oatmeal="" and="" a="" low="" fat="" diet.="" proposed="" sec.="" 101.81(a)(3)="" describes="" the="" relationship="" between="" oat="" bran="" and="" oatmeal,="" foods="" low="" in="" saturated="" fat="" and="" cholesterol,="" and="" reduction="" in="" the="" chd="" risk="" factors.="" the="" paragraph="" states="" that="" several="" studies="" have="" shown="" that="" diets="" high="" in="" oatmeal="" or="" oat="" bran="" are="" associated="" with="" reduced="" blood="" lipid="" levels.="" this="" information="" encapsulates="" the="" scientific="" evidence="" about="" how="" oatmeal="" and="" oat="" bran="" can="" contribute="" to="" reduction="" in="" heart="" disease="" risk="" factors.="" proposed="" sec.="" 101.81(b)="" describes="" the="" significance="" of="" the="" diet-="" disease="" relationship.="" in="" proposed="" sec.="" 101.81(b)(1),="" the="" agency="" recounts="" that="" chd="" remains="" a="" major="" public="" health="" concern="" in="" the="" united="" states="" because="" the="" disease="" accounts="" for="" more="" deaths="" than="" any="" other="" disease="" or="" group="" of="" diseases.="" the="" claim="" states="" that="" early="" management="" of="" modifiable="" risk="" factors="" for="" chd="" is="" a="" major="" public="" health="" goal="" that="" can="" assist="" in="" reducing="" the="" risk="" of="" chd.="" this="" information="" is="" consistent="" with="" the="" evidence="" that="" lowering="" blood="" total="" and="" ldl-cholesterol="" levels="" reduces="" the="" risk="" of="" chd="" (56="" fr="" 60727,="" 58="" fr="" 2739,="" and="" refs.="" 3="" through="" 6="" and="" 47).="" in="" proposed="" sec.="" 101.81(b)(2),="" the="" significance="" of="" the="" relationship="" between="" oatmeal="" and="" oat="" bran="" and="" chd="" risk="" factors="" in="" context="" of="" the="" total="" diet="" is="" discussed.="" the="" agency="" recounts="" that="" many="" americans'="" intakes="" of="" saturated="" fat="" and="" cholesterol="" exceed="" recommended="" levels,="" and="" it="" summarizes="" public="" health="" recommendations="" for="" the="" diet="" (56="" fr="" 60727="" at="" 60738="" and="" sec.="" 101.75(b)(3)).="" this="" paragraph="" also="" states="" that="" scientific="" evidence="" demonstrates="" that="" diets="" high="" in="" oatmeal="" and="" oat="" bran="" and="" low="" in="" saturated="" fat="" and="" cholesterol="" are="" associated="" with="" reduced="" blood="" lipids.="" fda="" tentatively="" concludes="" that="" the="" latter="" statement="" is="" scientifically="" valid="" based="" on="" the="" evidence="" that="" it="" has="" reviewed="" on="" this="" nutrient-disease="" relationship.="" b.="" nature="" of="" the="" claim="" in="" sec.="" 101.81(c)(1)="" (21="" cfr="" 101.81(c)(1)),="" fda="" is="" proposing="" to="" require="" that="" all="" of="" the="" general="" requirements="" for="" health="" claims="" set="" out="" in="" sec.="" 101.14="" be="" met.="" this="" provision="" is="" consistent="" with="" the="" provisions="" of="" the="" other="" specific="" health="" claim="" regulations="" in="" part="" 101,="" subpart="" e,="" of="" the="" code="" of="" federal="" regulations="" (cfr)="" (21="" cfr="" part="" 101,="" subpart="" e).="" in="" sec.="" 101.81(c)(2)(i),="" fda="" is="" proposing="" to="" authorize="" a="" health="" claim="" on="" the="" relationship="" between="" diets="" high="" in="" oat="" bran="" or="" oatmeal="" and="" the="" risk="" of="" chd.="" the="" agency="" is="" proposing="" to="" do="" so="" based="" on="" its="" review="" of="" the="" scientific="" evidence="" on="" this="" nutrient-disease="" relationship="" which="" shows="" that="" diets="" that="" are="" high="" in="" oat="" bran="" or="" oatmeal="" help="" to="" reduce="" total="" and="" ldl-cholesterol="" levels="" in="" individuals="" with="" normal="" to="" elevated="" blood="" total="" cholesterol="" (refs.="" 8,="" 11,="" 12,="" 15,="" 17,="" 20,="" 21,="" 23="" through="" 25,="" 29,="" 35,="" 39,="" 44,="" and="" 45).="" this="" result="" is="" significant="" for="" the="" risk="" of="" heart="" disease="" because="" elevated="" levels="" of="" total="" and="" ldl-cholesterol="" are="" associated="" with="" increased="" risk="" of="" chd="" (refs.="" 3="" through="" 6).="" in="" sec.="" 101.81(c)(2)(i)(a),="" the="" agency="" is="" proposing="" to="" require,="" consistent="" with="" other="" health="" claims,="" that="" the="" relationship="" be="" qualified="" with="" the="" terms="" ``may''="" or="" ``might.''="" these="" terms="" are="" used="" to="" make="" clear="" that="" not="" all="" persons="" can="" necessarily="" expect="" to="" benefit="" from="" these="" dietary="" changes="" (56="" fr="" 60727="" at="" 60740="" and="" 58="" fr="" 2552="" at="" 2573).="" in="" sec.="" 101.81(c)(2)(i)(b),="" the="" agency="" is="" proposing="" to="" require,="" consistent="" with="" other="" authorized="" health="" claims,="" that="" the="" terms="" ``coronary="" heart="" disease''="" or="" ``heart="" disease''="" be="" used="" in="" specifying="" the="" disease.="" these="" terms="" are="" commonly="" used="" in="" dietary="" guidance="" materials,="" and="" therefore="" they="" should="" be="" readily="" understandable="" to="" the="" consumer="" (56="" fr="" 60727="" at="" 60740="" and="" 58="" fr="" 2552="" at="" 2573).="" in="" sec.="" 101.81(c)(2)(i)(c)(1),="" the="" agency="" is="" proposing="" that="" the="" claim="" describe="" the="" relationship="" between="" diets="" high="" in="" oatmeal="" or="" oat="" bran="" and="" risk="" for="" chd.="" based="" on="" its="" review="" of="" the="" scientific="" evidence="" submitted="" with="" the="" petition,="" the="" agency="" tentatively="" concludes="" that="" there="" is="" significant="" scientific="" agreement="" that="" diets="" high="" in="" oat="" bran="" or="" oatmeal="" may="" help="" to="" reduce="" blood="" total="" and="" ldl-cholesterol="" levels,="" the="" major="" modifiable="" risk="" factors="" for="" chd="" (refs.="" 12,="" 17,="" 20,="" 21,="" 25,="" 29,="" 35,="" 44,="" and="" 45).="" the="" petitioner="" stated="" in="" its="" petition="" that="" there="" is="" significant="" scientific="" evidence="" to="" show="" that="" the="" effect="" of="" oats="" on="" lowering="" serum="" lipids="" is="" independent="" of="" a="" diet="" low="" in="" saturated="" fat="" and="" cholesterol.="" in="" light="" of="" this="" evidence,="" the="" petitioner="" argued="" that="" any="" health="" claim="" that="" is="" authorized="" need="" not="" refer="" to="" such="" a="" diet.="" the="" petitioner="" explained="" that="" important="" public="" health="" policy="" objectives,="" as="" well="" as="" fda's="" statutory="" mandate="" to="" authorize="" health="" claims="" supported="" by="" significant="" scientific="" agreement,="" mandate="" that="" fda="" issue="" a="" regulation="" that="" requires="" only="" that="" claims="" describe="" the="" relationship="" between="" oat="" products="" and="" reduced="" risk="" of="" chd="" (ref.="" 1,="" p.="" 68).="" the="" agency="" acknowledges="" that="" there="" were="" a="" number="" of="" studies="" that="" showed="" that="" high="" intakes="" of="" oat="" bran="" and="" oatmeal="" lowered="" blood="" total="" and="" ldl-cholesterol="" in="" subjects="" that="" otherwise="" consumed="" a="" typical="" american="" diet="" (refs.="" 12,="" 17,="" 20,="" 21,="" 25,="" 29,="" 35,="" 44,="" and="" 45).="" however,="" as="" stated="" in="" section="" v.a.="" of="" this="" document,="" chd="" is="" a="" major="" public="" health="" concern="" in="" the="" united="" states,="" and="" that="" the="" totality="" of="" the="" scientific="" evidence="" provides="" strong="" and="" consistent="" support="" that="" diets="" high="" in="" saturated="" fat="" and="" cholesterol="" are="" associated="" with="" elevated="" levels="" of="" blood="" total="" and="" ldl-cholesterol,="" and="" thus="" chd="" (56="" fr="" 60727="" [[page="" 306]]="" at="" 60737).="" dietary="" estimates="" for="" american="" adults="" show="" that="" the="" average="" saturated="" fat="" intakes="" of="" american="" adults="" are="" about="" 13="" percent="" of="" calories,="" total="" fat="" intakes="" are="" about="" 37="" percent="" of="" calories,="" and="" average="" cholesterol="" intakes="" range="" from="" 300="" to="" over="" 400="" mg="" daily="" for="" adult="" men="" and="" women="" (56="" fr="" 60727="" at="" 60738).="" the="" current="" intakes="" of="" saturated="" fat="" and="" total="" fat="" are="" thus="" well="" in="" excess="" of="" recommended="" goals="" of="" less="" than="" 10="" percent="" and="" 30="" percent="" of="" calories.="" dietary="" guidelines="" from="" both="" government="" and="" private-recognized="" scientific="" bodies="" conclude="" that="" the="" majority="" of="" the="" american="" population="" would="" benefit="" from="" decreased="" consumption="" of="" dietary="" saturated="" fat="" and="" cholesterol="" (refs.="" 3="" through="" 6).="" the="" results="" of="" several="" studies="" showed="" that="" while="" daily="" consumption="" of="" oat="" bran="" or="" oatmeal="" lowered="" total="" cholesterol="" and="" ldl-cholesterol,="" the="" effects="" of="" dietary="" intake="" of="" oat="" bran="" or="" oatmeal="" were="" particularly="" evident="" when="" the="" diets="" were="" low="" in="" saturated="" fat="" and="" cholesterol="" (refs.="" 11,="" 15,="" 24,="" 39,="" and="" 43).="" thus,="" the="" agency="" tentatively="" finds="" that="" it="" will="" be="" more="" helpful="" to="" americans'="" efforts="" to="" maintain="" healthy="" dietary="" practices="" if="" the="" effect="" of="" oats="" on="" serum="" lipids="" is="" described="" in="" context="" of="" a="" healthy="" diet.="" this="" information="" is="" extremely="" important="" to="" a="" full="" understanding="" of="" the="" significance="" of="" the="" claim.="" the="" agency="" tentatively="" finds="" that="" for="" the="" public="" to="" understand="" fully,="" in="" the="" context="" of="" the="" total="" daily="" diet,="" the="" significance="" of="" consumption="" of="" oat="" bran="" and="" oatmeal="" on="" the="" risk="" of="" chd="" (see="" section="" 403(r)(3)(b)(iii)="" of="" the="" act),="" information="" about="" the="" total="" diet="" needs="" to="" be="" included="" as="" part="" of="" the="" claim.="" therefore,="" in="" sec.="" 101.81(c)(2)(i)(c)(2),="" the="" agency="" is="" proposing="" to="" require="" that="" the="" claim="" include="" the="" fact="" that="" the="" effect="" of="" dietary="" consumption="" of="" oatmeal="" or="" oat="" bran="" on="" the="" risk="" of="" chd="" is="" particularly="" evident="" when="" these="" foods="" are="" consumed="" as="" part="" of="" a="" diet="" that="" is="" low="" in="" saturated="" fat="" and="" cholesterol.="" based="" on="" its="" review="" of="" the="" scientific="" evidence="" submitted="" with="" the="" petition,="" the="" agency="" tentatively="" concludes="" that="" there="" is="" significant="" scientific="" agreement="" that="" diets="" high="" in="" oat="" bran="" or="" oatmeal="" and="" low="" in="" saturated="" fat="" and="" cholesterol="" are="" associated="" with="" reduced="" blood="" total="" and="" ldl-cholesterol="" levels="" (refs.="" 11,="" 15,="" 23,="" 24,="" 39,="" 42,="" and="" 43).="" fda="" is="" proposing="" to="" require="" that="" this="" dietary="" information="" be="" included="" as="" part="" of="" the="" full="" health="" claim="" to="" ensure="" that="" people="" understand="" the="" significance="" of="" the="" information="" in="" the="" claim.="" a="" diet="" low="" in="" saturated="" fat="" and="" cholesterol="" is="" important="" because="" if="" intake="" of="" these="" dietary="" components="" are="" not="" controlled,="" then="" there="" is="" a="" significant="" question="" as="" to="" whether="" high="" fiber="" diets="" will="" have="" their="" full="" effect="" on="" blood="" total="" and="" ldl-cholesterol="" levels,="" and="" thus="" on="" the="" risk="" of="" heart="" disease.="" however,="" based="" on="" information="" supplied="" by="" the="" petitioner,="" fda="" tentatively="" concludes="" that="" a="" claim="" that="" diets="" high="" in="" oat="" bran="" or="" oatmeal="" may="" reduce="" the="" risk="" of="" heart="" disease="" is="" truthful,="" not="" misleading,="" and="" scientifically="" valid="" without="" this="" additional="" information.="" therefore,="" fda="" tentatively="" finds="" that="" it="" is="" appropriate="" to="" require="" that="" a="" label="" that="" bears="" an="" oat="" bran="" or="" oatmeal="" health="" claim="" disclose="" the="" fact="" that="" a="" diet="" should="" be="" high="" in="" oat="" bran="" and="" oatmeal="" and="" low="" in="" saturated="" fat="" and="" cholesterol,="" but="" that="" it="" is="" not="" necessary="" to="" require="" that="" the="" latter="" dietary="" information="" be="" disclosed="" in="" immediate="" proximity="" of="" the="" oat="" bran="" or="" oatmeal="" claim="" each="" time="" the="" claim="" appears="" on="" the="" label="" or="" in="" labeling="" (see="" the="" discussion="" of="" sec.="" 101.81(c)(2)(ii)="" below).="" fda="" is="" proposing="" to="" require="" only="" that="" the="" full="" statement="" of="" the="" claim="" disclose="" the="" fact="" that="" the="" effect="" of="" the="" dietary="" intake="" of="" oat="" bran="" or="" oatmeal="" is="" particularly="" evident="" when="" the="" diet="" is="" low="" in="" saturated="" fat="" and="" cholesterol.="" proposed="" sec.="" 101.81(c)(2)(i)(d),="" consistent="" with="" other="" authorized="" health="" claims,="" requires="" that="" the="" claim="" not="" attribute="" any="" degree="" of="" risk="" reduction="" of="" chd="" to="" consumption="" of="" oat="" products.="" none="" of="" the="" studies="" that="" the="" agency="" reviewed="" provide="" a="" basis="" for="" determining="" the="" percent="" reduction="" in="" risk="" of="" chd="" likely="" from="" consuming="" diets="" high="" in="" oat="" products.="" the="" agency="" considered="" proposing="" to="" require="" that="" the="" claim="" state="" that="" the="" development="" of="" chd="" depends="" on="" many="" factors.="" this="" statement="" has="" been="" required="" in="" the="" two="" authorized="" heart="" disease="" health="" claims="" (secs.="" 101.75="" and="" 101.77)="" (although="" the="" agency="" has="" recently="" proposed="" to="" delete="" this="" requirement="" in="" a="" document="" that="" published="" in="" the="" federal="" register="" of="" december="" 21,="" 1995="" (60="" fr="" 66206)="" (hereinafter="" referred="" to="" as="" the="" 1995="" proposal).="" the="" petitioner="" requested="" that="" the="" statement="" regarding="" the="" multifactorial="" nature="" of="" chd="" be="" listed="" under="" optional="" requirements="" for="" the="" health="" claim="" (ref.="" 1,="" p.="" 68).="" the="" petitioner="" stated="" that="" based="" on="" an="" ever="" increasing="" background="" of="" health="" information="" made="" available="" through="" various="" media,="" consumers="" already="" understand="" that="" foods="" are="" not="" drugs,="" and="" that="" health="" enhancement="" depends="" not="" only="" on="" consumption="" of="" a="" particular="" food="" but="" also="" on="" other="" dietary="" practices,="" exercise,="" heredity,="" lifestyle,="" and="" a="" host="" of="" other="" factors.="" the="" petitioner="" did="" not="" provide="" any="" data="" to="" support="" this="" observation.="" the="" petition="" stated="" that="" the="" ``depends="" on="" many="" factors''="" language="" makes="" the="" health="" claim="" cumbersome,="" unnecessarily="" long,="" and="" detracts="" from="" its="" central="" and="" critical="" consumer="" message.="" the="" petition="" stated="" that="" using="" the="" required="" statement="" ``may="" help''="" (i.e.,="" ``may="" help="" reduce="" the="" risk="" of="" heart="" disease'')="" more="" simply,="" directly,="" and="" succinctly="" indicates="" to="" consumers="" that="" oatmeal="" and="" oat="" bran="" are="" not="" magic="" bullets,="" and="" that="" other="" factors="" are="" associated="" with="" chd="" risk.="" the="" agency="" agrees="" with="" the="" petitioner="" that="" the="" requirement="" that="" the="" claim="" use="" the="" term="" ``may''="" or="" ``might''="" to="" relate="" the="" ability="" of="" oat="" bran="" or="" oatmeal="" to="" reduce="" the="" risk="" of="" heart="" disease="" is="" intended="" to="" reflect="" the="" multifactorial="" nature="" of="" the="" disease.="" in="" response="" to="" comments="" on="" the="" scientific="" standard="" proposed="" for="" health="" claims,="" the="" agency="" stated="" in="" the="" 1993="" health="" claims="" final="" rule="" (58="" fr="" 2478="" at="" 2505):="" *="" *="" *="" further,="" absolute="" claims="" about="" diseases="" affected="" by="" diet="" are="" generally="" not="" possible="" because="" such="" diseases="" are="" almost="" always="" multifactorial.="" diet="" is="" only="" one="" factor="" that="" influences="" whether="" a="" person="" will="" get="" such="" a="" disease.="" for="" example,="" in="" the="" case="" of="" calcium="" and="" osteoporosis,="" genetic="" predisposition="" (e.g.,="" where="" there="" is="" a="" family="" history="" of="" fragile="" bones="" with="" aging)="" can="" play="" a="" major="" role="" in="" whether="" an="" individual="" will="" develop="" the="" disease.="" because="" of="" factors="" other="" than="" diet,="" some="" individuals="" may="" develop="" the="" disease="" regardless="" of="" how="" they="" change="" their="" dietary="" patterns="" to="" avoid="" the="" disease.="" for="" those="" individuals,="" a="" claim="" that="" changes="" in="" dietary="" patterns="" will="" reduce="" the="" risk="" of="" disease="" would="" be="" false.="" thus,="" health="" claims="" must="" be="" free="" to="" use="" the="" term="" ``may''="" with="" respect="" to="" the="" potential="" to="" reduce="" the="" risk="" of="" disease.="" *="" *="" *="" the="" agency="" notes="" that="" fda="" has="" been="" asked="" in="" a="" petition="" from="" the="" national="" food="" processors="" association="" (nfpa)="" (docket="" no.="" 94p-0390)="" to="" reevaluate="" the="" required="" elements="" of="" the="" health="" claim="" and="" to="" consider="" a="" number="" of="" options="" including="" the="" option="" of="" using="" an="" abbreviated="" health="" claim="" and="" eliminating="" the="" multifactorial="" element="" of="" the="" health="" claim="" requirements.="" in="" the="" 1995="" proposal,="" the="" agency="" initiated="" rulemaking="" that,="" in="" part,="" proposed="" to="" eliminate="" or="" make="" optional="" some="" of="" the="" required="" elements.="" more="" specifically,="" the="" agency="" proposed="" to="" make="" optional="" the="" statement="" ``a="" disease="" caused="" by="" many="" factors''="" (see="" section="" iv.e.="" of="" the="" 1995="" proposal),="" and="" to="" permit="" the="" use="" of="" certain="" abbreviated="" health="" claims="" on="" the="" label="" or="" labeling="" of="" a="" product="" (see="" section="" iv.c.="" of="" the="" 1995="" proposal)="" (60="" fr="" 66206).="" in="" this="" proposed="" rule="" on="" oat="" bran="" and="" oatmeal="" and="" chd,="" the="" agency="" is="" proposing="" to="" make="" the="" phrase="" ``depends="" on="" many="" factors''="" optional="" information.="" in="" place="" of="" the="" requirement="" for="" stating="" the="" multifactorial="" nature="" of="" [[page="" 307]]="" the="" disease,="" the="" agency="" is="" proposing="" sec.="" 101.81(c)(2)(i)(e)="" to="" require="" that="" the="" claim="" not="" imply="" that="" the="" consumption="" of="" oat="" bran="" and="" oatmeal="" is="" the="" only="" recognized="" means="" of="" achieving="" a="" reduced="" risk="" of="" chd.="" thus,="" the="" agency="" tentatively="" concludes="" that="" the="" concept="" of="" the="" multifactorial="" nature="" of="" chd="" will="" be="" preserved="" without="" adding="" additional="" words="" to="" the="" claim.="" the="" agency="" requests="" comment="" on="" whether="" consumers="" will="" be="" misled="" to="" believe="" that="" reduction="" of="" risk="" will="" be="" achieved="" if="" the="" multifactorial="" nature="" of="" chd="" is="" not="" stated="" on="" the="" claim.="" this="" proposed="" rule="" would="" also="" permit="" use="" of="" a="" shortened="" version="" of="" the="" claim="" in="" conjunction="" with="" the="" full="" claim="" (see="" section="" iv.c.="" of="" the="" 1995="" proposal).="" c.="" presentation="" of="" the="" claim="" in="" proposed="" sec.="" 101.81(c)(2)(ii),="" the="" agency="" is="" providing="" for="" how="" the="" health="" claim="" is="" to="" be="" presented="" on="" the="" label="" or="" labeling.="" this="" paragraph="" states="" that="" all="" of="" the="" elements="" listed="" in="" sec.="" 101.81(c)(2)(i)="" must="" be="" included="" in="" one="" presentation="" of="" the="" claim="" on="" the="" label="" or="" labeling.="" as="" discussed="" in="" sections="" v.a.="" and="" b.="" of="" this="" document,="" the="" scientific="" evidence="" provides="" strong="" and="" consistent="" support="" that="" diets="" high="" in="" saturated="" fat="" and="" cholesterol="" are="" associated="" with="" elevated="" levels="" of="" blood="" total="" and="" ldl-cholesterol,="" the="" major="" modifiable="" risk="" factors="" for="" chd.="" because="" the="" typical="" american="" diet="" tends="" to="" be="" high="" in="" saturated="" fat="" and="" cholesterol,="" dietary="" guidelines="" recommend="" that="" americans="" modify="" their="" intakes="" of="" food="" that="" contain="" significant="" levels="" of="" saturated="" fat="" and="" cholesterol.="" from="" a="" public="" health="" standpoint,="" it="" is="" important="" for="" the="" public="" to="" comprehend="" the="" significance="" of="" the="" relationship="" between="" diets="" high="" in="" oat="" bran="" or="" oatmeal="" and="" chd="" risk="" in="" context="" of="" a="" diet="" low="" in="" saturated="" fat="" and="" cholesterol.="" this="" relationship="" is="" supported="" by="" significant="" scientific="" evidence="" as="" discussed="" above.="" however,="" the="" 1995="" proposal="" permits="" a="" short,="" simple="" statement="" of="" certain="" health="" claims="" that="" is="" truthful,="" not="" misleading,="" and="" scientifically="" valid,="" which="" may="" be="" used="" on="" the="" principal="" display="" panel,="" as="" long="" as="" the="" full="" claim="" appears="" on="" the="" particular="" label="" or="" in="" the="" particular="" labeling="" in="" which="" the="" short="" statement="" appears,="" and="" there="" is="" a="" referral="" statement="" from="" the="" shortened="" to="" the="" full="" claim="" (60="" fr="" 66206).="" in="" recognition="" of="" this="" fact,="" fda="" is="" providing="" in="" proposed="" sec.="" 101.81(c)(2)(ii)="" that="" if="" a="" full="" statement="" of="" the="" claim="" appears="" on="" a="" label="" or="" in="" a="" piece="" of="" labeling,="" other="" presentations="" of="" the="" claim="" may="" appear="" on="" the="" label="" or="" in="" labeling="" that="" do="" not="" include="" the="" information="" required="" in="" proposed="" sec.="" 101.81(c)(2)(i)(c)(2)="" so="" long="" as="" there="" is="" a="" referral="" statement="" to="" the="" full="" statement="" of="" the="" claim="" in="" immediate="" proximity="" with="" the="" shortened="" statement.="" fda="" has="" explained="" above="" the="" basis="" for="" its="" tentative="" conclusion="" that="" the="" shortened="" claim="" need="" not="" include="" the="" information="" in="" paragraph="" (c)(2)(i)(c)(2)="" regarding="" the="" importance="" of="" low="" saturated="" fat="" and="" cholesterol="" diet.="" the="" referral="" statement="" that="" fda="" is="" proposing="" accompany="" the="" shortened="" claim="" is="" consistent="" with="" that="" provided="" for="" in="" the="" general="" requirements="" for="" nutrient="" content="" claims="" (sec.="" 101.13)="" and="" health="" claims="" (sec.="" 101.14(d)(2)(iv)).="" this="" referral="" statement="" is="" short="" and="" thus="" consistent="" with="" the="" use="" of="" an="" abbreviated="" claim.="" it="" is="" important,="" however,="" because="" the="" agency="" tentatively="" finds="" that="" it="" is="" essential="" that="" the="" consumer="" be="" directed="" to="" the="" full="" claim.="" specifically="" drawing="" the="" consumer's="" attention="" to="" the="" full="" claim="" will="" help="" to="" ensure="" that="" he="" or="" she="" is="" able="" to="" comprehend="" the="" information="" that="" is="" being="" presented="" in="" the="" context="" of="" the="" total="" daily="" diet.="" in="" its="" 1993="" health="" claims="" final="" rule,="" the="" agency="" stated="" that="" it="" did="" not="" believe="" that="" it="" is="" appropriate="" to="" use="" abbreviated="" health="" claims="" as="" referral="" statements="" (58="" fr="" 2478="" at="" 2512).="" the="" agency="" was="" concerned="" that="" an="" abbreviated="" claim="" would="" not="" include="" facts="" that="" are="" material="" in="" light="" of="" the="" representation="" that="" is="" made="" and="" that="" are="" necessary="" to="" understand="" the="" claim="" in="" the="" context="" of="" the="" daily="" diet.="" the="" agency="" was="" concerned="" that="" confusion="" is="" possible="" whenever="" the="" full="" health="" claim="" information="" appears="" in="" a="" location="" different="" from="" that="" of="" the="" reference="" statement="" and="" is="" especially="" likely="" to="" occur="" when="" a="" multiplicity="" of="" labeling="" is="" associated="" with="" a="" product.="" the="" agency="" has="" tentatively="" concluded="" that="" this="" proposed="" rule="" addresses="" these="" concerns.="" it="" is="" providing="" for="" an="" abbreviated="" statement="" that="" reflects="" the="" facts="" that="" are="" material="" under="" section="" 201(n)="" of="" the="" act="" (21="" u.s.c.="" 321(n))="" and="" that="" are="" necessary="" to="" ensure="" that="" the="" claim="" is="" scientifically="" valid.="" it="" is="" also="" providing="" for="" an="" accompanying="" referral="" statement="" to="" additional="" information="" that="" is="" necessary="" for="" a="" full="" understanding="" of="" the="" claim.="" the="" agency="" is="" concerned,="" however,="" about="" the="" possibility="" that="" consumers="" may="" not="" read="" the="" complete="" claim,="" and="" thus="" that="" they="" will="" not="" have="" all="" of="" the="" facts="" necessary="" to="" fully="" understand="" the="" significance="" of="" the="" claim="" being="" made="" and="" to="" comprehend="" the="" claim="" in="" the="" context="" of="" the="" daily="" diet.="" for="" this="" reason,="" the="" agency="" is="" asking="" for="" data="" to="" demonstrate="" that="" permitting="" a="" shortened="" claim="" in="" this="" manner="" will="" not="" significantly="" decrease="" the="" likelihood="" that="" consumers="" will="" read="" the="" full="" claim="" so="" long="" as="" it="" appears="" prominently="" on="" the="" label="" or="" in="" the="" piece="" of="" labeling.="" in="" new="" sec.="" 101.81="" (c)(2)(ii)(a)="" and="" (c)(2)(ii)(b),="" the="" agency="" is="" proposing,="" consistent="" with="" requirements="" for="" nutrient="" content="" claims="" in="" sec.="" 101.13="" (g)(1)="" and="" (g)(2),="" requirements="" for="" the="" typesize="" and="" location="" of="" the="" referral="" statement.="" fda="" has="" long="" held="" that="" accompanying="" information="" should="" be="" in="" a="" size="" reasonably="" related="" to="" that="" of="" the="" information="" that="" it="" modifies.="" section="" 403(f)="" of="" the="" act="" requires="" that="" information="" required="" under="" the="" act="" be="" placed="" on="" the="" label="" with="" such="" conspicuousness="" as="" to="" render="" it="" likely="" to="" be="" read.="" section="" 403(r)(2)(b)="" of="" the="" act="" requires="" that="" a="" referral="" statement="" for="" nutrient="" content="" claims="" appear="" prominently,="" although="" it="" does="" not="" specify="" specific="" requirements="" such="" as="" to="" typesize="" or="" style.="" for="" nutrient="" content="" claims,="" fda="" established="" type="" size="" requirements="" for="" referral="" and="" disclosure="" statements="" related="" to="" the="" area="" of="" the="" surface="" bearing="" the="" principal="" display="" panel="" rather="" than="" to="" the="" type="" size="" used="" for="" the="" nutrient="" content="" claim.="" the="" proportionality="" between="" the="" size="" of="" the="" referral="" statement="" and="" the="" size="" of="" the="" label="" ensures="" that="" the="" referral="" statement="" is="" presented="" with="" appropriate="" prominence.="" however,="" when="" the="" claim="" is="" less="" than="" twice="" what="" the="" minimum="" size="" of="" the="" referral="" statement="" would="" be="" given="" the="" size="" of="" the="" label="" and="" sec.="" 101.105(i)="" (21="" cfr="" 101.105(i))="" the="" type="" size="" of="" the="" referral="" statement="" may="" be="" less="" than="" that="" required="" under="" sec.="" 101.105="" for="" net="" quantity="" of="" contents.="" in="" such="" circumstances,="" the="" referral="" statement="" is="" of="" appropriate="" prominence="" if="" it="" is="" at="" least="" one-half="" the="" size="" of="" the="" claim="" and="" not="" less="" than="" one-="" sixteenth="" of="" an="" inch.="" this="" approach="" to="" the="" type="" size="" requirement="" for="" the="" referral="" statement="" provides="" flexibility="" to="" firms="" in="" utilizing="" label="" space="" but="" still="" ensures="" adequate="" prominence="" for="" this="" statement.="" because="" health="" claim="" referral="" statements="" are="" used="" similarly="" to="" those="" that="" accompany="" nutrient="" content="" claims="" and="" are="" likely="" to="" appear="" on="" the="" principal="" display="" panel,="" the="" agency="" tentatively="" concludes="" that="" a="" health="" claim="" referral="" statement="" should="" have="" the="" same="" type="" size="" requirements="" as="" those="" for="" nutrient="" content="" claims.="" therefore,="" the="" agency="" tentatively="" concludes="" that="" the="" requirements="" for="" the="" referral="" statement="" set="" forth="" in="" sec.="" 101.105="" (c)(2)(ii)(a)="" and="" (c)(2)(ii)(b)="" are="" appropriate="" when="" a="" shortened="" health="" claim="" is="" used="" and="" is="" including="" them="" in="" this="" proposed="" rule.="" d.="" nature="" of="" the="" food="" proposed="" sec.="" 101.81(c)(2)(iii)(a)="" requires="" that="" the="" food="" bearing="" the="" health="" claim="" contain="" 13="" g="" of="" oat="" bran="" or="" 20="" g="" [[page="" 308]]="" oatmeal,="" and="" that="" the="" oat="" bran="" or="" oatmeal="" contain,="" without="" fortification,="" at="" least="" 1.0="" g="" of="">-glucan soluble fiber. The
paragraph states that oat -glucan be determined by the
Association of Official Analytical Chemists (AOAC) official method
(i.e., method 992.28), per reference amount customarily consumed
(RACC).
The requirement that the food contain oat bran or oatmeal is
consistent with the scientific evidence that shows that oat bran or
oatmeal, when consumed as a food or as an ingredient in food, helps to
lower total and LDL-cholesterol.
The agency is not proposing to permit a claim for oat gums or oat
fibers, substances that may be manufactured by different methods and
are not well defined chemically or physically. These substances, like
all food fibers, are a complex matrix and factors, such as the
fermentability; particle size; molecular weight; chemical structure;
water holding capacity; nonfiber components; net charge; viscosity; and
cation-exchange capacity, binding, and chelation, may affect their
physiological properties (Ref. 7).
The effects of processing on the physiological properties of oat
bran were evidenced in three studies. In a study by Torronen et al.
(Ref. 38), a specially processed oat bran concentrate incorporated into
bread to provide 11.2 g/d -glucan showed no effect on lowering
serum lipids in a controlled study with hypercholesterolemic subjects.
Two other studies testing a specially processed oat fiber source
providing 3.3 g/d -glucan soluble fiber (Ref. 35) and oat gum
providing 5.8 g/d -glucan soluble fiber (Ref. 12) showed
significant reductions in blood total and LDL-cholesterol levels. The
latter two studies showing a cholesterol-lowering response did not
adequately characterize the material being tested to permit their (oat
fiber source and oat gum) inclusion in the regulations, however. If
manufacturers can document, through appropriate studies, that dietary
consumption of a well-characterized oat product, e.g., purified
extracts of oat gum or modified oat fiber isolates, has the effect of
lowering total and LDL-cholesterol levels, and has no adverse effects
on other heart disease risk factors (e.g., HDL-cholesterol), they
should submit that information in comments or petition FDA to amend
Sec. 101.81 to cover the substance.
Because the subject of this health claim petition is the effect of
oatmeal or oat bran on the risk of CHD, it is appropriate to consider
the levels of oat bran and of oatmeal intake that have been shown to
have significant effects on the levels of serum total and LDL-
cholesterol in establishing qualifying levels for foods to bear an
oatmeal or oat bran and CHD health claim. In the clinical studies that
showed that consumption of oatmeal or oat bran lowered total and LDL-
cholesterol, daily consumption ranged from 35 g (Ref. 43) to 84 g (Ref.
15) of oat bran and 34 g (Ref. 17) to 150 g (Ref. 39) of oatmeal. Based
on values provided in the petition, 35 g of oatmeal would provide about
1.75 g of -glucan soluble fiber, and 34 g of oat bran would
provide about 2.5 g of -glucan soluble fiber (Ref. 1, p. 66).
The higher the daily intake of oatmeal and oat bran, the higher the
intake of -glucan soluble fiber and the better the response in
lowering serum lipids. This observation is supported by the
metaanalysis of oat products by Ripsin et al. (Ref. 33) and is
consistent with the agency's comments on the Davidson et al. study
(Ref. 15) in the preamble to the 1993 dietary fiber and CVD final rule
(58 FR 2552 at 2568):
* * * [B]ased on the results of this study, an intake of soluble
fiber (in this case, -glucan from oats) of about 3 g per
day or more was beneficial in that it resulted in a significant
lowering of serum cholesterol in persons consuming a low-fat diet.
An intake of 3 g of -glucan soluble fiber is equivalent to
approximately 60 g of oatmeal or 40 g of oat bran (dry weight) (Ref. 1,
p. 67), the approximate midpoints of the consumption ranges of oat bran
and oatmeal that had an effect on blood lipids. The petitioner
suggested that 40 g of oat bran, 60 g of oatmeal, and 3 g -
glucan soluble fiber be considered as the standard for determining the
qualifying levels of oat bran and oatmeal for this health claim.
Applying a regression analysis to the results of Davidson et al. (Ref.
15), and using -glucan soluble fiber as a marker for oat bran
and oatmeal, the petitioner determined that 3 g -glucan would
be required to achieve a 5 percent reduction in serum cholesterol (Ref.
1, p. 22-27). The petition stated that a 5 percent reduction in serum
cholesterol is a desirable goal because that is the level that was
achieved as a result of a dietary fat and cholesterol focused
intervention in the Multiple Risk Factor Intervention Trial (MRFIT) and
Lipid Research Council (LRC) clinical trials (Refs. 1 and 40).
The petitioner stated that while current research may not
demonstrate that -glucan is the only component of oats that
affects blood lipids, it does suggest that it is an excellent marker
for cholesterol reduction potential (Ref. 1, p. 64). The petitioner
stated that the amount of -glucan also serves as a marker for
the content of oat bran and oatmeal in foods. Using 40 g of oat bran,
60 g of oatmeal, and 3 g -glucan as the qualifying amounts for
a CHD claim, the petitioner suggested that a single serving of an oat-
containing product (i.e., 1 RACC) should provide \1/3\ of this amount
(based on 3 servings a day). Thus, an oat bran-containing product would
have to contain at least 13 g oat bran (\1/3\ x 40 g) that provides 1
g -glucan (\1/3\ x 3 g) soluble fiber per RACC. An oatmeal-
containing product would have to contain no less than 20 g oatmeal (\1/
3\ x 60) that provides 1 g -glucan soluble fiber. The
petitioner stated that this approach is reasonable because it would
permit a wide variety of low fat, oat-containing products, e.g.,
muffins, cereals, and breads, to qualify for this health claim. The
petitioner provided several examples of meals, developed on the basis
of U.S. Dietary Guidelines, that demonstrated how 40 g of oat bran and
60 g of oatmeal, providing 3 g of -glucan soluble fiber, could
be incorporated into a diet that is consistent with dietary guidelines
(Ref. 1, pp. 43-54).
The agency agrees that, based on Davidson et al. (Ref. 15), the
metaanalysis (Ref. 33), and other studies that reported the amount of
-glucan soluble fiber in oat products, 3 or more grams of oat
-glucan soluble fiber were associated with significant
reductions in serum cholesterol. The agency also agrees that not all
oat bran or oatmeal-containing products that might otherwise qualify
for this claim contain that amount per RACC of oat product. Based on
nutrient composition data presented in the petition (Ref. 1, pp. 38-
39), only oat bran hot and cold cereals contain 3 g -glucan
soluble fiber would qualify for this proposed health claim. Thus,
limiting eligibility for the claim to products with 3 g -
glucan soluble fiber would have the unintended effect of eliminating a
number of low fat, oat-containing products, e.g., oatmeal cereals,
oatmeal waffles, oat bran muffins, and oatmeal breads, from bearing an
oatmeal or oat bran and CHD health claim.
The petition states that the most common oat food forms are oat
bran and oatmeal consumed as hot cereals (Ref. 1, p.33). The mean daily
dietary intake by oat consumers of oatmeal and oat bran hot cereals is
43.3 g (dry weight basis) and the median intake is 40.1 g (Ref. 1, p.
33). The petition states that the 90th and 95th percentiles of intake
are 71.3 and 84.2 g (dry weight basis) per day, respectively.
Therefore, it is reasonable to assume that a person could consume a
total of, or more than, 40 g oat bran, 60 g oatmeal, or a combination
of the
[[Page 309]]
two that provides 3 g -glucan soluble fiber if the oat
products are consumed over the course of a day.
The agency has generally made the assumption that a daily food
consumption pattern includes three meals and a snack (see 58 FR 2302 at
2379, January 6, 1993). Therefore, one approach to determining the
qualifying levels of oat bran, oatmeal, and oat -glucan
soluble fiber for a CHD health claim is to divide the effective levels
of these substances by four eating occasions per day. Using this
approach, an oat bran product would have to provide at least 10 g of
oat bran and 0.75 g -glucan soluble fiber, and an oatmeal
product would have to provide at least 15 g of oatmeal and 0.75 g
-glucan soluble fiber per RACC in order to qualify to bear an
oat and CHD health claim. However, considering that the mean daily
dietary intake of oatmeal and oat bran is 43 g, and that that amount is
consumed mostly in the form of hot cereal, and considering the nature
of this food, it is not expected that people will consume oat-
containing products 4 times a day. The agency is persuaded by the
petitioner's argument that oat products can reasonably be expected to
be consumed 3 times a day, being incorporated into a variety of
products. Thus, an oat bran-containing product would have to provide no
less than 13 g oat bran and 1 g -glucan soluble fiber per
RACC, and an oatmeal- containing product would have to provide no less
than 20 g oatmeal and 1 g -glucan soluble fiber. Therefore,
the agency tentatively finds that use of 13 g oat bran and 20 g oatmeal
that provide 1 g -glucan soluble fiber as the qualifying
criteria for this proposed rule is appropriate and is proposing these
levels in this document.
The proposed qualifying requirement of 1 g -glucan soluble
fiber per RACC of oat bran or oatmeal-containing product is higher than
the amount of soluble fiber that is required for a food to qualify to
bear the fruits, vegetables, and grain products and CHD health claim
(Sec. 101.77). Under Sec. 101.77(c)(ii)(C), a food need only contain,
without fortification, 0.6 g soluble fiber per RACC. In the preamble to
the 1993 dietary fiber and CVD final rule, the agency explained that
the 0.6 g of soluble fiber was based in part on the recommendation by
the LSRO expert panel that 25 percent of the recommended daily intake
of fiber be soluble fiber (58 FR 2552 at 2573 and 2574). The agency
also stated that the 0.6 g soluble fiber is consistent with the
definition of a ``good source'' of a nutrient (i.e., 10 percent of the
daily reference value (DRV)). The agency explained that the 10 percent
level is deemed useful and appropriate because very few foods could
naturally meet the requirement for a ``high'' source of soluble fiber.
The current dietary guidance recommendations of five or more servings
of fruits and vegetables and six or more servings of grain products
daily, if followed, would likely result in intakes of soluble fiber
close to or exceeding the recommended daily intake of 6 g (58 FR 2552
at 2574). Thus, the 0.6 g of soluble fiber was intended to allow a
number of fruits, vegetables, and grain products to qualify. The agency
stated that without this alternate level very few fruits, vegetables,
and grain products would qualify for the health claim (58 FR 2552 at
2574).
Based on the scientific evidence reviewed in this document, higher
daily intakes of oat bran and oatmeal (about 40 g and 60 g,
respectively) that provided 3 g/d or more of -glucan soluble
fiber were associated with significant cholesterol-lowering benefits
(Refs. 15 and 33). As discussed above, it is reasonable to assume that
oat bran and oatmeal would likely not be consumed in more than three
eating occasions per day. Therefore, the agency tentatively finds that
the proposed criterion that the oat bran or oatmeal provide 1 g
-glucan soluble fiber per RACC is appropriate for this health
claim. The agency is asking for comments on this tentative
determination.
In Sec. 101.81(c)(2)(iii)(B), the agency is proposing, consistent
with other authorized heart disease health claims, that foods bearing
the health claim meet requirements for ``low saturated fat,'' ``low
cholesterol,'' and ``low fat.'' In the preamble to the final rule on
fruits, vegetables, and grain products and heart disease (Sec. 101.77,
58 FR 2552 at 2572), the agency stated that populations with diets rich
in these low saturated fat and low cholesterol foods experience many
health advantages, including lower rates of heart disease. In the
preamble to the proposed rule on dietary lipids and heart disease (56
FR 60727 at 60739), the agency stated that while total fat is not
directly linked to increased risk of CHD, it may have significant
indirect effects. Foods that are low in total fat facilitate reductions
in intakes of saturated fat and cholesterol to recommended levels.
Therefore, the agency tentatively concludes that proposed
Sec. 101.81(c)(2)(iii)(B) sets forth an appropriate requirement for
food to be eligible to bear the oatmeal and oat bran/CHD claim.
E. Optional Information
FDA is proposing in Sec. 101.81(d)(1) that the claim may state that
the development of heart disease depends on many factors and,
consistent with authorized CHD health claims, may list the risk factors
for heart disease that are listed in Secs. 101.75(d)(1) and
101.77(d)(1). The agency is also proposing, in response to the
petition, that the claim may provide additional information about the
benefits of exercise and body weight management. This additional
information can provide a context that is useful for an understanding
of the relationship between oat bran and oatmeal and heart disease, but
manufacturers should be cautioned that it should not be presented in a
way that is misleading to the consumer.
In proposed Sec. 101.81(d)(2), consistent with Secs. 101.75(d)(2)
and 101.77(d)(2), FDA is providing that the claim may state that the
relationship between a diet high in oat bran or oatmeal and reduced
risk of heart disease is through the intermediate link of ``blood
cholesterol'' or ``blood total cholesterol'' and ``LDL- cholesterol.''
The relationship between oat bran or oatmeal and reduced blood total
cholesterol and LDL-cholesterol is supported by the scientific evidence
presented in this proposal.
In Sec. 101.81(d)(3), the agency is proposing that, consistent with
Secs. 101.75(d)(3) and 101.77(d)(3), the claim may include information
from Sec. 101.81(a) and (b). These paragraphs summarize information
regarding the relationship between diets high in oat bran or oatmeal
and the risk of CHD and about the significance of that relationship.
This information helps to convey the seriousness of CHD and the role
that a diet high in oat bran and oatmeal can play to help reduce the
risk of CHD.
In Sec. 101.81(d)(4), the agency is proposing that the claim may
state that oat bran or oatmeal are good sources of dietary fiber,
particularly soluble fiber. In referring to the fiber components the
claim may use the terms ``fiber,'' ``dietary fiber,'' and ``soluble
fiber.'' If the term ``soluble fiber'' is used in the claim, the
declaration of soluble fiber content is required. This proposed
provision is consistent with Sec. 101.9(c)(6)(i)(A), which states that
the declaration of soluble fiber on the nutrition label is voluntary,
except that when a claim is made on the label or in labeling about
soluble fiber, label declaration is required.
The agency is proposing that the claim may include any of the
optional information authorized to be included
[[Page 310]]
in Secs. 101.75(d)(5), (d)(6), and (d)(7) and 101.77(d)(5), (d)(6), and
(d)(7). The health claim may state that diets high in oat bran or
oatmeal and low in saturated fat and cholesterol are part of a dietary
pattern that is consistent with dietary guidelines for Americans. The
claim may state that individuals with elevated serum lipids should
consult their physicians for medical advice and treatment and may
include information on the prevalence of CHD in the United States. The
intent of this information is to provide consumers with information
that will help them understand the seriousness of CHD in the United
States and to help them understand that diets high in oat bran or
oatmeal are consistent with dietary guidelines.
In proposed Sec. 101.81(d)(8), in response to the petition, the
claim may provide information about the amount of food, such as bowls,
servings or slices, to be consumed daily. This information may give the
consumer a better perspective on how much oat bran and oatmeal is
needed to help lower serum cholesterol levels.
F. Model Health Claims
In proposed Sec. 101.81(e), FDA is providing model health claims to
illustrate the requirements of new Sec. 101.81. FDA emphasizes that
these model health claims are illustrative only. These model claims
illustrate the required, and some of the optional, elements of the
proposed rule. If the agency authorizes a claim about the relationship
between oat products and CHD, manufacturers will be free to design
their own claim so long as it is consistent with Sec. 101.81(c).
In Sec. 101.81(e)(1), the model claim illustrates all of the
required elements of the proposed health claim. The claim states
``Diets high in [oat bran or oatmeal] and low in saturated fat and
cholesterol may reduce the risk of heart disease.''
In Sec. 101.81(e)(2), the model claims provide examples of a
shortened claim with the required referral statement.
VI. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(11) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
VII. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity).
The Regulatory Flexibility Act requires analyzing options for
regulatory relief for small businesses. FDA finds that this proposed
rule is not a significant rule as defined by Executive Order 12866. In
accordance with the Regulatory Flexibility Act, the agency certifies
that the proposed rule will not have a significant impact on a
substantial number of small businesses.
This proposed rule will not result in significant costs to
industry. Some oat manufacturers are currently using FDA's approved
health claim regarding the benefits of fruits, vegetables, and grain
products. This proposed health claim will allow them to specifically
highlight the benefits of oat bran and oatmeal. Consumers will benefit
from the additional information regarding the relationship of oat
products and CHD.
VIII. Paperwork Reduction Act
FDA tentatively concludes that this proposed rule contains no
reporting, recordkeeping, labeling, or other third party disclosure
requirements; thus there is no ``information collection'' necessitating
clearance by the Office of Management and Budget. However, to ensure
the accuracy of this tentative conclusion, FDA is seeking comment on
whether this proposed rule to permit health claims on the association
between oat products (i.e., oat bran and oatmeal) and reduced risk of
CHD imposes any paperwork burden.
IX. Effective Date
FDA is proposing to make these regulations effective upon
publication in the Federal Register of a final rule based upon this
proposal.
X. Comments
Interested persons may, on or before April 3, 1996, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
XI. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. The Quaker Oats Co., ``Petition for Health Claim--Oat Products
and Coronary Heart Disease,'' March 22, 1995 [CP1].
2. Scarbrough, F. Edward, CFSAN, FDA, Letter to Ted Moeller, Quaker
Oats Co., June 29, 1995.
3. DHHS, Public Health Service (PHS), ``The Surgeon General's Report
on Nutrition and Health,'' U.S. Government Printing Office,
Washington, DC, pp. 83-137, 1988.
4. National Research Council, National Academy of Sciences, ``Diet
and Health,'' National Academy Press, Washington, DC, pp. 291-309
and 529-547, 1989.
5. DHHS, PHS, and the National Institutes of Health (NIH),
``National Cholesterol Education Program: Report of the Expert Panel
on Detection, Evaluation, and Treatment of High Blood Cholesterol in
Adults,'' NIH, Bethesda, MD, pp. 1-79, 1989.
6. DHHS, PHS, and NIH, ``National Cholesterol Education Program:
Population Panel Report,'' Bethesda, MD, pp. 1-27, 1989.
7. LSRO, FASEB, ``Physiological Effects and Health Consequences of
Dietary Fiber,'' Bethesda, MD, 1987.
8. Anderson, J. W., N. H. Gilinsky, D. A. Deakins, S. F. Smith, D.
S. O'Neal, D. W. Dillon, and P. R. Oeltgen, ``Lipid Responses of
Hypercholesterolemic Men to Oat-bran and Wheat Bran Intake,''
American Journal of Clinical Nutrition, 54:678-683, 1991.
9. Anderson, J. W., D. B. Spencer, C. C. Hamilton, S. F. Smith, J.
Tietyen, C. A. Bryant, and P. Oeltgen, ``Oat-bran Cereal Lowers
Serum Total and LDL Cholesterol in Hypercholesterolemic Men,''
American Journal of Clinical Nutrition, 52:495-499, 1990.
10. Bartram, P., S. Gerlach, W. Scheppach, F. Keller, and H. Kasper,
``Effect of a Single Oat Bran Cereal Breakfast on Serum Cholesterol,
Lipoproteins, and Apolipoproteins in Patients with
Hyperlipoproteinemia Type IIa,'' Journal of Parenteral and Enteral
Nutrition, 16:533-537, 1992.
11. Beling, S., L. Detrick, and W. Castelli, ``Serum Cholesterol
Response to a Processed Oat Bran Cereal Among Hypercholesterolemics
on a Fat-modified Diet,'' unpublished clinical trial submitted by
the Quaker Oats Co., 1991.
12. Braaten, J. T., P. J. Wood, F. W. Scott, M. S. Wolyneta, M. K.
Lowe, P. Bradley-White, M. W. Collins, ``Oat Beta-glucan Reduces
Blood Cholesterol Concentration in Hypercholesterolemic Subjects,''
European Journal of Clinical Investigation, 48:465-474, 1994.
[[Page 311]]
13. Bremer, J. M., R. S. Scott, and C. J. Lintott, ``Oat Bran and
Cholesterol Reduction: Evidence Against Specific Effect,'' Australia
and New Zealand Journal of Medicine, 21:422-426, 1991.
14. Cara, L., C. Cubois, P. Borel, M. Armand, M. Senft, H. Portugal,
A. M. Pauli, P. M. Bernard, and D. Lairon, ``Effects of Oat Bran,
Rice Bran, Wheat Fiber, and Wheat Germ on Postprandial Lipemia in
Healthy Adults,'' American Journal of Clinical Nutrition, 55:81-88,
1992.
15. Davidson, M. H., L. D. Dugan, J. H. Burns, J. Bova, K. Story,
and K. B. Drennan, ``The Hypocholesterolemic Effects of Beta-glucan
in Oatmeal and Oat Bran--a Dose-Controlled Study,'' Journal of the
American Medical Association, 265(14):1833-1839, 1991.
16. Demark-Wahnefried, W., J. Bowering, and P. S. Cohen, ``Reduced
Serum Cholesterol with Dietary Change Using Fat-Modified and Oat
Bran Supplemented Diets,'' Journal of the American Dietetic
Association, 90:223-229, 1990.
17. Gold, K. V., and D. M. Davidson, ``Oat Bran as a Cholesterol-
reducing Dietary Adjunct in a Young, Healthy Population,'' Western
Journal of Medicine, 148:299-302, 1988.
18. Gormley, T. R., J. Kevany, J. P. Egan, and R. McFarland,
``Investigation of the Potential of Porridge as a
Hypocholesterolemic Agent,'' Israel Journal of Food Science and
Technology, 2:85-91, 1978.
19. He, J., M. J. Klag, P. K. Whelton, J-P. Mo, J-Y. Chen, P-S. Mo,
and G-Q. He, ``Oats and Buckwheat Intakes and Cardiovascular Disease
Risk Factors in an Ethnic Minority of China,'' American Journal of
Clinical Nutrition, 61:366-372, 1995.
20. Hegsted, M., M. M. Windhauser, K. Morris, and S. B. Lester,
``Stabilized Rice Bran and Oat Bran Lower Cholesterol in Humans,''
Nutrition Research, 13:387-398, 1993.
21. Kahn, R. F., K. W. Davidson, J. Garner, and R. S. McCord, ``Oat
Bran Supplementation for Elevated Serum Cholesterol,'' Family
Practice Research Journal, 10:37-46, 1990.
22. Kastan, H. H., S. Stern, D. J. A. Jenkins, K. Hay, N. Marcon, S.
Minkin, and W. R. Bruce, ``Wheat Bran and Oat-bran Supplements'
Effects on Blood Lipids and Lipoproteins,'' American Journal of
Clinical Nutrition, 55:976-980, 1992.
23. Keenan, J. M., J. B. Wenz, S. Myers, C. Ripsin, and Z. Huang,
``Randomized Controlled Cross-over Trial of Oat Bran in
Hypercholesterolemic Subjects,'' Journal of Family Practice, 33:600-
608, 1991.
24. Kelley, M. J., J. Hoover-Plow, J. F. Nichols-Bernhard, L.S.
Verity, and H.B. Brewer, ``Oat Bran Lowers Total and Low-Density
Lipoprotein Cholesterol but Not Lipoprotein in Exercising Adults
with Borderline Hypercholesterolemia,'' Journal of the American
Dietetic Association, 94:1419-1421, 1994.
25. Kestin, M., R. Moss, P. M. Clifton, and P. J. Nestel,
``Comparative Effects of Three Cereal Brans on Plasma Lipids, Blood
Pressure, and Glucose Metabolism in Mildly Hypercholesterolemic
Men,'' American Journal of Clinical Nutrition, 52:661-666, 1990.
26. Leadbetter, J., M. J. Ball, and J. I. Mann, ``Effects of
Increasing Quantities of Oat Bran in Hypercholesterolemic People,''
American Journal of Clinical Nutrition, 54:841-845, 1991.
27. Lepre, F., and S. Crane, ``Effect of Oat Bran on Mild
Hyperlipidaemia,'' The Medical Journal of Australia, 157:305-306,
1992.
28. Mackay, S., and M. J. Ball, ``Do Beans and Oat Bran Add to the
Effectiveness of a Low-fat Diet?'', European Journal of Clinical
Nutrition, 46:641-648, 1992.
29. Marlett, J. A., K. B. Hosig, N. W. Vollendorf, F. L. Shinnick,
V.S. Haack, and J. A. Story, ``Mechanism of Serum Cholesterol
Reduction by Oat Bran,'' Hepatology, 20:1450-1457, 1994.
30. O'Brien, L. T., R. J. Barnard, and J. A. Hall, ``Effects of a
High-Complex-Carbohydrate Low-cholesterol Diet plus Bran Supplement
on Serum Lipids,'' Journal of Applied Nutrition, 37:26-34, 1985.
31. O'Kell, R. T., and A. A. Duston, ``Lack of Effect of Dietary
Oats on Serum Cholesterol,'' Missouri Medicine, 85:726-728, 1988.
32. Poulter, N., C. L. Chang, A. Cuff, C. Poulter, P. Sever, and S.
Thom, ``Lipid Profiles after the Daily Consumption of an Oat-Based
Cereal: A Controlled Crossover Trial,'' American Journal of Clinical
Nutrition, 58:66-69, 1993.
33. Ripsin, C. M., J. M. Keenan, D. R. Jacobs, P. J. Elmer, R. R.
Welch, L. Van Horn, K. Liu, W. H. Turnbull, F. W. Thye, M. Kestin,
M. Hegsted, D. M. Davidson, M. H. Davidson, L. D. Dugan, W. Demark-
Wahnefried, and S. Beling, ``Oat Products and Lipid Lowering--A
Metaanalysis,'' Journal of the American Medical Association,
267:3317-3325, 1992.
34. Saudia, T. L., B. R. Barfield, and J. Barger, ``Effect of Oat
Bran Consumption on Total Serum Cholesterol Levels in Healthy
Adults,'' Military Medicine, 157:567-568, 1992.
35. Spiller, G. A., J. W. Farquhar, J. E. Gates, and S. F. Nichols,
``Guar Gum and Plasma Cholesterol, Effect of Guar Gum and an Oat
Fiber Source on Plasma Lipoproteins and Cholesterol in
Hypercholesterolemic Adults,'' Arteriosclerosis and Thrombosis,
11:1204-1208, 1991.
36. Stewart, F. M., J. M. Neutze, and R. Newsome-White, ``The
Addition of Oat Bran to a Low Fat Diet Has No Effect on Lipid Values
in Hypercholesterolaemic Subjects,'' New Zealand Medical Journal,
106:398-340, 1992.
37. Swain, J. F., I. L. Rouse, C. B. Curley, and F. M. Sacks,
``Comparison of the Effects of Oat Bran and Low Fiber Wheat on Serum
Lipoprotein Levels and Blood Pressure,'' New England Journal of
Medicine, 322:147-152, 1990.
38. Torronen, R., L. Kansanen, M. Uusitupa, O. Hanninen, O.
Myllymaki, H. Harkonen, and Y. Malkki, ``Effects of an Oat Bran
Concentrate on Serum Lipids in Free-Living Men with Mild to Moderate
Hypercholesterolaemia,'' European Journal of Clinical Nutrition,
46:621-627, 1992.
39. Turnbull, W. H., and A. R. Leeds, ``Reduction of Total and LDL-
cholesterol in Plasma by Rolled Oats,'' Journal of Clinical
Nutrition and Gastroenterology, 2:1-4, 1987.
40. Grover, S. A., M. Abrahamowicz, L. Joseph, C. Brewer, L. Coupal,
S. Suissa, ``The Benefits of Treating Hyperlipidemia to Prevent
Coronary Heart Disease,'' Journal of the American Medical
Association, 267:816-822, 1992.
41. Uusitupa, M. I. J., E. Ruuskanen, E. Makinen, J. Laitinen, E.
Toskala, K. Kervinen, and A. Kesaniemi, ``A Controlled Study on the
Effect of Beta-Glucan-Rich Oat Bran on Serum Lipids in
Hypercholesterolemic Subjects: Relation to Apolipoprotein E
Phenotype,'' Journal of the American College of Nutrition, 11:651-
659, 1992.
42. Van Horn, L., L. A. Emidy, K. Liu, Y. Liao, C. Ballew, J. King,
and J. Stamler, ``Serum Lipid Response to a Fat-Modified, Oatmeal-
Enhanced Diet,'' Preventive Medicine, 17:377-386, 1988.
43. Van Horn, L., K. Liu, D. Parker, L. Emidy, Y. Liao, W. H. Pan,
D. Giumetti, J. Hewitt, and J. Stamler, ``Serum Lipid Response to
Oat Product Intake with a Fat-Modified Diet,'' Journal of the
American Dietetic Association, 86:759-764, 1986.
44. Van Horn, L., A. Moag-Stahlberg, K. Liu, C. Ballew, K. Ruth, R.
Hughes, J. Stamler, ``Effects on Serum Lipids of Adding Instant Oats
to Usual American Diets,'' American Journal of Public Health,
81:183-188, 1991.
45. Whyte, J., R. McArthur, D. Topping, and P. Nestel, ``Oat Bran
Lowers Plasma Cholesterol in Mildly Hypercholesterolemic Men,''
Journal of the American Dietetic Association, 92:446-449, 1992.
46. Zhang, J. G. Hallmans, H. Andersson, I. Bosaeur, P. Aman, P.
Tidehag, R. Stenling, E. Lundin, and S. Dahlgren, ``Effect of Oat
Bran on Plasma Cholesterol and Bile Acid Excretion in Nine Subjects
With Ileostomies,'' American Journal of Clinical Nutrition, 56:99-
105, 1992.
47. Sempos, C. T., J. I. Cleeman, M. D. Carroll, C. L. Johnson, P.
S. Bachorik, D. J. Gordon, V. L. Burt, R. R. Briefel, C. D. Brown,
K. Lippel, and B. M. Rifkind, ``Prevalence of High Blood Cholesterol
Among U.S. Adults. An Update Based on Guidelines from the Second
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1993.
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49. Saltsman, Joyce J., CFSAN, FDA, Memorandum to file, May 19,
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Processors Association, May 11, 1995.
List of Subjects in 21 CFR Part 101
Food labeling, Incorporation by reference, Nutrition, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 101 be amended as follows:
PART 101--FOOD LABELING
1. The authority citation for 21 CFR part 101 is revised to read as
follows:
Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act
(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 501,
502, 505, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321, 331, 342, 343, 348, 351, 352, 355, 371).
2. New Sec. 101.81 is added to subpart E to read as follows:
Sec. 101.81 Health claims: Oat products and risk of coronary heart
disease.
(a) Relationship between diets high in oatmeal and oat bran and the
risk of coronary heart disease. (1) Cardiovascular disease means
diseases of the heart and circulatory system. Coronary heart disease
(CHD) is the most common and serious form of cardiovascular disease and
refers to diseases of the heart muscle and supporting blood vessels.
High blood total cholesterol and low density lipoprotein (LDL)-
cholesterol levels are associated with increased risk of developing
CHD. High CHD rates occur among people with high total cholesterol
levels of 240 milligrams per deciliter (mg/dL) (6.21 millimoles per
liter (mmol/L)) or above and LDL-cholesterol levels of 160 mg/dL (4.13
mmol/L) or above. Borderline high risk total cholesterol levels range
from 200 to 239 mg/dL (5.17 to 6.18 mmol/L) and 130 to 159 mg/dL (3.36
to 4.11 mmol/L) of LDL-cholesterol. The scientific evidence establishes
that diets high in saturated fat and cholesterol are associated with
increased levels of blood total- and LDL-cholesterol and, thus, with
increased risk of coronary heart disease.
(2) Populations with a low incidence of coronary heart disease tend
to have relatively low blood total cholesterol and LDL-cholesterol
levels. These populations also tend to have dietary patterns that are
not only low in total fat, especially saturated fat, and cholesterol
but are also relatively high in fiber-containing fruits, vegetables,
and grain products, such as oatmeal and oat bran.
(3) Oat bran and oatmeal are low in saturated fat and cholesterol
and a good source of soluble fiber. Scientific evidence demonstrates
that diets high in these oat products are associated with reduced blood
total and LDL-cholesterol levels.
(b) Significance of the relationship between diets high in oatmeal
and oat bran and the risk of coronary heart disease. (1) Coronary heart
disease is a major public health concern in the United States. It
accounts for more deaths than any other disease or group of diseases.
Early management of risk factors for coronary heart disease is a major
public health goal that can assist in reducing the risk of coronary
heart disease. High blood total and LDL-cholesterol are major
modifiable risk factors in the development of CHD.
(2) Intakes of saturated fat exceed recommended levels in the diets
of many people in the United States. Intakes of cholesterol are, on
average, at or above recommended levels. One of the major public health
recommendations relative to coronary heart disease risk is to consume
less than 10 percent of calories from saturated fat and an average of
30 percent or less of total calories from all fat. Recommended daily
cholesterol intakes are 300 mg or less per day. Scientific evidence
demonstrates that diets high in oat bran and oatmeal and low in
saturated fat and cholesterol are associated with lower blood total and
LDL-cholesterol levels.
(c) Requirements. (1) All requirements set forth in Sec. 101.14
shall be met.
(2) Specific requirements. (i) Nature of the claim. A health claim
associating diets high in oatmeal or oat bran with reduced risk of
coronary heart disease may be made on the label or labeling of a food
described in paragraph (c)(2)(iii) of this section, provided that:
(A) The claim states that oatmeal or oat bran ``may'' or ``might''
reduce the risk of heart disease.
(B) In specifying the disease, the claim uses the following terms:
``heart disease'' or ``coronary heart disease.''
(C) The claim states that:
(1) Diets high in oatmeal or oat bran may reduce the risk of
coronary heart disease; and
(2) The effect of dietary intake of oatmeal or oat bran on the risk
of coronary heart disease is particularly evident when these foods are
consumed as part of a diet that is low in saturated fat and
cholesterol.
(D) The claim does not attribute any degree of risk reduction for
coronary heart disease to diets high in oat bran or oatmeal and low in
saturated fat and cholesterol.
(E) The claim does not imply that consumption of oat bran or
oatmeal is the only recognized means of achieving a reduced risk of
coronary heart disease.
(ii) Presentation of the claim. All of the elements listed in
paragraph (c)(2)(i) of this section must be included in one
presentation of the claim displayed prominently on the label or in the
labeling on which the claim appears. Other presentations of the claim
on that label or labeling, including on the principal display panel,
need not include the information in paragraph (c)(2)(i)(C)(2) of this
section provided that, displayed prominently and in immediate proximity
to a shortened statement of the claim, the following referral statement
is used: ``See __________ for more information'' with the blank filled
in with the identity of the panel on which is presented the statement
of the claim that includes all of the elements in paragraph (c)(2)(i)
of this section.
(A) The referral statement ``See [appropriate panel] for more
information'' shall be in easily legible boldface print or type, in
distinct contrast to other printed or graphic matter, that is no less
than that required by Sec. 101.105(i) for net quantity of contents,
except where the size of the claim is less than 2 times the required
size of the net quantity of contents statement, in which case the
referral statement shall be no less than one-half the size of the claim
but no smaller than one-sixteenth of an inch.
(B) The referral statement shall be immediately adjacent to any
presentation of the health claim that does not include all of the
elements in paragraph (c)(2)(i) of this section, and there may be no
intervening material between the claim and the referral statement. If
the abbreviated health claim appears on more than one panel of the
label, the referral statement shall be adjacent to the claim on each
panel except for the panel that bears the full health claim, where it
may be omitted.
(iii) Nature of the food. (A) The food shall contain no less than
20 g oatmeal or 13 g oat bran that provides, without fortification, at
least 1 g of -glucan soluble fiber per reference amount
customarily consumed. Beta-glucan will be determined by method No.
992.28 from the ``Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 15th ed. (1993), which is
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incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies may be obtained from the Association of Official
Analytical Chemists, 481 North Frederick Ave., suite 500, Gaithersburg,
MD 20877-2504, or may be examined at the Center for Food Safety and
Applied Nutrition's Library, 200 C St. SW., rm. 3321, Washington, DC,
or at the Office of the Federal Register, 800 North Capitol St. NW.,
suite 700, Washington, DC;
(B) The food shall meet the nutrient content requirements in
Sec. 101.62 for a ``low saturated fat,'' ``low cholesterol,'' and ``low
fat'' food.
(d) Optional information. (1) The claim may state that the
development of heart disease depends on many factors and may identify
one or more of the following risk factors for heart disease about which
there is general scientific agreement: A family history of coronary
heart disease; elevated blood total and LDL-cholesterol; excess body
weight; high blood pressure; cigarette smoking; diabetes; and physical
inactivity. The claim may also provide additional information about the
benefits of exercise and management of body weight to help lower the
risk of heart disease.
(2) The claim may state that the relationship between intake of oat
bran and oatmeal and reduced risk of heart disease is through the
intermediate link of ``blood cholesterol'' or ``blood total- and LDL-
cholesterol.''
(3) The claim may include information from paragraphs (a) and (b)
of this section, which summarize the relationship between oat bran or
oatmeal and coronary heart disease and the significance of the
relationship.
(4) The claim may state that oat bran and oatmeal are good sources
of dietary fiber, particularly soluble fiber. In referring to the oat
fiber component, the claim may use the terms ``fiber,'' ``dietary
fiber,'' or ``soluble fiber.'' If the claim uses the term soluble
fiber, the total soluble fiber content shall be declared in the
nutrition information panel, consistent with Sec. 101.9(c)(6)(i)(A).
(5) The claim may state that a diet low in saturated fat and
cholesterol and high oatmeal or oat bran is consistent with ``Nutrition
and Your Health: Dietary Guidelines for Americans,'' U.S. Department of
Agriculture (USDA) and Department of Health and Human Services (DHHS),
Government Printing Office (GPO);
(6) The claim may state that individuals with elevated blood total-
and LDL-cholesterol should consult their physicians for medical advice
and treatment. If the claim defines high or normal blood total- and
LDL-cholesterol levels, then the claim shall state that individuals
with high blood cholesterol should consult their physicians for medical
advice and treatment;
(7) The claim may include information on the number of people in
the United States who have heart disease. The sources of this
information shall be identified, and it shall be current information
from the National Center for Health Statistics, the National Institutes
of Health, or ``Nutrition and Your Health: Dietary Guidelines for
Americans,'' USDA and DHHS, GPO;
(8) The claim may provide information about the amounts of oat-
containing food, e.g., bowls, servings, slices, to be consumed in a
day.
(e) Model health claim. The following model health claims may be
used in food labeling to describe the relationship between oat bran and
oatmeal and reduced risk of heart disease:
(1) The following is an example of a full claim: Diets high in [oat
bran/oatmeal] and low in saturated fat and cholesterol may reduce the
risk of heart disease.
(2) The following are examples of a shortened claim:
(A) [Front panel] Diets high in [oat bran or oatmeal] may reduce
the risk of heart disease
See [side/back] panel for more information
(B) [Front panel] Eating [oat bran or oatmeal] daily may reduce
heart disease risk
See [side/back] panel for more information
Dated: December 22, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
Note: The following tables will not appear in the Code of
Federal Regulations.
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