[Federal Register Volume 62, Number 16 (Friday, January 24, 1997)]
[Proposed Rules]
[Pages 3635-3636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-1785]
[[Page 3635]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket Nos. 94P-0390 and 95P-0241]
Food Labeling: Health Claims; Availability of FDA Report of
Effects of Food Label Health Claim Statements; Reopening of Comment
Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; reopening of comment period.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a report entitled ``Consumer Impacts of Health Claims:
An Experimental Study'' (the FDA Study). The FDA Study is relevant to
issues under consideration in the rulemaking that FDA instituted on
December 21, 1995, with a proposal to amend its regulations on nutrient
content and health claims to provide greater flexibility in the use of
these claims on food products. FDA is adding this report and two
related studies on abbreviated health claim statements to the
administrative record of that rulemaking. In addition, FDA is reopening
the comment period for the December 21, 1995, proposed rule (60 FR
66206) to provide interested persons with an opportunity to obtain the
FDA Study and to submit comments.
DATES: Written comments by March 10, 1997.
ADDRESSES: Submit written requests for single copies of the FDA Study
``Consumer Impacts of Health Claims: An Experimental Study'' and the
studies submitted by The Quaker Oats Co. to the contact person listed
below. Send two self-addressed adhesive labels to assist in processing
your request. A copy of the FDA Study and received comments are
available for public examination in the Dockets Management Branch (HFA-
305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through Friday.
The FDA Study may also be viewed on the FDA World Wide Web site (http:/
/www.fda.gov) by selecting Foods, then Food Labeling from the menus
presented. Submit written comments to the Dockets Management Branch
(address above). Comments should be identified with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Alan S. Levy, Center for Food Safety
and Applied Nutrition (HFS-727), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-205-9448.
SUPPLEMENTARY INFORMATION: In the Federal Register of December 21, 1995
(60 FR 66206), FDA published a proposed rule, entitled ``Food Labeling:
Nutrient Content Claims, General Principles; Health Claims, General
Requirements and Other Specific Requirements for Individual Health
Claims'' (the December 1995 proposal), to amend its regulations on
nutrient content and health claims to provide greater flexibility in
the use of these claims on food products. The agency proposed to permit
the use of shortened versions of authorized health claims and to
eliminate some of the required elements of these claims. The proposed
rule provided a 90-day period for public comment. The agency extended
the comment period for an additional 120 days on March 22, 1996. The
comment period closed on July 18, 1996.
FDA has recently completed research on the effects of food label
health claim statements on consumers. This research bears directly on
the issues involving health claims that were raised in the December
1995 proposal. FDA believes that it may be appropriate to consider that
research in developing a final rule in the subject rulemaking.
Therefore, FDA is placing the FDA Study on this research in the docket
for the December 1995 proposal and is reopening the comment period on
the proposal to provide an opportunity for interested parties to
comment on the FDA Study. FDA is providing 45 days so that interested
parties have sufficient time to obtain the study and submit comments on
it.
Shortly after publication of the December 1995 proposal, FDA
published a proposed rule to authorize a health claim on the
association between oat bran and oatmeal and the risk of coronary heart
disease (61 FR 296, January 4, 1996). In response to that proposal, FDA
received a comment from The Quaker Oats Co. that included two studies
on the use of abbreviated health claims. Inasmuch as shortened health
claims were a primary focus of the December 1995 proposal, the agency
has submitted these studies to Docket Number 94P-0390 for consideration
in the rulemaking on the December 1995 proposal. Interested parties may
submit comments on these studies during the reopened comment period.
I. The FDA Study
A. Background
The final report of the Keystone National Policy Dialogue on Food,
Nutrition, and Health (Ref. 1) reviewed several issues raised by the
food labeling regulations that FDA adopted in response to the Nutrition
Labeling and Education Act of 1990. This report identified issues
related to health claims as among those most in need of study. The
report also noted the lack of research about how consumers respond to
health claims on food labels and raised a number of specific questions
about the relative effectiveness of specific language contained in FDA
model health claim statements. The report strongly recommended that
consumer research be conducted to evaluate the impact of alternate
forms of health claim statements on food labels.
The goal of the regulations governing health claims, to help
consumers achieve a healthier diet, is one with which virtually
everyone agrees, but there are many viewpoints, and no small
controversy, about how to best achieve it. Uncertainty about how best
to structure health claims arises from the lack of experience with this
type of claim, but it also reflects the diversity of opinion about how
health claims will affect consumer behavior.
The Department of Health and Human Services provided funds to FDA
to conduct research on the effect of health claims on consumer
understanding and behavior, so that the agency would have a firm
empirical basis to evaluate the requirements that it has adopted and
any revisions that it may contemplate. The agency designed a study to
investigate the effects of different versions of health claim
statements on a range of variables chosen to represent some of the
different possible effects of health claims.
A preliminary focus group study evaluated a number of proposed
health claim statements developed by the Keystone Dialogue as
alternatives to FDA's model health claim statements (Ref. 1, pp. 141 to
150). The results suggested that FDA's model claims could be improved,
and it highlighted some basic issues underlying consumer reactions.
Central to consumer reactions to health claims was the credibility and
authoritativeness of the claims. The brevity of a claim was seen by
consumers as a significant element of the effectiveness of health
claims, but preferences for brevity seemed to depend on the degree of
familiarity (i.e., amount of prior knowledge) with the given diet/
disease relationship. The focus group results also emphasized the
importance of looking at several different kinds of health claims,
because consumer reactions were noticeably different depending on
familiarity with the claim. FDA used the results from the
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focus groups to identify the independent variables for a larger study.
B. Study Design
The FDA Study was a shopping mall intercept study. Subjects were
primary food shoppers recruited at a mall with central interviewing
facilities at eight sites around the country. The sample size was
approximately 175 persons per site (total sample size was 1,403
persons), with quotas for age and education to ensure that the full
range of population characteristics were represented in the sample.
Subjects were randomly assigned to an experimental condition. In the
central interviewing facility, an interviewer administered the
experimental protocol in a 20 to 25 minute session. Subjects were
presented, one at a time, with realistic product packages. The packages
were of typical size and organization for the particular type of
product, including front and back label information appropriate for the
product category. The product types and health claims represented
included: Cheese lasagna/saturated fat and cholesterol and risk of
coronary heart disease; yogurt/calcium and osteoporosis; and breakfast
cereal/folic acid and risk of neural tube defects.
The presentation style, authority, and brevity of the health claim
were experimentally manipulated. Each product label seen represented a
cell in the experimental design. The order of presentation of the
products and the type of health claim were counterbalanced to avoid
confounding effects. A series of questions about each product measured
purchase intentions and communication effectiveness of the product
label (e.g., perceived health benefits, compellingness), as well as
personal and household characteristics. Information search behavior was
observed and recorded.
C. Conclusions
The results of the FDA Study (Ref. 2) show that shorter claims are
more effective than longer claims, that endorsed health claims have
liabilities compared to nonendorsed claims, and that splitting claims
between the front and back label makes little difference. The results
also show that the ability of health claims to accurately communicate
health information about a product appears to be fairly limited and
involves tradeoffs between different kinds of valid health information.
II. The Quaker Oats Co. Studies
The Quaker Oats Co. submitted reports of two studies pertaining to
the use of abbreviated health claim statements as a comment to Docket
No. 95P-0197 (61 FR 296). The consumer research in the first report,
entitled ``Quaker Oatmeal On-Pack Health Claim Survey,'' provided data
on the question of whether consumers would read the full claim if only
an abbreviated claim appeared on the front of the label (Ref. 3). The
data were based on a national telephone survey of 301 consumers. The
respondents were asked about four types of new highlighted messages on
the front of a package of breakfast cereal (health or nutrition;
improvements to the product; price; special offers or rebates). The key
questions concerned how likely respondents would be to read each of the
four types of messages on the front of a package, and, if they noticed
a new highlighted message on the front of the package that was about
health benefits and that stated that additional information could be
found on the back of the package, how likely they were to read the
additional information.
The second report, entitled ``Consumer Perception Study of a
Statement Related to Heart Disease on the Label of Quaker Oats,''
presented consumer research comparing an abbreviated oatmeal claim (``A
diet high in oatmeal may help reduce the risk of heart disease.'') with
a full fiber-heart disease health claim (``Diets low in saturated fat
and cholesterol and high in grains, fruits and vegetables that contain
fiber, particularly soluble fiber, may reduce the risk of heart
disease, a condition associated with many factors.'') (Ref. 4). The
data were from a national shopping mall intercept study of 826
consumers. Participants saw one of three mocked-up cereal packages that
contained the abbreviated claim, the long claim, or no claim (control
condition).
The report stated that the presence of either health claim,
compared to the control condition, increased the number of participants
who recognized that a diet high in oatmeal may help reduce the risk of
heart disease. There were no significant differences in terms of the
impact of the claims on consumers' perceptions of the product or their
beliefs about the diet-disease relationship.
III. Comments
Interested persons may by March 10, 1997, submit to the Dockets
Management Branch (address above) written comments regarding the
studies being added to this docket. 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.
IV. 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 Keystone Center, ``The Final Report of The Keystone
National Policy Dialogue on Food, Nutrition, and Health,'' Keystone,
CO and Washington, DC, March 1996.
2. Food and Drug Administration, U.S. Department of Health and
Human Services, ``Consumer Impacts of Health Claims: An Experimental
Study,'' Washington, DC, December 1996.
3. The Quaker Oats Co., ``Quaker Oatmeal On-Pack Health Claim
Survey,'' Chicago, IL, March 1996.
4. The Quaker Oats Co., ``Consumer Perception Study of a
Statement Related to Heart Disease on the Label of Quaker Oats,''
Chicago, IL, November 1995.
Dated: January 17, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-1785 Filed 1-23-97; 8:45 am]
BILLING CODE 4160-01-F
