[Federal Register Volume 59, Number 67 (Thursday, April 7, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-8268]
[[Page Unknown]]
[Federal Register: April 7, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket Nos. 94N-058C and 94N-058F]
Dietary Fiber and Cancer and Coronary Heart Disease; Notice of
Public Conference
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public conference.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that it
is cosponsoring, with other health research organizations, a public
conference to update and summarize the scientific information available
on the association between dietary fiber and cancer and dietary fiber
and coronary heart disease. The conference will also provide an
opportunity to discuss the criteria that should be used in determining
whether significant scientific agreement on the validity of a dietary
fiber-cancer or a dietary fiber-coronary heart disease relationship
exists. The conference will include invited summary presentations and
panel discussions by expert scientists and public discussions of the
scientific evidence.
DATES: The public conference will be held on May 12 and 13, 1994, 8
a.m. to 5:30 p.m. Interested persons may submit written comments by May
9, 1994. Data received by May 2, 1994, will be forwarded to the
individuals preparing presentations or serving as panelists for the
conference for possible inclusion in their reviews and discussions.
ADDRESSES: The public conference will be held at the Marriott Gateway,
1700 Jeff Davis Hwy., Arlington, VA. Submit to the Dockets Management
Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420
Parklawn Dr., Rockville, MD 20857, written comments, data, new data not
previously submitted, or information regarding this notice. Comments
relating to dietary fiber and cancer are to be identified with the
docket number 94N-058F. Comments relating to dietary fiber and coronary
heart disease are to be identified with document number 94N-058C.
Received comments may be seen in the office above between 9 a.m. and 4
p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: James T. Tanner, Office of Special
Nutritionals (HFS-451), Food and Drug Administration, Washington, DC
20204, 202-205-4168.
SUPPLEMENTARY INFORMATION: The Nutrition Labeling and Education Act of
1990 (the 1990 amendments) required that FDA consider health claims on
food labels for 10 nutrient-disease relationships and determine, based
on the totality of the publicly available scientific evidence, whether
there is significant scientific agreement among qualified experts
regarding the validity of these relationships. In the Federal Register
of January 6, 1993, FDA issued final rules announcing its decision not
to authorize the use on the label or labeling of foods of health claims
relating to an association between dietary fiber and cancer (58 FR
2537) or dietary fiber and coronary heart disease (58 FR 2552).
The agency concluded that there was not significant scientific
agreement among qualified experts that a claim relating dietary fiber
to reduced risk of cancer was adequately supported by the totality of
publicly available scientific evidence. FDA concluded that the role for
dietary fiber itself was not supported by the available data, but that
consumption of diets low in fat and high in fiber-containing grain
products, fruits, and vegetables may be associated with reduced risk of
some cancers (58 FR 2537 at 2548).
The agency also concluded that there was not significant scientific
agreement among qualified experts that a claim relating dietary fiber
to reduced risk of coronary heart disease was adequately supported by
the totality of publicly available scientific evidence. As was the case
with respect to dietary fiber and cancer, FDA concluded that the role
of fiber itself was not supported by the available data, but that
consumption of diets low in saturated fat and cholesterol and high in
fruits, vegetables, and grain products that contain fiber, particularly
soluble fiber, may be associated with reduced risk of coronary heart
disease (58 FR 2552 at 2578).
In the Federal Register of October 14, 1993 (58 FR 53296), FDA
published a proposed rule not to authorize health claims on five
nutrient-disease relationships, including dietary fiber and cancer and
dietary fiber and coronary heart disease, for dietary supplements of
vitamins, minerals, herbs, or other similar nutritional substances. In
that proposal, FDA reviewed the available evidence on the relationship
of dietary fiber and cancer and on the relationship of dietary fiber
and coronary heart disease. Based on its tentative conclusion that
there is not significant scientific agreement among qualified experts
that the totality of publicly available scientific evidence supported
these nutrient-disease relationships, FDA proposed not to authorize
claims on these relationships. On January 4, 1994, in a new
statutorily-mandated rulemaking, changes in the agency's regulations
(21 CFR 101.71(a) and (b)) reflecting those that FDA had proposed in
October 1993, became final by operation of law (see 59 FR 436, January
4, 1994). However, the rulemakings that FDA instituted in October 1993
continue (59 FR 436).
On May 12 and 13, 1994, FDA will cosponsor a public conference with
other units of the Department of Health and Human Services, including
the National Institutes of Health and the Centers for Disease Control
and Prevention, the American Cancer Society, the American Heart
Association, the Institute of Medicine, the American Medical
Association, the Federal Trade Commission, and the Congressional
Research Service to review the publicly available evidence on the
relationship of dietary fiber and cancer and the relationship of
dietary fiber and coronary heart disease with particular emphasis on
refining the issues relative to dietary fiber definition and levels to
disease risk. The purpose of this public conference is to update and
summarize the scientific information available on these associations
and to discuss criteria that should be used to determine whether a
significant scientific agreement on the validity of these nutrient-
disease relationships exists. FDA is taking this action because it is
aware, based on its review of the evidence on these nutrients-disease
relationships, that at least some promising evidence exists. The agency
believes that the conference will help elucidate whether recent
developments have provided the basis for significant scientific
agreement. The agency notes that the review of the issues regarding
dietary fiber/disease claims on dietary supplements is ongoing. FDA
solicits the input of all segments of the food industry and of other
interested persons on these issues, however, because the agency
intends, if the evidence justifies, to authorize any claims that are
warranted for foods in conventional food form as well as for dietary
supplements.
FDA has invited experts in medicine, nutrition, epidemiology,
pathology, and other disciplines related to dietary fiber and cancer
and dietary fiber and coronary heart disease to serve as speakers and
panelists. They will summarize and update the publicly available
evidence, react to any evidence that is presented, and provide
additional comment based on their individual expertise. Others may
submit data from new research and will be given the opportunity to
participate during the open discussions. Cancer and coronary heart
disease will be the focus of the conference because they are the
diseases that were highlighted by the 1990 amendments.
The conference will be divided into four major parts as follows:
(1) Opening and overview of dietary fiber; (2) dietary fiber and
coronary heart disease; (3) dietary fiber and cancer; and (4) the
criteria for determining whether significant scientific agreement on
dietary fiber and cancer or dietary fiber and coronary heart disease
exits.
Interested persons may, on or before May 9, 1994, submit to the
Dockets Management Branch (address above) written comments regarding
this notice. 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.
Dated: April 1, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-8268 Filed 4-6-94; 8:45 am]
BILLING CODE 4160-01-F
