[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