[Federal Register Volume 64, Number 173 (Wednesday, September 8, 1999)]
[Notices]
[Pages 48841-48842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-23337]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket Nos. 91N-0101, 91N-0098, 91N-0103, and 91N-100H]


Food Labeling; Health Claims and Label Statements; Request for 
Scientific Data and Information

AGENCY: Food and Drug Administration, HHS

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting 
scientific data, research study results, and other related information 
on four substance-disease relationships in order to reevaluate the 
scientific evidence for these relationships. The agency is taking this 
action to comply with a recent court decision in which FDA was 
instructed to reconsider whether to authorize health claims for these 
relationships in dietary supplement labeling. The four health claims to 
be reconsidered are: ``Consumption of antioxidant vitamins may reduce 
the risk of certain kinds of cancer,'' ``Consumption of fiber may 
reduce the risk of colorectal cancer,'' ``Consumption of omega-3 fatty 
acids may reduce the risk of coronary heart disease,'' and ``0.8 mg of 
folic acid in a dietary supplement is more effective in reducing the 
risk of neural tube defects than a lower amount in foods in common 
form.'' The agency will use the data and information to determine, for 
each substance-disease relationship, if an appropriate scientific basis 
exists to support the issuance of a proposed rule to authorize a health 
claim for the relationship.

DATES: Written comments by November 22, 1999.

ADDRESSES: Written comments to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852.

FOR FURTHER INFORMATION CONTACT: Christine J. Lewis, Center for Food 
Safety and Applied Nutrition (HFS-451), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-4168.

SUPPLEMENTARY INFORMATION: The Nutrition Labeling and Education Act of 
1990 (the 1990 amendments), which amended the Federal Food, Drug, and 
Cosmetic Act (the act), directed the Secretary of Health and Human 
Services, among other things, to evaluate the scientific evidence on 10 
substance-disease relationships to determine their scientific validity 
as the basis for health claims in food labeling. For conventional 
foods, the 1990 amendments state that a health claim is permitted only 
if FDA determines that there is significant scientific agreement among 
qualified experts that the claim is supported by the totality of 
publicly available scientific evidence, including evidence from well-
designed studies conducted in a manner that is consistent with 
generally recognized scientific procedures and principles (section 
403(r)(3)(B)(i) of the act (21 U.S.C. 343(r)(3)(B))). While the 1990 
amendments allowed FDA to consider a different scientific standard for 
health claims for dietary supplements (section 403(r)(5)(D) of the act 
(21 U.S.C. 343(r)(5)(D))), FDA issued regulations in 21 CFR 101.14(c) 
in 1994 that applied the same standard as that used for health claims 
for conventional foods (59 FR 395, January 4, 1994).
    FDA conducted rulemakings in which it reviewed the scientific 
evidence for all 10 substance-disease relationships. Although the 
agency issued regulations authorizing health claims for most of these 
relationships, it concluded that there was insufficient scientific 
agreement regarding the scientific validity of the four health claims 
listed in the Summary section of this document. Therefore, the agency 
issued regulations providing that these claims were not authorized. 
(See Sec. 101.71(a), (c), (e) (21 CFR 101.79(c)(2)(i)(G)).

[[Page 48842]]

    Several dietary supplement marketers and nonprofit organizations 
that had submitted comments during the health claims rulemakings filed 
suit in Federal district court on constitutional and statutory grounds 
seeking, among other things, authorization to make the following health 
claims for use in the labeling of dietary supplements: (1) 
``Consumption of antioxidant vitamins may reduce the risk of certain 
kinds of cancer,'' (2) ``Consumption of fiber may reduce the risk of 
colorectal cancer,'' (3) ``Consumption of omega-3 fatty acids may 
reduce the risk of coronary heart disease,'' and (4) ``0.8 mg of folic 
acid in a dietary supplement is more effective in reducing the risk of 
neural tube defects than a lower amount in foods in common form.'' 
Their constitutional and statutory challenges were rejected in the 
district court; however, on appeal the district court decision was 
reversed, and FDA was instructed to reconsider the four health claims 
(Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999)).
     As a first step in complying with the court's decision, FDA 
intends to reevaluate the scientific evidence for the four substance-
disease claims listed above. The agency is now in the process of 
preparing scientific summaries on each of these four topics. To ensure 
that all relevant scientific evidence is considered in the rulemaking 
process and to allow timely development of these summaries, FDA is 
requesting that anyone who has or is aware of relevant scientific data, 
research study results, or information related to these four substance-
disease relationships submit the materials to Dockets Management Branch 
(address above). Such information, if submitted to FDA, must be 
considered publicly available. If used in the agency's scientific 
review, information submitted to FDA will become part of the public 
record for the evaluation of these relationships.
    The agency has established four dockets to compile information 
relating to each of the four topic areas; docket numbers are as 
specified in Table 1 below. FDA advises that the Federal Register 
documents listed in the footnotes to the table have been incorporated 
into each of the referenced dockets (Docket Nos. 91N-0101, 91N-0098, 
91N-0103, and 91N-100H). FDA is requesting data and information other 
than the information contained or referred to in these Federal Register 
documents. As a guideline, therefore, the agency is requesting data and 
information from 1992 to the present for the four topic areas.
    FDA is allowing 75 days for the submission of data. Individuals and 
organizations submitting information or data relating to a specific 
topic should submit two copies of the information to the Dockets 
Management Branch (address above) by November 22, 1999. Separate 
submissions should be made for each topic area, and each submission 
should be identified with the appropriate docket number given below. 
Submissions received may be seen in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

                                 Table 1
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               Topic                             Docket No.
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Antioxidant vitamins and cancer     91N-0101
 \1\ and \2\
Fiber and colorectal cancer \3\     91N-0098
 and \4\
Omega-3 fatty acids and coronary    91N-0103
 heart disease \5\ and \6\
Folic acid (dietary supplement vs.  91N-100H
 food form) and neural tube
 defects \7\ and \8\
 
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\1\ ``Food Labeling: Health Claims and Label Statements; Antioxidant
  Vitamins and Cancer,'' Department of Health and Human Services, Food
  and Drug Administration, proposed rule, Federal Register (56 FR 60624
  to 60651, November 27, 1991).
 
\2\ ``Food Labeling: Health Claims and Label Statements; Antioxidant
  Vitamins and Cancer,'' Department of Health and Human Services, Food
  and Drug Administration, final rule, Federal Register (58 FR 2622 to
  2660, January 6, 1993).
 
 \3\ ``Food Labeling: Health Claims; Dietary Fiber and Cancer,''
  Department of Health and Human Services, Food and Drug Administration,
  proposed rule, Federal Register (56 FR 60566 to 60582, November 27,
  1991).
 
\4\ ``Food Labeling: Health Claims and Label Statements; Dietary Fiber
  and Cancer,'' Department of Health and Human Services, Food and Drug
  Administration, final rule, Federal Register (58 FR 2537 to 2551,
  January 6, 1993).
 
\5\ ``Food Labeling: Health Claims and Label Statements; Omega-3 Fatty
  Acids and Coronary Heart Disease,'' Department of Health and Human
  Services, Food and Drug Administration, proposed rule, Federal
  Register (56 FR 60663 to 60689, November 27, 1991).
 
\6\ ``Food Labeling: Health Claims and Label Statements; Omega-3 Fatty
  Acids and Coronary Heart Disease,'' Department of Health and Human
  Services, Food and Drug Administration, final rule, Federal Register
  (58 FR 2682 to 2738, January 6, 1993).
 
\7\ ``Food Labeling: Health Claims and Label Statements; Folate and
  Neural Tube Defects,'' Department of Health and Human Services, Food
  and Drug Administration, proposed rule, Federal Register (58 FR 53254
  to 53295, October 14, 1993).
 
\8\ ``Food Labeling: Health Claims and Label Statements; Folate and
  Neural Tube Defects,'' Department of Health and Human Services, Food
  and Drug Administration, final rule, Federal Register (61 FR 8752 to
  8781, March 5, 1996).
 


    Dated: September 1, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-23337 Filed 9-7-99; 8:45 am]
BILLING CODE 4160-01-F