[Federal Register Volume 65, Number 17 (Wednesday, January 26, 2000)]
[Notices]
[Pages 4252-4253]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1127]


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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; Reopening of Comment Period

    Editorial Note: Due to a printing error FR Document 00-1127 did 
not appear in the printed version of the Federal Register on 
Wednesday, January 19, 2000. It is printed in its entirety below.

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Request for written comments; reopening of comment period.

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SUMMARY:  The Food and Drug Administration (FDA) is reopening for 75 
days the comment period for the submission of scientific data, research 
study results, and other related information on four substance-disease 
relationships that was announced in the Federal Register of September 
8, 1999 (64 FR 48841). This action is being taken in response to 
requests for more time to submit data and information to FDA.

DATES:  Written comments by April 3, 2000.

ADDRESSES:  Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration (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:  In the Federal Register of September 8, 
1999 (64 FR 48841), FDA requested scientific data, research study 
results, and other related information on four substance-disease 
relationships in order to reevaluate the scientific evidence for these 
relationships. FDA stated that it was taking this action to comply with 
a

[[Page 4253]]

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 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 stated that it 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.
    The agency received requests to reopen the comment period on the 
September 8, 1999, notice to allow interested persons to comment after 
reviewing FDA's guidance on the ``significant scientific agreement'' 
standard for health claims in 21 U.S.C. 343(r)(3)(B)(i) and 21 CFR 
101.14(c). The availability of that guidance was announced on December 
22, 1999 (64 FR 71794). The agency has agreed to reopen the comment 
period on the September 8, 1999, notice for 75 days in response to the 
requests.
    The agency has established four dockets to compile information 
relating to each of the four topic areas; docket numbers are specified 
in Table 1 below. FDA is allowing 75 days for the submission of 
additional 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 April 
3, 2000. 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.
    Scientific data, research study results, and other related 
information on four substance-disease relationships that is submitted 
to the 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.

                                                    Table 1.
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                         Topic                                                  Docket No.
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Antioxidant vitamins and cancer                          91N-0101
Fiber and colorectal cancer                              91N-0098
Omega-3 fatty acids and coronary heart disease           91N-0103
Folic acid (dietary supplement vs. food form) and        91N-100H
 neural tube defects
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    Dated: January 11, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-1127 Filed 1-18-00; 8:45 am]
BILLING CODE 4160-01-F

    Editorial Note:  Due to a printing error FR Document 00-1127 did 
not appear in the printed version of the Federal Register on 
Wednesday, January 19, 2000. It is printed in its entirety above.

[FR Doc. 00-1127 Filed 1-25-00; 8:45 am]
BILLING CODE 1505-01-D