[Federal Register Volume 62, Number 47 (Tuesday, March 11, 1997)]
[Proposed Rules]
[Pages 11129-11130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6145]
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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; Extension of Comment
Period
Agency: Food and Drug Administration, HHS.
Action: Proposed rule; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA) is extending to April
24, 1997, the comment period for a proposal to amend its regulations on
nutrient content claims and health claims to provide additional
flexibility in the use of these claims on food products, which
published in the Federal Register of December 21, 1995 (66206). In the
Federal Register of January 24, 1997 (3635), the comment period for
this proposal was reopened to provide interested persons an opportunity
to review three studies that are relevant to issues under consideration
in this rulemaking. The agency is taking this action in response to
requests for an extension to allow interested persons additional time
to review these studies and to submit comments.
DATES: Written comments by April 24, 1997.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
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 January 24, 1997,
FDA announced the availability of a report entitled ``Consumer Impacts
of Health Claims: An Experimental Study'' (the FDA Study). FDA advised
that the FDA Study bore directly on the issues involving health claims
that were raised in a rulemaking that FDA had instituted on December
21, 1995, with a proposal entitled ``Food Labeling: Nutrient Content
Claims, General Principles; Health Claims, General Requirements and
Other Specific Requirements for Individual Health Claims'' (the
nutrient content/health claim proceeding) (60 FR 66206). FDA also
announced the availability of two other studies that it
[[Page 11130]]
had received in a comment to a separate rulemaking. Because it might
consider the results of these three studies in developing a final rule
in the nutrient content/health claim proceeding, FDA also announced
that it was reopening the comment period for that rulemaking to provide
an opportunity for interested persons to comment on the studies.
FDA has received two requests for an extension of the comment
period. The requests were from a trade association, for an extension of
30 days, and from a consumer group, for an extension of 45 days. The
request from the consumer group indicated a need to seek outside
experts to review and analyze the studies and, if necessary, to conduct
survey research. The other, from the trade association whose petition
led to the nutrient content/health claim proceeding, noted that the
author of the FDA Study had remarked in the study's Executive Summary
about the complexity of the study findings and said that it was
``equally complex for interested parties to analyze the research and to
comment on the applicability of the findings to the proposed rule.''
After careful consideration, FDA has decided that some additional
time is necessary for interested persons to review the results of the
FDA Study and other studies and to submit meaningful comments on them.
Therefore, FDA is extending the comment period for the proposal for an
additional 45 days, until April 24, 1997.
Interested persons may, on or before April 24, 1997, submit to the
Dockets Management Branch (address above) written comments regarding
the studies that were added to this docket on January 24, 1997. 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.
Dated: March 6, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-6145 Filed 3-7-97; 9:39 am]
BILLING CODE 4160-01-F
