[Federal Register Volume 65, Number 234 (Tuesday, December 5, 2000)]
[Proposed Rules]
[Pages 75887-75888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-30827]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 94P-0036]


Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient 
Content Claims, and Health Claims; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

[[Page 75888]]


ACTION: Proposed rule; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening to January 
19, 2001, the comment period for a document published in the Federal 
Register of November 17, 1999 (64 FR 62746). In that document, FDA 
proposed to amend its regulations on nutrition labeling to require that 
the amount of trans fatty acids present in a food, including dietary 
supplements, be included in the amount and percent Daily Value declared 
for saturated fatty acids. FDA also proposed that, wherever saturated 
fat limits are placed on nutrient content claims, health claims, or 
disclosure or disqualifying levels, the amount of trans fatty acids be 
limited as well. Finally, FDA proposed to define the nutrient content 
claim ``trans fat free.'' FDA is taking this action in response to 
comments on the November 17, 1999, proposal to ensure that interested 
parties have an adequate opportunity to comment on the issue of whether 
the agency should define the nutrient content claims ``reduced trans 
fat'' and ``reduced saturated and trans fats.''

DATES: Submit written comments on nutrient content claims for ``reduced 
trans fat'' and ``reduced saturated and trans fats'' by January 19, 
2001.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. You may also send comments to the Dockets 
Management Branch at the following e-mail address: 
[email protected] or via the Internet at http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm.

FOR FURTHER INFORMATION CONTACT: Susan Thompson, Center for Food Safety 
and Applied Nutrition (HFS-832), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-205-5587.

SUPPLEMENTARY INFORMATION:

I. Reopening of Comment Period

    In the Federal Register of November 17, 1999 (64 FR 62746), FDA 
(we) proposed to amend our regulations on nutrition labeling to require 
that the amount of trans fatty acids present in a food, including 
dietary supplements, be included in the amount and percent Daily Value 
declared for saturated fatty acids. We also proposed that, wherever 
saturated fat limits are placed on nutrient content claims, health 
claims, or disclosure or disqualifying levels, the amount of trans 
fatty acids be limited as well. Finally, we proposed to define the 
nutrient content claim ``trans fat free.'' In that document, we 
requested comments on the proposal by February 15, 2000. In the Federal 
Register of February 16, 2000 (65 FR 7806), we extended the comment 
period to April 17, 2000.
    Ten comments responding to the proposal (see Docket 94P-0036, 
Comment numbers 1776, 2113, 2117, 2125, 2128, 2133, 2135, 2138, 2139, 
and EMC 475) requested that the final rule define the nutrient content 
claim ``reduced trans fat.'' We had not proposed a definition for this 
claim, and had suggested that persons who believe that such a claim is 
useful could petition the agency under Sec. 101.69 (21 CFR 101.69) (64 
FR 62746 at 62760). Other comments (see Docket 94P-0036, Comment 
numbers 2136 and 2139) suggested a criterion (i.e., 25 percent less 
saturated fat and trans fat combined) for the claim ``reduced saturated 
fat'' that we believe may be more appropriate as a criterion for the 
claim ``reduced saturated and trans fats.''
    We have considered these comments and believe that some members of 
the public may not have anticipated these issues and thus did not 
address them in comments. To ensure that all interested parties have 
had an opportunity to comment on whether the final rule should define 
the claims ``reduced trans fat'' and ``reduced saturated and trans 
fats,'' we are reopening the comment period for the November 17, 1999, 
proposed rule for a period of 45 days. Comments submitted during this 
period are to be limited to those that directly address the two claims 
identified above. We are not requesting comments on any other issue, 
and we do not intend to consider such comments if submitted.

II. How to Submit Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments by January 19, 2001. You may also send 
comments to the Dockets Management Branch at the following e-mail 
address: [email protected], or via the Internet at http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm. 
You must submit two copies of comments, identified with the docket 
number found in brackets in the heading of this document, except that 
you may submit one copy if you are an individual. You may review 
received comments in the Dockets Management Branch between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: November 29, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-30827 Filed 12-4-00; 8:45 am]
BILLING CODE 4160-01-F