[Federal Register: December 5, 2000 (Volume 65, Number 234)]
[Proposed Rules]]
[Page 75887-75888]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05de00-18]
 
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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:
FDADockets@oc.fda.gov 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: FDADockets@oc.fda.gov, 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