[Federal Register Volume 69, Number 222 (Thursday, November 18, 2004)]
[Proposed Rules]
[Pages 67513-67514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-25529]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
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 

  Federal Register / Vol. 69, No. 222 / Thursday, November 18, 2004 / 
Proposed Rules  

[[Page 67513]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket Nos. 1994P-0390 and 1995P-0241]


Food Labeling: Nutrient Content Claims, General Principles; 
Health Claims, General Requirements and Other Specific Requirements for 
Individual Health Claims; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening for 60 
days the comment period for the proposed rule entitled ``Food Labeling: 
Nutrient Content Claims, General Principles; Health Claims, General 
Requirements and Other Specific Requirements for Individual Health 
Claims'' (60 FR 66206, December 21, 1995) (the 1995 proposal). In that 
document, FDA proposed to amend its existing nutrient content claims 
and health claims regulations to provide additional flexibility in the 
use of these claims on food products. FDA reopened the comment period 
for the 1995 proposal to seek comment on the proposed amendments to 
permit unqualified health claims on certain foods that do not contain 
10 percent or more of one of certain required nutrients, the proposed 
amendments to provide criteria that FDA would consider in determining 
whether to grant an exemption from disqualifying nutrient levels 
related to unqualified health claims of certain nutrients, and the 
proposed amendments to retain the word ``may'' or ``might'' in 
unqualified health claims. In addition, FDA sought comment on the 
proposed use of unlisted synonyms and abbreviated health claims. The 
comment period for the 1995 proposal closed on July 6, 2004. FDA is 
reopening the comment period again in response to four requests for 
additional time to submit comments to FDA.

DATES: Submit written or electronic comments by January 18, 2005.

ADDRESSES: You may submit comments, identified by Docket Nos. 1994P-
0390 and 1995P-0241, by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
     E-mail: [email protected]. Include Docket Nos. 1994P-
0390 and 1995P-0241 in the subject line of your e-mail message.
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name 
and Docket No(s). or Regulatory Information Number (RIN) for this 
rulemaking. All comments received will be posted without change to 
http://www.fda.gov/ohrms/dockets/default.htm, including any personal 
information provided. For detailed instructions on submitting comments 
and additional information on the rulemaking process, see the 
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this 
document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket numbers, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ritu Nalubola, Center for Food Safety 
and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-2371.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 21, 1995, FDA proposed to amend 
its existing regulations on nutrient content claims and health claims 
to provide additional flexibility in the use of these claims on food 
products. Specifically, FDA proposed the following: (1) To allow 
additional synonyms for nutrient content claims without specific 
preclearance by the agency (i.e., unlisted synonyms), (2) to permit 
health claims on certain foods that do not currently qualify to bear a 
claim because they do not contain 10 percent of one or more of certain 
required nutrients, (3) to permit the use of shortened versions of 
authorized health claims (i.e., abbreviated health claims) under 
certain circumstances, (4) to eliminate and/or make optional some of 
the specific health claim elements required by regulation, and (5) to 
provide criteria that FDA would consider in determining whether to 
grant an exemption from disqualifying nutrient levels to permit some 
foods to bear an unqualified health claim even though they contain high 
levels of one or more of certain nutrients. FDA proposed these 
amendments in response to petitions submitted by the National Food 
Processors Association (NFPA) (Docket No. 1994P-0390) and the American 
Bakers Association (ABA) (Docket No. 1995P-0241). FDA requested 
comments on the 1995 proposal by March 20, 1996, which was later 
extended to July 18, 1996 (61 FR 11793, March 22, 1996). The comment 
period was reopened in 1997 to obtain comment on an FDA study and two 
consumer research studies submitted by industry (62 FR 3635, January 
24, 1997), and then extended to allow interested persons more time to 
review the studies and submit comments (62 FR 11129, March 11, 1997).
    In the Federal Register of May 4, 2004 (69 FR 24541), FDA reopened 
for 60 days the comment period for the 1995 proposal. In the May 4, 
2004, notice reopening the comment period, FDA noted that since the 
publication of the 1995 proposal, FDA established a task force for the 
Consumer Health Information for Better Nutrition Initiative (the task 
force). The purpose of the initiative is to make available more and 
better information about conventional foods and dietary supplements to 
help American

[[Page 67514]]

consumers improve their health and decrease their risk of contracting 
diseases by making sound dietary choices. The task force issued a final 
report on July 10, 2003 (68 FR 41387, July 11, 2003), which recommended 
that FDA seek public comment on several topics related to qualified 
health claims (i.e., claims that do not meet the significant scientific 
agreement (SSA) standard of evidence required by the Federal Food, 
Drug, and Cosmetic Act and FDA regulations to evaluate the scientific 
validity of health claims) and unqualified health claims (i.e., health 
claims that are supported by SSA and authorized by FDA by regulation). 
Some of the topics identified in the task force report were 
specifically addressed in the 1995 proposal. FDA reopened the comment 
period on the 1995 proposal to seek comment on these topics, which 
include the following: (1) The proposed amendments to permit 
unqualified health claims on certain foods that do not contain 10 
percent or more of one of certain required nutrients; (2) the proposed 
amendments to provide criteria that FDA would consider in determining 
whether to grant an exemption from disqualifying nutrient levels 
related to unqualified health claims of certain nutrients; and (3) the 
proposed amendments to retain the word ``may'' or ``might'' in 
unqualified health claims to describe the relationship between a 
substance and a disease or health-related condition. In addition, FDA 
sought comment on the proposed use of unlisted synonyms and abbreviated 
health claims. Specifically, for unlisted synonyms (i.e., terms not 
defined by regulation), FDA repeated its request for data or other 
information demonstrating that unlisted synonyms that are anchored to 
defined terms in nutrient content claims are reasonably understood by 
consumers to be synonyms of the defined terms. FDA also sought comments 
on the petition process in 21 CFR 101.69(n) for synonyms and examples 
of synonyms that industry may be seeking to use. For abbreviated health 
claims, FDA sought comments and requested data or other information 
regarding whether abbreviated health claims would mislead consumers.
    Following publication of the May 4, 2004, notice reopening the 
comment period, FDA received four requests for an extension of the 
comment period to allow interested persons additional time to comment. 
Two of the requests were submitted by NFPA and ABA, the petitioners. 
The requesters asserted that more time is needed, given the complexity 
of the issues, to thoroughly review the specific elements of the 1995 
proposal. Some requesters further supported their requests for 
additional time by noting that more than 7 years have passed since the 
1995 proposal was last considered in comments and FDA's May 4, 2004, 
notice reopening the comment period. NFPA and ABA, which are trade 
associations, specifically stated that, over the intervening years, 
many of their member companies' representatives who were responsible 
for consideration of the technical aspects of the 1995 proposal have 
left their companies and have been replaced by staff that are less 
familiar with the 1995 proposal, subsequent comments, and underlying 
petitions. In addition, NFPA and ABA asserted that because the 
character of their membership has changed and current members may 
advocate different views of the issues raised in the 1995 proposal and 
in comments on the 1995 proposal received through 1997, additional time 
is needed to ensure that all members' concerns are addressed to 
accurately comment and respond to FDA. Another requester, also a trade 
association, also requested more time to ensure that all of its 
members' concerns are addressed to accurately comment and respond to 
FDA.
    FDA has considered the requests for additional time to submit 
comments and, because the comment period for the 1995 proposal closed 
on July 6, 2004, FDA is again reopening the comment period on the 1995 
proposal for an additional 60 days to provide interested persons an 
opportunity to comment on the issues identified herein and in FDA's May 
4, 2004, notice reopening the comment period for the 1995 proposal.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments in response to FDA's 
request for comments and available data or other information identified 
in FDA's May 4, 2004, notice reopening the comment period on the 1995 
proposal. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Identify comments with the docket numbers found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: November 8, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-25529 Filed 11-17-04; 8:45 am]
BILLING CODE 4160-01-S