[Federal Register: January 5, 2007 (Volume 72, Number 3)]
[Proposed Rules]               
[Page 519-520]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05ja07-16]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket Nos. 1994P-0390 (formerly 94P-0390) and 1995P-0241 (formerly 
95P-0241)]

 
Food Labeling: Nutrient Content Claims, General Principles; 
Health Claims, General Requirements and Other Specific Requirements for 
Individual Health Claims; Withdrawal in Part

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; withdrawal in part.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
is withdrawing certain proposed amendments of a proposed rule that 
published in the Federal Register of December 21, 1995 (60 FR 66206), 
related to the calcium and osteoporosis health claim (21 CFR 101.72). 
FDA is taking action in response to a health claim petition submitted 
by The Beverage Institute for Health and Wellness to amend the calcium 
and osteoporosis claim. Elsewhere in this issue of the Federal 
Register, FDA is publishing a proposed rule to amend the calcium and 
osteoporosis claim.

DATES: The proposed rule that published on December 21, 1995 (60 FR 
66206) is withdrawn in part for Sec.  101.72(c)(2)(i)(A), (B), and (E) 
as of January 5, 2007.

FOR FURTHER INFORMATION CONTACT: Jillonne Kevala, Center for Food 
Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1450.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 21, 1995, FDA published a 
proposed rule entitled ``Nutrient Content Claims, General Principles; 
Health Claims, General Requirements and Other Specific Requirements for 
Individual Health Claims'' (60 FR 66206), the 1995 proposal, to amend 
its regulations on health claims and nutrient content claims to provide 
more flexibility in the use of these claims on food products, and to 
amend specific requirements to certain individual health claims. FDA 
took this action in response to citizen petitions submitted by the 
National Food Processors Association (NFPA) (Docket No. 1994P-0390) and 
the American Bakers Association (ABA) (Docket No. 1995P-0241). The 
agency has extended or reopened the comment period for the 1995 
proposal four times in response to requests by stakeholders and other 
FDA initiatives and developments. The most recent reopening of the 
comment period was announced in the Federal Register of May 4, 2004 (69 
FR 24541), and the comment period was open until July 6, 2004.
    On July 12, 2004, the agency received a health claim petition 
submitted by The Beverage Institute for Health and Wellness requesting 
that the agency amend the calcium and osteoporosis health claim to, 
among other things, simplify the language used in the claim. In 
response to this health claim petition, FDA is publishing elsewhere in 
this issue of the Federal Register a proposed rule to, among other 
things, simplify the language used in the calcium and osteoporosis 
health claim. Accordingly, the agency is withdrawing certain proposed 
amendments to the specific requirements in the calcium and osteoporosis 
health claim.

II. Withdrawn Proposed Amendments to Sec.  101.72(c)(2)(i)(A), (B), and 
(E) of the 1995 Proposal

    In the 1995 proposal, FDA proposed to simplify Sec.  
101.72(c)(2)(i)(A) by limiting the requirement to a balanced statement 
that reflects the importance of the essential nutrient calcium over a 
lifetime in a healthful diet to reduce osteoporosis risk, but that does 
not imply that calcium is the only risk factor for the development of 
osteoporosis, and to eliminate the provision in Sec.  
101.72(c)(2)(i)(A) that the specific risk factors, including sex, race, 
age, and the need for an adequate level of exercise be stated in any 
claim. Elsewhere in this issue of the Federal Register, FDA is 
proposing alternative amendments to Sec.  101.72(c)(2)(i)(A). 
Therefore, FDA is withdrawing this proposed amendment of the 1995 
proposal.
    In the 1995 proposal, FDA proposed to revise Sec.  
101.72(c)(2)(i)(B) by removing the requirement to identify by race or 
ethnicity those populations at particular risk for the development of 
osteoporosis, but to retain identification of teen and young women, 
irrespective of race or ethnicity, as the focus of the claim. Elsewhere 
in this issue of the Federal Register, FDA is proposing alternative 
amendments to Sec.  101.72(c)(2)(i)(B). Therefore, FDA is withdrawing 
this proposed amendment of the 1995 proposal.
    In the 1995 proposal, FDA proposed to increase the amount of 
calcium

[[Page 520]]

present in a food that triggers the requirement in Sec.  
101.72(c)(2)(i)(E) that the claim include a statement that reflects the 
limit of the benefits derived from dietary calcium intake. Elsewhere in 
this issue of the Federal Register, FDA is proposing alternative 
amendments to Sec.  101.72(c)(2)(i)(E). Therefore, FDA is withdrawing 
this proposed amendment of the 1995 proposal.

III. Related Action

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a proposed rule to amend Sec.  101.72 to, among other things: (1) 
Eliminate the requirement in Sec.  101.72(c)(2)(i)(A) that the claim 
list sex, race, and age as specific risk factors for the development of 
osteoporosis; (2) eliminate the requirement in Sec.  101.72(c)(2)(i)(B) 
that the claim does not state or imply that the risk of osteoporosis is 
equally applicable to the general U.S. population, and that the claim 
identify the populations at particular risk for the development of 
osteoporosis; and (3) eliminate the requirement in Sec.  
101.72(c)(2)(i)(E) that the claim include a statement that reflects the 
limit of the benefits derived from dietary calcium intake, when the 
level of calcium in the food exceeds a set threshold level.
    Comments specific to the proposed amendments in Sec.  
101.72(c)(2)(i)(A), (B), and (E) that were submitted in response to the 
1995 proposal were considered in the development of the proposed rule 
that responds to the health claim petition submitted by The Beverage 
Institute for Health and Wellness.
    Authority: Therefore, under the Federal Food, Drug, and Cosmetic 
Act and under authority delegated to the Commissioner of Food and 
Drugs, the proposed rule published on December 21, 1995 (60 FR 66206), 
is withdrawn in part for Sec.  101.72(c)(i)(A), (B), and (E).

    Dated: December 18, 2006.
Michael M. Landa,
Deputy Director, Regulatory Affairs, Center for Food Safety and Applied 
Nutrition.
[FR Doc. E6-21996 Filed 1-4-07; 8:45 am]

BILLING CODE 4160-01-S