[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66206) is withdrawn in part for Sec. 101.72(c)(2)(i)(A), (B), and (E)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