Food Labeling: Nutrient Content Claims, General Principles; Health Claims, General Requirements and Other Specific Requirements for Individual Health Claims; Withdrawal in Part, 519-520 [E6-21996]
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Federal Register / Vol. 72, No. 3 / Friday, January 5, 2007 / Proposed Rules
(d) Optional information. (1) The
claim may include the term ‘‘vitamin D’’
if the food meets or exceeds the
requirements for a ‘‘high’’ level of
vitamin D as defined in § 101.54(b);
(2) The claim may include
information from paragraphs (a) and (b)
of this section.
(3) The claim may include
information on the number of people in
the United States who have osteoporosis
or low bone density. The sources of this
information must be identified, and it
must be current information from the
National Center for Health Statistics, the
National Institutes of Health, or the
National Osteoporosis Foundation.
(4) The claim may state that the role
of adequate calcium intake, or when
appropriate, the role of adequate
calcium and vitamin D intake,
throughout life is linked to reduced risk
of osteoporosis through the mechanism
of optimizing peak bone mass during
adolescence and early adulthood. The
phrase ‘‘build and maintain good bone
health’’ may be used to convey the
concept of optimizing peak bone mass.
When reference is made to persons with
a family history of the disease,
menopausal women, and elderly men
and women, the claim may also state
that adequate intake of calcium or
adequate intake of calcium and vitamin
D, if applicable, is linked to reduced
risk of osteoporosis through the
mechanism of slowing the rate of bone
loss.
(e) Model health claims. The
following model health claims may be
used in food labeling to describe the
relationship between calcium and
osteoporosis:
Physical activity and adequate calcium
throughout life, as part of a well-balanced
diet, may reduce the risk of osteoporosis.
Adequate calcium as part of a healthful diet,
along with physical activity, may reduce the
risk of osteoporosis in later life.
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(f) Model additional health claims for
calcium and vitamin D. The following
model health claims may be used in
food labeling to describe the
relationship between calcium, vitamin
D, and osteoporosis:
Physical activity and adequate calcium and
vitamin D throughout life, as part of a wellbalanced diet, may reduce the risk of
osteoporosis.
Adequate calcium and vitamin D as part of
a healthful diet, throughout life along with
physical activity, may reduce the risk of
osteoporosis in later life.
Dated: December 18, 2006.
Michael M. Landa,
Deputy Director, Regulatory Affairs, Center
for Food Safety and Applied Nutrition.
[FR Doc. E6–22573 Filed 1–4–07; 8:45 am]
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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.
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
§ 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
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519
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 § 101.72(c)(2)(i)(A), (B), and (E) of the
1995 Proposal
In the 1995 proposal, FDA proposed
to simplify § 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 § 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 § 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 § 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
§ 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
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Federal Register / Vol. 72, No. 3 / Friday, January 5, 2007 / Proposed Rules
present in a food that triggers the
requirement in § 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 § 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 § 101.72 to, among other
things: (1) Eliminate the requirement in
§ 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
§ 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 § 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 § 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 § 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]
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[USCG–2006–25767 formerly CGD09–06–
123]
RIN 1625–AB11
Safety Zones; U.S. Coast Guard Water
Training Areas, Great Lakes
Coast Guard, DHS.
Notice of proposed rulemaking;
withdrawal.
AGENCY:
ACTION:
SUMMARY: The Coast Guard is
withdrawing its notice of proposed
rulemaking (NPRM) concerning the
establishment of safety zones
throughout the Great Lakes for the
purpose of conducting gunnery training.
The Coast Guard is authorized to
conduct training in realistic conditions
and in locations including in, on, and
over the internal waters of the United
States. In order to maximize safety, the
NPRM proposed establishing safety
zones in order to maintain Coast Guard
control over the training area during
training periods. This NPRM is being
withdrawn, however, because of
comments received from the public
regarding the number and location of
the proposed safety zones, the frequency
of use, notification procedures as well
as other concerns raised by the public.
There will be no further gunnery
training on the Great Lakes to satisfy
non-emergency training requirements
unless we first propose to the public
and then publish a final rule. Because
the Coast Guard is mandated to provide
for the safety and security of the more
than 30 million people in Great Lakes
region, the critical infrastructure that
make up the Great Lakes system, and
the vessels that use it, we are evaluating
all available options, including a new
NPRM for gunnery training.
DATES: The notice of proposed
rulemaking is withdrawn on January 5,
2007.
FOR FURTHER INFORMATION CONTACT:
Commander Gustav Wulfkuhle,
Enforcement Branch, Response
Division, Ninth Coast Guard District,
Cleveland, OH at (216) 902–6091.
SUPPLEMENTARY INFORMATION:
Regulatory History
On August 1, 2006, the Coast Guard
published a notice of proposed
rulemaking (NPRM) (71 FR 43402) to
establish permanent safety zones
throughout the Great Lakes which
would restrict vessels from portions of
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the Great Lakes during live-fire gun
exercises that would be conducted by
Coast Guard cutters and small boats.
The initial comment period for the
NPRM ended on August 31, 2006. In
response to public requests, the Coast
Guard re-opened the comment period
(71 FR 53629, September 12, 2006) from
September 12, 2006 to November 13,
2006, in order to provide the public
more time to submit comments and
recommendations. On September 19
and 27, 2006, the Coast Guard published
brief documents announcing the dates
and other information on public
meetings regarding the NPRM and the
gunnery exercises. (71 FR 54792,
56420).
On October 12, 2006, the Coast Guard
announced the addition of three more
public meetings and again stated that
more detailed information related to the
meetings would be published at a later
date. (71 FR 60094). On October 23, the
Coast Guard published a document
containing detailed information about
five additional public meetings. (71 FR
62075).
Background
Thirty-four safety zones were to be
located throughout the Great Lakes in
order to accommodate 56 separate Coast
Guard units. The proposed safety zones
were all located at least three nautical
miles from the shoreline.
The Coast Guard proposed to
establish permanent zones on the Great
Lakes to provide the public with more
notice and predictability when
conducting infrequent periodic training
exercises of brief duration, and to give
the public an opportunity to comment
on the proposals. The proposed safety
zones would have appeared on National
Oceanographic and Atmospheric
Administration nautical charts, which
would have provided a permanent
reference for mariners.
The proposed safety zones would
have been utilized only upon notice by
the cognizant Captain of the Port for the
area involved in the exercise. Under the
procedure outlined in the NPRM, the
cognizant Captain of the Port would
have issued notice of the enforcement of
a live-fire exercise safety zone by all
appropriate means to effect the widest
publicity among the affected segments
of the public including publication in
the Federal Register as practicable, in
accordance with 33 CFR 165.7(a). Such
means of notification would have
included, but not been limited to,
Broadcast Notice to Mariners or Local
Notice to Mariners before, during, and at
the conclusion of training exercises.
The coordinates of the proposed
safety zones were published on August
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]]>Agencies
[Federal Register Volume 72, Number 3 (Friday, January 5, 2007)]
[Proposed Rules]
[Pages 519-520]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-21996]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
