CooperVision, Inc.; Filing of Color Additive Petitions, 49707 [C1-2011-16089]
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Federal Register / Vol. 76, No. 155 / Thursday, August 11, 2011 / Proposed Rules
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
21 CFR Part 73
Blakeley Fitzpatrick, Center for Food
Safety and Applied Nutrition (HFS–
830), 5100 Paint Branch Pkwy., College
Park, MD 20740, 240–402–2176.
SUPPLEMENTARY INFORMATION:
[Docket Nos. FDA–2011–C–0344 and FDA–
2011–C–0463]
I. Background
Food and Drug Administration
CooperVision, Inc.; Filing of Color
Additive Petitions
Correction
In proposed rule document 2011–
16089 appearing on page 37690 in the
issue of Tuesday, June 28, 2011, make
the following correction:
On page 37690, in the first column, in
the twelfth line from the bottom of the
page,
‘‘methacryloxyethyl)phenstyamino]’’
should read
‘‘methacryloxyethyl)phenlyamino]’’.
[FR Doc. C1–2011–16089 Filed 8–10–11; 8:45 am]
BILLING CODE 1505–01–D
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket Nos. FDA–2000–P–0102, FDA–
2000–P–0133, and FDA–2006–P–0033]
Food Labeling; Health Claim;
Phytosterols and Risk of Coronary
Heart Disease; Reopening of the
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Proposed rule; reopening of
comment period.
ACTION:
The Food and Drug
Administration (FDA) is reopening the
comment period for the proposed rule
published in the Federal Register of
December 8, 2010, proposing to amend
regulations on plant sterol/stanol esters
and risk of coronary heart disease
(CHD). FDA is reopening the comment
period because the Agency received a
request for additional time to comment
on the proposed rule.
DATES: The comment period for the
proposed rule published December 8,
2010 (75 FR 76526), is reopened. Submit
either electronic or written comments
by October 25, 2011.
ADDRESSES: Submit electronic
comments https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
emcdonald on DSK2BSOYB1PROD with PROPOSALS
SUMMARY:
VerDate Mar<15>2010
15:43 Aug 10, 2011
Jkt 223001
In the Federal Register of December 8,
2010 (75 FR 76526), FDA proposed to
amend its regulations in § 101.83 (21
CFR 101.83) on plant sterol/stanol esters
and risk of CHD (the phytosterols
proposed rule). Among other revisions,
the Agency proposed to: (1) Adopt the
term ‘‘phytosterols’’ as inclusive of both
plant sterols and stanols; (2) permit
claims on products with phytosterols,
derived from either vegetable oils or tall
oils, containing at least 80 percent of
beta-sitosterol, campesterol,
stigmasterol, sitostanol, and/or
campestanol (combined weight); (3)
replace the analytical methods FDA
uses to determine the amount and
nature of the substance with the
Sorenson and Sullivan method for
evaluation of campesterol, stigmasterol,
and beta-sitosterol in those foods for
which the method has been validated;
(4) revise the daily dietary intake of
phytosterols necessary to justify the
CHD risk reduction claim (2 grams (g)
per day) and the minimum amount of
phytosterols (non-esterified weight)
required to be in a serving of the food
(0.5 g per reference amount customarily
consumed (RACC)); (5) for conventional
food, limit the use of the claim to the
food uses of phytosterols that have been
submitted to FDA in a generally
recognized as safe notification to which
the Agency had no further questions
and where the conditions of use are
consistent with the eligibility
requirements for the health claim; (6)
remove the requirement that the health
claim include a recommendation that
phytosterols be consumed in two
servings eaten at different times of the
day, but require that the substance be
taken with meals or snacks; (7)
eliminate the enumeration of specific
conventional foods eligible to bear the
claim; (8) allow for the use of the health
claim on phytosterol ester-containing
dietary supplements (esterified with
food-grade fatty acids) but not on
nonesterified phytosterol-containing
dietary supplements; (9) clarify that the
limited exemption from the total fat
disqualifying level of more than 13 g
total fat per 50 g of food when the RACC
is 30 g or less or 2 tablespoons or less
applies to vegetable oil spreads
resembling margarine; (10) permit liquid
vegetable oils to be exempt from the
total fat disqualifying level on a per
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49707
RACC, per labeled serving size, and per
50 g basis; and (11) permit liquid
vegetable oils to be exempt from the
minimum nutrient requirement and
vegetable oil spreads resembling
margarine to meet the 10 percent
minimum nutrient requirement by the
addition of Vitamin A consistent with
FDA’s fortification policy.
Interested persons were originally
given until February 22, 2011, to
comment on the proposed rule.
II. Request for Comments
After publication of the phytosterols
proposed rule, the Agency received two
petitions for an administrative stay of
action and two letters requesting that
FDA extend its enforcement discretion
based on FDA’s February 14, 2003, letter
of enforcement discretion to Cargill
Health and Food Technologies. Based
on concerns that 75 days was not
enough time for industry to come into
compliance with § 101.83 or to make the
claim consistent with the proposed
requirements in the phytosterols
proposed rule, the Agency issued, in the
Federal Register of February 18, 2011,
an extension of its enforcement
discretion based on the February 14,
2003, letter (76 FR 9525).
On February 10, 2011, the Agency
received a comment on the phytosterols
proposed rule by Venable LLP
requesting an extension of the comment
period until April 23, 2011, because the
period of time allowed for comment did
not provide enough time for them to
collect, assess, and comment on the
relevant data regarding the cholesterollowering efficacy of nonesterified
phytosterols in dietary supplements.
FDA did not respond to Venable LLP’s
request within the comment period and
cannot extend a closed comment period.
However, the Agency is reopening the
comment period for this rule in
response to Venable LLP’s request. The
Agency recognizes that additional time
to review and comment on the data
related to the relationship between
nonesterified phytosterols and reduced
risk of CHD would be helpful and
consistent with sound public policy,
therefore FDA is reopening the
comment period for all interested
persons on the phytosterols proposed
rule to allow for comments to be
submitted to the docket.
Following receipt of comments on
this document, FDA intends to publish
a final rule, which will amend § 101.83.
The reopening of the comment period
may result in the submission of
additional information that may cause
the Agency to reconsider its proposed
amendments to the phytosterols and
risk of coronary heart disease health
E:\FR\FM\11AUP1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 155 (Thursday, August 11, 2011)]
[Proposed Rules]
[Page 49707]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: C1-2011-16089]
[[Page 49707]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket Nos. FDA-2011-C-0344 and FDA-2011-C-0463]
CooperVision, Inc.; Filing of Color Additive Petitions
Correction
In proposed rule document 2011-16089 appearing on page 37690 in the
issue of Tuesday, June 28, 2011, make the following correction:
On page 37690, in the first column, in the twelfth line from the
bottom of the page, ``methacryloxyethyl)phenstyamino]'' should read
``methacryloxyethyl)phenlyamino]''.
[FR Doc. C1-2011-16089 Filed 8-10-11; 8:45 am]
BILLING CODE 1505-01-D
