Health Claim; Phytosterols and Risk of Coronary Heart Disease, 9842-9844 [2012-3940]
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9842
Federal Register / Vol. 77, No. 34 / Tuesday, February 21, 2012 / Rules and Regulations
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
Subchapter K—Regulations Under the
Public Utility Regulatory Policies Act of
1978
DEPARTMENT OF ENERGY
Federal Energy Regulatory
Commission
Adoption of the Amendment
18 CFR Part 292
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR part 71 as follows:
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
[Docket No. RM09–23–000]
Revisions to Form, Procedures and
Criteria for Certification of Qualifying
Facility Status for a Small Power
Production or Cogeneration Facility
Federal Energy Regulatory
Commission, DOE.
AGENCY:
1. The authority citation for part 71
continues to read as follows:
ACTION:
Authority: 49 U.S.C. 106(g), 40103, 40113,
40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p.389.
SUMMARY:
■
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of FAA Order 7400.9V,
Airspace Designations and Reporting
Points, dated August 9, 2011 and
effective September 15, 2011, is
amended as follows:
■
Paragraph 6011 United States area
navigation routes.
*
*
*
*
This document contains
corrections to the final regulations
(Docket No. RM09–23–000) which were
published in the Federal Register of
Tuesday, March 30, 2010 (75 FR 15950).
The final rule document adopted
revisions to FERC Form 556 and to
Commission procedures and criteria for
the certification of qualifying status for
a small power production or
cogeneration facility.
DATES:
*
T–288 Gillette, WY (GCC) to Wolbach, NE
(OBH) [Amended]
Gillette, WY (GCC) VOR/DME
(Lat. 44°20′52″ N., long. 105°32′37″ W.)
KARAS, WY INT
(Lat. 44°16′23″ N., long. 104°18′50″ W.)
Rapid City, SD (RAP) VORTAC
(Lat. 43°58′34″ N., long. 103°00′42″ W)
WNDED, SD WP
(Lat. 43°19′14″ N., long. 101°32′19″ W.)
Valentine, NE (VTN) NDB
(Lat. 42°51′42″ N., long. 100°32′59″ W.)
Ainsworth, NE (ANW) VOR/DME
(Lat. 42°34′09″ N., long. 99°59′23″ W.)
FESNT, NE WP
(Lat. 42°03′57″ N., long. 99°17′18″ W.)
Wolbach, NE (OBH) VORTAC
(Lat. 41°22′33″ N., long. 98°21′13″ W.)
[FR Doc. 2012–3813 Filed 2–17–12; 8:45 am]
S.L.
Higginbottom (Legal Information),
Office of the General Counsel, Federal
Energy Regulatory Commission, 888
First Street NE., Washington, DC 20426.
Telephone: 202–502–8561, Email:
samuel.higginbottom@ferc.gov.
FOR FURTHER INFORMATION CONTACT:
The final
regulations that are the subject of these
regulations amended 18 CFR 292.602(c)
and affect the Commission’s grant of
exemption of qualifying small power
production facilities and cogeneration
facilities from certain Federal and State
laws and regulations.
As published, the final regulations
contained errors which involved the
removal of subparagraphs from 18 CFR
292.602(c)(1). These subparagraphs
contain critical information concerning
which state laws apply to qualifying
small power production facilities and
qualifying cogeneration facilities.
List of Subjects in 18 CFR Part 292
BILLING CODE 4910–13–P
Electric power, Electric power plants,
Electric utilities.
Kimberly D. Bose,
Secretary.
Accordingly, 18 CFR part 292 is
corrected by making the following
correcting amendment:
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16:13 Feb 17, 2012
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1. The authority citation for part 292
continues to read as follows:
■
Authority: 16 U.S.C. 791a–825r, 2601–
2645; 31 U.S.C. 9701; 42 U.S.C. 7101–7352.
2. Section 292.602(c) is amended by
adding paragraphs (c)(1)(i) and (c)(1)(ii)
to read as follows:
■
§ 292.602 Exemption to qualifying facilities
from the Public Utility Holding Company
Act of 2005 and certain State laws and
regulations.
*
*
*
*
*
(c) * * *
(1) * * *
(i) The rates of electric utilities; and
(ii) The financial and organizational
regulation of electric utilities.
*
*
*
*
*
[FR Doc. 2012–3811 Filed 2–17–12; 8:45 am]
BILLING CODE 6717–01–P
Effective date: February 21, 2012.
SUPPLEMENTARY INFORMATION:
Issued in Washington, DC, on February 2,
2012.
Gary A. Norek,
Acting Manager, Airspace, Regulations and
ATC Procedures Group.
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Final rule; correcting
amendment.
PART 292—REGULATIONS UNDER
SECTION 201 AND 210 OF THE
PUBLIC UTILITY REGULATORY
POLICIES ACT OF 1978 WITH REGARD
TO SMALL POWER PRODUCTION AND
COGENERATION
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. FDA–2000–P–0102 (formerly
2000P–1275), FDA–2000–P–0133 (formerly
2000P–1276), and FDA–2006–P–0033
(formerly 2006P–0316)]
Health Claim; Phytosterols and Risk of
Coronary Heart Disease
AGENCY:
Food and Drug Administration,
HHS.
Notification; extension of
enforcement discretion.
ACTION:
The Food and Drug
Administration (FDA) is extending the
period of time that it intends to exercise
enforcement discretion concerning the
use of the health claim for phytosterols
and risk of coronary heart disease
(CHD), in a manner that is consistent
with FDA’s February 14, 2003, letter of
enforcement discretion to Cargill Health
and Food Technologies, until
publication of a final rule.
DATES: Submit either electronic or
written comments by April 23, 2012.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
SUMMARY:
E:\FR\FM\21FER1.SGM
21FER1
Federal Register / Vol. 77, No. 34 / Tuesday, February 21, 2012 / Rules and Regulations
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Blakeley Fitzpatrick, Center for Food
Safety and Applied Nutrition (HFS–
830), 5100 Paint Branch Pkwy., College
Park, MD 20740, 240–402–1450.
SUPPLEMENTARY INFORMATION: For the
reasons described herein, FDA intends
to continue to exercise enforcement
discretion with respect to the use of a
health claim regarding reduced risk of
coronary heart disease (CHD) for
phytosterol-containing conventional
food and dietary supplements, in a
manner that is consistent with FDA’s
February 14, 2003, letter of enforcement
discretion to Cargill Health and Food
Technologies, until publication of a
final rule.
mstockstill on DSK4VPTVN1PROD with RULES
I. Regulatory History
In the Federal Register of September
8, 2000 (65 FR 54686), FDA issued an
interim final rule (IFR) authorizing a
health claim for plant sterol/stanol
esters and CHD. Among other
requirements, we established in the IFR
that spreads and dressings for salads
must contain at least 0.65 grams (g) of
plant sterol esters per reference amount
customarily consumed (RACC) to be
eligible to bear the health claim and that
spreads, dressings for salad, snack bars,
and dietary supplements in soft gel form
must contain at least 1.7 g of plant
stanol esters per RACC to be eligible to
bear the health claim.
FDA received a letter, dated January
6, 2003, from Cargill Health and Food
Technologies requesting that FDA issue
a letter stating its intention not to
enforce certain requirements in the IFR.
The letter cited new scientific evidence
and comments submitted to FDA in the
plant sterol/stanol esters health claim
rulemaking in support of extending the
authorized health claim to all forms and
sources of phytosterols and product
forms that might effectively reduce
blood cholesterol levels. In response to
the letter submitted by Cargill and other
comments received to the IFR, we
issued a letter of enforcement discretion
on February 14, 2003 (the 2003 letter)
(Ref. 1). In the letter, we explained that
we would consider exercising
enforcement discretion, pending
publication of the final rule, with
respect to certain requirements of the
health claim. Specifically, we stated we
would consider such discretion with
regard to the use of the claim in the
labeling of a phytosterol-containing
food, including foods other than those
specified in § 101.83(c)(2)(iii)(A) (21
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CFR 101.83(c)(2)(iii)(A)), if: (1) The food
contains at least 400 milligrams (mg) per
RACC of phytosterols; (2) mixtures of
phytosterol substances (i.e., mixtures of
sterols and stanols) contain at least 80percent beta-sitosterol, campesterol,
stigmasterol, sitostanol, and
campestanol (combined weight); (3) the
food meets the requirements of
§ 101.83(c)(2)(iii)(B) through
(c)(2)(iii)(D); (4) products containing
phytosterols, including mixtures of
sterols and stanols in free (nonesterified) forms, use a collective term
in lieu of the terms required by
§ 101.83(c)(2)(i)(D) in the health claim to
describe the substance (e.g., ‘‘plant
sterols’’ or ‘‘phytosterol’’); (5) the claim
specifies that the daily dietary intake of
phytosterols that may reduce the risk of
CHD is 800 mg or more per day,
expressed as the weight of free
Phytosterol; (6) vegetable oils for home
use that exceed the total fat
disqualifying level can bear the health
claim along with a disclosure statement
that complies with § 101.13(h); and (7)
the use of the claim otherwise complies
with § 101.83. Thus, the 2003 letter
described intended enforcement
discretion with respect to: (1) Different
forms and mixtures of phytosterols in a
wider variety of products and (2) the use
of the claim on foods containing lower
levels of phytosterols than set forth in
the IFR.
In the Federal Register of December 8,
2010 (75 FR 76526), we published a
proposed rule that, if finalized, would
amend § 101.83 (the 2010 proposed
rule). The 2010 proposed rule, in part,
responds to a health claim petition we
received on May 5, 2006, and it also
includes the evaluation of new scientific
data that was not available when we
published the IFR.
We stated in the 2010 proposed rule
for phytosterols and the risk of CHD
health claim that, pending publication
of a final rule, FDA intends to consider
the exercise of its enforcement
discretion on a case-by-case basis when
a health claim regarding phytosterols
and CHD is made in a manner that is
consistent with the proposed rule (75
FR 76526 at 76546).
The 2010 proposed rule also stated
that, beginning 75 days after the date of
publication of the proposed rule
(February 21, 2011), FDA did not intend
to exercise its enforcement discretion
based on the 2003 letter (75 FR 76526
at 76546). We stated that starting on
February 21, 2011, all products bearing
the health claim would have to be in
compliance with § 101.83, or if health
claims were made in a manner
consistent with the proposed rule, we
would consider exercising enforcement
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9843
discretion pending publication of a final
rule.
In the 2010 proposed rule, we
proposed to make several changes to the
requirements for the nature of the food
eligible to bear the claim that differ from
the requirements in current § 101.83 and
from the basis for enforcement
discretion in the 2003 letter. Among
other changes, FDA proposed to
increase the amount of phytosterols that
must be present in the food product
from 0.4 to 0.5 g of phytosterols per
RACC and to only allow the use of the
claim in dietary supplements containing
the esterified form of phytosterols. In
addition, we proposed that a
conventional food would be eligible to
bear the claim if it is the subject of a
GRAS notification to which FDA had no
further questions.
After publication of the proposed
rule, we received requests from industry
to extend the 75-day period from the
date of publication of the proposed rule
for the exercise of FDA enforcement
discretion based on the 2003 letter. We
subsequently issued a notice in the
Federal Register of February 18, 2011,
extending the period during which we
intended to exercise enforcement
discretion based on the 2003 letter to
February 21, 2012 (76 FR 9525) (the
February 18, 2011 notice).1
In the February 18, 2011 notice, FDA
stated that it intended to exercise
enforcement discretion until February
21, 2012, with respect to the use of a
claim regarding reduced risk of CHD in
the labeling of a phytosterol-containing
food, including foods other than those
specified in § 101.83(c)(2)(iii)(A), based
on the factors set forth in the 2003 letter
for the use of such claim in the labeling
of food. FDA also stated that the
February 18, 2011 notice did not change
how we intend to consider exercising
our enforcement discretion when claims
are made consistent with the proposed
requirements in the proposed rule, and
that our decision to extend the period of
time during which we would consider
the exercise of our enforcement
discretion only related to FDA’s
enforcement discretion based on the
2003 letter.
II. Current Extension of Intent To
Exercise Enforcement Discretion
Since publication of the February 18,
2011, notice, we have received two
1 In the February 18, 2011, notice, we identified
two letters (from the Council for Responsible
Nutrition and the Consumer Healthcare Products
Association) and two petitions for an administrative
stay of action (from Cargill, Inc., and Pharmachem
Laboratories, Inc.). These two petitions are under
FDA consideration and neither the February 18,
2011 notice, nor this notice, represents a decision
on the petitions, in whole or in part.
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Federal Register / Vol. 77, No. 34 / Tuesday, February 21, 2012 / Rules and Regulations
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additional petitions; one requesting an
administrative stay of action with an
embedded citizen petition and the other
requesting an administrative stay of
action. Each of the requests for an
administrative stay of action concern
FDA’s use of enforcement discretion
related to labeling of dietary
supplements, pending the publication of
a final rule.2 In addition, FDA received
numerous comments on the 2010
proposed rule requesting that FDA
extend the period of enforcement
discretion based on the 2003 letter until
publication of a final rule. FDA has
received new scientific data and
information, through comments to the
2010 proposed rule, or submitted with
petitions, relating to several of the
factors we set forth in the 2003 letter,
e.g., the possible health benefit of free
phytosterols in dietary supplements and
the minimum daily consumption
amount of phytosterols necessary to
achieve the claimed effect. We are
reviewing the comments and
information we received and do not
intend to make a determination as to the
daily phytosterols consumption amount
needed to achieve the claimed effect or
the eligibility of dietary supplements
containing free phytosterols to bear the
authorized health claim until the
publication of the final rule.
Based on the new data and
information currently under our review
that may be important, to our
2 FDA received a petition for an administrative
stay of action with an embedded citizen petition
from Pharmavite LLC (‘‘Pharmavite petition’’) dated
February 24, 2011, and a petition for an
administrative stay from Botanical Laboratories,
Inc. (‘‘Botanical petition’’), dated March 18, 2011
(Docket Nos. FDA–2000–P–0102, FDA–2000–P–
0133, and FDA–2006–P–0033). Specifically,
Pharmavite LLC requests FDA to stay its February
18, 2011, decision to discontinue enforcement
discretion for dietary supplements containing free
phytosterols that have been shown, through an
adequate and well-controlled clinical trial, to
reduce low density lipoprotein (LDL) and total
cholesterol, pending publication of a final rule for
the health claim. In a citizen petition embedded in
the petition for an administrative stay, Pharmavite
LLC also asked us to agree that: (1) A dietary
supplement produced by Pharmavite LLC has been
shown to effectively reduce LDL and total
cholesterol; (2) FDA will continue to exercise
enforcement discretion to permit this dietary
supplement to bear an appropriately worded claim
pursuant to the 2010 proposed regulation, pending
publication of a final rule addressing the health
claim; and (3) the final rule will allow those dietary
supplements containing free phytosterols that have
been shown through an adequate and wellcontrolled clinical trial to effectively reduce LDL
and total cholesterol to bear the claim. Botanical
Laboratories, Inc., requested that FDA stay its
February 18, 2011, decision to discontinue
enforcement discretion for dietary supplements
containing phytosterols in liquid form until the
issuance of a final rule for the health claim. We are
currently considering these petitions. This
document does not represent a decision on these
petitions, in whole or in part.
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consideration in deciding what
requirements to include in the final
rule, and the need to focus FDA’s
resources on other public health
priorities, we find it appropriate to
continue to extend our consideration of
the exercise of enforcement discretion
for the labeling of foods, including
dietary supplements, bearing a health
claim regarding phytosterols and risk of
CHD consistent with the 2003 letter,
until publication of the final rule.
Therefore, FDA is extending the
period during which it intends to
exercise enforcement discretion,
consistent with the factors set forth in
the 2003 letter, until publication of a
final rule for the phytosterols and risk
of CHD health claim. This document
does not change how FDA intends to
consider exercising its enforcement
discretion when claims are made
consistent with the proposed
requirements in the proposed rule.
Food, including dietary supplements,
bearing the health claim would be
required to comply with any revised
requirements established in the final
rule when the final rule becomes
effective.
ACTION:
Correcting amendment.
This document contains
corrections to the final regulations (TD
9571), which were published in the
Federal Register on January 17, 2012
(77 FR 2225) that provide guidance
regarding the allocation and
apportionment of interest expense.
SUMMARY:
This correction is effective on
February 21, 2012, and is applicable on
January 17, 2012.
DATES:
FOR FURTHER INFORMATION CONTACT:
Jeffrey L. Parry, (202) 622–3850 (not a
toll-free call).
SUPPLEMENTARY INFORMATION:
Background
The temporary regulations (TD 9571)
that are the subject of these corrections
are under section 864 of the Internal
Revenue Code.
Need for Correction
As published, the temporary
regulations contain errors that may
prove to be misleading and are in need
of clarification.
III. Reference
List of Subjects 26 CFR Part 1
The following reference has been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m. Monday
through Friday.
Income taxes, Reporting and
recordkeeping requirements.
1. Center for Food Safety and Applied
Nutrition, Food and Drug
Administration, Letter of Enforcement
Discretion from FDA to Cargill Health &
Food Technologies, Docket No. FDA–
2000–P–0102, document ID DRAFT–
0059 (formerly 2000P–1275/LET3) and
Docket No. FDA–2000–P–0133,
document ID DRAFT–0127 (formerly
2000P–1276/LET4), February 14, 2003.
Dated: February 15, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–3940 Filed 2–17–12; 8:45 am]
Correction of Publication
Accordingly, 26 CFR part 1 is
corrected by making the following
correcting amendments:
PART 1—INCOME TAXES
Paragraph 1. The authority citation
for part 1 continues to read in part as
follows:
■
Authority: 26 U.S.C. 7805 * * *
§ 1.861–9T
[Corrected]
Par. 2. Section 1.861–9T is amended
by revising paragraph (l) to read as
follows:
■
§ 1.861–9T Allocation and apportionment
of interest expense (temporary).
BILLING CODE 4160–01–P
*
Internal Revenue Service
*
*
*
*
(l) Expiration date. The applicability
date of paragraphs (e)(2), (e)(3), and
(h)(4) expires on January 13, 2015.
26 CFR Part 1
§ 1.861–11T
[TD 9571]
■
DEPARTMENT OF THE TREASURY
Par. 3. Section 1.861–11T is amended
by revising paragraph (i) to read as
follows:
RIN 1545–BJ84
Allocation and Apportionment of
Interest Expense; Correction
Internal Revenue Service (IRS),
Treasury.
AGENCY:
PO 00000
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[Corrected]
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§ 1.861–11T Special rules for allocating
and apportioning interest expense of an
affiliated group of corporations (temporary).
*
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*
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]]>Agencies
[Federal Register Volume 77, Number 34 (Tuesday, February 21, 2012)]
[Rules and Regulations]
[Pages 9842-9844]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3940]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. FDA-2000-P-0102 (formerly 2000P-1275), FDA-2000-P-0133
(formerly 2000P-1276), and FDA-2006-P-0033 (formerly 2006P-0316)]
Health Claim; Phytosterols and Risk of Coronary Heart Disease
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification; extension of enforcement discretion.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is extending the period
of time that it intends to exercise enforcement discretion concerning
the use of the health claim for phytosterols and risk of coronary heart
disease (CHD), in a manner that is consistent with FDA's February 14,
2003, letter of enforcement discretion to Cargill Health and Food
Technologies, until publication of a final rule.
DATES: Submit either electronic or written comments by April 23, 2012.
ADDRESSES: Submit electronic comments to https://www.regulations.gov.
Submit written
[[Page 9843]]
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Blakeley Fitzpatrick, Center for Food
Safety and Applied Nutrition (HFS-830), 5100 Paint Branch Pkwy.,
College Park, MD 20740, 240-402-1450.
SUPPLEMENTARY INFORMATION: For the reasons described herein, FDA
intends to continue to exercise enforcement discretion with respect to
the use of a health claim regarding reduced risk of coronary heart
disease (CHD) for phytosterol-containing conventional food and dietary
supplements, in a manner that is consistent with FDA's February 14,
2003, letter of enforcement discretion to Cargill Health and Food
Technologies, until publication of a final rule.
I. Regulatory History
In the Federal Register of September 8, 2000 (65 FR 54686), FDA
issued an interim final rule (IFR) authorizing a health claim for plant
sterol/stanol esters and CHD. Among other requirements, we established
in the IFR that spreads and dressings for salads must contain at least
0.65 grams (g) of plant sterol esters per reference amount customarily
consumed (RACC) to be eligible to bear the health claim and that
spreads, dressings for salad, snack bars, and dietary supplements in
soft gel form must contain at least 1.7 g of plant stanol esters per
RACC to be eligible to bear the health claim.
FDA received a letter, dated January 6, 2003, from Cargill Health
and Food Technologies requesting that FDA issue a letter stating its
intention not to enforce certain requirements in the IFR. The letter
cited new scientific evidence and comments submitted to FDA in the
plant sterol/stanol esters health claim rulemaking in support of
extending the authorized health claim to all forms and sources of
phytosterols and product forms that might effectively reduce blood
cholesterol levels. In response to the letter submitted by Cargill and
other comments received to the IFR, we issued a letter of enforcement
discretion on February 14, 2003 (the 2003 letter) (Ref. 1). In the
letter, we explained that we would consider exercising enforcement
discretion, pending publication of the final rule, with respect to
certain requirements of the health claim. Specifically, we stated we
would consider such discretion with regard to the use of the claim in
the labeling of a phytosterol-containing food, including foods other
than those specified in Sec. 101.83(c)(2)(iii)(A) (21 CFR
101.83(c)(2)(iii)(A)), if: (1) The food contains at least 400
milligrams (mg) per RACC of phytosterols; (2) mixtures of phytosterol
substances (i.e., mixtures of sterols and stanols) contain at least 80-
percent beta-sitosterol, campesterol, stigmasterol, sitostanol, and
campestanol (combined weight); (3) the food meets the requirements of
Sec. 101.83(c)(2)(iii)(B) through (c)(2)(iii)(D); (4) products
containing phytosterols, including mixtures of sterols and stanols in
free (non-esterified) forms, use a collective term in lieu of the terms
required by Sec. 101.83(c)(2)(i)(D) in the health claim to describe
the substance (e.g., ``plant sterols'' or ``phytosterol''); (5) the
claim specifies that the daily dietary intake of phytosterols that may
reduce the risk of CHD is 800 mg or more per day, expressed as the
weight of free Phytosterol; (6) vegetable oils for home use that exceed
the total fat disqualifying level can bear the health claim along with
a disclosure statement that complies with Sec. 101.13(h); and (7) the
use of the claim otherwise complies with Sec. 101.83. Thus, the 2003
letter described intended enforcement discretion with respect to: (1)
Different forms and mixtures of phytosterols in a wider variety of
products and (2) the use of the claim on foods containing lower levels
of phytosterols than set forth in the IFR.
In the Federal Register of December 8, 2010 (75 FR 76526), we
published a proposed rule that, if finalized, would amend Sec. 101.83
(the 2010 proposed rule). The 2010 proposed rule, in part, responds to
a health claim petition we received on May 5, 2006, and it also
includes the evaluation of new scientific data that was not available
when we published the IFR.
We stated in the 2010 proposed rule for phytosterols and the risk
of CHD health claim that, pending publication of a final rule, FDA
intends to consider the exercise of its enforcement discretion on a
case-by-case basis when a health claim regarding phytosterols and CHD
is made in a manner that is consistent with the proposed rule (75 FR
76526 at 76546).
The 2010 proposed rule also stated that, beginning 75 days after
the date of publication of the proposed rule (February 21, 2011), FDA
did not intend to exercise its enforcement discretion based on the 2003
letter (75 FR 76526 at 76546). We stated that starting on February 21,
2011, all products bearing the health claim would have to be in
compliance with Sec. 101.83, or if health claims were made in a manner
consistent with the proposed rule, we would consider exercising
enforcement discretion pending publication of a final rule.
In the 2010 proposed rule, we proposed to make several changes to
the requirements for the nature of the food eligible to bear the claim
that differ from the requirements in current Sec. 101.83 and from the
basis for enforcement discretion in the 2003 letter. Among other
changes, FDA proposed to increase the amount of phytosterols that must
be present in the food product from 0.4 to 0.5 g of phytosterols per
RACC and to only allow the use of the claim in dietary supplements
containing the esterified form of phytosterols. In addition, we
proposed that a conventional food would be eligible to bear the claim
if it is the subject of a GRAS notification to which FDA had no further
questions.
After publication of the proposed rule, we received requests from
industry to extend the 75-day period from the date of publication of
the proposed rule for the exercise of FDA enforcement discretion based
on the 2003 letter. We subsequently issued a notice in the Federal
Register of February 18, 2011, extending the period during which we
intended to exercise enforcement discretion based on the 2003 letter to
February 21, 2012 (76 FR 9525) (the February 18, 2011 notice).\1\
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\1\ In the February 18, 2011, notice, we identified two letters
(from the Council for Responsible Nutrition and the Consumer
Healthcare Products Association) and two petitions for an
administrative stay of action (from Cargill, Inc., and Pharmachem
Laboratories, Inc.). These two petitions are under FDA consideration
and neither the February 18, 2011 notice, nor this notice,
represents a decision on the petitions, in whole or in part.
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In the February 18, 2011 notice, FDA stated that it intended to
exercise enforcement discretion until February 21, 2012, with respect
to the use of a claim regarding reduced risk of CHD in the labeling of
a phytosterol-containing food, including foods other than those
specified in Sec. 101.83(c)(2)(iii)(A), based on the factors set forth
in the 2003 letter for the use of such claim in the labeling of food.
FDA also stated that the February 18, 2011 notice did not change how we
intend to consider exercising our enforcement discretion when claims
are made consistent with the proposed requirements in the proposed
rule, and that our decision to extend the period of time during which
we would consider the exercise of our enforcement discretion only
related to FDA's enforcement discretion based on the 2003 letter.
II. Current Extension of Intent To Exercise Enforcement Discretion
Since publication of the February 18, 2011, notice, we have
received two
[[Page 9844]]
additional petitions; one requesting an administrative stay of action
with an embedded citizen petition and the other requesting an
administrative stay of action. Each of the requests for an
administrative stay of action concern FDA's use of enforcement
discretion related to labeling of dietary supplements, pending the
publication of a final rule.\2\ In addition, FDA received numerous
comments on the 2010 proposed rule requesting that FDA extend the
period of enforcement discretion based on the 2003 letter until
publication of a final rule. FDA has received new scientific data and
information, through comments to the 2010 proposed rule, or submitted
with petitions, relating to several of the factors we set forth in the
2003 letter, e.g., the possible health benefit of free phytosterols in
dietary supplements and the minimum daily consumption amount of
phytosterols necessary to achieve the claimed effect. We are reviewing
the comments and information we received and do not intend to make a
determination as to the daily phytosterols consumption amount needed to
achieve the claimed effect or the eligibility of dietary supplements
containing free phytosterols to bear the authorized health claim until
the publication of the final rule.
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\2\ FDA received a petition for an administrative stay of action
with an embedded citizen petition from Pharmavite LLC (``Pharmavite
petition'') dated February 24, 2011, and a petition for an
administrative stay from Botanical Laboratories, Inc. (``Botanical
petition''), dated March 18, 2011 (Docket Nos. FDA-2000-P-0102, FDA-
2000-P-0133, and FDA-2006-P-0033). Specifically, Pharmavite LLC
requests FDA to stay its February 18, 2011, decision to discontinue
enforcement discretion for dietary supplements containing free
phytosterols that have been shown, through an adequate and well-
controlled clinical trial, to reduce low density lipoprotein (LDL)
and total cholesterol, pending publication of a final rule for the
health claim. In a citizen petition embedded in the petition for an
administrative stay, Pharmavite LLC also asked us to agree that: (1)
A dietary supplement produced by Pharmavite LLC has been shown to
effectively reduce LDL and total cholesterol; (2) FDA will continue
to exercise enforcement discretion to permit this dietary supplement
to bear an appropriately worded claim pursuant to the 2010 proposed
regulation, pending publication of a final rule addressing the
health claim; and (3) the final rule will allow those dietary
supplements containing free phytosterols that have been shown
through an adequate and well-controlled clinical trial to
effectively reduce LDL and total cholesterol to bear the claim.
Botanical Laboratories, Inc., requested that FDA stay its February
18, 2011, decision to discontinue enforcement discretion for dietary
supplements containing phytosterols in liquid form until the
issuance of a final rule for the health claim. We are currently
considering these petitions. This document does not represent a
decision on these petitions, in whole or in part.
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Based on the new data and information currently under our review
that may be important, to our consideration in deciding what
requirements to include in the final rule, and the need to focus FDA's
resources on other public health priorities, we find it appropriate to
continue to extend our consideration of the exercise of enforcement
discretion for the labeling of foods, including dietary supplements,
bearing a health claim regarding phytosterols and risk of CHD
consistent with the 2003 letter, until publication of the final rule.
Therefore, FDA is extending the period during which it intends to
exercise enforcement discretion, consistent with the factors set forth
in the 2003 letter, until publication of a final rule for the
phytosterols and risk of CHD health claim. This document does not
change how FDA intends to consider exercising its enforcement
discretion when claims are made consistent with the proposed
requirements in the proposed rule. Food, including dietary supplements,
bearing the health claim would be required to comply with any revised
requirements established in the final rule when the final rule becomes
effective.
III. Reference
The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 a.m. and 4 p.m. Monday through Friday.
1. Center for Food Safety and Applied Nutrition, Food and Drug
Administration, Letter of Enforcement Discretion from FDA to Cargill
Health & Food Technologies, Docket No. FDA-2000-P-0102, document ID
DRAFT- 0059 (formerly 2000P-1275/LET3) and Docket No. FDA-2000-P-
0133, document ID DRAFT-0127 (formerly 2000P-1276/LET4), February
14, 2003.
Dated: February 15, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3940 Filed 2-17-12; 8:45 am]
BILLING CODE 4160-01-P
