
[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]


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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.

ACTION: Notification; extension of enforcement discretion.

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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 http://www.regulations.gov. 
Submit written

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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

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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.
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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


