[Federal Register Volume 76, Number 34 (Friday, February 18, 2011)]
[Proposed Rules]
[Pages 9525-9527]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-3678]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2000-P-0102, FDA-2000-P-0133, and FDA-2006-P-0033]


Health Claim; Phytosterols and Risk of Coronary Heart Disease

AGENCY: Food and Drug Administration, HHS.

ACTION: 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. In the proposed rule for this health claim that published 
on December 8, 2010 (75 FR 76526), the Agency provided a period of 75 
days from the date of publication of the proposed rule during which FDA 
intended to exercise its enforcement discretion for the use of such 
claim consistent with the 2003 letter. FDA is extending this period 
during which the Agency intends to exercise enforcement discretion to 
February 21, 2012.

DATES: Submit either electronic or written comments by April 19, 2011.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written

[[Page 9526]]

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, 301-436-2176.

SUPPLEMENTARY INFORMATION: 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, the Agency 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.
    The Agency 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 (Ref. 1). 
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 may effectively reduce blood 
cholesterol levels. In response to the letter submitted by Cargill and 
other comments received to the IFR, the Agency issued a letter of 
enforcement discretion on February 14, 2003 (the 2003 letter). In such 
letter, the Agency explained that it would consider exercising 
enforcement discretion, pending publication of the final rule, with 
respect to certain requirements of the health claim. Specifically, the 
Agency stated it 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 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 21 
CFR 101.13; 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), the 
Agency issued a proposed rule that, if finalized, would amend Sec.  
101.83. The proposed rule, in part, responds to a petition received on 
May 5, 2006, and it also includes the evaluation of new scientific data 
that was not available when the IFR was published.
    The Agency stated in the proposed rule for the phytosterols and 
risk of CHD health claim that, pending issuance 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 proposed rule also states that, beginning 75 days after the 
date of publication of the proposed rule (February 21, 2011), FDA does 
not intend to exercise its enforcement discretion based on the 2003 
letter. Therefore, starting on February 21, 2011, all products bearing 
the health claim must be in compliance with Sec.  101.83, or if the 
health claim is made in a manner that is consistent with the proposed 
rule, the Agency may exercise enforcement discretion.
    In the proposed rule, the Agency 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.
    Since publication of the proposed rule, the Agency has 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.\1\ In particular, many of the 
comments stated that 75 days was not enough time for industry to come 
into compliance with Sec.  101.83 or to make the claim consistent with 
the proposed requirements in the proposed rule. FDA understands almost 
all dietary supplement products in the marketplace contain the free 
form of phytosterols, specifically in solid tablet dosage forms. One 
reason that the free form is used more frequently in the production of 
dietary supplements is because it has less bulk, and therefore, 
manufacturers can produce smaller pills that are easier for consumers 
to swallow. Based on the totality of publicly available scientific 
evidence for the cholesterol-lowering effects of nonesterified 
phytosterols in dietary supplements at the time that the proposed rule 
was published, the Agency determined that the evidence was inconsistent 
and tentatively concluded that the scientific evidence for the 
relationship between dietary supplements containing nonesterified 
phytosterols and CHD did not meet the significant scientific agreement 
standard. The Agency, therefore, proposed to amend Sec.  
101.83(c)(2)(iii)(B) to make the use of the health claim available only 
to phytosterol ester-containing dietary supplements that meet all of 
the specific requirements in Sec.  101.83. Therefore, based on the

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Agency's determination in the proposed rule, dietary supplements 
containing the free form of phytosterols would have to be relabeled or 
reformulated by February 21, 2011. The comments that the Agency 
received from industry stated that 75 days is not enough time to 
reformulate or relabel dietary supplements containing free phytosterols 
and requested that FDA consider extending its enforcement discretion 
for the use of the health claim in a consistent manner with the 2003 
letter.
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    \1\ The agency received two letters from trade associations 
representing dietary supplement manufacturers and distributors. One 
was submitted by the Council for Responsible Nutrition on December 
22, 2010, seeking an extension of the Agency's enforcement 
discretion based on the 2003 letter and one was submitted by the 
Consumer Healthcare Products Association on January 31, 2011, 
requesting that FDA permit manufacturers of dietary supplement 
products with claims regarding free phytosterols and heart disease 
that were marketed prior to December 8, 2010 (the date of issuance 
of the proposed rule), to continue marketing of such products until 
a final rule is published. In addition, the Agency received two 
petitions for an administrative stay of action, one from Cargill, 
Inc., dated January 7, 2011 (``Cargill petition''), and another from 
Pharmachem Laboratories, Inc., dated January 28, 2011 (``Pharmachem 
petition'') (Docket Nos. FDA-2000-P-0102, FDA-2000-P-0133, and FDA-
2006-P-0033). The Agency is currently considering these petitions. 
This document does not represent a decision on the petitions, in 
whole or in part. We note that Cargill, Inc., and Pharmchem 
Laboratories, Inc., both requested in their petitions that FDA stay 
rescission of enforcement discretion under the 2003 letter pending 
issuance of the final rule. FDA's decision set forth in this 
document to extend consideration of enforcement discretion based on 
the 2003 letter until February 21, 2012, is consistent with Cargill 
and Pharmachem's requests except for the duration of the Agency's 
enforcement discretion.
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    The Agency also understands that there are many conventional foods 
currently available in the marketplace that contain phytosterols at a 
level of 0.4 g free phytosterol equivalents per RACC. These foods 
contain phytosterol ingredients that have not been the subject of a 
generally recognized as safe (GRAS) notification letter to which the 
Agency had no further questions at a level greater than 0.4 g free 
sterol equivalents per RACC. A level of 0.4 g free sterol equivalents 
per RACC is less than the new proposed requirement of 0.5 g of 
phytosterols per RACC, based on the nonesterified weight of 
phytosterols. Products with 0.4 g free sterol equivalents per RACC 
would also have to be reformulated or relabeled beginning on February 
21, 2011.
    Based on these concerns about reformulation and relabeling during a 
75-day period, FDA considers it appropriate to extend the period of 
time that it intends to exercise enforcement discretion based on the 
2003 letter. FDA intends to exercise enforcement discretion until 
February 21, 2012, with regard to the use of a claim about 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. Information submitted by industry and trade 
associations about the amount of time necessary to reformulate, 
relabel, and to submit a GRAS notification in addition to the Agency's 
experience with the economic impact of labeling and reformulation 
changes on industry have served as the basis for the Agency's extension 
of the period during which it intends to exercise enforcement 
discretion to February 21, 2012, based on the 2003 letter. 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. Rather, this document only 
relates to FDA's enforcement discretion based on the 2003 letter, and 
FDA will determine what, if any, further action is necessary, pending 
its review of the Cargill and Pharmachem petitions. Food bearing the 
health claim would be required to comply with any revised requirements 
established in the final rule when the final rule becomes effective.

References

    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 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-3678 Filed 2-17-11; 8:45 am]
BILLING CODE 4160-01-P