
[Federal Register Volume 76, Number 155 (Thursday, August 11, 2011)]
[Proposed Rules]
[Pages 49707-49708]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20406]


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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.

ACTION: Proposed rule; reopening of comment period.

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SUMMARY: 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 http://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.

FOR FURTHER INFORMATION CONTACT: Blakeley Fitzpatrick, Center for Food 
Safety and Applied Nutrition (HFS-830), 5100 Paint Branch Pkwy., 
College Park, MD 20740, 240-402-2176.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 8, 2010 (75 FR 76526), FDA 
proposed to amend its regulations in Sec.  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 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 Sec.  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 cholesterol-
lowering 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 Sec.  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

[[Page 49708]]

claim. The Agency notes that a final rule may vary from the proposal. 
To the extent that manufacturers have labeled their products consistent 
with the proposed requirements, and the final requirements differ from 
what the Agency proposed, manufacturers will be required to change 
their labels to conform to the final rule.

III. How To Submit Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: August 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-20406 Filed 8-10-11; 8:45 am]
BILLING CODE 4160-01-P


