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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]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

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. 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                               ( print 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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 § 101.83. Therefore, based on the                           ( print page 9527)                        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.                

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 § 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.

# Footnotes

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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[FR Doc. 2011-3678 Filed 2-17-11; 8:45 am]

BILLING CODE 4160-01-P