03-21228. Small Entity Compliance Guide on Labeling Trans

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a small entity compliance guide (SECG) for a final rule published in the Federal Register of July 11, 2003, entitled “Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims.” This SECG, also entitled “Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims,” is intended to help small businesses understand that final rule and to set forth in plain language the requirements of the regulation.

DATES:

Submit written or electronic comments on the SECG at any time.

ADDRESSES:

Submit written comments concerning this SECG to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments. Submit written requests for single copies of the SECG to the Industry Activities Staff, Center for Food Safety and Applied Nutrition (HFS-565), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835. Send one self-adhesive address label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the SECG.

FOR FURTHER INFORMATION CONTACT:

Julie Schrimpf, Center for Food Safety and Applied Nutrition (HFS-800), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-2373, FAX [phone].

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of July 11, 2003 (68 FR 41434), FDA issued a final rule requiring that trans fatty acids be declared in the nutrition label of conventional foods and dietary supplements on a separate line immediately under the line for the declaration of saturated fatty acids. This final rule becomes effective on January 1, 2006.

We examined the economic implications of that final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-602) and determined that the final rule would have a significant economic impact on a substantial number of small entities.

In compliance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121), we are making available this SECG stating in plain language the requirements of the final rule.

FDA is issuing this SECG as level 2 guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115). This SECG represents the agency's current thinking on the subject. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You may use an alternative approach if such approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance (see FOR FURTHER INFORMATION CONTACT).

II. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on the SECG entitled “Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims.” Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. A copy of the SECG and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet may obtain the document at http://www.cfsan.fda.gov/​dms/​guidance.html.

Dated: August 12, 2003.

William K. Hubbard,

Associate Commissioner for Policy and Planning.