Rules and Regulations. Notification of availability

Agency: Food and Drug Administration, HHS
Action: Notification of availability
Citation: FR Doc. 2016-03697 · Docket No. FDA-2016-N-0585 · 21 CFR 101

Summary

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled “Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids—Small Entity Compliance Guide.” The small entity compliance guide (SECG) is intended to help small entities comply with the final rule titled “Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids.”

Dates

Submit either electronic or written comments on FDA guidances at any time.

Supplementary Information

I. Background In the Federal Register of April 28, 2014 (79 FR 23262), (see also Docket Nos. FDA-2007-0601, FDA-2004-N-0382, FDA-2005-P-0371, and FDA-2006-P-0224 (formerly Docket Nos. 2004N-0217, 2005P-0189, and 2006P-0137)), we issued a final rule prohibiting certain nutrient content claims for foods, including conventional foods and dietary supplements, that contain omega-3 fatty acids based on our determination that such nutrient content claims do not meet the requirements of the Federal Food, Drug, and Cosmetics Act. The final rule became effective January 1, 2016. We examined the economic implications of the final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612) and determined that the final rule may 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 (Pub. L. 104-121, as amended by Pub. L. 110-28), we are making available the SECG to explain the actions that a small entity must take to comply with the rule. We are issuing the SECG consistent with our good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG represents the current thinking of the FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Electronic Access Persons with access to the Internet may obtain the SECG at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov . Use the FDA Web site listed in the previous sentence to find the most current version of the guidance. Dated: February 18, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-03697 Filed 2-22-16; 8:45 am]