2012-5314. Abbott Laboratories; Filing of Food Additive Petition

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of petition.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that Abbott Laboratories has filed a petition proposing that the food additive regulations be amended to provide for the expanded safe use of vitamin D₃ as a nutrient supplement in food.

FOR FURTHER INFORMATION CONTACT:

Judith Kidwell, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1071.

SUPPLEMENTARY INFORMATION:

Under the Federal Food, Drug, and Cosmetic Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food additive petition (FAP 2A4788) has been filed by Abbott Laboratories, 3300 Stelzer Rd., Columbus, OH 43219. The petition proposes to amend § 172.380 (21 CFR 172.380) to provide for the safe use of vitamin D₃ as a nutrient supplement in meal replacement beverages and meal replacement bars that are not intended for special dietary use in reducing or maintaining body weight and for use in foods that are sole sources of nutrition for enteral tube feeding.

The Agency has determined under 21 CFR 25.32(k) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

Dated: February 29, 2012.

Dennis M. Keefe,

Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition.