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Start Preamble
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.
Start Further InfoFOR 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.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY 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.
Start SignatureDated: February 29, 2012.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition.
[FR Doc. 2012-5314 Filed 3-5-12; 8:45 am]
BILLING CODE 4160-01-P
Document Information
- Published:
- 03/06/2012
- Department:
- Food and Drug Administration
- Entry Type:
- Proposed Rule
- Action:
- Notice of petition.
- Document Number:
- 2012-5314
- Pages:
- 13232-13232 (1 pages)
- Docket Numbers:
- Docket No. FDA-2012-F-0138
- PDF File:
- 2012-5314.pdf
- Supporting Documents:
- » Reference 4 - Memorandum from A. Khan, Toxicology Review Group, Division of Petition Review, to J. Kidwell, Regulatory Group I, Division of Petition Review, February 11, 2014 re Food Additives Permitted for Direct Addition to Food for Human Consumption; V
- » Reference 3 - Memorandum from D. Folmer, Chemistry Review Group, Division of Petition Review, to J. Kidwell, Regulatory Group I, Division of Petition Review, February 7, 2013 re Food Additives Permitted for Direct Addition to Food for Human Consumption; V
- » Reference 2 - Memorandum from D. Folmer, Chemistry Review Group, Division of Petition Review, to J. Kidwell, Regulatory Group I, Division of Petition Review, December 11, 2013 re Food Additives Permitted for Direct Addition to Food for Human Consumption;
- » Reference 1 - Committee to Review Dietary Reference Intakes for Vitamin D and Calcium, Food and Nutrition Board, Institute of Medicine, ‘‘Dietary Reference Intakes for Calcium and Vitamin D,’’ National Academies Press, Washington, DC, 2011. re Food Additi
- » List of References - re Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3
- » Reference 4 - Memorandum from A Khan to J Kidwell February 11 2014
- » Reference 3 - Memorandum from D Folmer to J Kidwell February 7 2013
- » Reference 2 - Memorandum from D Folmer to J Kidwell December 11 2013
- » References List from FDA/CFSAN
- CFR: (1)
- 21 CFR 172