United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2014_register executive 2014-10-07 article Rules and Regulations D09002ee1c7f8d34b D09002ee1c7f8d3b5 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of vitamin D<INF>3</INF> as a nutrient supplement in meal replacement beverages 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 feedings. We are taking this action in response to a petition filed by Abbott Laboratories (Abbott). 79 FR 46993 https://www.govinfo.gov/app/details/FR-2014-08-12/2014-18969 2014-18969 fr12au14-6 4164-01-P Docket No. FDA-2012-F-0138 https://www.govinfo.gov/app/details/FR-2014-08-12/2014-18969 https://www.govinfo.gov/content/pkg/FR-2014-08-12/html/2014-18969.htm https://www.govinfo.gov/content/pkg/FR-2014-08-12/pdf/2014-18969.pdf Food Additives Incorporation by Reference Reporting and Recordkeeping Requirements 4 p. 46993 46996 79 FR 46993 Title 21 Part 172 21 CFR Part 172 Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3; Federal Register Vol. 79, Issue RULE 2014-18969 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2014-08-12 2014-09-11 Docket No. FDA-2012-F-0138 4164-01-P 2014-18969 Final rule.

The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of vitamin D<INF>3</INF> as a nutrient supplement in meal replacement beverages 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 feedings. We are taking this action in response to a petition filed by Abbott Laboratories (Abbott).

This rule is effective August 12, 2014. See section VII "Objections" for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by September 11, 2014. The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of August 12, 2014. 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. Food Additives Incorporation by Reference Reporting and Recordkeeping Requirements Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 , http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html http://www.regulations.gov http://www.usp.org Vol. 79, no. 155 Office of the Federal Register, National Archives and Records Administration 2014-08-12 continuing daily deposited born digital 421 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-08-12 P0b002ee189da2386 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr12au14 https://www.govinfo.gov/app/details/FR-2014-08-12 https://www.govinfo.gov/content/pkg/FR-2014-08-12/pdf/FR-2014-08-12.pdf https://www.govinfo.gov/content/pkg/FR-2014-08-12/xml/FR-2014-08-12.xml fdlp 46961 47372 DGPO 2014-10-07 2024-06-02 FR-2014-08-12 machine generated eng FR FR-2014-08-12 79 155