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U.S. Department of Health and Human Services

Final Rules: Food Additives and Color Additives
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Petition(s): FAP 2A4788

Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3

Petitioner: Abbott Laboratories
Docket number (legacy and/or former docket number(s)): FDA-2012-F-0138
Subject additive and intended use: amending the food additive regulations in 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 feeding.
21 CFR* affected: 172.380 Vitamin D3
Substance(s)*, (CAS Registry® No.): Vitamin D3, (67-97-0)
Federal Register publication history: Mar 6, 2012 77 FR 13232 Notice of petition
Aug 12, 2014 79 FR 46993 Final Rule Aug 12, 2014

 

*Definitions

  • 21 CFR: Title 21 of the Code of Federal Regulations.
  • Substance: The name of the substance listed in the CFR.
  • CAS Registry® No.: Chemical Abstract Service (CAS) Registry Number® for the substance.
  • Petitions (see also Questions and Answers About the Petition Process)
    • FAP: Food Additive Petition
    • CAP: Color Additive Petition
    • GRP: GRAS Affirmation Petition (replaced by GRAS Notification Program in 1998)
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