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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 670.200 Status of Vitamins and Minerals in Type B and C Medicated Feed and in Non-Medicated Feed June 1986

Final

CPG Sec. 670.200 Status of Vitamins and Minerals in Type B and C Medicated Feed and in Non-Medicated Feed

Issued by:
Guidance Issuing Office
Center for Veterinary Medicine
Office of Regulatory Affairs

BACKGROUND:

Poultry and livestock usually subsist entirely upon feeds scientifically formulated to provide a diet complete with all known vitamin and mineral requirements for maximum production. Vitamins and minerals as well as other nutrients are often provided to operators of feed mills in concentrated form to facilitate mixing of medicated and non-medicated feed. We have established no regulations which set forth the optimum or required daily vitamin/mineral intake for any animal species. We are, however, guided in this regard by data in the scientific literature and information appearing in such standard texts as the Nutritional Requirements of Domestic Animals published by the National Academy of Sciences - National Research Council or in other published literature. All medicated and non-medicated feeds should provide the target species with adequate levels of each of the vitamins and minerals they are labeled as containing in accordance with the published data.

Beyond providing adequate nutritional levels of required vitamins and minerals animal feed should not be misbranded by any direct or implied therapeutic or other claim for special benefits from the nutritional content. Nor should feeds be represented as tonic or conditioners or capable of providing "stamina" or "strength" or for increasing milk or egg production or butterfat content or bear any similar claims unless supported by the literature or so approved.

Animal feeds should be properly formulated so as to be safe for the animals and so as not to produce unsafe tissue residues. All nutritional additives in feed should be either GRAS or the subject of a food additive regulation prescribing their safe use.

POLICY:

The Center for Veterinary Medicine will not generally object to the marketing of type B or type C medicated feeds or of non-medicated feeds containing vitamins and minerals or other nutrients provided they conform to the following guidelines:

  1. The nutritional additives are either GRAS or the subject of a food additive regulation describing their safe use.
  2. The product provides vitamins and minerals or other nutrients it is represented to contain at concentrations reasonably consistent with sound nutritional practice for that species.
  3. The labeling clearly states the common or usual name of each nutrient, and is not otherwise false or misleading in any particular.
  4. The labeling should bear no disease prevention or therapeutic claims, including growth promotional representations attributed to the added nutritional ingredients except where supportable by scientific data.
  5. Finally, the product should neither be superpotent nor subpotent or otherwise formulated so as to pose a hazard to the health of the target animal or to humans consuming edible products derived from the target animal.

While there is no formal compliance program concerning the vitamin-mineral content of non-medicated feeds, appropriate regulatory action may be recommended against seriously violative products.

Issued: 10/1/80
Revised: 6/1/86


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002