Veterinary Nutraceuticals

Veterinary Nutraceuticals and Veterinary Dietary Supplements

Veterinary pet supplements and pet nutraceuticals fall under the purview of the Food and Drug Administration – Center for Veterinary Biologics, and are not recognized as a separate class of product. These products are regulated under the Federal Food, Drug, and Cosmetic Act (FFDCA).  However, veterinary dietary supplements are not subject to the Dietary Supplement and Health Education Act (DSHEA).  One valuable resource is the National Animal Supplement Council, which can assist companies on the various aspects of the veterinary nutritional supplement market for veterinary and animal health applications.

Animal dietary supplements (e.g., animal nutraceuticals) which claim to cure, treat, prevent or mitigate a disease would be considered a new animal drug and subject to a formal approval process.

Market for Veterinary Supplements

The veterinary nutritional supplement and nutraceutical market consists of products similar to the human nutraceutical market, including dietary supplements.  Although no definitive market statistics are currently available, the veterinary supplement market is estimated to represent between $500-$750 million dollars in the United States.

Examples

veterinary nutraceuticals

  • Veterinary joint supplements
  • Veterinary skin supplements
  • Veterinary probiotics
  • Veterinary immune supplements
  • Veterinary dietary supplements

Regulatory Information on Animal Health Supplements

The FDA-CVM Compliance Policy Guide (CPG) Sec. 690.100 was issued in Oct. 1980 and revised in Mar. 1995, which specifically addresses the regulation of nutritional supplements for companion animals. The policy stated that the CVM will “not generally object to the marketing of nutritional supplements for oral administration to companion animals provided they conform with certain criteria.  However, in Feb. 2020, this policy was withdrawn.  Questions regarding nutritional supplements for companion animals may be addressed by the FDA-CVM or animal health consultants.

veterinary supplements

Terminology: Nutritional supplements are often referred to as animal nutraceuticals, animal supplements, pet supplements, pet nutraceuticals, animal dietary supplements among other terms.

Labeling

Labeling of veterinary nutraceuticals and supplements is important, and should be consistent with veterinary nutraceutical guidelines for labeling. Labeling should include the:

  • Brand Name and Product Name
  • Purpose Statement
  • Guaranteed Analysis
  • List of Ingredients
  • Directions for Use
  • Warning and/or Caution Statements
  • Manufacturer’s Name and Address
  • Quantity Statement

Regulatory Links

 

Other Links

 

Additional Information Concerning Veterinary Nutraceuticals

Other Regulatory Considerations

Pet nutraceuticals and pet supplements are considered drugs of discretion by the US Food and Drug Administration – Center for Veterinary Medicine.   Companies should ensure their products meet certain criteria before marketing dietary supplements for companion animals.  Products should not have any statements that suggest therapeutic or disease prevention claims, or are misleading or false. The FDA-CVM, on a number of occasions, has issued Warning Letters to companies that are considered in violation of the FFDCA.

Manufacturing of Veterinary Nutraceuticals

The manufacture of veterinary and pet nutraceuticals and supplements should be to Good Manufacturing Practices (GMP).

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Veterinary Regulations