How are dietary supplements for animals regulated?

Answer:

  • For animals, the U.S. Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM) regulates two classes of products: food and drugs. Depending on the intended use, an animal dietary supplement is considered either a food or drug. There is no separate category for “supplements” for animals.1
  • In the Dietary Supplement Health and Education Act (DSHEA) of 1994, the term “dietary supplement” was defined but it did not specify if the definition applied to humans, animals, or both. The main effect of DSHEA was to reclassify certain dietary ingredients from regulation as food additives, which require pre-market approval.2
  • In 1996, CVM published a notice in the Federal Register to explain that DSHEA did not apply to animal products.1
  • Simply, federal laws and regulations do not recognize a category of products for animals called “dietary supplements.” Depending on the stated intended use, the product is either a food or drug, regulated by the FDA.1
  • Many owners purchase products intended for human use for their pets. It is important to know that manufacturers of human dietary supplements do not have to provide FDA with evidence that their dietary supplements are effective or safe. However, they are not permitted to market unsafe or ineffective products.2
  • Once a human dietary supplement is marketed, the FDA has to prove that the product is not safe in order to restrict its use or remove it from the market.2
  •  In contrast, before being allowed to market a drug, manufacturers must obtain FDA approval by providing convincing evidence that it is both safe and effective.3
  • Some supplements that are safe for humans can be toxic to dogs or cats. Therefore, it is imperative that pet owners consult with their veterinarians before giving a dietary supplement to their pet.
The Science Behind our Recommendations
1. Definition of food and drug. Association of American Feed Control Officials Web site. http://petfood.aafco.org/DefinitionofFoodDrugs.aspx. Accessed July 4, 2013. 2. FDA’s regulation of pet food. U.S. Food and Drug Administration Web site. http://www.fda.gov/AnimalVeterinary/ResourcesforYou/ucm047111.htm. Accessed July 4, 2013. 3. Background information: dietary supplements. National Institutes of Health, Office of Dietary Supplements Web site. Informatihttp://ods.od.nih.gov/factsheets/DietarySupplements-HealthProfessional/. Accessed July 4, 2013.