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Dietary Supplements

These include herbs, botanicals, nutraceuticals and other novel ingredients, whether used in pet food, treats, beverages, or as dietary supplements.

  • Supplements for Animals Not Approved by the FDA
    • The FDA considers animal food supplements that are not approved nutrients included in the AAFCO list of approved ingredients or GRAS (Generally Recognized As Safe) to be unapproved food additives or unapproved new animal drugs. These supplements may not be used or put on a label unless the FDA approves of the ingredient or the ingredient is considered GRAS. A supplement ingredient may be approved as a flavoring agent, but if approved as such, no therapeutic claims may be made for that product.  Sometimes the food product with an added novel ingredient will be considered both a drug and a food if the claims made for the intended use of that product are considered drug claims.  A drug is defined as an article (other than food) intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals. Diseases resulting from essential nutrient deficiencies would not be included in the definition, thus classifying the food as a drug. A food can make a claim to alter the structure or function of the body only as it relates to the product's taste, aroma or nutritive value. If a structure or function claim is made on an animal food product to indicate that it will prevent a disease that is not a nutrional deficiency, the FDA wil interpret that claim as a drug claim. The FDA's Program Policy and Manual Guide 1240.3605, Regulating Animal Foods with Drug Claims, provides the matrix used by the FDA to determine whether a product is to be classified as a drug.
  • For companies that market supplement products that are not included in feed, visit the Web site of the National Animal Supplement Council (NASC). The NASC is an industry trade association comprised of of supplement manufacturers that works to promote the responsible and safe sale of supplements for pets. The NASC has designed a program to ensure safety of supplements for animals including adverse event reporting, which has reduced FDA's enforcement and oversight activities on these products. 
  • CBD

    • One of the more recent products to come onto the pet product marketplace are products containing CBD, cannabis or cannabis derivatives. Interest in these products increased  when Congress passed the Agriculture Improvement Act of 2018 (the 2018 Farm Bill). Among other things, this law established a new category of cannabis classified as “hemp” – defined as cannabis and cannabis derivatives with extremely low (no more than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). The 2018 Farm Bill removed hemp from the Controlled Substances Act, which means that it is no longer a controlled substance under federal law. At the same time, Congress explicitly preserved the FDA’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act.

      The FDA requires a cannabis product (hemp-derived or otherwise) that’s marketed with a claim of therapeutic benefit to be approved by the FDA for its intended use before it may be introduced into interstate commerce. Additionally, it is unlawful to introduce food containing added CBD, or the psychoactive compound THC, into interstate commerce, or to market CBD or THC products as dietary supplements. This is because CBD and THC are active ingredients in FDA-approved drug products and were the subject of substantial clinical investigations before they were marketed as food. In such situations, with certain exceptions that are not applicable here, the only path that the FD&C Act allows for such substances to be added to foods or marketed as dietary supplements is if the FDA first issues a regulation, through notice-and-comment rulemaking, allowing such use. 

      FDA has announced  (April 2019) that they intend to evaluate potential pathways for the regulation of cannibis products  and have announced a public hearing on the issue, that they will form an internal working group, and that they intend to issue warning letters to companies marketing CBD products with egregious and unfounded claims that are aimed at vulnerable populations. For more see the FDA Commissioner's announcement on cannibis products.  Many states are also proposing laws and or regulations to regulate cannabis products. We await more updates on whether the regulation for CBD products in edible products versus supplements will differ.

  • Supplement Claims for Humans
    • FDA’s position is that dietary supplements for animals do not fall under DHSEA (the Dietary Supplement Health and Education Act) and thus, cannot be marketed for animals. However, the FDA has provided guidance relating to claims on dietary supplements for human consumption. The FDA has issued final rules as to the type of statements that can be made concerning the effect of a dietary supplement on structure and function of the body. The FDA’s "Small Entity Compliance Guide for Structure and Function Claims" may be helpful in seeing the types of claims that can be made with human supplements.
    • The guide discusses the distinction between claims that are structure/function claims and disease claims, the latter requiring prior approval by the FDA. Statements that describe the role of a nutrient or ingredient intended to affect the structure or function in humans or that characterize the documented mechanism by which a nutrient acts to maintain such structure or function are permitted statements as long as they are not disease claims. Dietary supplements can make claims about nutrient deficiency diseases. The structure function/claims used must be substantiated, and FDA must be notified regarding the intention to make such a claim when the product is first marketed, and a mandatory disclaimer statement, contained in the law, must be included. The Compliance Guide sets forth 10 criteria that may be useful in determining if a statement is a disease claim.