Walk into any mainstream pet store and it is evident that the pet supplement industry is booming. Pet store shelves are packed with animal counterparts to human supplements, such as joint health supplements for cats and dogs. Because of the prevalence of such products, one would never guess that FDA does not recognize dietary supplements for pets as a class of products.
Before the Dietary Supplement and Health Education Act of 1994 (“DSHEA”), which paved the way for the dietary supplement industry to become what it is today, human dietary supplements were regulated as either food or drugs, depending upon their intended use. Additionally, dietary supplement ingredients had to receive preapproval from FDA to be used as food additives, which was extremely burdensome, or be generally recognized as safe (GRAS). After DSHEA, dietary supplements were officially recognized as a sub-category of food, and dietary ingredients were exempted from being regulated as food additives. As a result, dietary ingredients could be used without premarket approval so long as they were marketed in dietary supplements prior to October 15, 1994.
Animal supplements, unfortunately, were not addressed in DSHEA. Inapplicability of the Dietary Supplement Health and Education Act to Animal Products, 61 Fed. Reg. 17706 (April 22, 1996). Thus, the regulations that apply to dietary supplements for humans do not apply to animals. Substances marketed as dietary supplements for animals still fall under the pre-DSHEA regulatory scheme and are considered food, food additives, new animal drugs, or generally recognized as safe (“GRAS”) depending on their intended use. Animal supplements typically fall into the category of “animal feed.” As a general matter, all animal supplements must be comprised of ingredients that are GRAS (either GRAS by regulation or self-determination), approved as a food additives, or listed as ingredients in the Official Publication of the Association of American Feed Control Officials (AAFCO).
Because animal supplements are not governed by DSHEA, they are technically not permitted to bear claims other than those concerning the nutrition, aroma, or taste of the supplement. On a case-by-case basis, FDA’s Center for Veterinary Medicine (“CVM”) has allowed references to “nutritional support” of specific organs or body functions. Additionally, FDA has incorporated the tenets of the Nutrition Labeling Education Act (NLEA) into animal feed regulation, and thus, allows a manufacturer to include meaningful health information on labels. Manufacturers must provide the agency with scientific substantiation that the statement is truthful and non-misleading. CVM must generally review and accept the claim before it can be placed on a product’s label. As with human supplements, claims about the treatment, mitigation, or prevention of disease will automatically render the product an unapproved new drug.
In light of the above, the animal supplement industry has more uncertainty and risk than the human supplement industry. A version of DSHEA for animal supplements must be passed to remedy this. Without such legislation, those in the animal supplement industry are at the mercy of FDA.