Dietary Supplements for Pets – Are They Drugs?

There is some confusing discussion in the public literature about how the FDA’s Center for Veterinary Medicine (FDA-CVM) regulates animal supplements. A recent article by Dr. L. Phillips Brown[1] and excerpted by J. Taylor[2] mentions that “FDA-CVM accepts the marketing of oral supplements for animals provided there is a recognized benefit, purpose or utility and they are not a substitute for a complete and balanced diet or represented to prevent or cure disease.” This statement suggests that oral supplements for animals, like dietary supplements for humans, are regulated under the Dietary Supplement Health Education Act (DSHEA). This rationale should not be used for marketing supplements for animals. The FDA-CVM’s assessment of DSHEA is that it was not intended for and does not apply to animals.[3] A notice for this policy was published in the Federal Register on April 22, 1996.[4] Nevertheless, the FDA-CVM has stated that it “does not object to the OTC marketing of dietary supplements in tablet, capsule, powder or liquid form for companion animals, similar to the special dietary preparations that are sold for humans” (FDA Compliance Policy Guide Section 690.100).[5] FDA-CVM has been clear in stating that the term “dietary supplement” in this sense only pertains to nutrients, which would include vitamins, minerals, protein supplements and fatty acid sources. The other types of supplements FDA-CVM recognizes (animal health supplements) are considered different from nutritional supplements and are regulated as drugs by FDA-CVM. Because FDA-CVM does not recognize DSHEA, many substances that are legally marketed in human dietary supplements would fall under the drug category for use in pets.

Under current law, nutritional supplements are considered foods and should achieve either Generally Recognized as Safe (GRAS) or food additive status. FDA-CVM will not generally object to the marketing of nutritional supplements for oral administration to companion animals provided that “there is a known need for each nutrient ingredient represented to be in the product for each animal for which the product is intended, the label represents the product for use only in supplementation of and not as a substitute for good daily rations, the product provides a meaningful but not excessive amount of each of the nutrients it is represented to contain, the labeling should bear no disease prevention or therapeutic (including growth promotional) representations…and should not be false or misleading” … and “the product is neither over-potent nor under-potent nor otherwise formulated so as to pose a hazard to the health of the target animal.”[6]

Meeting these requirements has been particularly onerous for dietary supplement manufacturers because the nutritional needs of companion animals have not been fully characterized and the process by which a nutritional need could be established could be very expen