Animal Supplements in the USA – What You Need to Know
How are animal supplements regulated in the USA?
Dietary supplements are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA). The U.S. Food and Drug Administration (FDA)’s Center for Veterinary Medicine (CVM) confirms that the DHSEA does not apply to animal products. Therefore, animal supplements are not regulated as dietary supplements in the USA, but rather as food, or drugs, depending on the intended use.
What are Animal Supplements/Feed?
Animal (pet) food or feed products are regulated by the CVM and they are defined as “animal food ingredient, to become part of an ingredient or food, or added to an animal’s drinking water”. The Federal Food, Drug, and Cosmetic Act (FD&C Act) sets requirements in sections 402 and 403 on food and products may be deemed adulterated or misbranded if requirements are not satisfied. For example, false information on food labels, unsanitary food packaging, and animal feed containing poisonous substances.
The FD&C Act states that any substance added or going to be part of the animal food, directly or indirectly, must follow food additive regulation or be Generally Recognized as Safe (GRAS) for that intended use. Examples of GRAS animal feed ingredients are forages, grains, and most of the vitamins and minerals. Other substances that do not appear in final animal food products but to give flavour or texture may also be considered food additives. The approved food additive list for animal feed can be found in 21 CFR 573 and partial GRAS list for animal feed can be found in 21 CFR 582 and 584.
What Claims Can I Make For My Product?
The FD&C Act states that if the product contains structure function claims or its intended use is to cure, treat, prevent, or mitigate disease, the product is considered a new animal drug. All new animal drugs require approval through New Animal Drug Application by providing evidence on its safety and efficacy for its intended use. Food labels can have statements on the label regarding the product’s nutrition, aroma, or taste. The CVM publishes policy and permits some health information on the animal food label such as urinary tract health and dental health. These claims require approval by CVM before they can go on the label. All claims need to be truthful and accurate in the indicated species.
How Does the FDA Enforce Animal Supplements?
The FDA will flag “animal supplement” products that are being marketed as foods, but make egregious claims, for example, intending to treat a disease. Other examples include shelf-life evaluation, mislabelling, and containing unapproved substances or additives (e.g. CBD). The FDA may issue warning letters to businesses making these claims without proper substantiation. If this is the case, work closely with the FDA and see what changes are required to the product.
How We Can Help
QSS offers regulatory services for your animal food or drug products to make sure they are in compliance with the applicable regulations. Contact us today to learn more!