This story was first published in the July/August 2002 issue of FDA Consumer magazine, published by the U.S. Food and Drug Administration. It is information meant for consumers on issues the FDA sees in regard to dietary supplements for animals.
Dietary supplements for pets and other animals have been marketed for many years; some are sold legally and others are not.
Dietary supplements for animals, such as most vitamin and mineral products, are considered animal feeds. Ensuring that animal feeds are safe and properly labeled—a requirement of the Federal Food, Drug, and Cosmetic Act—is part of the responsibility of the FDA's Center for Veterinary Medicine (CVM).
Foods for animals do not require FDA approval before they are marketed, but they must be made with ingredients that meet at least one of the two following requirements:
- be approved food additives, or
- be substances that are "generally recognized as safe" (GRAS) for their intended use.
However, on a case-by-case basis, CVM has exercised enforcement discretion for substances that do not raise any safety concerns, often because the company has submitted the information needed to list the ingredient in the AAFCO Official Publication. The Association of American Feed Control Officials (AAFCO) includes officials from all the states, the U.S. federal government, Canada, and Costa Rica. These officials are responsible for enforcing the laws regulating the production, labeling, distribution or sale of animal feeds. CVM often works with AAFCO in regulating animal feeds.
Some foods and other products containing dietary supplements for animals, such as St. John's wort, do not meet any of the requirements. And some "dietary supplement" products are being marketed to treat or prevent disease—for example, chondroitin sulfate to treat arthritis. This moves a product from the supplement category into the drug category. CVM officials, who also regulate animal drugs, are concerned that these products have not been shown to be safe and effective. And, some owners may be using these products instead of getting appropriate veterinary treatment for their animals.
Quite a few animal supplement products are being sold as a result of the Dietary Supplement Health and Education Act (DSHEA), passed by Congress in 1994, and these products generally contain ingredients similar to those in human dietary supplements. The FDA believes that DSHEA does not apply to animals, and that many of the products being sold are in violation of the Federal Food, Drug, and Cosmetic Act.
The FDA published an explanatory notice to this effect in the Federal Register in 1996.
CVM officials are concerned about these products because there is no scientific data showing that they are safe or even contain the ingredients listed on the label. These concerns focus on three main areas:
- Human food safety Supplements that are used in food animals must be shown to be safe for people who consume products from the animals. Without these data, there is no assurance that an animal-derived food is safe.
- Animal safety Supplements must be shown to be safe for the animals. CVM and AAFCO have not received data showing that these products have actually been tested on animals to show that a particular level is appropriate or safe for the animals.
- Manufacturing quality Supplements must be shown to be manufactured to a consistent standard (for example, shown to contain a given amount of the ingredient).
CVM cautions people to check with their veterinarians before giving their pets or other animals any supplements, whether alone or in a food product. "Many people do not appreciate that dogs and cats are not small furry people," says CVM's pet food specialist William Burkholder, D.V.M., Ph.D. "They often think that a supplement that they may take themselves is good for their pet, but that may not be the case."
On the Web: ANIMAL SUPPLEMENTS