FDA Dietary Supplement Rule Not Applicable to Veterinary Products

Scientific studies performed over the past decade have demonstrated the widespread availability of poor quality and potentially unsafe dietary supplements for both human and animal consumption. These include supplements that:

  • Do not contain the type or amount of ingredient listed on the manufacturer's label;
  • Recommend subtherapeutic dosages; and
  • Are potentially contaminated by harmful components, such as heavy metals and pesticides, or by other ingredients during the manufacturing process.

Dietary supplements for veterinary consumption are essentially void of any form of government regulation.

Earlier this year, the U.S. Food and Drug Administration (FDA) announced its "final rule" mandating that human dietary supplements must be manufactured in accordance with current good manufacturing practices (cGMPs)--a set of guidelines that ensure supplements are manufactured, packaged, and stored in a quality manner, are free of contaminants and impurities, and are labeled correctly.

According Laura Alvey, a spokeswoman for the FDA, no changes in the manufacturing guidelines or processes of veterinary dietary supplements are anticipated.

Barbara Eves, DVM, senior manager of scientific communications at Nutramax Laboratories Inc. explained, "Unfortunately, it is still a buyer-beware market in the veterinary supplement industry. Veterinarians and horse owners should ask veterinary supplement manufacturers for documentation of product claims and safety (published peer-reviewed research) to be certain that they are purchasing a quality product."

Outside of the FDA regulations, the National Animal Supplement Council (NASC) in 2004 initiated a Quality Seal Program as part of its ongoing effort to improve and standardize the animal supplement industry. The seal is a way for consumers to know that when they buy a product, they buy from a reputable manufacturer. Different from the NASC logo, the seal signifies that the company has been independently audited for the implementation of specific standards and conformance with quality system requirements.

As recently summarized in two scientific studies (see www.TheHorse.com/ViewArticle.aspx?ID=10073), poor quality supplements are unlikely to be effective when administered to horses, are an unnecessary expense, and can pose health risks if the unregulated products are contaminated with such chemicals as pesticides or heavy metals.

For more information on the FDA regulations see www.fda.gov/consumer/updates/dietarysupps062207.html.

About the Author

Stacey Oke, DVM, MSc

Stacey Oke, MSc, DVM, is a practicing veterinarian and freelance medical writer and editor. She is interested in both large and small animals, as well as complementary and alternative medicine. Since 2005, she's worked as a research consultant for nutritional supplement companies, assisted physicians and veterinarians in publishing research articles and textbooks, and written for a number of educational magazines and websites.

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