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U.S. Department of Health and Human Services

Animal & Veterinary

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NRC Publishes Report on Horse, Cat, Dog Dietary Supplement Safety

by Jon. F. Scheid, Editor
FDA Veterinarian Newsletter May / June 2008 Volume XXIII, No III

The National Research Council (NRC) has published a report examining considerations for the safe use of dietary sup-plements in companion animals, highlighting needs for consistent data, a good system of adverse event reporting, and clarification of the regulations covering the supplements.

The Center for Veterinary Medicine commissioned the report, “Safety of Dietary Supplements for Horses, Dogs, and Cats,” to help the Food and Drug Administration address the public’s desire to use dietary supplements for companion animals.

The Dietary Supplement Health and Education Act (DSHEA), passed in 1994, created a less restricted pathway for die-tary supplements for humans to get to market. Since then, CVM has maintained that the less restrictive pathway should not apply to products for animals. However, according to the report’s summary, FDA and other regulatory bodies are “un-der pressure” to resolve the gulf between the public’s desire to use the products and the different regulatory requirements. The committee was charged with developing considerations about the safety of the products, but not about product utility or efficacy.

According to the summary, “The report was intended to help form the basis of a more general framework for evaluating animal dietary supplement safety.” The committee used public data to conduct safety assessments of three dietary sup-plements – lutein, evening primrose oil, and garlic. “The knowledge gained from conducting these assessments allowed the committee to review and begin to define factors that should be considered when evaluating the safety of animal die-tary supplements in general,” the summary said.

A key finding listed in the report’s summary was that data on safety for dietary supplements fell short of what would typically be required for reviewing the safety of animal drugs or animal food additives. In addition, it said, “There is a clear need for a comprehensive adverse event reporting system.” Existing systems have limitations for supplements, it said.

The report also recommended that FDA review the regulation of animal dietary supplements. The regulations need to differentiate between an animal dietary supplement, a food additive, and an animal drug, “as well as factors that differenti-ate regulation of human and animal dietary supplements.”

To develop the report, the NRC assembled a committee of experts, including animal nutritionists, veterinarians, clinical pharmacologists, and toxicologists. Dr. William Price, special assistant to the Director of CVM’s Division of Animal Feeds and project officer for the report, described the panel members as “highly qualified scientists” in the areas of animal health and nutrition.

On the panel were:

  • Dr. Jim E. Riviere, (Chair), D.V.M., Ph.D., North Carolina State University
  • Dr. Dawn M. Boothe, D.V.M., Ph.D., Auburn University
  • Dr. Gail L. Czarnecki-Maulden, Ph.D., Nestle Purina PetCare PT
  • Dr. David A. Dzanis, D.V.M., Ph.D., Dzanis Consulting and Collaborations
  • Dr. Patricia A. Harris, M.R.C.V.S., Ph.D., Waltham Centre for Pet Nutrition
  • Dr. Wouter H. Hendricks, Ph.D., Wageningen Agricultural University
  • Dr. Claudia A. Kirk, D.V.M., Ph.D., The University of Tennessee
  • Dr. Lori K. Warren, Ph.D., University of Florida

Copies of the report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washignton, DC 20055; (800) 624-6242, or (in the Washington, DC, area) (202) 334-3313; http://nap.edu.