Evidence-based medicine for animal supplements – part 1 – Where is the clinical evidence demonstrating that animal supplements are safe and effective? Here’s a review of the evidence that’s currently available, and the limitations facing the industry.
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by William Bookout, BS, MBA
hen United States Congress passed the Dietary Supplement Health Education Act (DSHEA) in 1994, they failed to consider the potential application and benefits of supplements for animals. The Food and Drug Administration, Center for Veterinary Medicine (FDACVM) published a notice in the Federal Register stating that due to the lack of specific references to animals, DSHEA did not apply to products for animals1. Consequently, there are only two categories under existing US law for these types of products, determined by their intended use:
or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause A, B, or C.”
“SEC. 201. [21 U.S.C. 321] Definitions; generally for the purposes of this Act2
Economic considerations
“Food (Animal Food/Feed) – (f)(1) The term ‘food’ means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article. “Drug (Animal Drugs) – (g)(1) The term ‘drug’ means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure
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integrative veterinary care
This means that animal supplements, if they are not intended to provide nutrition to animals, are considered by the FDA to be unapproved drugs; therefore, safety and effectiveness for their intended use in specific species has not been evaluated by the agency. For a product to be an “approved” drug, a company must submit a New Animal Drug Application (NADA) with safety, efficacy and quality data that are then evaluated by the agency.
Meeting this burden of proof is impossible for animal supplements. The time required to develop a new animal drug can be between six to eight years with an investment of approximately $100 million, so submitting the data and information required to receive approval is both time consuming and very costly. For a company to afford it, it must accomplish at least two things: 1) recover its investment, which is reflected in the price it charges for the products, and 2) try to protect the business opportunity by patenting the product as a barrier to competitors.
Allowable product claims Labeling claims are probably the most misunderstood and misused aspect of animal supplement regulation. Under current US law, products marketed for animals that are similar to human dietary supplements have
