Written by Dr. Rob Silver DVM, MS
Pet supplements have become a rapidly growing segment of the Animal Health industry. Often one hears the complaint that animal supplements are not regulated, and are the “Wild West” when it comes to quality control and oversight of product claims. This is not true. Pet supplements are regulated by the US Food and Drug Administration (FDA) as “unapproved drugs.”
The FDA’s Regulatory Perspective: Food, Drugs, and Supplements
In the eyes of the FDA, if an animal supplement product is not a food or a drug, there is no legislated guidance to regulate that product. The FDA is very binary, as its name implies (Food and Drug Administration). By definition, supplements are neither drugs nor food.
Even though dietary supplements are neither food nor drugs, they can positively influence health. The FDA is concerned that dietary supplements’ health benefits could be considered drug claims. Therefore, the FDA forbids companies from describing the benefits of their supplements with medical claims.
Medical Claims and Compliance: The Case of Glucosamine
A medical claim describes a product as being able to treat, cure, or mitigate a disease. In the case of the supplement glucosamine, its medical claim is that it can help improve arthritis, a medical diagnosis. In the eyes of the FDA, products with labels that state glucosamine can help arthritic pets are making a medical claim. By FDA standards, this medical claim classifies glucosamine as a drug.
Glucosamine is, in fact, an “unapproved drug” because it hasn’t been subjected to the long and expensive process of FDA drug approval.
In 2001, the FDA threatened to pull glucosamine off the shelves of veterinary hospitals and pet stores because they considered it to be an unapproved drug given that arthritis-treatment claims were being made.
DSHEA: A Framework for Human Supplements, But Not for Animals
Human supplements are regulated by the FDA, guided by legislation passed by Congress in 1994. This legislation, the Dietary Supplement Health and Education Act (DSHEA), defines how the FDA can regulate human dietary supplements and informs companies about the information they are required to display on product labels, advertising, and even on social media. The FDA provides label templates that companies must follow. When in violation of these DSHEA requirements, a company’s product(s) may have the FDA issue a stop-sale, and the product may be confiscated by the FDA, causing significant financial loss for the company.
There is no comparable legislation for animal supplements. The FDA has stated very firmly that DSHEA does not apply to animal supplements. As mentioned, in their view, ALL animal supplements are unapproved drugs and subject to potential removal from the marketplace, if they violate this prohibition regarding medical claims.
Educating the Veterinary Community About Animal Supplements
Ultimately, reputable brands like Real Mushrooms need to educate the public about the power of natural supplements for pets through indirect means.
The use of mushrooms for pets is still so new that most veterinarians aren’t sure how to recommend them or guide their clients on administering an effective amount. Real Mushrooms and I, an integrative veterinarian with 43 years of practical experience, have been working to collect case reports from veterinarians and feedback from pet parents about using these mushrooms to support pet health. I’ve also been conducting pilot studies and research to establish a solid, objective foundation for their use in promoting pet well-being.
I’ve published a book, “There’s a Mushroom For That” to provide veterinarians and pet parents with a comprehensive guide to understanding and using mushrooms to support their pets’ health—and their own.
Conclusion: Balancing Safety and Compliance
In conclusion, the regulation of pet supplements is designed to create a safe and consistent supply of animal health products in the marketplace, to ensure a positive customer and pet experience. That safety, though, comes with the cost of companies not being able to make drug claims for their products.
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