Introduction
With integrative veterinary care becoming increasingly common, many veterinarians are utilizing dietary supplements and prescribing them to their patients for a variety of different reasons. Naturally, many veterinary practices may want to streamline the treatment process by selling dietary supplements and other over-the-counter (“OTC”) products directly to their patients. While this seems like a routine progression, it is important for veterinarians and veterinary practice owners to understand how these products are regulated, in order to ensure they maintain compliance in marketing and selling products from their practice.
Integrative Veterinary Care
Integrative veterinary care includes the use of complementary therapies and treatment options, in addition to conventional veterinary medicine, in order to offer a more comprehensive approach to treatment. Much like humans, all animals are different, and there are a variety of factors that can be used to help determine the best treatment options for each veterinary patient. Perhaps the most common treatment option for animals outside of traditional medicine is the use of dietary supplements and other diet-related approaches. Dietary supplements in particular may be prescribed by veterinarians for a number of different reasons, with uses ranging from treatment or prevention of a particular condition to general health and wellbeing. Examples of commonly used dietary supplements for animals include:
· Antioxidants
· B-Vitamins
· Calcium
· Chondroitin
· Colostrum
· Enzymes
· Glandulars
· Glucosamine
· Milk Thistle
· Probiotics
· Fish Oil
However, despite the wide range of potential uses in veterinary practice, dietary supplements for animals lack the same comprehensive regulation as their human counterparts. As explored below, the lack of regulations specifically addressing dietary supplements for animals creates a unique “gray area” in determining how they should be regulated at the federal level. As a result, depending on their intended use, dietary supplements for animals may be regulated as either food or drugs, each regulated quite differently.
Regulatory Overview
The Federal Food, Drug, and Cosmetic Act (“FD&C Act”) is the primary food and drug law in the United States, giving the Food and Drug Administration (“FDA”) authority to regulate and oversee the safety of food, drugs, medical devices, and cosmetics. The FDA is responsible for ensuring the safety of food products and drugs for both humans and animals. This includes regulating safety and efficacy, as well as how food and drug products are manufactured and labeled.
The FD&C Act defines “drug” to include in relevant part, “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” and “articles [other than food] intended to affect the structure or function of the body of man or other animals.”[1] Conversely, the FD&C Act defines “food” as “articles used for food or drink for man or other animals…and articles used for components of any such article,” which courts have interpreted to mean products used primarily for nutrition, taste, or aroma, or components of that product.[2] Noticeably absent from the FD&C Act was a clear answer or guidance on whether dietary supplements were to fall under the category of food or drugs. As a result, dietary supplements generally fell under the definition of food and were regulated as such. However, because dietary supplements were also subject to labeling requirements, as more health claims were made about supplements, they were pushed towards falling under the FDA’s definition of a drug.
In 1994, the Dietary Supplement Health and Education Act[3] (“DSHEA”) was passed, amending the FD&C Act to create an additional category and regulatory framework for dietary supplements. Shortly thereafter, the FDA made a clear determination that DSHEA did not apply to products for use in animals. Therefore, unlike dietary supplements for humans, products marketed as dietary supplements for animals would not fall under a separate category of FDA regulation and would be regulated as animal food or animal drugs, depending on their intended use. Because the distinction between regulation as animal food or drugs hinges in part on the products intended use, this issue becomes incredibly important to veterinarians who prescribe and/or sell certain nutritional products and dietary supplements directly to their patients. This is because for certain products or supplements, whether they should be regulated as a food or drug can be decided in part on how and/or why the veterinarian prescribes and communicates their intended use.
The “Gray Area”
One clear issue before the adoption of DSHEA was that as the supplement industry continued to grow, more health claims were being made about various supplements, and it was becoming increasingly difficult to classify a product as either a food or drug. The very fact that additional legislation was created to specifically address regulation of dietary supplements makes it abundantly clear that there was a gap in the regulation that needed to be filled. While DSHEA recognized and filled this “gap” for human products, the FDA’s determination in 1996 that DSHEA does not apply to animal products has left a significant gray area and only fostered more confusion surrounding the regulation of dietary supplements for animals.
After making the determination that DSHEA did not apply to animal products, the FDA published guidance in the Federal Register explaining some of the underlying reasons behind the agency’s decision.[4] One of the primary issues the FDA highlighted was the lack of available information on the safe use of dietary supplements in animals compared to humans. The FDA observed that many substances that fell under the definition of dietary supplements for humans, such as herbs and other botanicals, had a history of use in humans that could be used to establish reasonably safe levels. The same history of use did not exist for animals. Similarly, the FDA also noted that unlike humans, each animal species requires different nutrients, absorbs and metabolizes nutrients differently, and can exhibit different toxic reactions to food and its components, thus making it even more difficult to compile adequate information. While the reasoning provided by the FDA helped demystify the decision, it did little to address the gray area that was left behind.
Where are we now?
Today, over twenty years since the FDA determined DSHEA was inapplicable to animal products, the same gray area exists in the regulation of dietary supplements for animals. As integrative veterinary care becomes more prevalent throughout the industry, many veterinary practices are continuing to expand their range of services to include more holistic therapies and treatment options, many of which include the use of dietary supplements, botanicals, and other nutritional products. In addition to the enigmatic classification of food versus drug, each of these categories may include products that can be prescribed for a variety of reasons, further complicating the analysis. For example, while a veterinarian may suggest a supplement to one patient for their general health and wellness, the same veterinarian may prescribe the same supplement to a different patient in order to treat a specific condition or ailment such as joint pain or gastrointestinal issues. As this example demonstrates, based on the regulatory framework discussed above, the same product could theoretically fall into the regulatory definition of a food or drug, depending on its intended use.
Why is this important?
While these regulatory concerns are often shouldered mainly by the manufacturers of the products, it can become an issue for veterinary practices that sell pre-packaged dietary supplements directly to patients or compound their own blend of supplements to package and sell to patients. While this entire concept seems like a very niche issue, it can potentially affect other areas of a veterinary practice, such as how holistic treatment options and dietary supplement use are marketed to patients, as well as compliance concerns related to proper licensure to sell over-the-counter products directly to patients either in person or online.
The Business Angle
Understanding how a specific veterinary practice treats patients through holistic treatment methods that include the use of dietary supplements, as well as whether the practice sells or intends to sell such products directly to patients, are important considerations in assessing the risk of a potential acquisition. While this article has highlighted some of the ambiguities in federal regulation of dietary supplements for animals, there are still a variety of state-level regulatory considerations that can vary considerably from state to state. Whether you are a current veterinary practice owner that sells dietary supplements and/or over the counter products, or are in the market to acquire a practice that does, it is always important to review the veterinary board regulations of the state in which the practice is located in order to ensure the practice has all required licenses and is in compliance with any other regulatory requirements for the marketing, use, and sale of dietary supplements for animals. The attorneys at the National Veterinary Law Group at Mandelbaum Barrett PC are available to answer any questions you may have.
[1] 21 U.S.C.A. § 321(g)(1).
[2] 21 U.S.C.A. § 321(f).
[3] Pub.L. No. 103–417, 108 Stat. 4325 (1994).
[4] Federal Register, Vol. 61, No. 78, April 22, 1996.