[Excerpted from the 2011 Annual Conference Proceedings, American Holistic Veterinary Medical Association]
Under current law in the United States, only two legal categories exist for animal products which are similar to human dietary supplements: animal food/feed or animal drugs. There is no other choice categorically, which means legally. Most people are unaware of this situation for animal supplements in addition to not knowing that many commonly utilized ingredients are not approved for use in animals. Examples of unapproved ingredients include those often found in joint products such as Glucosamine, Chondroitin Sulfate and Methylsulfonylmethane (MSM), and virtually all herbal ingredients if they are in products for purposes other than flavorings.
When the Dietary Supplement Health Education Act (DSHEA) became law, the legislation amended the Federal Food, Drug and Cosmetic Act to create a specific legal category under food for human dietary supplements. Companion animals (dogs, cats and horses) were not included in the original language of the bill. Nevertheless, with the dramatic expansion of the human dietary supplement industry, the natural extension was to make similar products for animals in response to consumer demand recognizing the benefits for companion animals. This was a great idea except for one thing: the products are technically illegal and, in 2002, were very close to being removed from the marketplace.
Since that time when strong enforcement policies were recommended and with the support and encouragement from some visionary AHVMA Members, the situation has progressed from one of genuine survival of the industry to one of cooperation with regulatory agencies. We have achieved solutions which are in the best interests of the majority of the stakeholders. Who are the stakeholders? Everyone influenced by animal supplements: consumers, manufacturers, dealers, distributors, veterinarians, regulators, raw material suppliers, stores, breeders, trainers and, not least importantly, the animals themselves.
In 1994, the Dietary Supplement Health Education Act was passed by the United States Congress and signed into law by President Clinton in October. This legislation created a specific category of products, Dietary Supplements, as a subset of Food under the Federal Food, Drug and Cosmetic Act and allowed the labeling and marketing of dietary supplements for human use. Unfortunately, when the issue was debated in Congress, animals were not considered and language was not included in the legislation to allow similar products for animals to be regulated as “Dietary Supplements” as provided for people. Examination of the Congressional record when the bill was finalized shows Congress neither specifically included nor excluded the application to animals. Although it may have been reasonable to at least include animals which are not intended for human consumption, such as dogs, cats and horses, the topic of animals was overlooked, probably because the animal supplement industry did not exist to any significant degree in 1994 and the purpose of DSHEA was to address the increasing consumer demand for dietary supplements for people.
The primary agency responsible for the regulation of animal food and drugs is the Food and Drug Administration, Center for Veterinary Medicine (FDA-CVM). FDA-CVM works closely with the states through regulatory associations like the Association of American Feed Control Officials (AAFCO) to help ensure both federal and state laws are followed and companies remain in compliance. In 1996, FDA-CVM published a notice in the Federal Register explaining why the Agency believes DSHEA does not apply to animals.
ANIMAL FOOD / FEED AND ANIMAL DRUGS
The Federal Food, Drug and Cosmetic Act (the Act) defines food (animal feed) and a drug as:
Food - "articles used for food or drink for man or other animals...and articles used for components of any such article." There is no requirement that animal foods have pre-market approval by FDA-CVM. The Act does require that animal foods, like human foods, be pure and wholesome, contain no harmful or deleterious substances, and be truthfully labeled.
Drug - "an article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease, or an article intended to affect the structure or function of the body other than food." In the drug definition, the courts have interpreted "food" as something that provides nutrition, taste or aroma. If a food affects the structure or function of the body, it does so by these properties (e.g., a food may provide nutrients such as calcium for proper bone structure). However, if a substance affects the structure or function of the body apart from its nutritive value, such as improvement in joint function, it may be considered a drug. Structure/function effects extending beyond the "food" umbrella also include claims for improved or increased production and performance, and alteration or improvement in function.
When a substance, including one considered food, is intended to be used for the treatment or prevention of disease or for a "non-food" structure/function effect, FDA considers it a drug. Under the Act, a new animal drug must be shown to be safe and effective for its intended use by adequate data from controlled scientific studies as part of a New Animal Drug Application (NADA). If a product on the market is not approved, it may be deemed an adulterated drug and subject to regulatory action.
ASSOCIATION OF AMERICAN FEED CONTROL OFFICIALS (AAFCO): WHO ARE THEY AND WHAT ROLE DO THEY PLAY?
“A basic goal of AAFCO is to provide a mechanism for developing and implementing uniform and equitable laws, regulations, standards and enforcement policies for regulating the manufacture, distribution and sale of animal feeds; resulting in safe, effective, and useful feeds. The Association thereby promotes new ideas and innovative procedures and urges their adoption by member agencies, for uniformity.”
“Purpose and Function of AAFCO: The purpose of the corporation shall be to establish and maintain an Association through which officials of any state, dominion, federal or other governmental agency and employees thereof charged with a responsibility in enforcing the laws regulating the production, labeling, distribution, or sale of animal feeds or livestock remedies may unite to explore the problems encountered in administering such laws, to develop just and equitable standards, definitions and policies to be followed in enforcing such laws, to promote uniformity in such laws, regulations and enforcement policies, and to cooperate with members of the industry producing such products in order to promote the effectiveness and usefulness of such products.”
In summary, AAFCO is a not-for-profit private volunteer association whose members MUST be regulatory officials from a state, federal or foreign government. AAFCO, as an association, has NO REGULATORY AUTHORITY or enforcement ability. The association tries to promote and encourage consistency through the development and publication of “model” regulations which each individual state may adopt.
Recognizing the growing problem by the increasing number of companion animal products entering the market, AAFCO attempted to be proactive and formed committees to try and address the issue:
• Feed Labeling Subcommittee on Nutritional Health and Nutrient Function Claims (1998)
• Nutraceutical Regulatory Advisory Panel (NRAP, 1998-1999)
• Novel Ingredients Regulatory Framework Task Force (NIRFTF, 1999-2000)
• Botanicals and Herbs Committee (2000-2002)
Each committee failed to identify a viable pathway for dealing with “unapproved” ingredients, non-nutritional uses and the rapidly increasing number of products. All were disbanded and finally the Enforcement Strategy for Marketed Ingredients was formed (ESMI, 2001-2004). The charter was simple: to identify and recommend enforcement policy and ACTIVELY REMOVE PRODUCTS FROM THE MARKETPLACE which contained ingredients not approved for use in animal feed. The National Animal Supplement Council was formed in direct response to these announcements.