The National Animal Supplement Council (NASC) was formed in 2001 to deal with the regulation of animal feed as a drug.Under the direction of Bill Bookout, its president, the NASC represents $1 billion of the animal product industry and works very closely with regulators on this issue.
The issue for companies marketing products for non-human food chain animals is similar to that which existed for Human Dietary Supplements prior to Congress Passing DSHEA in October 1994. The Dietary Supplement Health and Education Act (DSHEA) does not apply to animal products. If a product does not meet the definition of a food, then it is classified as a drug. Legally there are only those two categories for these products. In eight states, including California, animal drugs must be registered.
NASC has developed potential legislation which would basically include animal products within the intent of DSHEA. The bill would have animal supplements regulated the way human supplements are currently. By existing published precedent, companies can market products under regulatory discretion (provisional registration) provided they act responsibly. Everyone—the FDA’s Center for Veterinary Medicine (FDA-CVM), the states, and NASC—knows that it would be both impossible and unfair to require companies to meet the requirements currently mandated for submitting an NADA (New Animal Drug Application) and meeting the requirements for approved drugs. Having said this, if the products are animal remedies and they are developed in a state with animal remedy laws, the companies are required to appropriately register their products. California, for example, has a remedy law that applies to livestock, and horses are considered livestock.
Jessica Lynn at Earth Song Ranch was contacted by the California Dept. of Agriculture with a request that she register her animal supplements as drugs for a $180 fee. Feed must also be registered. If she satisfies the requirements, the state of California may grant her conditional registration of her products just as they do for other companies.
According to Bill Bookout, NASC represents over 90% of the industry on this issue. They have an excellent working relationship with the state of California (and most other states, for that matter), the Association of American Feed Control Officials, and FDA-CVM. NASC has worked both cooperatively and constructively with the regulatory agencies at the state and federal levels to establish a short-term framework for these products, which we believe may become the foundation for responsible conduct in the long term.
AAHF will monitor the potential introduction of this legislation. We will keep you informed.