Supplement Regulation News

The threat of a supplement regulatory crackdown motivated 25 ingredient suppliers, manufacturers, and distributors to join with the National Animal Supplement Council (NASC) on April 3-4 to hammer out a proposed Compliance Plus program. This program is a "work in progress," according to NASC president Bill Bookout. He said this proposal gives supplement manufacturers a starting point in negotiating with state and federal regulators on a mutually acceptable way to bring supplements into compliance without unfairly penalizing responsible industry participants.

The animal supplement group convened prior to a scheduled mid-April meeting of the Association of American Feed Control Officers (AAFCO). At that meeting, AAFCO representatives planned to select one or more animal feed supplement ingredients and stage a nationwide "regulatory event" in order to bring attention to the problem of illegal animal supplements. While the proposed Compliance Plus program has succeeded in delaying that "event" until this fall, the supplement manufacturers still have many details to iron out before many of the ingredients in their products are considered "approved" or "legal" (as defined by AAFCO's Official Publication) and not subject to regulatory action.

The first hurdle was for the Compliance Plus program to even be considered by AAFCO. John Breitsman, president of AAFCO (a non-profit organization of state and federal feed regulators that has no regulatory power, but helps guide national interpretation of feed laws), said the proposal was "great news. All we're seeking is compliance. This is a great first step."

However, Breitsman added, there are ingredients on the market that still need to be addressed on the regulatory level. "There are products that pose a problem to (animal) health," he said. "But other ingredients can achieve some standards and should be on the market."

Breitsman said that the Food and Drug Administration (FDA) must review the proposed program before AAFCO will have any comments on it. Sharon Benz, PhD, a member of the FDA's Nutrition and Labeling Team in the Division of Animal Feeds, Center for Veterinary Medicine (CVM), said the program is under review by CVM and she had no comment on it at this time.

"I understand the frustration of regulators because it may have seemed that the industry was just ignoring requests for compliance," said Bookout. "However, the issues are complicated by the broad availability of human products containing many of the same ingredients and the lack of patent protection for product formulations. Our hope is that we can, in cooperation with the regulatory agencies, jointly develop a solution that can work for everyone."

Program Details

The complete Compliance Plus program can be viewed on the NASC web site at www.nasc.cc. Included in the Compliance Plus program proposal are the following:

  • That this program is aligned with AAFCO's objectives of reasonably assuring product quality and safety;
  • It creates an adverse event reporting system;
  • It requires NASC members to adopt manufacturing/quality controls;
  • It includes a mandatory self-policing label claim enforcement standard voluntarily implemented by NASC members;
  • It has a realistic mechanism for funding research to meet the requirements of the ingredient definition process of AAFCO;
  • It does not apply to animals intended as human food; and
  • It strives to protect animal safety and comply with regulations.

In a letter to AAFCO, the NASC stated: "NASC recognizes that individual state feed control officials are charged with enforcing the present laws related to animal supplements. This charge includes protecting the health and safety of animals, as well as protecting consumers from false or misleading label claims and products of inferior quality or that have been identified as having safety concerns.

"The members of NASC understand, respect, and support this vital function, and intend to comply with these existing laws and regulations. Further, NASC feels that animal health and safety may be further enhanced through its members voluntarily adopting an adverse event reporting system and manufacturing quality procedures." Bookout explained that these two elements would help provide the reasonable expectation of product quality while also providing a viable method of monitoring product safety concerns for consumers.

In order to meet AAFCO ingredient definitions, NASC participating members propose to contribute 2% of sales from products containing targeted ingredients for research. The group selected three non-herbal and two herbal/botanical ingredients for their first funding/regulatory quest. The non-herbal ingredients are glucosamine, chondroitin, and methylsulfonylmethane (MSM). The two herbal/botanical ingredients tentatively are garlic and rehmannia. Currently, NASC has pledges of more than $50,000 for the research on glucosamine.

It was estimated that the attendees at the NASC meeting represented approximately 40% of the dollar volume of supplement products sold for dogs, cats, and horses in the United States. It's expected that other companies will join the group as the benefits of membership become more widely recognized throughout the industry.

About the Author

Kimberly S. Brown

Kimberly S. Brown was the Publisher/Editor of The Horse: Your Guide To Equine Health Care from June 2008 to March 2010, and she served in various positions at Blood-Horse Publications since 1980.

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