Comfrey Targeted for Enforcement Action

The Enforcement Strategy for Marketed Ingredients (ESMI) Working Group of the Association of Animal Feed Control Officers (AAFCO) cited an increasing number of unapproved or undefined ingredients appearing in animal feed and pet food as well as "growing concerns about consumer protection, protection of animal health, and food safety" as the reason behind taking a more active role in enforcement. The group intends to initially target one ingredient for regulatory attention at the state and federal level, and that ingredient will be the focus of its enforcement activities. The first target ingredient for upcoming enforcement actions, identified at the AAFCO annual meeting in August, is comfrey contained in feed, feed ingredients, or supplements to be added to feed. State regulators intend to seek out feed products with comfrey and stop the sales of these products. (For additional information on the planned enforcement action, check the AAFCO Website at

Earlier this year, AAFCO (a non-profit organization of state and federal feed regulators that has no regulatory power, but helps guide national interpretation of feed laws) 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.

The threat of a supplement regulatory crackdown motivated 25 industry participants to join with the National Animal Supplement Council (NASC) to hammer out a proposed Compliance Plus program early this year. This program gives supplement manufacturers a starting point to constructively work with state and federal regulators on a mutually acceptable way to bring supplements for non-human food chain animals into compliance without unfairly penalizing responsible industry participants, according to NASC president Bill Bookout.

"I understand the frustration of regulators because it may have seemed that the industry was just ignoring requests for compliance," said Bookout after the initial compliance program was designed. "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."

In a letter to AAFCO earlier this year, 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 and working with AAFCO, NASC submitted an ingredient definition for Glucosamine to FDA/CVM in July.

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 and membership has increased significantly in the last several months. It's expected that other companies will join the group as the benefits of membership become more widely recognized throughout the industry.

Bookout noted on Sept. 23 that the NASC “seal” will start appearing on products manufactured by members in the next few months. This seal is designed to let consumers know that the manufacturer is focusing on four areas as a member of NASC: Implementation of adverse reaction reporting system; research; truthful labels; and manufacturing standards and quality. He said without assurances of quality / integrity production and labeling, the problems in the supplement industry will continue.

He noted, for example, that the raw material cost of biotin, often contained in hoof care products, went up tremendously last year. Therefore, consumers should question how much biotin is contained in a product that didn’t have an increase in price that matched that for the raw product.

More on Comfrey

According to the Physicians Desk Reference for Herbal Medicines, which is written for human medicine, comfrey (Symphytum officinale) is used externally for bruises and sprains, and internally for gastritis and gastrointestinal ulcers. “In folk medicine, it is used for rheumatism, bronchitis, pleuritis, and as an antidiarrheal agent,” noted the reference. It went on to say that “one should entirely forgo internal administration of the drug, due to the presence, however small, of pyrrolizidine alkaloids which have hepatotoxic (toxic to liver cells) and carcinogenic (cancer-causing) effects. It has been determined that traces of the alkaloids present a danger.”

The next step in the current regulatory action would be for the FDA Center for Veterinary Medicine to release supporting information on the reasons comfrey should not be contained in animal feeds or supplements. However, notes Bookout, since manufacturers know that comfrey has been targeted, they are already taking steps to remove it from products. The NASC has committed to support a targeted justified enforcement strategy by the regulatory agencies. 

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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