Many horsemen use supplements with ingredients like MSM, glucosamine, chondroitin and herbs to keep horses performing at peak ability. But while these products seem to keep horses healthier, several government regulatory agencies are determined to regulate them more tightly—or even remove them from the marketplace entirely.
Many of these supplement ingredients, commonly termed nutraceuticals, are at present unregulated for human use. The Food and Drug Administration (FDA) enforces laws regarding food and drugs, but since nutraceuticals are neither nutrients nor drugs, they have existed largely outside the FDA’s regulatory process.
However, animal supplements are subject to regulation. By law, ingredients in animal supplements must be approved food additives, GRAS (generally recognized as safe) substances, or other approved ingredients listed by the Association of American Feed Control Officials (AAFCO). If a product is not approved, it may be subject to regulatory action.
Under current laws, supplements for horses are considered either a food (in which case they are regulated by the various states, under direction from AAFCO), or a drug, which makes them the responsibility of the FDA’s Center for Veterinary Medicine (CVM). Since the nutraceuticals do not fall into either category, this has created jurisdictional confusion, and the regulatory agencies are demanding that supplements be declared either a food or a drug.
The Government Acts (Sort of)
Congress cleared up the status of nutraceutical use by humans in 1994 when it passed the Dietary Supplements to Health and Education Act (DSHEA). In 1996, though, the FDA ruled that DSHEA does not apply to animals. So while humans can legally take supplements, use in horses is still technically illegal.
There is some reason for caution. Many products that are approved for humans (such as chocolate and aspirin) can be harmful or deadly to some kinds of animals. There is also concern that untested ingredients might pass to humans through food animals. Thus animal supplements have stricter regulations than human dietary supplements.
One reason for this is that horses are classified as livestock. Regulations for feed ingredients for livestock in most states fall under jurisdiction of state departments of agriculture. AAFCO advises state regulators by publishing a list of “defined” substances that are acceptable or recognized as feed ingredients. However, officials in each state can choose whether to follow AAFCO’s recommendations. Many herbal supplements and nutraceuticals are not on the list of approved products, and some states’ feed laws question the sale of any product containing ingredients not found on the list.
In years past, animal supplement regulations have been a low priority for FCA/CVM and AAFCO, so being in technical violation of the law meant little. CVM usually does not take regulatory action as long as labels are consistent with accepted intended use, labeling or advertising does not make drug claims, and there’s no new data that raises questions concerning safety or suitability.
But the situation has been changing. Some state agencies have been under pressure from AAFCO and their own regulatory bodies to remove undefined products from the market completely, or to demand research to prove safety and efficacy.
In 1998 AAFCO created a task force to guide decisions about unlisted ingredients. Some states, such as Iowa, became more aggressive in prohibiting sales. In August 2001, AAFCO formed ESMI (an Enforcement Strategy for Marketed Ingredients team) to focus on novel ingredients unapproved for use as animal feeds or used for purposes other than approved usage. AAFCO encouraged state officials to go after unapproved or illegal supplements and remove them from the market.
The Manufacturers Respond
This announcement created panic among feed companies and animal owners who had been using supplements. The animal supplement manufacturers don’t necessarily want to remain unregulated, but they want to be fairly and consistently regulated. Their goal is to resolve this issue so these supplements (many of which have been used for more than a decade) can become legal.
There is concern that untested ingredients might pass to humans through food animals. . . horses are classified as livestock.
The American Pet Products Manufacturers Association tried to get some supplements officially approved through existing routes. In addition, a letter writing campaign, directed at the FDA, state departments of agriculture and elected officials, pointed out the inconsistency of having these products legal for humans but not for horses. The public outcry softened the push to remove undefined ingredients from the market, but some states are still taking aggressive stands.
Companies supplying supplements for pets and horses (animals not used for human food) formed the National Animal Supplement Council (NASC) in June 2001. NASC was determined to come up with a way to address this issue in a responsible form.
NASC recognized the deficiencies in DSHEA; it did not include standards to assure product integrity during manufacture, and studies conducted on human products showed some did not meet label claims for ingredient amounts. Since supplements (for humans or animals) can’t be patented, investing millions of dollars to get one approved is not appealing to any manufacturing company. Another supplier could copy their formulation and sell it for less money.
So NASC proposed some Best Manufacturing Practice Standards that all NASC members must follow—to ensure quality and integrity of a product—along with an Adverse Event reporting system. Legitimate safety issues can be identified by product or ingredient. This enables any user of an animal supplement to report the adverse event. The information is available to regulatory bodies.
This system was implemented in April 2003. People can report an adverse event via NASC’s toll free number: 966-833-NASC (6272) or website (www.nasc.cc). NASC member companies are required as a condition of membership to report, follow up and evaluate any legitimate adverse event and take appropriate action.
NASC also wants consistency in labeling and is working with regulatory agencies to define what is acceptable. NASC also hopes to submit research data, funded cooperatively across all members’ products, so the investment could be spread across a broad industry segment.
And that is where the matter stands now—unresolved, but moving toward resolution. AAFCO is currently taking action against comfrey. NASC agrees that comfrey is a concern to human and animal safety, and recommended that its members remove comfrey from any product they provide. Many states are also following AAFCO and FDA/CVM recommendations to target comfrey.
Horsemen were concerned that glucosamine would be a target. But most states are not taking action against glucosamine at this time. Still, some state feed officials continue to take action beyond AAFCO recommendations, regardless of NASC’s efforts, and some commonly used supplements are at risk of being removed from local markets.