Animal Supplement Crackdown

Many supplements used by horse owners and veterinarians every day are illegal and thus could be taken off the market. State regulators say that after five years of trying to get manufacturers to meet legal requirements, they are cracking down on illegal ingredients in animal supplements, even though the products have been manufactured, advertised, and sold for years.

Many of these "nutraceuticals" or "nutritional supplements" are illegal because the manufacturer has not complied with Food and Drug Administration (FDA) ingredient recognition processes, ingredient definition applications as designed by the Association of American Feed Control Officials (AAFCO), has not followed state licensing requirements, and/or because the product makes false label claims. The products don't necessarily contain ingredients considered dangerous, although that could be true in some cases. Vitamins, minerals, and amino acid additives to feeds generally are legal.

While the FDA is ultimately responsible for the foods and drugs that go into animals, it is the state regulators working in conjunction with the FDA who routinely enforce the regulations on a day-to-day basis. The state regulators work together through AAFCO. This 100-year-old, not-for-profit organization of state and federal (including Canada) feed regulators has no regulatory authority, but because its members are state and federal regulators, many of the recommendations from the group are adopted by states.

In an effort to prove they are serious about this problem of illegal food ingredients and to get manufacturers to "step up" and get legal, many state regulators have agreed to have an "event" that calls for nationwide (including Canada) regulatory actions against an as-yet unnamed ingredient in animal supplements. The planned event will occur after a 60-day notification is given to the public and industry, which could come as soon as mid-April. Some regulators are going ahead with regulatory actions prior to that event since these products are illegal.

States can decide to regulate feeds and supplements as they see fit. Some states are more strict than others. For example, glucosamine and chondroitin are unapproved ingredients. However, some states regulate these products differently. Kentucky, for example, allows those ingredients to be sold if they meet certain requirements, such as not making false label claims, being licensed with the state's Regulatory Services, guaranteeing the minimum concentration of active ingredient, and listing the source of the ingredients (plus other requirements).

Human and animal nutritional supplements are not regulated the same way. In 1994, the Dietary Supplement Health Education Act (DSHEA) amended the Federal Food, Drug, and Cosmetic Act to define a dietary supplement as a product intended to supplement the diet and that contains at least one or more of the following--a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use to supplement the diet by increasing intake; or a concentrate, metabolite, constituent, extract, or combination of any of the previously mentioned ingredients. DSHEA, however, does not cover animal products.

In other words, an ingredient that is legal to sell for humans is not legal to sell for animals.

The Manufacturers' Side

Paul Deblinger, Director of Corporate Communications with Nutramax Laboratories, which manufacturers human and animal supplements, said, "DSHEA has its flaws, but provides the mechanism to bring dietary supplements to consumers.

"Legislation is the answer," added Deblinger. "Everyone involved needs to go to Congress and have them write a better law that includes companion animals and horses. They need to revisit DSHEA and correct the weaknesses.

"Consumers are concerned that all of these supplements (for humans and animals) should be safe and effective, that advertising is truthful and not misleading, that the products be labeled correctly so that what is on the label is in the bottle, and that they be manufactured following high industry standards with stringent quality controls," Deblinger concluded.

Nick Hartog, the owner of Grand Meadows, has long advocated addressing the issues facing the supplement industry and is a founder of the National Association of Equine Supplement Manufacturers. Hartog says that AAFCO must take some of the blame for the problem today with animal supplements because of their failure to take action when these products first became available, some as many as 10 years ago. He says that lack of regulation in effect gave "implied consent" to the production and marketing of these supplements.

"Manufacturers are not opposed to regulations because of safety, but there is a much higher incidence of problems in pharmaceutical drugs than there are with feed supplements," he said. "Their removal from sale will cause tremendous angst among pet and horse owners who feel there is a benefit to these products."

Hartog suggests that horse and pet owners contact their state regulatory officials, state representatives, and governor to let them know that in the absence of safety and labeling concerns, your state should not ban animal food supplements.

The Regulatory Side

John Breitsman, president of AAFCO and a feed program specialist in Pennsylvania, said, "We want to protect consumers and animals. Consumers should contact nutritional supplement suppliers and ask them if the supplement is registered with the state officials and if it contains approved ingredients. If it does contain unapproved ingredients, then ask why the company doesn't go through the process to get that product or feed ingredient approved.

"Some things are sold as nutritional supplements intended for therapeutic or medicinal purposes. These products are drugs by design," added Breitsman.

"Manufacturers want these products to be classified as food rather than drugs because they don't want to meet the requirements of the drug approval process. If these products are designed as nutritional supplements, they need to meet the minimum food regulations.

"Consumers have the right to buy what they want, but my job is to try and make sure that manufacturers who market commercial feed and feed ingredients meet the established minimum standard. Why establish a lower standard for products that deserve a higher standard than food?

"Consumers are confused because the message supplied by the interested parties concerned about the removal of unapproved ingredients is not necessarily complete," Breitsman continued. "We don't have any proof about the safety of some of these products. Consumers argue they want to have the freedom to do what they want, but they also don't want to hurt their horses or waste their money.

"We've been begging them (manufacturers) to bring their ingredients to the table, and not one company did so. We'll appoint an investigator to work with the industry if they show an interest.

"Wouldn't consumers want these products to meet the minimum safety and efficacy requirements under law?" he concluded.

Label Claims

A problem with labeling is that an ingredient or product that is not a drug cannot make medical claims. The company can't include claims for improved or increased production and performance, or alteration or improvement in function. A food product can't say it can be used to remedy any illness or problem. Only a drug can make claims to diagnose, cure, mitigate, treat, or prevent disease.

There are ways ingredients can be approved by the FDA and accepted by AAFCO. However, some of the processes can take years and cost thousands of dollars per ingredient. Information on this process can be found through FDA by contacting Communications Staff, HFV-12, FDA/Center for Veterinary Medicine, 7519 Standish Place, Rockville, MD 20855; or from AAFCO at PO Box 478, Oxford, IN 47971, web site www.aafco.org. You also can find your state's AAFCO contact person on that web site.

If horse/pet owners want the same exemptions as humans got with DSHEA, then they need to write their Congressmen to have a federal law passed that tells regulators to leave animal nutritional supplements alone. However, said one regulator, "Consumers need to recognize that DSHEA permits manufacturers to market ineffective, sometimes harmful supplements that are largely unregulated unless FDA can prove the supplement is harmful. DSHEA opens the marketplace, but is this really in the long-term best interest of the consumer?"

If you wish to write in opposition or support of these regulatory crackdowns, see the listing of congressional contact information at www.house.gov/writerep/. Further information on the supplement ingredient crackdown can be found at www.TheHorse.com; see article Quick Find #3397, #3398, and #3401.

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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