Navigating the Nutraceutical Pet Food Seas

Health and wellness is on everyone’s mind these days—and that sentiment extends to our domestic companions, as well. As of 2007, according to the American Veterinary Medical Association, Schaumburg, IL, 37.2% of households care for dogs, while 32.4% have cats.

The nutritional value of pet food is increasingly top-of-mind, particularly in the wake of the 2007 melamine-tainted pet-food recalls. Not only are people more attentive to the type of everyday pet food they feed their companions, they’re also seeking more nutritionally enhanced foods and supplements.

However, although dietary supplements for humans face regulation under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the act does not provide stipulations for our four-legged furry friends. “Congress did not include language that covered animals in DSHEA,” says Bill Bookout, president, National Animal Supplement Council, Valley Center, CA. Therefore, he notes, there is no official legal category for nutraceutical pet foods in the United States.

However, the market for such products continues to grow. And federal officials have even stipulated some guidelines for dietary supplements for companion animals like dogs, cats and horses.

Sailing the regulatory seas

FDA’s Center for Veterinary Medicine (CVM), Rockville, MD, maintains a list of ingredients approved for pet foods, a category that includes treats. If a nutritional ingredient not on that list is included in a pet food, that food is considered adulterated. For instance, methylsulfonylmethane (MSM, an organic sulfur compound found in plant and animal tissues), as well as glucosamine and chondroitin (components of cartilage)—all common human dietary supplements taken to help alleviate osteoarthritis symptoms—are not approved for use in pet food.

Part of the rationale behind CVM’s reticence to approve such ingredients is that the agency does not make distinctions between domestic companion animals and those raised for human consumption. Proving that glucosamine and chondroitin can improve the quality of life for some aging dogs and cats—and is also safe for healthy pets—is one matter, but determining that the ingredients are safe for animals destined for the dinner plate is a much thornier prospect.

“There are potential tissue residues from nontraditional, novel substances. So, when you talk about feeding them to food-producing animals, you incur a higher regulatory burden than if you are providing them to an animal that is not going to be used as meat, or produce milk or eggs, for use in the human food chain,” says William Burkholder, veterinary medical officer, division of animal feeds, CVM. Also, some ingredients don’t receive approval due to nonexistent nutritional guidelines for recommended daily intake.

FDA is clear that “when a substance, including one considered food, is intended to be used for the treatment or prevention of disease or for a ‘non-food’ structure/function effect, FDA considers it a drug,” as noted in the May/June 2002 issue of the FDA Veterinarian newsletter. That same issue clearly makes the point that DSHEA does not apply to animals, but then illustrates how companies can legally market animal dietary supplements.

“FDA has exercised regulatory discretion for products marketed for benefit primarily for dogs, cats and horses, or companion animals—non-human-food-chain animals—provided that there are some pretty strict guidelines followed in terms of having good manufacturing practice standards in place for process controls, the company having adverse-event reporting systems in place that can help manage risk, and having labeling that’s pretty limited in terms of the claims these products make,” says Bookout.

The key is to make sure the ingredients used are on the list of approved food additives and GRAS substances in Title 21, Part 570 to 584 of the Code of Federal Regulations, as well as appear on the list of ingredient definitions in the annually published “Official Publication” of the Association of American Feed Control Officials (AAFCO). For ingredients not covered in both of those sources, manufacturers can submit a Food Additive Petition (see access.gpo.gov/nara/cfr/waisidx_01/21cfr571_01.html).

Approved ingredients

Although some healthy—often clinically proven—ingredients remain verboten per CVM, formulators looking to tap into the emerging nutraceutical pet-food market have a number of green-light options at their disposal.