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.

Collagen. Although glucosamine, chondroitin and MSM are officially off limits for now, other joint-health ingredients have been developed for possible use in pet foods. InterHealth Nutraceuticals, Benicia, CA, carries a form of type II collagen derived from chicken that a study in the Journal of Veterinary Pharmacology and Therapeutics (2005; 28(4): 385-390) shows is twice as effective in decreasing pain in osteoarthritic dogs than glucosamine and chondroitin. Marlen Otten, marketing manager, InterHealth Nutraceuticals, suggests that the ingredient is well suited to fortifying pet treats, since it works best on an empty stomach.

Essential fatty acids. Although some omega-fatty acids, such as those from evening-primrose and borage-seed oil, are not permitted pet foods, others are fair game. Fish, flaxseed and sunflower oils are all approved, and contribute to a healthy skin and coat. Omega-3s also provide anti-inflammatory action, including inflammation associated with allergens, in addition to the ever-lengthening list of proven health benefits.

Fruits and vegetables. Including ingredients like blueberries, carrots, cranberries, spinach, sweet potatoes and tomatoes—all of which contain clinically proven, healthy components like antioxidants—in pet foods is generally safe territory, according to CVM. “Those are acceptable ingredients,” says Burkholder. However, although tomatoes may be OK, lycopene is not, per AAFCO, “as an isolated, individual constituent,” he notes.

As with foods for people, some types of label claims can get manufacturers into troubled waters. But gray areas exist. Many whole-food ingredients contribute notable levels of antioxidants. “If you claim some sort of antioxidant function, you may or may not run into problems,” says Burkholder. “It would depend on the wording. The ingredients, in and of themselves, are not the problem, it’s what people want to say about them.”

Green-lipped mussel. These mollusks contain glycosaminoglycans, polysaccharides that act like glucosamine and chondroitin to improve joint health. This ingredient inhabits what Burkholder calls an “ill-defined state” of approval. “We have told individual firms that if it is the whole mussel—something that would be acceptable for selling or using in foods for people—we would not have any objection.”

Inulin. “Good digestive health, through the power of prebiotics, contributes to improved nutrient absorption, increased immunity, shiny coat, healthy stools and improved nitrogen metabolism,” says Joseph O’Neill, vice president of sales and marketing, BENEO-Orafti, Morris Plains, NJ.

Inulin is an approved ingredient—but don’t call it a prebiotic. “CVM has a longstanding history that the words ‘prebiotic’ and ‘probiotic’ are drug claims,” says Burkholder.

Taurine. Taurine, a constituent of bile, is important in cat food, as felines cannot synthesize the amino acid. AAFCO recommends cat foods contain at least 0.1% taurine. This helps clear the way for a preventive label claim for taurine, according to CVM. “Taurine deficiency has been demonstrated to produce central retinal degeneration and dilated cardiomyopathy—those are the two big ones. It also has neurological and reproductive effects in cats,” says Burkholder.

Taurine also functions as a neurotransmitter, and has shown potential in controlling seizures, anxiety and aggressive behavior in dogs.

Gray areas abound in this emerging subcategory of pet food. To wit: Vitamins C and E are approved for use in pet food as preservatives. However, increasing use levels to garner a health-related antioxidant effect is not permitted. “That would be an unapproved use of an approved ingredient,” says Bookout.

At the end of the day, a single, signifying question stands alone: Is the pet food in danger of crossing into drug territory? “Are you using it to treat or prevent a disease,” asks Burkholder, “or are you using it to provide nutritive value?”

That’s a line formulators would be wise to watch closely.

Nutraceutical Pet Sales Poised to Soar

A Feb. 2008 report from Rockville, MD–based Packaged Facts, “Pet Supplements and Nutraceutical Treats in the U.S.,” notes, “Although formal regulatory status continues to evade pet supplements, the market is advancing at impressive rates, with sales expected to jump 39% by 2012 to reach $1.7 billion.”

The report goes on to state that attainment of formal regulatory status will likely “create a huge boom in the market as consumers respond to the bolstered credibility of pet supplements and new products and companies rush to market,” citing such market drivers as the growing interest in the products among U.S. pet owners, the aging and overweight pet population, the steady influx of new products, and increased usage and recommendation of clinically proven supplements by the veterinary community.