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Dietary Supplements for Pets and Structure Function Claims

In 2002, FDA’s Center for Veterinary Medicine (CVM) made it abundantly clear it does not believe the Dietary Supplement Health and Education Act (DSHEA) pertained to pets or other animals (Federal Register 61:17706-17708). This position is, however, a myopic response to the downstream issues of potential consumer fraud and pet safety.

CVM’s contention that DSHEA does not pertain to animals is based on its literal reading of DSHEA wherein there was no mention of animals, only humans. That is, in the definition of a dietary supplement §201(ff), specifically §(1)(E), “a dietary substance for use by man to supplement the diet by increasing the total dietary intake;” despite the fact that in the Federal Food Drug and Cosmetic Act, §201(f) “The term ‘food’ means (1) articles used for food or drink for man or other animals,” Regardless of the technical merits of CVM’s argument, the interpretation does not serve its constituents well – the facts are as follows.

There are currently 60 million dogs and 70 million cats in the US and pet food sales in this country are in the neighborhood of a phenomenal $18.8 billion dollars. The number of pets is expected to increase significantly as baby boomers age and become empty nesters. Already, the pets are beginning to reflect the demographics of their masters with the age of the average dog at 6.6 years and 8 years for the average cat (if the pet is the only one of that species in the house). Life expectancy of pets has increased because of the better food and care pets receive. Because of the increased age of the pets, the physiological state of the pet also reflects that of their owners with 52% of dogs and 55% of cats over seven years as being obese, accompanied by mobility problems including arthritis (especially in breeds with hip dysplasia), periodontal disease and diabetes. Half the pet food purchased in the U.S. is by families with an income of $70,000 and these people tend to be well-educated; interestingly, this is the same demographic that is the greatest users of dietary supplements.

One of the primary reasons for the success of the dietary supplement industry is that an ageing public does not feel it is well served by either the pharmaceutical industry or the medical profession. This population has been told there are no quick and easy solutions to the erosion in their quality of life and they feel that reaching back to “natural solutions” is logical, cost effective and experience-based (e.g., the “healing hand of mother nature”).  This attitude has propelled the dietary supplement/functional food industry to an equally astounding $25 billion dollars a year in sales.

So then, the nexus of these facts is that, with so many ageing and disaffected consumers willing to purchase quality of life in a bottle, what is to prevent these supplements from being ground up and placed into pet food or sprinkled on top or hidden in a treat? People empathize with their pets and an arthritic or allergy bedeviled pet owner will feel compelled to share with the pet whatever supplement the owner believes has helped him. In short, if the substance helps the owner, why could it not also help his pet?

Owners would not knowingly harm their pets, but it is counter-intuitive for most people to believe that dietary supplements, determined safe for humans, are not also safe for pets. After all, is not the safety of supplements and other substances based on and approved on the results of animal tests? CVM is first to disabuse people of that notion that safe for humans does not equate to safety in all animals, with the favorite examples of the toxic nature of chocolate and grapes to dogs. Although seeming paradoxes are fascinating facts, this knowledge is out of the reach of most pet owners and these owners feel pets would not be harmed by a supplement – however flawed, the logic is obvious, “if the supplement is OK for me, then how can it harm my pet”?

This refusal to legitimize supplements for pets and thus, a vehicle for safety assessment for pets, is where the short-sightedness of CVM policy on dietary supplements is a disservice to its constituents. A plea of a lack of resources as a reason for not allowing review of substances is not an acceptable answer. Recall that there were more phone calls to FDA’s hotline over melamine in pet food than there ever have been to any human food scare. People feel strongly about their pets and the solution could be relatively easy, if CVM is willing to exhibit some flexibility.

While CVM has maintained DSHEA does not pertain to animals, an equally strong argument could be made that it does. What the law does not provide, is a pedantic recitation of how supplements should be approved and an avenue available in drawing on the resources of an industry willing to improve its sales. What could be done for supplements is similar to that for food ingredients in the concept of the generally recognized as safe (GRAS) notification process.  In this scenario, competent toxicologists would prepare supplement dossiers describing the safety of a substance, including a review of the scientific literature and, if required, testing results in the target species.  The safety of the substance would be reviewed by an expert panel, a disinterested third party.  Once a substance had been shown to be safe, it could be marketed with a claim, based on valid test results, which would be reviewed by the expert panel.  The difference here between a common New Dietary Ingredient Notification (NDIN) and use of an expert panel, is that under DSHEA, anyone, regardless of qualifications can declare something safe and it is up to FDA to make the final determination.  Using this system of qualified experts, CVM would have some assurance the substance is safe, because qualified experts are placing their reputations at risk and implement enforcement discretion.  Further, there is a handy back-up system in place with the Reportable Food Registry.  This system, capitalizing on the efforts of experts and backed up with statutory requirements for reporting on adverse effects of supplements, will lighten the work load for CVM and allow safe and effective supplements for use with pets and, insulate consumers from fraud.

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