by George A. Burdock and Ray A. Matulka
FDA’s Center for Veterinary Medicine (CVM) has made it clear it does not believe dietary supplements may be added to animal feed (Federal Register 61:17706-17708); but, this may change, at least for companion animals such as horses, cats and dogs.
CVM’s contention that the Dietary Supplement Heath and Education Act (DSHEA) does not pertain to animals is based on its 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.” Also in support of this argument, CVM noted the legislative history for DSHEA, albeit limited, contained no mention of animal use for dietary supplements. However, what CVM failed to mention was Congress specifically decreed the legislative history should not be considered when interpreting the Act. The fact remains that DSHEA is only an amendment to the omnibus Federal Food, Drug and Cosmetic Act (FFDCA) and, if animals were to be specifically exempted, the exempted status of animals would have been noted in the amendment. After all, in the definition of food in the omnibus statute, the FFDCA, food is defined in §201(f): “The term ‘food’ means (1) articles used for food or drink for man or other animals…”
CVM’s second line of defense against use of supplements in feed is based on the Nutrilab Inc. v. Schweiker 1983 court decision (713 F.2d. 335, 338 (7th Cr. 1983)), which asserts food is something “consumed for taste, aroma or nutritive value.” Although the court’s finding specifically referred to “food,” on this occasion, CVM decided the decision also refers to “feed,” and has indicated for something to be added to food (feed), it must have one of the three characteristics cited by the court or have a technical effect (e.g., preservative, flow agent, buffering agent, etc.).
Insofar as supplements would rarely double as having a “technical effect,” the requirement to be in compliance with the court’s definition (i.e., taste, aroma or nutritive value) for inclusion of a supplement in feed may embrace thresholds that are easy to meet (i.e., taste or aroma) or difficult (nutritive value). Documentation of meeting the former thresholds of taste and aroma could be as simple as a demonstration of a preference for one food over another. However, incorporating a substance into feed for companion animals on a claim of contribution of nutritive value will be difficult, simply because so little is actually known about the nutritional needs of companion animals, inasmuch as one of the few resources on dog and cat nutrition is the National Research Council publication, “Nutrient Requirements of Dogs and Cats” of 2006, and is regarded by many as woefully inadequate. Further, the process by which a nutritional need could be established would be very expensive and time consuming, and because companion animals would have to be rendered nutritionally deficient in order to conduct the test, such treatment would arouse the ire of unforgiving pet owners, who would likely boycott the product.
The requirements by CVM are in stark contrast to those of the Center for Food Safety and Nutrition (CFSAN) for human food, which allows ingredients to be added to food, not so much on the basis of aroma, taste or nutrition, but on the safety of the substance. That is, if a substance may be proven to be safe, it may be added to food. The stated rationale for the addition to food may be as simple as the substance is intended for those who wish to increase their consumption of that particular ingredient. A good example is lycopene, which, although it has no demonstrable taste or aroma, and has no “official” standing as a nutrient, is allowed in food because consumers feel increased lycopene consumption is beneficial, and has been shown as such in many scientific studies.
The long-held rationale by CVM that it must protect the nation’s food supply by closely monitoring ingredients going into animal feed is justified because an ingredient may well find its way into the human diet via the milk, meat or eggs produced by the animal. Inasmuch as companion animals, especially dogs and cats, are not used as food, CVM is struggling to find a pathway that will allow consumers to feed their pets according to their wishes, but to protect the consumers from fraud and to ensure the safety of pets.
George Burdock, Ph.D., is the founder and president, and Ray Matulka, Ph.D., is director of toxicology, with the Burdock Group , an Orlando, FL-based toxicology consulting company providing clients in the food, beverage, dietary supplement, personal care and pet food industries with safety and compliance solutions for FDA- and USDA-regulated products.
Want to learn more about the possibility of incorporating nutraceutical and nutritional ingredients in pet products? Join George Burdock, Ph.D., for the session “The Future of Dietary Supplements as Pet Food Ingredients” on Nov. 12, 2009, at SupplySide West. Get more details at SupplySideShow.com/West .