Inspections, Compliance, Enforcement, and Criminal Investigations
CPG Sec. 690.100 Nutritional Supplements for Companion Animals
The *Center for* Veterinary Medicine is often asked to comment on the status under the Act of products intended for the nutritional supplementation of foods for animals. Such products would include vitamins, minerals, protein supplements, and fatty acid sources. The diets of livestock, poultry and fur-bearing animals are usually planned by nutritionists or other experts, and the nutritional ingredients are sold through industrial channels. On the other hand, nutritional supplements for companion animals such as cats, dogs and horses not intended for food, as well as other pets, are mostly sold over-the-counter direct to lay customers and are generally intended merely for the dietary supplementation of the particular species for which they are intended.
Malnutrition, with the exception of obesity, is infrequent in companion animals. Most receive ample nutrition to sustain healthy life through their regular daily diet. Most dog and cat foods are likewise rich in nutrients either through the natural content of the ingredients or because of manufacturer supplementation.
Animals on balanced rations do not require extra nutritional supplementation; in fact, excessive amounts of certain nutrients may cause health problems. Nevertheless, *CVM* does not object to the OTC marketing of dietary supplements in tablet, capsule, powder, or liquid form for companion animals similar to the special dietary preparations sold for humans. We have, however, advised that such products should provide meaningful amounts of each of the nutrients they are represented to contain and these nutrients should be of known value for the intended or target animal.
The nutritional needs of animals do not necessarily parallel those of humans. For instance, only a few species are known to require Vitamin C in their diet. As most animals either receive adequate amounts of vitamins, minerals, protein (essential amino acids), fat (fatty acids) and carbohydrate in their diet or are able to synthesize them from a ration balanced to observe National Research Council nutrient requirements, we are not aware that supplementation would serve a useful purpose. FDA has published no regulation concerning the vitamin, mineral, or other dietary properties as special dietary products for animals as contemplated by section 403(j). In arriving at a level of supplementation which represents the best information presently available, FDA uses The Nutritional Requirements of Domestic Animals, a standard test published by the National Academy of Sciences-National Research Council. We have usually accepted as adequate those products providing a meaningful level of nutrition when compared with the NAS/NRC recommendations.
These products should not be misbranded by any direct or implied therapeutic or other claims for special benefits from their use. This would include representations for the products as a tonic, conditioner or toner which is proscribed by 21 CFRa. Nor should they bear such vague therapeutic suggestions as promotion of "health," "stamina," "strength," or that they are of any special value for breeding purposes or for show or racing purposes or for working animals, or that by virtue of their formulation "i.e., "chelated," "timed release," "natural") they are superior to the ordinary vitamin-mineral preparations of commerce. We would consider animal nutritional supplements to be adulterated if they contain upon analysis significantly more or significantly less of label declaration of a nutrient which could effect the health of the target animal. Further, nutritional supplements should contain no drugs or unsafe food additives, either as direct or indirect ingredients. Guidance in individual cases may be obtained from HFV-236.
Nutritional supplements marketed in injectable form are considered to be drugs and are not purview to this guide. As drugs, their status as new animal drugs must be resolved on a case by case basis.
The *Center for* Veterinary Medicine will not generally object to the marketing of nutritional supplements for oral administration to companion animals provided they conform to the following restrictions:
1. There is a known need for each nutrient ingredient represented to be in the product for each animal for which the product is intended.
2. The label represents the product for use only in supplementation of and not as a substitute for good daily rations.
3. The product provides a meaningful but not excessive amount of each of the nutrients it is represented to contain.
4. The labeling should bear no disease prevention of therapeutic, including growth promotional, representations.
5. The labeling should not be otherwise false or misleading in any particular.
6. The product is neither over-potent nor under-potent nor otherwise formulated so as to pose a hazard to the health of the target animal.
Appropriate regulatory action may be recommended against violative products. Except in cases of adulteration involving health considerations, the *Warning* Letter is the initial action of choice to achieve compliance.
a 21 CFR 500.52
*Material between asterisks is new or revised*