Last month, I listened to a podcast interviewing the owner of Straight Arrow, the parent company that produces Mane and Tail and Cowboy Magic products. As a lifelong horse owner (including several grey horses that love mud), I cannot remember a time when I did not have a Mane and Tail and/or Cowboy Magic product in my tack room. The interview took place after the podcasters toured the Cowboy Magic manufacturing facility, which, according to the podcast interview, is a state of the art facility which adheres to strict quality assurances. When listening to the details of how their products are manufactured, I realized that many animal owners may not know what regulatory standards apply to the manufacturing of pet grooming products.
According to the FDA, the “animal counterpart of a cosmetic is commonly referred to as a ‘grooming aid.’” See FDA, Animal Products FDA Regulates, available at https://www.fda.gov/animal-veterinary/resources-you/animal-products-fda-regulates (hereinafter, “FDA Guidelines”). The FDA is only empowered to regulate cosmetics that pertain to human use:
The term “cosmetic” means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.
21 U.S.C. § 321(i). Therefore standard animal grooming products do not fall within the control of the FDA. See FDA Guidelines. However, if animal grooming products are also made for human use, if the products are intended for any therapeutic purpose, or if the products are intended to affect the structure or function of the animal, they are subject to FDA regulation as a new animal drug. Id. Thus, a product like Mane and Tail, which is marketed for human use as well as animal use, is subject to FDA regulations.
A “new animal drug” is “any drug intended for use in animals other than man, including any drug intended for use in animal feed” but not including the animal feed, the composition of which is such that the drug is not generally recognized as safe and effective for the use under the conditions prescribed, recommended, or suggested in the labeling of the drug. See 21 U.S.C. § 321(v); see also FDA, New Animal Drug Applications, available at https://www.fda.gov/animal-veterinary/development-approval-process/new-animal-drug-applications. New animal drugs may not be sold until they are approved or conditionally approved by the FDA’s Center for Veterinary Medicine.
Thus, the answer as to what standards apply to the production of animal grooming products is, like most things in the law: it depends. A pet shampoo that merely claims to make the fur soft and shiny is unlikely to be subject to FDA regulations, whereas a shampoo that claims to prevent anemia or illness caused by fleas or ticks would be subject to FDA regulations and EPA regulations (governing all pet pesticide treatments). Of course, pet grooming products must still comply with packaging and labeling requirements governed by FTC and state consumer protection laws, and any claims about the efficacy of the product must be substantiated by competent and reliable scientific evidence.
We are available if you need advice related to any animal products you are manufacturing, distributing or selling.