FDA Releases CPG for Labeling and Marketing of Therapeutic Animal Foods
On September 10, 2012, the U.S. Food and Drug Administration (FDA) released a draft compliance policy guide (“CPG”) entitled “Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat or Prevent Disease in Dogs and Cats.” Therapeutic animal food products are products that, based on the product’s labeling and indications for use, meet the statutory definition of an animal drug under the Federal Food, Drug, and Cosmetic Act (“FDCA”). Pursuant to 21 U.S.C. 321(g)(1)(B), a product that is labeled as intended to diagnose, cure, mitigate, treat, or prevent diseases is a drug. Further, a product that is labeled as intended to provide nutrients in support of an animal’s daily nutrient needs also satisfies the definition of a drug under 21 U.S.C. 321(f). This proposed CPG outlines how the FDA intends to enforce its regulatory authority over the labeling and marketing practices of manufacturers of animal food products that meet these definitions.
Animal food products that purport to diagnose, cure, mitigate, treat, or prevent disease have been available on the U.S. market for over fifty years, but were generally only sold through, and used under the direction of, licensed veterinarians. The FDA, however, has noticed a recent rise in the sale of therapeutic animal food products directly from manufacturers to consumers. This uptick in marketing and sales toward consumers sparked FDA concern about whether product labeling adequately informs consumers about the effectiveness and safety of products for pet consumption. As a result, the FDA has released this CPG to address continued concerns over the sale and use of unapproved therapeutic animal foods that are not used under the direction of veterinarians.
In this CPG, the FDA takes a stricter stance on how foods that bear health claims should be regulated. Specifically, the FDA takes the position that in order to market these therapeutic animal food products in compliance with federal regulations, manufacturers must obtain animal drug approval from the FDA. This process would require FDA approval indicating that the product is safe for use, only includes food additives that are generally recognized as safe (“GRAS”), and in compliance with requirements for facility registration, listing, and current good manufacturing practices.
According to this CPG, the FDA does not generally intend to recommend or initiate regulatory actions against dog and cat food products that are labeled as drugs when all the following factors are present:
- The product is made available to the public only through licensed veterinarians or through retail or internet sales to individuals purchasing the product under the directions of a veterinarian.
- The product is not marketed as an alternative to approved new animal drugs.
- The manufacturer is registered under section 415 of the FDCA.
- The product’s labeling complies with all food labeling requirements for such products.
- The product does not include indications for a disease claim (e.g., obesity, renal failure) on the label.
- Distribution of labeling and promotional materials with any disease claims for the product is limited to that it is provided only to veterinary professionals.
- Electronic resources for the dissemination of labeling information and promotional materials are secured so that they are available only to veterinary professionals.
- The product contains only ingredients that are GRAS ingredients, approved food additives, or feed ingredients defined in the 2012 Official Publication of the Association of American Feed Control Officials.
- The label and labeling of the product is not false and misleading in other respects.
The release of this CPG puts manufacturers of animal food products on notice that the FDA will closely scrutinize product labeling, particularly any claims that give the impression that a product purports to diagnose, cure, treat, or prevent diseases in animals. The FDA, however, will continue to take into consideration other factors in determining whether to take regulatory enforcement action. Specifically, the FDA has narrowed its enforcement attention to prioritize products that:
- Are marketed as alternatives to approved new animal drugs
- Contain unapproved food additives, unless the use of that unapproved food additive conforms to uses as listed in the 2012 Official Publication of the Association of American Feed Control Officials
- Include words or vignettes on the label of the product(s) that explicitly or implicitly indicate diseases for which the product is to be used.
- Are made directly available to the public circumventing the role of a licensed veterinarian for provision of directions for use, supervision of treatment and evaluation of the treatment outcome.
The FDA’s decision to develop and release a CPG on the regulation of therapeutic animal food products is an interesting one. Historically, the FDA has regulated pet foods similarly to human foods. In this CPG, the FDA’s description of therapeutic animal foods sounds rather similar to the language the FDA uses to describe human medical foods under section 21 U.S.C. 360ee(b)(3). The FDA defines a medical food as “a food which is formulated to be consumed under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” In the regulations for medical foods, the FDA species further criteria for meeting the statutory definition of a medical food. The FDA has not outlined similar criteria for animal foods. Even though there are distinct similarities in the FDA’s descriptions of therapeutic pet foods and human medical foods, the FDA has yet to specifically clarify what constitutes a therapeutic pet food product, how it interprets the meaning of use “under the direction of licensed veterinarians,” or whether the sale of these products is restricted to licensed veterinarians.
Despite the lack of clarity regarding the definition of a therapeutic drug product, manufacturers should not take this CPG lightly. The information proposed in this CPG suggests that the FDA intends to strictly enforce animal drug approval requirements for these animal food products and also plans to considerably tighten its oversight on pet food labeling claims. Because the use of health claims on product labeling would require manufacturers to undergo the drug approval process, manufacturers should take extra caution when developing claims about a product’s safety and efficacy in affecting the body or treating health conditions.
Overall, this proposal could have a significant impact on the cost of bringing therapeutic animal food products to market. The heightened threat of enforcement action could result in significant costs associated with filing applications for new drug approval, testing, re-formulation, and/or re-labeling. Moreover, the animal drug approval pathway would likely extend the timeline required for a product to become compliant with applicable regulations and eligible for distribution and sale.
The FDA is currently seeking public comment on this proposed draft compliance policy guide (Docket No. FDA-2012-D-0755). To ensure that comments are considered before the FDA begins work on the final draft, all comments should be submitted prior to November 9, 2012. Fuerst Ittleman David & Joseph will continue to monitor the FDA’s enforcement of this Compliance Policy Guide for therapeutic pet foods. For more information, please contact us at email@example.com