FDA Issues Draft Compliance Guide for Marketing Pet Food Intended to Treat or Prevent Disease

The Food and Drug Administration (FDA) has announced a draft compliance
policy guide (CPG) concerning the “Labeling and Marketing of Nutritional
Products Intended for Use to Diagnose, Cure, Mitigate, Treat, or Prevent
Disease in Dogs and Cats.” According to the September 10, 2012, Federal
Register notice, the draft CPG explains how FDA plans “to use its enforcement
discretion with regard to the labeling and marketing of dog and cat food
products that are labeled and/or marketed as intending to diagnose, cure,
mitigate, treat, or prevent diseases and to provide nutrients in support of
meeting the animal’s total daily nutrient requirements.”

Issued in response to new animal drug provisions of the Federal Food, Drug,
and Cosmetic Act (FD&C Act), the draft CPG seeks to address an observed
increase in the number of cat and dog food products “that make labeling or
marketing claims” about disease diagnosis, treatment or prevention. It also
sets forth the Center for Veterinary Medicine’s “current thinking with respect
to the factors it will consider before determining whether to take regulatory
action” against these products.

Meanwhile, FDA has reiterated that it does not “generally intend to recommend or initiate regulatory actions” against dog or cat food products covered in the CPG provided that manufacturers (i) “make the products available to the public only through licensed veterinarians or through retail or Internet sales to individuals purchasing the product under the direction of a veterinarian”; (ii) “do not market such products as approved new animal drugs”; (iii) are registered under section 415 of the FD&C Act; (iv) “comply with all food labeling requirements for such products”; (v) “do not include indications for a disease claim (e.g., obesity, renal failure) on the label of such products”; (vi) “limit distribution of material with any disease claims for such products only to veterinary professionals”; (vii) “secure electronic resources for the dissemination of labeling information and promotional materials such that they are available only to veterinary professionals”; (viii) “include only ingredients that are general[sic] regarded as safe (GRAS) ingredients, approved additives, or feed ingredients defined in the 2012 Official Publication of the Association of American Feed Control Officials (AAFCO) for the intended uses in such products”; and (iv) ensure that “the label and labeling for such products are not false and misleading in other respects.” The agency has requested written comments by November 9, 2012.