As a general matter, companies may not make therapeutic or “drug” claims in connection with the marketing of food or feed, including pet food. However, in reality, therapeutic pet food products have been marketed for years without official drug approvals in accordance with FDA’s longstanding enforcement discretion policy in this space.
In 2012, FDA issued a draft Compliance Policy Guide (CPG) explaining the criteria that the Agency would consider when determining whether to take enforcement action regarding dog and cat food diets intended to treat specific diseases. FDA generally has exercised enforcement discretion with respect to “drug requirements” for therapeutic pet food products where:
(1) the product provided all or most nutrients in support of an animal’s total required daily nutrient needs;
(2) labels and marketing materials made available to the general public did not contain claims to treat or prevent disease; and
(3) the products were distributed only through licensed veterinarians.
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