FDA Issues Draft Compliance Guide on Pet Food Intended to Diagnose, Cure, Mitigate, Treat or Prevent Disease, Including Obesity

September 21, 2012

By Riëtte van Laack

Earlier this month, FDA announced the publication of a draft level 1 Compliance Policy Guide (“CPG”) titled “Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat or Prevent Disease in Dogs and Cats.” 

The CPG in clear terms sets out FDA’s enforcement policy for cat and dog products that are intended for use as drug and to provide nutrients in support of a pet’s total daily nutrient requirements.  Unless (conditionally) approved or subject to an index listing, these products are unapproved new drugs.

FDA will give priority of enforcement to products that: (1) are marketed as alternatives to approved animal drugs; (2) contain unapproved food additives that do not conform to a definition by the Association of American Feed Control Officials (“AAFCO”); (3) include on the label claims or symbols that imply a disease claim; and (4) are available to the general public without any involvement of a licensed veterinarian.

To qualify as a product with a low likelihood of enforcement action by FDA, nine requirements concerning the manufacturer, the label, and the labeling and marketing of the product must be met.  Amongst others, the manufacturer must be registered as a food facility, the product label must not include indications for a disease claim (which includes obesity claims), the product be available only through a licensed veterinarian or under the supervision of a licensed veterinarian, and the dissemination of labeling and promotional materials must be limited so it will available to veterinary professionals only.

To ensure consideration by the Agency, comments should be submitted by November 9, 2012.