The Food and Drug Administration has released a draft Compliance Policy Guide Sec. 690.150 Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat or Prevent Disease in Dogs and Cats. This guidance is important for all manufacturers of dog or cat food products.
Increased Prevalence of Disease Claims and Product Availability Prompt Change
To date, FDA had exercised enforcement discretion for dog and cat food products for which disease claims were made when the products provided nutrients in support of the animal’s daily required nutrition needs, the manufacturer restricted labels and labeling, and the products were distributed only through licensed veterinarians. FDA determined that the enforcement discretion criteria needed to be tightened because of both the increasing number of products featuring disease claims and the increased availability of products through the internet.
The Criteria for Enforcement Discretion
Under the draft guidance, FDA will exercise its enforcement discretion against dog and cat food products that are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and to provide nutrients in support of meeting the animal’s total daily nutrient requirements when manufacturers meet each of the following conditions:
- Products are made available only through licensed veterinarians or through retail or internet sales to individuals purchasing the products under the direction of a veterinarian
- Products are not marketed as alternatives to approved new animal drugs
- The manufacturer is registered under section 415 of the FDCA (21 USC 350(d) Food Facility Registration)
- Products are in compliance with all food labeling requirements
- Product labels do not include indications for disease claims
- Distribution of materials with disease claims is limited to veterinary professionals
- Electronic resources for dissemination of labeling and promotional materials is secure such that it is only available to veterinary professionals
- Products only include ingredients that are GRAS, approved food additives, or feed ingredients as defined in the 2012 Official Publication of the Association of American Feed Control Officials (AAFCO)
- Product labels and labeling are not false or misleading in other respects (e.g., all therapeutic claims are substantiated)
Opportunity for Comment
These criteria leave most of the dog and cat food products available today potentially open to enforcement, depending on their distribution channels and claims. Industry stakeholders should closely review the proposed criteria and consider submitting comments to address issues of concern. Comments on the draft compliance policy guide are due November 9, 2012.