Regulatory Focus™ > News Articles > New Compliance Guide Calls on Veterinary Food Manufacturers to Adhere to Good Practices

New Compliance Guide Calls on Veterinary Food Manufacturers to Adhere to Good Practices

Posted 07 September 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has announced the release of a new draft compliance policy guide (CPG) regarding the labeling and marketing of veterinary food products intended for use in canine and feline species.

The CPG is intended to broadcast the agency's anticipated use of its enforcement discretion for products that are specifically intended to diagnose, treat, cure or prevent disease in the two species. FDA said its Center for Veterinary Medicine (CVM) has seen an uptick since the late 1980s in the number of food products making specious or unfounded claims directly to consumers or even through veterinary professionals.

In its Federal Register posting, FDA said it hopes to protect both consumers and the safety of their pets from unscrupulous products in issuing the CPG.

Products meeting eight criteria are likely to be exempt from FDA's enforcement activities, the agency said. Those criteria are:

  • Products are made available to consumers only through a licensed veterinary professional.
  • Unapproved products are not presented as alternatives to approved drugs.
  • Manufacturers are registered with FDA.
  • All food labeling requirements are met for the product.
  • The indications for a disease are not contained on the label or marketing material for a product.
  • Marketing claims for products are distributed only to veterinary professionals.
  • Only ingredients found to be generally regarded as safe (GRAS) are used in the product.
  • The labeling for the product is not false or misleading.

Comments on the CPG, Sec. 690.150: Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat or Prevent Disease in Dogs and Cats, are due by 9 November 2012.

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