- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Veterinary MedicineOffice of Regulatory Affairs
This document provides guidance to Food and Drug Administration (FDA) staff on how to address dog and cat food diets that are labeled and/or marketed as intended for use to diagnose, cure, mitigate, treat, or prevent diseases and are also labeled and/or marketed to provide all or most of the nutrients in support of meeting the animal's total daily nutrient requirements by serving as the pet’s sole diet. Section IV below lists the factors FDA intends to consider in determining whether to exercise enforcement discretion with regard to animal drug approval requirements for dog and cat food diets that claim to treat or prevent disease. This guidance does not apply to products intended for nutritional supplementation of foods for animals and/or products marketed as dietary supplements for animals.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2012-D-0755.