Description
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.
Scope & Applicability
Product Classes
3marketed as an alternative to approved new animal drugs
Diets intended for use as a sole source of nutrients
The category of products covered by this guidance.
Stakeholders
3products made available only through veterinary professionals
Entity responsible for submitting NDINs
Qualified personnel for recovery operations on live animals
Identified Hazards
Hazards
1FDA does not intend to exercise enforcement discretion when products present safety risks
Related CFR Sections (1)
- 21CFR570.30§ 570.30 Eligibility for classification as generally recognized as safe (GRAS).
(a) General recognition of safety may be based only on the views of experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food. The basis of such views may be eitherRead full regulation →
Related Warning Letters (5)
- 2025-04-29
Unapproved New Animal Drug Products
Holista LLC dba HolistaPet
- 2025-04-29
Unapproved New Animal Drug Products
Bailey’s Wellness, LLC dba Bailey’s CBD
- 2022-11-21
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Infusionz, LLC
- 2022-05-26
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Plantacea, LLC dba Kahm
- 2022-05-26
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Haniel Concepts, Inc. DBA Free State Oils, LLC
See Also (8)
- CVM GFI #122 Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion Carnivores and Omnivores (Status: Final)
- CVM GFI #221 Recommendations for Preparation and Submission of Animal Food Additive Petitions (Status: Final)
- CVM GFI #220 Use of Nanomaterials in Food for Animals (Status: Final)
- CVM GFI #235 Current Good Manufacturing Practice Requirements for Food for Animals (Status: Final)
- CVM GFI #120 Veterinary Feed Directive Regulation Questions and Answers (Status: Final)
- Guidance for Industry: Frequently Asked Questions About GRAS for Substances Intended for Use in Human or Animal Food (Status: Final)
- Guidance for Industry: Regulatory Framework for Substances Intended for Use in Human Food or Animal Food on the Basis of the Generally Recognized as Safe (GRAS) Provision of the Federal Food, Drug, and Cosmetic Act (Status: Final)
- CVM GFI #258 Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds (Status: Final)