Description
This guidance describes the Food and Drug Administration’s current thinking regarding the use of nanomaterials or the application of nanotechnology in food for animals. It is intended to help industry and other stakeholders identify potential issues related to the safety or regulatory status of food for animals containing nanomaterials or otherwise involving the application of nanotechnology.
Scope & Applicability
Product Classes
5Food intended for animal consumption subject to Part 507; Food for animal consumption manufactured, processed, packed, or held; Subject of the preventive controls regulation; Product manufactured by contract feed mills
Animal feed containing a VFD drug; Animal feed containing a VFD drug as a component.
Materials manipulated on the nanoscale level used in animal food
Approved substances for direct addition to food
Products involving the application of nanotechnology
Stakeholders
2Party submitting a citizen petition; party evaluating whether a food allergen is of public health importance; Party recommended to conduct systematic reviews and evidence scoring.
CVM division for pre-petition consultations
Regulatory Context
Attributes
4Approximately 1 nm to 100 nm
Factor for consideration in analytical assessment.
Biological property that may be altered by manufacturing changes; safety narrative should address bioavailability of the ingredients
Information regarding whether a device is cleared, approved, or under review.
Identified Hazards
Hazards
1Assessment of toxicity required in a 351(k) BLA
Related CFR Sections (3)
- 21CFR570.17§ 570.17 Exemption for investigational use and procedure for obtaining authorization to market edible products from experimental animals.
A food additive or food containing a food additive intended for investigational use by qualified experts shall be exempt from the requirements of section 409 of the act under the following conditions:Read full regulation →
- 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 →
- 21CFR570.35§ 570.35 Affirmation of generally recognized as safe (GRAS) status.
(a) The Commissioner, on his own initiative, may affirm that a substance that directly or indirectly becomes a component of food is GRAS under the conditions of its intended use.Read 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 #80 Evaluation the Utility of Anti-Salmonella Chemical Food Additives (Status: Final)
- CVM GFI #221 Recommendations for Preparation and Submission of Animal Food Additive Petitions (Status: Final)
- CPG Sec. 690.150 Labeling and Marketing of Dog and Cat Food Diets Intended to Diagnose, Cure, Mitigate, Treat, or Prevent Diseases (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)
- Guidance for Industry: Best Practices for Convening a GRAS Panel (Status: Final)
- CVM GFI #262 Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices (Status: Final)