- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Food Safety and Applied NutritionCenter for Veterinary MedicineOffice of Regulatory Affairs
The purpose of this document is to state that the Food and Drug Administration (FDA, we, or the Agency), at this time and based on our current understanding of the risks, does not intend to enforce certain regulatory requirements as they currently apply to certain entities and/or activities. The applicable requirements are established in our regulations entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (21 CFR Part 507); “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (21 CFR Part 117); “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” (21 CFR Part 1, Subpart L (FSVP)); “Mitigation Strategies to Protect Food Against Intentional Adulteration” (21 CFR Part 121); and “Standards for Growing, Harvesting, Packing, or Holding of Produce for Human Consumption” (21 CFR Part 112).
Section II of this document describes certain enforcement discretion policies that were issued previously and are relevant to the enforcement policies discussed in sections III.B and III.C. Section III describes new or extended enforcement discretion policies. Section III.A describes our extension of FDA’s enforcement discretion in certain circumstances when a receiving facility that is a contract manufacturer/processor not in compliance with certain supply-chain program requirements for food manufactured for a brand owner. Section III.B describes that we do not intend to enforce requirements of the Intentional Adulteration regulation for facilities under the preexisting farm-activity related enforcement policy. Section III.B also announces that FDA does not intend to enforce the Intentional Adulteration regulation’s requirement for reanalysis in certain circumstances—for example, when there is a single failure that is addressed through implementation of corrective action procedures. Section III.C describes that FDA does not intend to enforce the supplier approval and verification requirements in part 117, part 507, and the FSVP regulation with regard to supplier compliance with requirements that are already associated with an enforcement discretion policy.
We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115). This guidance is immediately effective because FDA has determined that prior public participation is not feasible or appropriate (21 CFR 10.115(g)(2)), on the basis that the guidance presents a less burdensome policy that remains consistent with FDA’s public health mission. As with all guidance documents, the public can comment on the guidance at any time (21 CFR 10.115(g)(5)). If FDA receives comments on the guidance document, FDA will review those comments and revise the guidance document when appropriate (21 CFR 10.115(g)(3)(ii)).
The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
In this guidance, pronouns such as “you” refer to entities that are covered by this guidance.
- FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
- FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration
- FSMA Final Rule on Produce Safety
- FSMA Final Rule for Preventive Controls for Human Food
- FSMA Final Rule for Preventive Controls for Animal Food
- FSMA Rules & Guidance for Industry
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-2021-D-0563.