Guidance for Industry: Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions

Description

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).

Scope & Applicability

• 21CFR10.115§ 10.115 Good guidance practices.

  (a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →

• 21CFR121.157§ 121.157 Reanalysis.

  (a) You must conduct a reanalysis of the food defense plan, as a whole at least once every 3 years;Read full regulation →

• 21CFR1.507§ 1.507 What requirements apply when I import a food that cannot be consumed without the hazards being controlled or for which the hazards are controlled after importation?

  (a) Circumstances. You are not required to conduct an evaluation of a food and foreign supplier under § 1.505 or supplier verification activities under § 1.506 when you identify a hazard requiring a control (identified hazard) in a food and any of the following circumstances apply:Read full regulation →

• 21CFR117.136§ 117.136 Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control.

  (a) Circumstances. If you are a manufacturer/processor, you are not required to implement a preventive control when you identify a hazard requiring a preventive control (identified hazard) and any of the following circumstances apply:Read full regulation →

• 21CFR507.36§ 507.36 Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control.

  (a) If you are a manufacturer/processor, you are not required to implement a preventive control when you identify a hazard requiring a preventive control (identified hazard) and any of the following circumstances apply:Read full regulation →

• 21CFR1.509§ 1.509 How must the importer be identified at entry?

  (a) You must ensure that, for each line entry of food product offered for importation into the United States, your name, electronic mail address, and unique facility identifier recognized as acceptable by FDA, identifying you as the importer of the food, are provided electronically when filing entryRead full regulation →

• 21CFR121.145§ 121.145 Food defense corrective actions.

  (a) Food defense corrective action procedures. As appropriate to the nature of the actionable process step and the nature of the mitigation strategy:Read full regulation →

• CGMP/Animal Food/Adulterated

  King Farm

  2025-12-23

• CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes

  Compass Group USA

  2025-11-11

• Foreign Supplier Verification Program (FSVP)

  V & L Produce, Inc.

  2025-10-28

• CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated

  Gracie's Kitchens, Inc.

  2025-09-30

• CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated

  Hans Bakery Inc. d/b/a Andersen’s Bakery

  2025-09-30

• CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated

  Tan Nam Corporation

  2025-09-30

• Foreign Supplier Verification Program (FSVP)

  Jalisco Fresh Produce, Inc.

  2025-09-09

• Foreign Supplier Verification Program (FSVP)

  Eurobread Inc. dba First Harvest

  2025-08-26

• Seafood HACCP/CGMP for Foods/Adulterated

  Chaohu Daxin Foodstuffs Co., Ltd.

  2025-08-19

• Foreign Supplier Verification Program (FSVP)

  A.D. Berries @ More LLC

  2025-07-15

• Small Entity Compliance Guide: Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules of the FDA Food Safety Modernization Act (Status: Final)
• CVM GFI #239 Human Food By-Products For Use As Animal Food (Status: Draft)
• Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities (Status: Draft)
• Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA (Status: Draft)
• CVM GFI #241 Small Entity Compliance Guide – What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507) (Status: Final)
• CPG Sec 615.115 Extralabel Use of Medicated Feeds for Minor Species (Status: Final)
• CVM GFI #235 Current Good Manufacturing Practice Requirements for Food for Animals (Status: Final)
• Draft Guidance for Industry: Application of the “Solely Engaged” Exemptions in Parts 117 and 507 (Status: Draft)