The purpose of this document is to state the intent of the Food and Drug Administration (FDA, we, or the Agency) not 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 Human Food” (21 CFR part 117); “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (21 CFR part 507); “Standards for Growing, Harvesting, Packing, or Holding of Produce for Human Consumption” (21 CFR Part 112); and “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” (21 CFR Part 1, Subpart L).

We are issuing this guidance consistent with our good guidance practices (GGP) 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)).

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.

Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

The use of the word should in Agency guidances 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.

Download the Guidance

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Related Information

• Fact Sheet
• FSMA Rules & Guidance for Industry

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Questions?

For questions regarding this document, contact FDA’s FSMA Technical Assistance Network by submitting the inquiry form.