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GUIDANCE DOCUMENT

Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements Due to COVID-19 Guidance for Industry July 2023

Download the Final Guidance Document
Final
Docket Number:
FDA-2023-D-2828
Issued by:
Guidance Issuing Office
Human Foods Program

Issued March 2020
Updated June 2020; July 2023 

The purpose of this guidance is to state the current intent of the Food and Drug Administration (FDA, we, or the Agency), in certain circumstances related to the impact of the coronavirus outbreak (COVID-19), not to enforce requirements in three foods regulations to conduct onsite audits of food suppliers if other supplier verification methods are used instead. 

The three regulations are Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 CFR part 117) (“part 117”) [1], Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR part 507) (“part 507”) [2], and Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (21 CFR part 1 subpart L) (“FSVP regulation”) [3]. 

This guidance (originally titled “Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Requirements During the COVID-19 Public Health Emergency”) was initially implemented without prior public comment on March 17, 2020, because FDA had determined that prior public participation was not feasible or appropriate (21 CFR 10.115(g)(2)) given the exigent circumstances related to the COVID-19 public health emergency.  FDA revised the guidance on June 4, 2020, to clarify how the policies apply to importers of dietary supplements.  For the reasons discussed in Section II.B., and to clarify that the policies continue to reflect our current thinking, FDA is now reissuing this guidance in accordance with 21 CFR 10.115(c) and 10.115(g)(4).  The policies are unchanged from the June 2020 guidance.

In general, FDA's guidance documents 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.

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[1] For more information on part 117, including links to guidance that discusses the requirements mentioned in this document, see FSMA Final Rule for Preventive Controls for Human Food.

[2] For more information on part 507, including links to guidance that discusses the requirements mentioned in this document, see FSMA Final Rule for Preventive Controls for Animal Food.

[3] For more information on the FSVP regulation, including links to guidance that discusses the requirements mentioned in this document, see FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals. 

Related Information

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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:

Dockets Management
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-2023-D-2828.

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