The U.S. Food and Drug Administration (FDA or “the agency”) recently issued guidance¹ announcing its intent to exercise enforcement discretion for several specific provisions in its regulations implementing the FDA Food Safety Modernization Act (FSMA). This new guidance builds on prior FDA enforcement discretion issued under FSMA, which remains in effect.²

The recently-issued guidance establishes new or extended enforcement discretion for three specific areas:

• Supply-Chain Program Requirements Applicable to Co-Manufacturers – In November 2017, FDA announced that it would exercise enforcement discretion with respect to certain supply-chain requirements applicable to co-manufacturers. The new guidance simply extends the existing enforcement discretion while the agency continues to consider the practical challenges related to compliance with supplier verification requirements for co-manufacturers.

This discrete enforcement discretion applies in two circumstances:

• Supplier Approval – FDA does not intend to take enforcement action if: (1) a brand owner conducts supplier approval activities, (2) the co-manufacturer describes these activities in its food safety plan, and (3) the co-manufacturer conducts any necessary supplier approval activities not conducted by the brand owner.

• Supplier Verification – FDA does not intend to take enforcement action if: (1) a brand owner determines and/or conducts supplier verification activities for its co-manufacturer, (2) the co-manufacturer describes these activities in its food safety plan, and (3) the co-manufacturer conducts any necessary supplier verification activities not conducted by the brand owner.

• Requirements Under the Intentional Adulteration Rule for Certain Entities or for Reanalysis – FDA has announced that it will exercise enforcement discretion for the IA rule in these two ways:

• • Facilities covered by FDA’s January 2018 enforcement policy related to farm-related activities – FDA does not intend to enforce the requirements of the IA regulation for those facilities that are under the farm-activity related enforcement policy described in its January 2018 enforcement policy guidance³ because they conduct certain farm-related activities, but are not considered farms under the “farm” definition (e.g., facilities that would be farms except for ownership of the facility; facilities that would be farms if they did not color RACs), while the agency pursues rulemaking that could change the definition of “farm.”

• • Reanalysis required by 21 CFR § 121.157(b)(3) – The IA regulation requires reanalysis of the food defense plan (FDP) in certain circumstances, including whenever a mitigation strategy, a combination of mitigation strategies, or the FDP as a whole is not properly implemented (21 CFR § 121.157(b)(3)). Improper implementation of mitigation strategies is also addressed by taking food defense corrective actions. Industry previously shared concerns with the agency regarding the duplicative requirement to reanalyze the FDP whenever a mitigation strategy is not properly implemented. Accordingly, FDA does not intend to enforce the requirement for reanalysis when improper implementation of mitigation strategies or combination thereof is addressed through implementation of corrective actions procedures that correct the problem and reduce the likelihood of recurrence. However, FDA intends to enforce the requirement in 21 CFR § 121.157(b)(3) to conduct a reanalysis when the FDP as a whole is not properly implemented.

• Supplier Approval and Verification Requirements for Suppliers that Are Themselves Subject to Enforcement Discretion for FDA’s FSMA Regulations – When a supplier itself is subject to enforcement discretion for compliance with the Preventive Controls for Human Food (PCHF), Preventive Controls for Animal Food (PCAF), or Produce Safety regulation,⁴ FDA will exercise enforcement discretion regarding a receiving facility or Foreign Supplier Verification Program (FSVP) importer who otherwise would be required to verify their supplier’s compliance with that FSMA rule (i.e., PCHF, PCAF, or Produce Safety). However, this enforcement discretion is limited and does not apply to all supplier verification requirements under FSVP or the supply-chain program requirements. An FSVP importer still must verify the supplier’s compliance with those provisions for which compliance is required and the agency is not exercising enforcement discretion.

We will continue to monitor FDA’s implementation and enforcement of FSMA.

References

1 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 (Mar. 11, 2022), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-current-good-manufacturing-practice-and-preventive-controls-foreign-supplier.

2 See, e.g., FDA Continues Enforcement Discretion Policy Relevant to Certain Co-Manufacturers under FSMA (Nov. 6, 2019), https://www.fda.gov/food/cfsan-constituent-updates/fda-continues-enforcement-discretion-policy-relevant-certain-co-manufacturers-under-fsma; Guidance for Industry: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds (Mar. 27, 2019), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-enforcement-policy-entities-growing-harvesting-packing-or-holding-hops-wine-grapes; Guidance for Industry: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs (Jan. 5, 2018), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-policy-regarding-certain-entities-subject-current-good-manufacturing-practice-and; Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food: Guidance for Industry, https://www.fda.gov/media/108732/download.

3 Guidance for Industry: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs (Jan. 5, 2018), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-policy-regarding-certain-entities-subject-current-good-manufacturing-practice-and.

4 For example, if a supplier is subject to the enforcement discretion outlined in FDA’s January 2018 or March 2019 guidance, cited above.