As we reported, FDA released a list on January 31, 2022 of important guidance topics that are a priority for completion this year.  The list includes enforcement policy guidance concerning five of the seven foundational rules implementing the FDA Food Safety Modernization Act (FSMA).

On March 14, 2022, FDA published notification of availability of Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions Guidance for Industry.  The March 2022 guidance describes new or extended FSMA enforcement discretion policies as follows:

• FDA extended the policy, announced in March 2019 Guidance for Industry: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds, not to enforce part 112 for entities engaged in the relevant activities while FDA considers rulemaking to address the unique circumstances of these commodities.

• FDA extended the enforcement policies announced in January 2018 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 as follows:

  • Until rulemaking involving certain farm-related activities is finalized, FDA will not enforce for listed entities (1) the part 117 (human food) and/or part 507 (animal food) preventive controls requirements; (2) the part 507 current good manufacturing practice (CGMP) requirements for the listed entities that are subject to the part 507 CGMPs; or (3) the part 117 CGMP requirements with regard to non-produce raw agricultural commodities (RACs).

  • Until the completion of new rulemaking that considers complex supply chain relationships and resource requirements, FDA will not enforce certain requirements for written assurances in part 117, part 507, the FSVP regulation, and Part 112 (the Produce Safety regulation).

  • While FDA considers the issue, it will not enforce the part 507 preventive controls requirements related to human food by-products if after separation from the human food, the entities are performing one of a limited number of identified manufacturing/processing activities.

• FDA clarified that the enforcement discretion policies under the January 2018 guidance extend to any requirement (under FSVP or the preventive controls supply-chain program requirements) for an importer or receiving facility to verify a supplier’s compliance with a FSMA requirement which itself is associated with an enforcement discretion policy, although FSVP requirements which are not associated with an enforcement discretion policy remain subject to FDA’s usual enforcement policies.

• FDA announced it does not intend to enforce the requirements of Part 121 (Intentional Adulteration) for those facilities that are under the farm-activity related enforcement policy described in the January 2018 guidance until the completion of rulemaking, which will clarify food facility registration requirements for those entities (e.g., facilities that would be farms except for ownership of the facility; facilities that would be farms if they did not color RACs).

• FDA announced it does not intend to enforce the requirement for reanalysis of the Food Defense Plan (FDP) in 21 CFR 121.157(b)(3) when improper implementation of a mitigation strategy or combination of mitigation strategies is addressed through implementation of corrective actions procedures that correct the problem and reduce the likelihood of recurrence.

• FDA extended the policy, announced in November 2017 Guidance for Industry: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food, which was extended in a November 6, 2019 update, as discussed here, not to enforce requirements for a supply-chain program for certain raw materials and other ingredients while FDA works to better understand additional practical challenges related to compliance with supplier verification and approval challenges related to co-manufacturing.

This guidance is immediately effective per FDA’s determination that prior public participation is not feasible or appropriate with respect to these new and extended enforcement policies because the guidance presents a less burdensome policy that remains consistent with FDA’s public health mission.  FDA will, however, review any comments that are received and revise the guidance when appropriate, as required under 21 CFR 10.115(g)(3)(ii).