FDA Issues Guidance on FSMA Enforcement Discretion Policies

FDA Issues Guidance on FSMA Enforcement Discretion Policies

March 15, 2022, Covington Alert

On March 11, 2022, the Food and Drug Administration (FDA) released a guidance document announcing its intent not to enforce certain requirements established under the Food Safety Modernization Act (FSMA) regulations. FDA will do so by extending existing enforcement discretion policies and implementing new enforcement discretion policies. These policies affect three categories of FSMA requirements:

(1) Supply-chain program requirements applicable to co-manufacturers under FDA’s Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls rules for human and animal foods (PC Rules);[1]

(2) Requirements under FDA’s Mitigation Strategies to Protect Food Against Intentional Adulteration rule (IA Rule);[2] and

(3) Supplier verification and approval requirements under FDA’s PC Rules and FDA’s Foreign Supplier Verification Programs for Importers of Food for Humans and Animals rule (FSVP Rule).[3]

The guidance notes that other existing FSMA enforcement discretion policies remain unchanged, including FDA’s Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds and FDA’s Enforcement Policy for Certain Entities Subject to CGMP and Preventive Controls, Produce Safety, and/or FSVP Requirements.

1. Enforcement Policy for Supply-Chain Program Requirements for Co-Manufacturers

FDA is extending its existing enforcement discretion policy regarding certain supply-chain program requirements for receiving facilities that act as co-manufacturers for brand owners of human and animal foods. Under this existing policy, FDA has stated that it will not take enforcement action against co-manufacturers who fail to complete certain supplier approval and supplier verification activities required by FDA’s PC Rules when (1) the brand owner conducts the supplier approval/verification activities; (2) the co-manufacturer describes those activities in its food safety plan; and (3) the co-manufacturer conducts any necessary supplier approval/verification activities not conducted by the brand owner. FDA is extending this policy as it continues to assess the unique challenges these supplier verification requirements raise for co-manufacturers (e.g., practical challenges surrounding information-sharing between brand owners and co-manufacturers).

The guidance clarifies that this enforcement discretion policy applies to co-manufacturers who are also importers, and who rely on the FSVP Rule’s exemption for importers who have established and implemented risk-based supply-chain programs in compliance with FDA’s PC Rule.[4] In such cases, FDA still requires that the importer comply with the FSVP Rule’s importer identification requirements.[5]

2. Enforcement Policy for Certain Entities Under the IA Rule

The guidance addresses two enforcement discretion policies regarding FDA’s IA Rule. First, FDA is extending an existing enforcement discretion policy under which it has chosen to not enforce the IA Rule against certain facilities that perform farm-like activities (e.g., facilities that would qualify as farms if they did not color raw agricultural commodities). FDA is currently pursuing rulemaking related to farm-related activities that could affect whether facilities subject to this policy are covered by the IA Rule. The agency intends to extend this policy while it pursues that rulemaking and other related solutions.

Second, FDA is implementing a new enforcement discretion policy under which it will not enforce the IA rule’s requirement that facilities reanalyze their food defense plans in response to implementation failures if they address the implementation failures through corrective actions. For this policy to apply, the corrective actions must both correct the problem and reduce the likelihood of recurrence. FDA specifically notes that if there is a recurrence of the implementation failure, it will require a reanalysis of the facility’s food defense plan. This policy does not apply in circumstances where a facility’s whole food defense plan is not properly implemented.

3. Enforcement Policy for Supplier Approval and Verification Requirements

Finally, the guidance announces that FDA does not intend to enforce the supplier approval and verification requirements at part 117, part 507, and the FSVP regulation as a means of confirming supplier compliance when such requirements are already associated with an enforcement discretion policy. Under FDA’s PC Rules and FSVP Rule, receiving facilities and importers must, under certain circumstances, conduct supplier approval and verification activities to ensure that foods their suppliers provide are produced in compliance with FDA’s regulations. Certain of these requirements are subject to enforcement discretion. When enforcement discretion covers a particular requirement, the supplier is not obligated to comply with that requirement. As such, situations will arise in which a supplier chooses not to comply with certain supplier approval and verification requirements, and receiving facilities and importers would be unable to verify the supplier’s compliance with those requirements. FDA’s new enforcement discretion policy addresses this challenge by clarifying that FDA will not take enforcement action against receiving facilities or importers for failure to verify suppliers’ compliance with FSMA requirements already associated with an enforcement discretion policy. This would include, for example, circumstances where suppliers choose not to comply with the requirements related to written assurances in part 117, part 507, and section 1.507 of the FSVP Rule because FDA has stated its intent to exercise enforcement discretion regarding those requirements.

FDA’s enforcement policy for supplier approval and verification requirements will be applicable for as long as the enforcement discretion policy affecting the underlying FSMA requirements remains in place.

What Can You Do?

Industry stakeholders should assess the extent to which their operations may be subject to these existing or new enforcement discretion policies. Because FDA’s enforcement discretion policies are temporary, stakeholders who rely on these policies should actively monitor for any future changes that may be relevant to their operations.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.