FDA Clarifies Enforcement Discretion Timeline, Policy for Supply-Chain Programs, FSVP
FDA’s ongoing policy of enforcement discretion for food facilities that have co-manufacturing agreements with brand owners and must comply with certain Food Safety Modernization Act requirements for supply-chain programs will remain in effect until further notice, while the agency considers its enforcement approach, including by way of a potential new rule.
Sign up for a free preview to unlock the rest of this article
Timely, relevant coverage of court proceedings and agency rulings involving tariffs, classification, valuation, origin and antidumping and countervailing duties. Each day, Trade Law Daily subscribers receive a daily headline email, in-depth PDF edition and access to all relevant documents via our trade law source document library and website.
In a recent guidance document announced in a March 14 Federal Register notice, FDA said it “has determined that it should continue to consider the additional practical challenges related to compliance with these provisions.” The enforcement discretion policy was first announced in 2017 (see 1711030032), and extended due to industry concerns in 2019, without any end date given at that time (see 1911060036).
In the guidance, FDA also clarified that it will apply a policy of enforcement discretion for certain regulatory requirements under its FSMA regulations to activities required under the Foreign Supplier Verification Program and applicable supply-chain program requirements, it said. That includes certain produce safety requirements for hops, wine grapes, pulse crops and almonds; FSMA requirements for certain farm-related activities; some written assurance requirements; and preventive controls requirements for human food by-products for use as animal food.
“When FDA does not intend to take enforcement action regarding a provision in one of those regulations for a particular entity, we also do not intend to take enforcement action regarding the requirement for an importer or receiving facility to verify the entity’s compliance with that provision,” FDA said. “Stated differently, FDA intends for its enforcement discretion policy to 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.”