FDA Gives Additional Time for 'Co-Manufacturers' to Comply With FSMA Supply-Chain Program Requirements

The Food and Drug Administration will give food facilities that have co-manufacturing agreements with brand owners additional time to comply with certain Food Safety Modernization Act requirements for supply-chain programs, it said in a guidance document released Nov. 3. “FDA does not intend to take enforcement action for two years against a co-manufacturer that is not in compliance with certain supply-chain program requirements related to supplier approval and supplier verification,” the agency said in a constituent update. “This enforcement discretion is conditional on the supplier approval and verification activities being divided between the brand owner and the co-manufacturer.”

The policy applies to contractual arrangements where a brand owner arranges for another party (the co-manufacturer) to manufacture or process human or animal food on its behalf, FDA said. Under FDA regulations on preventive controls on human and animal food, where food safety hazards are controlled elsewhere in the supply chain, “receiving facilities” must implement “supply-chain programs” to approve suppliers and monitor their activities related to the control of food safety hazards (see 1509100021 and 1509100073). Also, importers are deemed in compliance with most Foreign Supplier Verification Program requirements if they are also “receiving facilities” with supply-chain programs in place (see 1511160014).

According to FDA, industry has said it needs additional time to update contract arrangements to provide for sharing of information between brand owners and co-manufacturers. “To meet the requirements of the supply-chain program, the co-manufacturer may need detailed information from the brand owner,” FDA said. “Based on input from the food industry, FDA has determined that the industry needs more time to establish new contracts that will allow brand owners and co-manufacturers to share certain information, such as audits of suppliers,” it said.

The guidance says FDA does not intend to take enforcement action until Nov. 6, 2019, for supplier approval requirements where “(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.” Likewise, FDA won’t take enforcement action until that date for supplier verification activities where “(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,” it said.

Co-manufacturers must still comply with importer identification requirements of FSVP if they are FSVP importers, FDA said. “For each line entry of food product offered for importation into the United States, the importer must provide its name, electronic mail address, and unique facility identifier recognized as acceptable by FDA electronically when filing entry with" CBP, FDA said.