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FDA Issues Guidance to Allow “Co-Manufacturers” Additional Time to Implement Certain Supply-Chain Program Requirements

  • As our readership is well aware, three of the rules created to implement the FDA Food Safety Modernization Act (FSMA) – Preventive Controls for Human Foods, Preventive Controls for Animal Food, and the Foreign Supplier Verification Programs – have requirements for a supply-chain program for certain raw materials and other ingredients. FDA has designed the supply-chain program to address hazards requiring a supply-chain-applied control.
  • To meet the requirements of the supply-chain program, a co-manufacturer may need detailed information from the brand owner. FDA explains that “co-manufacturing” means a contractual arrangement whereby one party (the brand owner) arranges for a second party (the co-manufacturer) to manufacture/process human or animal food on behalf of the first party. Based on industry feedback, 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.
  • Today, the U.S. Food and Drug Administration (FDA) announced the availability of a guidance entitled “Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food: Guidance for Industry.” FDA states that this guidance is designed to give certain co-manufacturers more time to meet supplier approval and verification requirements under three FDA food safety regulations.  The guidance provides that 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. This enforcement discretion is conditional on the supplier approval and verification activities being divided between the brand owner and the co-manufacturer.
  • FDA will be accepting comments on this guidance document at any time via https://www.regulations.gov.
© 2020 Keller and Heckman LLPNational Law Review, Volume VII, Number 307



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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...