December 10, 2019

December 10, 2019

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December 09, 2019

Subscribe to Latest Legal News and Analysis

FDA Will Extend Enforcement Policy Allowing Some “Co-Manufacturers” Additional Time to Implement Certain FSMA Supply-Chain Program Requirements

We reported on the Food and Drug Administration’s (FDA) November 2017 guidance giving certain co-manufacturers two more years to comply with requirements for a supply-chain program for certain raw materials and other ingredients under the FDA Food Safety Modernization Act (FSMA) – Preventive Controls for Human Foods, Preventive Controls for Animal Food, and the Foreign Supplier Verification Programs.  FDA determined that more time was needed for brand owners to establish new contracts with the firms the brand owners select to supply their co-manufacturers.  To comply with the supply-chain program requirements, co-manufacturers often need detailed information about suppliers that only the brand owner has, and that cannot be shared because of confidentiality clauses in the contracts between brand owners and the co-manufacturers’ suppliers.

On November 6, 2019, the date that FDA’s enforcement policy applicable to certain co-manufacturers would have expired, FDA announced that a forthcoming notice will be published soon in the Federal Register extending the enforcement discretion policy while FDA works to better understand additional challenges industry is facing in trying to meet the FSMA supply-chain requirements.  The non-enforcement policy extension was granted after requests from the American Frozen Food Institute (AFFI) and Food and Beverage Issues Alliance (FBIA) indicated their members have yet to overcome the many contractual and logistical barriers to compliance with the supplier verification requirements as they relate to brand owners and co-manufacturers and further consultation between FDA and industry is needed to resolve these compliance challenges.

FDA’s November 6, 2019 announcement does not identify a new compliance deadline for co-manufacturers benefitting from the new extension of FDA’s enforcement policy for the relevant FSMA supply-chain program requirements.  Co-manufacturers are still responsible for other applicable requirements under the Federal Food, Drug, and Cosmetic Act.

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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...

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