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FDA Issues New FSMA Guidance on Supply Chain Requirements

Nov 08, 2017

The Food and Drug Administration released on Monday new guidance designed to give certain co-manufacturers more time to meet supplier approval and verification requirements under the Food Safety Modernization Act (FSMA). Three of the rules created to implement FSMA – Preventive Controls for Human Foods, Preventive Controls for Animal Food and Foreign Supplier Verification Programs – require a supply-chain program to address hazards control for certain raw materials and other ingredients.

The guidance states 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.

To meet the requirements of the supply-chain program, the co-manufacturer may need detailed information from the brand owner. 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.

The guidance, titled “Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food: Guidance for Industry,” is immediately effective.

Hogan Lovells, IDFA’s outside counsel, has prepared a memo with additional information on the guidance. Members may log in to read more here.

For more information, contact John Allan, vice president of regulatory affairs and international standards, at jallan@idfa.org.

 
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