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FSMA Compliance – What to Expect in the Next Few Months

FDA has released a Q&A document regarding the Agency’s expectations going forward for FSMA compliance now that the first set of major FSMA compliance dates have arrived. 

  • The first major FSMA compliance dates arrived on September 19, 2016 for the preventive controls rules for human and animal food under the FDA Food Safety Modernization Act (FSMA). In short, larger businesses are now subject to certain new standards.  In particular, human food facilities must meet preventive controls and Current Good Manufacturing Practice requirements (CGMPs), and animal food facilities must meet CGMPs.

  • Yesterday, Joann Givens, co-chair of the FSMA Operations Team Steering Committee and director of FDA’s Food and Feed Program in the Office of Regulatory Affairs, addressed questions that have been raised about what the next few months will look like. Highlights of the Q&A document include:

    • reiterating that the first year of compliance will affect the larger businesses, generally those with 500 or more employees;

    • underscoring the importance of documenting all steps taken to proactively prevent against food contamination events; and

    • indicating that the Agency will initially be focused on education, i.e., working with the food industry “to create a culture of food safety, a culture of compliance with procedures, processes, and practices that we know will minimize the risk of serious illness or death.” That being said, the Agency indicates that it would certainly take swift action, when necessary, to protect public health.

  • Stakeholders subject to FSMA should make every effort to be well-versed in the various regulatory obligations imposed by FSMA.

© 2020 Keller and Heckman LLP


About this Author

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...