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FSMA Update: FDA Issues Guidance on Enforcement Discretion Related to FSMA Provisions

  • Today, the FDA published guidance outlining key areas where it intends to exercise enforcement discretion in four of the rules that implement aspects of the Food Safety Modernization Act (FSMA). 83 FR 598. In short, this guidance document outlines the Agency’s intent to not enforce certain FSMA requirements as they currently apply to certain entities and/or activities. This enforcement discretion specifically relates to certain provisions in the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (PC Human Food), Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule (PC Animal Food), Foreign Supplier Verification Programs rule (FSVP), and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule (Produce Safety) and how they apply to:
    • facilities that would be farms except for certain factors and activities
    • written assurances provisions in all four rules related to the customer’s control of identified hazards that are a potential risk to public health
    • the animal food preventive controls requirements for certain manufacturing/processing activities performed on human food by-products used as animal food, and
    • FSVP requirements for importers of food contact substances.
  • As our readership is well aware, FDA had previously extended the compliance dates for many of the provisions covered by this guidance (see August 2016 compliance date extension). The enforcement discretion policies enumerated in the guidance will remain in place until and unless FDA decides to take further action on any of these issues.
© 2020 Keller and Heckman LLPNational Law Review, Volume VIII, Number 5
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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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