January 21, 2019

FDA Releases Small Entity Compliance Guide Reiterating January 2018 Guide on Extension of Certain Compliance Dates for Four FSMA Rules

  • As previously covered on this blog, on August 24, 2016, FDA published a final rule that extended and clarified the compliance dates for certain provisions in four of the foundational rules implementing the Food Safety Modernization Act (FSMA).  The implicated rules are (1) Preventive Controls for Human Food Rule, (2) Preventive Controls for Food for Animals Rule, (3) Produce Safety Rule, and (4) Foreign Supplier Verification Programs (FSVP) Rule.  FDA’s January 2018 “Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs: Guidance for Industry” announced FDA’s intent to exercise enforcement discretion with regard to the facilities and requirements that are addressed in the August 24, 2016 rule.
  • Section 212 of the Small Business Regulatory Enforcement Fairness Act (SBREFA) requires FDA to publish a small entity compliance guide (SECG) to assist small entities in complying with actions like the August 24, 2016 final rule on the four FSMA provisions and to explain and clarify the actions that a small entity must take to comply with the rule. The notification of availability of the guidance document “Food and Drug Administration Food Safety Modernization Act; Extension and Clarification for Certain Provisions of Four Implementing Rules: What You Need to Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide” (May 2018 SECG) was published in 83 Fed. Reg. 22193 (May 14, 2018).
  • The May 2018 SECG does not include any new substantive information and simply confirms FDA’s previous advice by directing the reader to the January 2018 guidance.  The “new” document appears to satisfy the Agency’s SBREFA obligations to provide guidance to small entities regarding the August 2016 final rule. 
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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...