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FDA Releases Compliance Guide for Small Businesses under FSMA Intentional Adulteration Rule

  • On May 27, 2016, FDA published its final rule to implement the intentional adulteration (or “food defense”) provisions of the FDA Food Safety Modernization Act (FSMA).  Click here for a copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule.
  • In short, the final rule establishes various food defense measures that registered facilities are required to implement to protect against the intentional adulteration of food.  As a general matter, facilities must prepare and implement a written food defense plan that identifies significant vulnerabilities and actionable process steps, mitigation strategies, and procedures for food defense monitoring, corrective actions, and verification.  Facilities also have new training and recordkeeping requirements under the final rule.  Several types of facilities and activities are exempt from compliance.  Specifically, the new requirements do not apply to:  (i) very small businesses; (ii) the holding of food, except the holding of food in liquid storage tanks; (iii) the packing, re-packing, labeling, or re-labeling of food where the container that directly contacts the food remains intact; (iv) activities thaft fall within the definition of “farm”; (v) animal food; (vi) alcoholic beverages under certain conditions; and (vii) certain on-farm food/activity combinations performed by small or very small businesses.
  • On August 24, 2017, the FDA announced the availability of a Compliance Guide to help small businesses comply with the Final Rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (or Intentional Adulteration Rule), mandated by FSMA.
  • The Compliance Guide was prepared in accordance with the Small Business Regulatory Enforcement and Fairness Act. The Guide provides nonbinding recommendations on topics including, but not limited to:
    • Who must comply with the rule and when;
    • Developing a food defense plan;
    • Records management; and
    • Education, training and qualifications.
  • The compliance date for small businesses under the Intentional Adulteration Rule is July 27, 2020. 
© 2020 Keller and Heckman LLPNational Law Review, Volume VII, Number 237


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...