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FDA Releases Intentional Adulteration Training Course

  • In partnership with the Food Safety Preventive Controls Alliance (FSPCA), FDA has developed a free 30-minute “Food Defense Awareness for the Intentional Adulteration (IA) Rule” online training course to assist industry in complying with Food Safety Modernization Act (FSMA) requirements under the Final Rules for Mitigation Strategies to Protect Food Against Intentional Adulteration.
  • The training is the first in a series of six anticipated training materials to be released in partnership with FSPCA; the subsequent trainings will cover: (1) an overview of the IA rule, (2) IA “key activity types, (3) IA identification and explanation of mitigation strategies, (4) vulnerability assessments, and (5) food defense plan preparation and reanalysis.
  • The IA rules require covered facilities to develop and implement a food defense plan that protects the facility’s most vulnerable points from acts of intentional adulteration intended to cause wide-scale public health harm.  The newly-released training course is separate from guidance documents that FDA is developing and planning to issue in installments in advance of the July 26, 2019 compliance date for most businesses. As reflected in recent comments by Commissioner Scott Gottlieb, there is confusion among industry concerning just what the rules require from industry.
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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...