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  1. FDA In Brief

FDA In Brief: FDA Publishes Third Installment of Intentional Adulteration Draft Guidance

February 13, 2020

Media Inquiries

  Amanda Turney

The following quote is attributed to Frank Yiannas, Deputy Commissioner for Food Policy and Response:

“The U.S. Food and Drug Administration has an unwavering commitment to the safety of the American food supply."

“The Intentional Adulteration Rule requires the food industry to implement risk-reducing strategies for processes in food facilities that are significantly vulnerable to intentional adulteration, including acts of terrorism."

“Today we issued a supplemental guidance for industry to support compliance with this rule and took another meaningful step in ensuring that our food supply remains among the safest in the world. ”

  • Today the FDA announced the availability of a supplemental draft guidance, “Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry” to support compliance with the Intentional Adulteration (IA) Rule under the FDA Food Safety Modernization Act. This is the third and last installment of the draft guidance for the IA rule.
  • Food facilities covered by the rule are required to develop and implement a food defense plan that identifies vulnerabilities and mitigation strategies for those vulnerabilities. These facilities are also required to ensure that the mitigation strategies are working by implementing mitigation strategy management components. Facilities are required to train certain personnel, as well as keep records of activities conducted under the rule.
  • This last installment of the IA rule draft guidance adds to the previously published guidance with chapters covering topics focusing on food defense corrective actions, food defense verification, reanalysis and recordkeeping. The installment also includes appendices on the FDA’s online Mitigation Strategy Database and how businesses can determine their status as a small or very small businesses under the rule.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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