FDA issues first installment of Intentional Adulteration rule guidance

Other installments to be released within the next six months.

FDA has announced the first installment of the draft guidance regarding the implementation of the requirements of the Intentional Adulteration rule is now available at The installment includes chapters on the components of the food defense plan; how to conduct vulnerability assessments using the key activity type method; how to identify and implement mitigation strategies; and food defense monitoring requirements.


The second installment of the draft guidance, which will be released later this year, will focus more on VAs and training requirements, while the third will concentrate on corrective action, verification, reanalysis and recordkeeping requirements. FDA plans to hold a public meeting on the draft guidance after the release of the second installment later this year.

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