September 26, 2022

Volume XII, Number 269

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September 23, 2022

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Food and Drug Administration (FDA) Issues Final Rule on Criteria for Administrative Detention of Food

Earlier this month, the Food and Drug Administration (FDA) issued a final regulation on the criteria for ordering the administrative detention of food, implementing Section 207 of the Food Safety Modernization Act (FSMA). FSMA lowered the standard for the FDA to order the administrative detention of food to whether FDA has “reason to believe” that the food is adulterated or misbranded. Before FSMA, FDA could only detain a food product when it had credible evidence that the food product presented a threat of serious adverse health consequences or death to humans or animals.

Consistent with FSMA, the final rule amends 21 C.F.R. § 1.378 to adopt the “reason to believe” standard. Similarly, 21 C.F.R. § 1.393 now states that FDA must issue the detention order in writing, in the form of a detention notice, when an officer or authorized employee has reason to believe the food is adulterated or misbranded. Under the rule, FDA can detain suspect food for a maximum of 30 days while it determines whether to take further enforcement action, such as seizure. If FDA does not issue a written order terminating the detention within 30 days, the detention terminates automatically after the 30 days pursuant to 21 C.F.R. § 1.384.

© 2022 BARNES & THORNBURG LLPNational Law Review, Volume III, Number 59
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About this Author

Barnes & Thornburg's Food, Drug & Device Law practice group helps pharmaceutical, biotechnology, medical device, diagnostic, food, dietary supplement and cosmetic companies, as well as other healthcare entities, throughout the product lifecycle, from concept, development and approval to manufacturing, marketing, ongoing compliance, investigation, enforcement actions and litigation. We advise clients on the ever-evolving laws and FDA regulations that govern their products and components. Moreover, we have the government experience and industry knowledge necessary to develop...

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