FDA Issues Final Rule Lowering Detention Standard for Food

Earlier this month, the US Food and Drug Administration (FDA) issued a Final Rule that adopts, without any change, the Agency’s interim final rule (IFR) changing the criteria for administratively detaining human or pet food. As ordered by the Food Safety Modernization Act (FSMA), the Final Rule officially codifies the expansion of FDA’s authority to detain food products the Agency believes are adulterated and/or misbranded. Before the passage of the FSMA, FDA was able to detain a food product only when it had “credible evidence” that a food presented a threat of serious adverse health consequences or death to humans or animals. However, under the new “reason to believe” standard, a food can be kept out of commerce for up to 30 days while the Agency determines whether to take further enforcement action, such as product seizure. Decisions regarding whether FDA has a “reason to believe” a food is adulterated or misbranded will be made on a case by case basis depending on the particular facts at issue involving the specific food items. Lowering the standard from one of “credible evidence” to “reason to believe” enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. Adoption of the new standard means that FDA may detain a food during an inspection, examination, or investigation or at the US port of entry when an inspector believes such food to be adulterated and/or misbranded. As a practical matter, for imported food, the area where this new standard will likely have the biggest impact, FDA can easily detain substantially more food items at US ports of entry.

We are continuing to follow FDA’s implementation of the Food Safety Modernization Act. For additional information, please contact Georgia C. Ravitz or James R. Ravitz. A link to the Final Rule follows here.

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