Thursday 24 August 2017

Final Administrative Detention Rule under FSMA Published

The Food and Drug Administration (FDA) issued a final regulation that adopts, without change, the interim final rule on administrative denetion of human and animal food (full PDF of “Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption“).

The new rule allows the FDAto detain on its own administrative authority food and feed products it believes are adulterated or misbranded. Previously, the Agency’s ability to administratively detain food products for humans or animals applied only when the agency had “credible evidence” that the food or feed presented a threat of serious adverse health consequences or death to humans or animals.

This is a dramatic shift in FDA authority. The FDA now simply needs “reason to believe” a food or feed product is misbranded or adulterated to order its detention.

According to FDA’s newly published Guidance for Industry: What You Need to Know About Administrative Detention of Foods, “administrative detention provides a means through which FDA can hold adulterated or misbranded food and prevent it from reaching the marketplace, thus further enhancing FDA’s ability to ensure the safety of food for U.S. consumers.”

Both human and animal food are subject to detention, except that which is regulated exclusively by the USDA under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act. The Guidance issued by the Agency states it may order the detention of any article of food that is found during an inspection, examination, or investigation if there is reason to believe that the article of food is adulterated or misbranded.

Under the expanded administrative detention authority, the FDA will be able to detain food and feed products that it has reason to believe are adulterated or misbranded for up to 30 days.

The interim rule is already in effect and in use by the Agency (see Food Court’s post on Chetak Chicago LLC).

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