Food & Beverages | New FDA Food Powers

Mandatory Recall Authority

Under the FSMA, FDA has new authority to order a mandatory recall when it believes there is a reasonable probability that a food is adulterated or misbranded, and that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals. The rule requires FDA to give the responsible party an opportunity to conduct a voluntary recall; upon refusal, the mandatory order can issue and the party has an opportunity to participate in an informal hearing within two days after the order has issued.

Inspection-Related Refusal Power

Under the FSMA, FDA may refuse food that derives from a foreign facility (or government) operator that refuses to permit FDA inspectors to inspect the establishment. For purposes of this provision, the refusal is deemed to have occurred if it is not permitted during the 24-hour period after a request is made, or after such other time period as agreed upon by FDA and the factory.