The Food and Drug Administration announced today its final rule for administrative detention of food products under the Food Safety Modernization Act (FSMA). The final rule adopts without changes the interim final rule "Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption," which expanded FDA's authority for detaining products to include foods the agency believes are adulterated or misbranded. The interim rule became effective July 2011.
In comments filed during the interim rule comment period, IDFA supported the regulations but asked the agency to develop clear criteria and guidance regarding when FDA would use the authority and when it wouldn't. Responding in the final rule, FDA said, "Decisions regarding whether FDA has 'reason to believe' that food is adulterated or misbranded will be made on a case-by-case basis because such decisions are fact specific."
FDA decided not to provide additional explanation of the criteria, saying only that it will consider the facts in each situation to determine when to order administrative detention.
"We suspect the criteria will become clearer through usage," said Clay Detlefsen, IDFA vice president of regulatory affairs. "However, we don't think FDA will use its authority with any great frequency, and we expect when they do use it, the use will be reasonable."
For more information, contact Detlefsen at firstname.lastname@example.org.
Invensys to Sponsor IDFA Webinar on Preventive Controls Rule
Just last month, FDA released a proposed rule on preventive controls for human food. To help members understand the proposed changes and how they will they affect dairy processors, IDFA will present the "Preventive Controls Webinar" on February 20.
The webinar, sponsored by IDFA Business Partner Invensys Operations Management, will be held 1:00 – 4:00 p.m. Details and registration information are available here.