February 05, 2013 Food, Food Safety Modernization Act, Law & Regulatory No Comments
The U.S. Food and Drug Administration recently announced its Final Rule for the Administrative Detention of Foods under the Food Safety Modernization Act (FSMA). The rule adopts the Interim Final Rule from May 2011 without change. With this Final Rule, FDA now has the power to administratively detain any food simply because FDA claims it has reason to believe the food is adulterated or misbranded. You may want to read that again: FDA may now administratively detain any food that it believes to be adulterated or misbranded with essentially no evidence whatsoever. And don’t try to figure out what constitutes “reason to believe.” FDA has already refused to define the phrase, leaving industry completely in the dark as to the types of circumstances that might lead to such a detention and with little-to-no recourse once the food is detained.
Essentially, FDA has just opened the “Guantanamo Bay” of food. Somewhere at FDA champagne is being passed around.
Before the passage of the Food Safety Modernization Act, FDA’s Administrative Detention powers were locked down under some fairly finite language limiting what it could do and when. Now, the floodgates are open and FDA is presented with quite the opposite of what it had before: It can detain just about anything whenever it wants, for very little reason (see chart):
FDA’s Burden of Proof
FDA must have “credible evidence or information”
FDA must have“reason to believe”
What FDA Must Prove
The food “presents a threat of serious adverse health consequences or death to humans or animals.”
The food “is adulterated or misbranded”
C’mon, Trust Me!
Domestic producers and manufacturers of food need to take note that FDA already has this new authority and can wield it at anytime. While FDA has only used this new authority twice in the last 15 months, industry can expect the agency to use this power more and more, especially as FSMA continues to move forward into implementation. FDA says that it intends to use this authority appropriately and in a manner consistent with the prevention-based goals of the Act. If you trust FDA and want to believe this then go right ahead. But if you’re just a bit wary of the fact that FDA now wields the power to detain anything for whatever it believes is a reason then by all means, stay alert and stay compliant.
Bonus: The two cases where FDA flexed its new Administrative Detention muscles are linked below. See if you think it was warranted in each:
October 2011: Rat and Insect Infestation
January 2012: Listeria in Salmon