Section 402 of the Food Safety Modernization Act of 2011 (FSMA) granted the Food and Drug Administration "expanded authority" to detain and seize any regulated food determined to be unsafe, adulterated or misbranded, "or otherwise failing to meet the requirements of the food safety law." On September 30, 2011 the first seizure/detention was ordered at the Dominguez Foods of Washington, Inc. in Zillah, Washington . The detention order covered "all of the food in the facility not in hermetically sealed containers." On October 17, 2011, a second seizure and detention was made of "various food products stored in a warehouse owned by Chetak Chicago LLC, in Streamwood, Ill.", collecting "more than 300 samples of materials showing significant unsanitary conditions.">
In addition to FDA's new seizure and detention powers, FSMA added significant civil penalties (i.e. "not more than $1,000,000 for each offense and every day is considered a separate offense) and expands on the criminal sanctions under the Food Drug and Cosmetic Act. Under prior law, the penalty was up to 1 year in prison. Now if the offense results in serious illness "the person committing the violation shall be imprisoned for not more than 5 years" and 10 years if it results in death. Couple these sanctions with the government's use of the Park Doctrine in prosecuting "C" suite officers, even when they had no actual knowledge of an offense, and there should be no question that ensuring compliance is the first item on the agenda and certainly compliance can no longer wait until an inspector knocks at the door.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
