FDA Exercised Expanded Power to Detain Food Products
Today, May 5, 2011, the United States Food & Drug Administration reminded Americans that "each year about 48 million people (1 in 6 Americans) are sickened, 128,000 are hospitalized, and 3,000 die from food borne diseases."
Yesterday, May 4, 2011, FDA issued the first rules to be promulgated under the controversial Food Safety Modernization Act that Congress passed on January 4, 2011. The two new rules expand powers FDA had originally received under the Bioterrorism Preparedness and Response Act of 2002.
The first rule lowers the standard FDA must meet before it can detain potentially unsafe food products and prevent them from reaching American consumers. Under the Bioterrorism Act, FDA could only detain food products if it had "credible evidence" that a food was contaminated or mislabeled in a way that "presented a threat of serious adverse health consequences or death to humans or animals." Now, FDA may detain potentially unsafe food products with only a reasonable belief that a product is adulterated or misbranded. FDA can detain such food products for up to 30 days while it determines whether more serious enforcement action is required, such as seizure or federal injunction against distribution.
FDA had never exercised its authority under the Bioterrorism Act to detain food products for which it had "credible evidence" of potentially serious threat to human or animal health. FDA believes that, under this new rule, it will be "more likely to use administrative detention against articles of food in situations which include, among others, where the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote." FDA described such situations as analogous to Class II food recalls. A Class II recall is one that involves a potential health hazard for which there is a remote probability that consuming the food product will lead to an adverse health effect.
The second rule expands the information food importers must provide FDA before their product arrives at the US border. In 2009, FDA had promulgated rules under the Bioterrorism Act that required importers to provide advance information such as country of origin to help FDA identify potentially unsafe food before it arrived in the United States. The new rule now requires importers to tell FDA in advance if any other country has refused entry to the same product. FDA can refuse entry if it does not receive prior notice, or if it has reason to believe were produced in unsanitary or unsafe conditions, thus making them adulterated or misbranded.
The number of prior notices that FDA received under the original regulation was large. During the 18 months that the rule was in effect, FDA received 10,116,018 prior notices for imported food. FDA and industry expects that number of prior notices will increase as the volume of imported food products, particularly fruits, vegetables, seafood and other perishable items, rises.
Both rules will take effect July 3, 2011. FDA will accept public comments on the rules until August 3, 2011, at which time it will consider any necessary modifications.