Recent, high profile recalls of contaminated food products have highlighted the difficulty of responding to a food safety concern after the products have made their way to consumers. The Food Safety Modernization Act (FSMA), which was signed into law by President Obama in January 2011, seeks to address these concerns more proactively by focusing on the prevention of food safety problems rather than responding after a problem arises. The FSMA gives the US Food and Drug Administration (FDA or the Agency) greater authority to regulate potentially unsafe food products before they reach the consumer. To implement the FSMA, the FDA is charged with drafting and promulgating more than fifty new regulations, guidance documents, programs and reports to Congress.
On May 4, 2011, FDA released the first two regulations issued pursuant to its new authorities under the FSMA. Both rules take effect on July 3, 2011 although the FDA will accept comments on these new rules until August 3, 2011.1
Expanded FDA Authority to Detain Unsafe Food
Congress first authorized FDA to administratively detain food pursuant to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act). Pursuant to its authority under the Bioterrorism Act, FDA, until now, had the authority to administratively detain a food product only if the Agency had credible evidence or information that the food product was contaminated or mislabeled in a way that presented a threat of serious adverse health consequences or death to humans or animals. However, due in part to this very high threshold for action, FDA has never utilized its authority to detain food under the Bioterrorism Act. Instead, FDA has historically worked with state agencies to embargo, or hold, a food product pursuant to the state’s authority while FDA pursued federal enforcement action.
The FSMA expands FDA authority to prevent potentially unsafe food products from entering the market if it has "reason to believe" the products are misbranded or adulterated. Pursuant to its new regulation implementing this provision of the FSMA, as of July 3rd, FDA can stop a food product if it believes that the product is unsafe. Although FDA has reaffirmed its intent to continue to work with state agencies to ensure food safety and, indeed, has committed to building stronger ties with those agencies, FDA is no longer required to rely on a state’s authority to hold food for which it lacks "credible evidence" of contamination. Under its new authority, FDA will be able to prevent commercial distribution of the products for up to 30 days — if necessary — to ensure that food that FDA believes is produced in unsanitary or unsafe conditions is not commercially available. During this time, FDA will determine whether an enforcement action, such as seizure or federal injunction, is necessary to permanently restrict the food product from entering the market.
Of course, for foods with a short shelf-life, FDA’s administrative detention could prevent the food from ever entering the market regardless of whether additional enforcement action is pursued. Thus, as FDA recognized, in some cases, where the FDA’s reasonable belief of contamination or misbranding is determined to be unfounded, the temporary administrative detention can render the product unmarketable once FDA releases the product from its administrative detention. In its interim final enforcement regulations, which becomes effective on July 3, 2011, an FDA officer or qualified employee may order the detention of any article of food found during an inspection, examination or investigation that the officer or employee has reason to believe is adulterated or misbranded. The FDA has not provided further guidance regarding the application of this standard noting that the determination of whether there is a reasonable basis for believing a product is adulterated or misbranded is likely to be highly fact specific and will therefore have to be made on a case-by-case basis. While this lower threshold for Agency action gives FDA a greater ability to prevent potentially unsafe food from entering the market, it also raises the potential for significant lost product and the attendant costs for food manufacturers, processors and distributors. Until FDA applies this standard in practice, however, the scope and impact of this change remain unclear.
Additional Import Prior Notice Information
The Bioterrorism Act also authorized FDA to establish and administer a prior notice system for incoming shipments of imported food. Under the Bioterrorism Act, importers are required to submit an electronic prior notice form prior to arrival of food articles at the port of entry providing FDA with information regarding the source, quantity, nature, manufacturer, shipper, consignee of the food product and details regarding the shipment and carrier. The FSMA authorized FDA to expand the information required prior to food importation to include the identification of "any country to which the article has been refused entry." Starting on July 3, FDA’s new rule will require that all food importations provide this additional information with the prior notice of incoming shipment. It is expected that this additional information will enable FDA to anticipate potential threats associated with food products that have denied entry to other countries and have the resources available to respond to the food product’s threat to humans or animals prior to the food entering the US marketplace.
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These two rules are the first of numerous rules that FDA is required to promulgate under the FSMA. The Agency has focused on meeting the deadlines and obligations imposed by the FSMA and new information, reports, and guidances are expected to be issued in the coming weeks and months. For example, in April alone, FDA announced the availability of a consumer-friendly web search engine for recall information, issued its first annual report to Congress regarding FDA’s oversight and involvement in protecting the US food supply, and released a guidance document to the seafood industry. We anticipate that the Agency will continue its efforts to implement the FSMA, and industry should anticipate the Agency will begin to utilize its new authorities for proactively protecting the US food supply.