FDA Completes Two Tasks Mandated by the FSMA

By Mike Rozembajgier

After releasing both its draft strategy to prevent smuggling and draft guidance on agency expectations for dietary ingredients, the Food and Drug Administration (FDA) has completed two critical tasks required by the Food Safety Modernization Act (FSMA). Both will help improve the FDA’s ability to regulate the marketplace and force product recalls.

These reports outline some of the agency’s plans for addressing the unique challenges and risks associated with regulating an increasingly global marketplace. Both programs are also essential to the prevention-based strategy called for in the six-month old FSMA.

The FDA’s anti-smuggling strategy, developed cooperatively with the Department of Health and Human Services (DHHS) and the Department of Homeland Security (DHS), is an effort to deal with threats posed by food products entering the U.S. without being subjected to FDA oversight. According to the draft report, the new measures will allow the FDA to “order administrative detention if there is reason to believe that an article of food is adulterated or misbranded.” The report goes on to say that these measures will allow the agency to improve the safety of the U.S. food supply by “preventing potentially harmful food from reaching U.S. consumers.”

The FDA plans to work with the U.S. Customs and Border Protection division of DHS to review historical data and assess target criteria for specific products, firms, and countries of origin. The agencies will share information and conduct joint investigations to identify shipments that may contain smuggled food.

The agency’s draft guidance on new dietary supplement ingredients is focused on informing and assisting manufacturers and distributors to determine when premarket safety notifications for new ingredients are necessary, and how those notifications should be prepared. Dietary supplement manufacturers are required to notify the FDA before they add new ingredients to their products. According to a press release detailing the two FSMA initiatives, the FDA states that its guidance on dietary supplement ingredients “is an important preventive control to ensure that consumers are not exposed to unnecessary public health risks from new ingredients with unknown safety profiles.”

The anti-smuggling strategy and the new guidance on dietary supplement ingredients are important first steps in the FDA’s increased risk management efforts. In today’s fast paced global marketplace, ensuring consumer safety is an increasingly difficult task that requires new and ever more sophisticated oversight and regulatory strategies. As the FDA works to meet these challenges under the FSMA, it will be better prepared to regulate the marketplace and initiate product recalls when necessary.

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