HHS OIG issues early alert criticizing FDA’s food recall procedures.
- Under the FDA Food Safety Modernization Act (FSMA), FDA now has mandatory recall authority over conventional foods. However, FDA has only threatened the use of this authority twice. In reality, firms continue to work voluntarily with FDA to recall risky foods under the Agency’s recall procedures and guidance.
- On June 9, 2016, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) issued an “early alert” to indicate that its ongoing audit of FDA’s food recall program found that “FDA did not have an efficient and effective food recall initiation process that helps ensure the safety of the Nation’s food supply.” Stating that FDA failed to ensure the prompt recall of risky foods, the OIG asserted that “consumers remained at risk of illness or death for several weeks after FDA was aware of a potentially hazardous food in the supply chain.” The OIG cited specific cases in which firms delayed the recall of foods potentially tainted with Salmonella and Listeria monocytogenes until 165 days and 81 days after FDA became aware of the contamination risk. The OIG did not provide any specific recommendations regarding how FDA should improve its policies, only that the Agency “update its policies and procedures to instruct its recall staff to establish set timeframes for (1) FDA to request that firms voluntarily recall their products and (2) firms to initiate voluntary food recalls.” A copy of the audit report is available here.
- FDA issued a press release responding to the OIG’s findings, acknowledging that among the thousands of food recalls it had overseen in a 3-year period, a small number had fallen well outside the average time frame of less than a week for recall initiation. Characterizing these days as “unacceptable,” FDA stated that it is already taking concrete steps to address the OIG’s concerns, including establishment of a rapid-response team made up of Agency leaders, and the introduction of new technologies to expedite the process.