OIG takes a bite at FDA’s food recalls

The FDA did not have an efficient and effective food recall initiation process to ensure the safety of the U.S. food supply, according to a highly critical Office of Inspector General (OIG) report. Specifically, the FDA did not have policies and procedures to ensure that firms or responsible parties initiated voluntary food recalls promptly. As a result, consumers remained at risk of illness or death for several weeks after FDA was aware of a potentially hazardous food in the supply chain and the issue required immediate attention.

The OIG recommended that the FDA update its policies and procedures to instruct its recall staff to establish set timeframes for: (1) the FDA to request that food manufacturers voluntarily recall their products; and (2) food manufacturers to initiate voluntary food recalls. The OIG audit follows a previous 2011 report titled “Review of the Food and Drug Administration’s Monitoring of Imported Food Recalls” (A-01-09-01500) that found the FDA’s food recall program was inadequate because the agency did not have the authority to require food manufacturers to recall certain foods, nor did the agency always follow its own procedures.

Recalls

Prior to the passage of the Food Safety Modernization Act (FMSA) (P.L. 111-353) in 2011, the FDA did not have the authority to require a food manufacturers to recall certain articles of food. However, the FSMA added section 423 to the Food, Drug, and Cosmetic Act (FDC Act), which gives the FDA authority to order a food manufacturer to recall food once the agency determines that (1) there is a reasonable probability that the food is adulterated or misbranded; and (2) it will cause serious adverse health consequences or death to humans or animals (known as the unwieldy SAHCODHA). To date the FDA has used its authority under FSMA twice.

The FDA relies on food manufacturers to voluntarily recall harmful articles of food. However, before issuing a mandatory food recall, the FDA provides the manufacturer an opportunity to “voluntarily” recall the product. The FDA may request the recall in a specific manner and if the firm refuses or fails to complete the recall, the agency can force the manufacturer to cease production of the food item.

Audits

The OIG selected what it termed a “judgmental” sample of 30 imported and domestic voluntary human food recalls reported to the FDA between 2012 and 2015. Although a potentially skewed sample – the OIG looked at recalls considering risk factors that included classification and length of time – the OIG noted that the FDA did not provide a timeline to the food manufacturer to adhere to in its voluntary food recall. For two recalls, specifically, the food manufacturers involved did not recall all of the potentially harmful products from market until 165 days and 81 days after the FDA became aware of the potential adulteration. The OIG partly attributed this massive delay on the FDA’s failure to have policies and procedures instructing its recall staff to establish firm deadlines.

The OIG concluded that the FDA should consider the report’s finding as the FDA continues with FSMA implementation. The FDA agreed, but the question remains to be answered whether the agency will be able to do so with continuing staffing and resource issues.