The U.S. Food and Drug Administration’s (FDA) process of recalling food products is not as timely as it should be in order to assure the safety of the country’s food supply, according to a study by the U.S. Department of Health and Human Services’ Office of Inspector General (OIG).
OIG reviewed documentation for 30 voluntary food recalls judgmentally selected from more than 1,500 food recalls reported to FDA between October 1, 2012, and May 4, 2015.
Prior OIG reviews focused on FDA oversight of recalls, but when those reviews were conducted, FDA did not have statutory authority to require food manufacturers to initiate recalls of most foods. However, FDA now has that authority under the Food Safety Modernization Act (FSMA).
In its most recent review, OIG put its attention on whether FDA is fulfilling its responsibility in safeguarding the nations food supply under its new authority. Specifically, OIG focused on the FDA’s oversight of company’s initiation of food recalls, monitoring of company-initiated recalls and maintenance of food recall data in the electronic recall data system.
The study found that FDA did not always:
- Evaluate health hazards in a timely manner
- Issue audit check assignments at the appropriate level
- Complete audit checks in accordance with its procedures
- Collect timely and complete status reports from companies that have issued recalls
- Track key recall data in the recall enterprise system (RES)
- Maintain accurate recall data in the RES
Recommendations for improvement
OIG recommends that the FDA use its Strategic Coordinated Oversight of Recall Execution (SCORE) initiative to establish set timeframes, expedite the decision-making process and move recall cases forward, and improve electronic recall data.
According to OIG, FDA agreed with the conclusion that it needs to help ensure that food recalls are initiated promptly in all circumstances, and stated that it will consider the results of the OIG review.
