In 2011, President Obama signed into law the FDA Food Safety Modernization Act, granting the Food and Drug Administration more power to regulate food safety and the ability to issue mandatory recalls of potentially contaminated and dangerous foods. But a new report from the Department of Health and Human Services, released Wednesday, has found the FDA’s food and supplement recall process remained slow and ineffective in the years after.
The report, conducted by the Office of Inspector General (OIG), is a review of 30 selected voluntary recalls overseen by the FDA from 2012 to 2015. It found systemic issues and delays in how the agency initiated recalls, monitored them, and recorded them down in their electronic database, among other issues. For instance, that the average length before a recall began once the FDA was aware of problems was 57 days.
“FDA did not always have an efficient and effective food-recall process that ensured the safety of the Nation’s food supply,” the report concluded.
Despite seemingly having more power than before, the report specifically found, the agency was still sometimes unable to enforce its demands in a timely fashion, in part because companies didn’t want to cooperate. In one case, involving the supplement company Nutrex, it took 10 months after they were given a warning letter by the FDA before the company finally pulled a product that contained unlisted ingredients; for most of that time, they were still able to offer people free samples of it. In another case, a recall of nut butter products sold by nSpired Natural Foods only began more than five months after the FDA first confirmed through its own investigation that an outbreak of Salmonella was traced to a plant that made their products—during which time, more people fell ill in an outbreak that ultimately sickened 14 people.
The results of the review were alarming enough to prompt the OIG into releasing an early draft of it in June 2016. Soon after, the FDA created a team that tried to address these concerns and speed up the food recall process. In a response letter by the FDA included in the current report, however, the agency was also defensive, claiming the reviews selected were “an extreme outlier” of how the FDA normally performs its work.
The review authors rebutted the agency’s claims that most food recalls were called less than four days after it become aware of potential health risks, pointing out they “did not find evidence that FDA had a reliable system for capturing the recall initiation date or the date FDA became aware of potentially hazardous food products.” A third of the recalls they reviewed, for example, had the wrong initiation date recorded in the FDA database, nor did the database include specifically when the agency first found out about suspect foods or supplements.
FDA Commissioner and former physician Scott Gottlieb, appointed by President Trump, has so far spearheaded some promising campaigns at his new post. Amidst concerns that the FDA under his control would be too friendly to the pharmaceutical industry, Gottlieb has pushed hard to deal with legitimate problems involving the country’s food and drug supply. In December, the FDA announced it was cracking down on homeopathic products (largely unregulated remedies that are basically just sugar pills); a month before that, it announced a hard new line on stem cell clinics selling bogus cures. Gottlieb has also taken steps to curb ever-rising drug prices by encouraging the production of more generic drugs.
The report recommends that the agency, through the initiative it established following the early draft’s release in June 2016, “establish set timeframes, expedite decision-making and move recall cases forward, and improve electronic recall data.” Because you don’t want to find out 57 days too late that your ice cream could kill you.