The FDA and Its Inefficient Food Recall Process

The FDA Food Safety Modernization Act signed by President Obama in 2011 gave the Food and Drug Administration additional powers to regulate food safety. It enhanced the agency’s authority and ability to issue binding recalls of potentially dangerous and contaminated food products.

However, the Department of Health and Human Services recently released a report that exposed the inadequate and slow recall process involving foods and supplements that persists at the FDA.

What the OIG report says about the process

The report was put together and issued by the Health and Human Services Office of Inspector General. From 2012 in 2015, the Office of Inspector General discovery several problems when they examined 30 voluntary recalls which had FDA oversight. These system wide problems include the FDA’s initiation, monitoring, and recording recalls in their electronic database. For example, the report found that on average it took the FDA nearly two months to initiate a recall effort after it became aware of a problem.

A food safety law in 2011 gave the FDA authority to mandate recalls. Before this law, the agency could only put pressure on businesses to initiate voluntary recall actions. However, it was discovered that as of August 2016, the FDA had only taken advantage of this power on two occasions. The report concluded that the FDA did not use its enhanced power to enforce its demands in a timely manner merely because some businesses did not cooperate with the FDA’s investigation or recall.

Examples

The investigation of a 2014 recall involving salmonella in a processing plant that made nut butters by a company called nSpired Natural Foods revealed several troubling problems.  Even after a number of illnesses were linked to the nSpired Natural Foods, it too five months before the contaminated food was recalled.

The FDA also waited 161 days after the discovery of the contaminated food to initiate its mandatory recall authority. Only 4 days later, nSpired Natural Foods voluntarily removed its product from the shelves.

The Inspector General’s report also found that it can take the FDA up to 10 months in some cases to remove dangerous products from stores.

FDA response to the OIG report

Not long after the OIG report was released, the FDA took action to address the report’s concerns and improve the speed of its food recall process.

Instead of fixing the system wide problem found in the report, the FDA disputed the report’s conclusion by claiming the 30 cases mentioned are the exception and not the rule of how the agency carries out its work. It claims that on average, it has only taken four days to initiate recalls on contaminated products.

However, the reviewers of the FDA’s claims found that no evidence existed of the agency having a “reliable system for capturing the recall initiation date or the date FDA became aware of potentially hazardous food products.” The FDA’s database, according to the Inspector General’s review, did not include the dates when the agency learned about potentially tainted food. Also, roughly a third of the recalls had the wrong recall initiation date listed in the FDA’s database.

The FDA, according to its Commissioner Scott Gottlieb, admits that it still has “more work to do” to improve its recall process. It is clear, however, that when businesses fail to self-police and issue voluntary recalls, delayed action by the FDA can result in deadly consequences.

Has your health suffered because of a tainted food product? At Harris Lowry Manton LLP, our experienced product liability lawyers in Atlanta and Savannah understand what you may be going through. We can fight aggressively for the compensation you may be entitled. Request a free consultation through our contact form, or call us in Atlanta at 404-961-7650 or in Savannah at 912-651-9967.