April 4, 2020

FDA Too Slow To Issue Recalls, HHS Audit Says

The FDA is too slow to get food companies to recall contamianted products, according to an audit by the Department of Health and Human Services (HHS). In some cases, firms waited for months before they recalled their products that caused many illnesses.


The HHS Office released a report that states “we found that the FDA did not have an efficient and effective food recall initiation process that helps ensure the safety of the Nation’s food supply. Specifically, FDA did not have policies and procedures to ensure that firms or responsible parties initiated voluntary food recalls promptly. This issue is a significant matter and requires FDA’s immediate attention.”

FDA relies on firms to recall food that can be harmful to the public health. The government did not have the authority to require a company to recall foods before 2011, but the Food Safety Modernization Act (FSMA) added section 423 to the FD&C Act, which gives them that authority. When the government determines that there is “a reasonable probability that the food is adulterated or misbranded and that it will cause serious adverse health consequences or death to humans or animals (referred to as SAHCODHA)”, the FDA can order the recall. This has only happened twice in the past five years.

The FDA must provide the firm with an opportunity to recall the product within a prescribed time frame. If the firm refuses, FDA can order them to ceases distribution. After the company is offered an informal hearing, FDA can order a recall.

HHS sampled 30 imported and domestic voluntary human food recalls for this report between October 1, 2012 and May 4, 2015. They performed site visits at 7 of the 11 FDA district offices responsible for monitoring the 30 recalls.

They found that the FDA’s policies and procedures did not instruct recall staff to prescribe to the firms a time and manner in which to initiate the recall. FDA did not have policies and procedures in place to ensure that the foods were recalled promptly. For all of the 30 voluntary recalls, FDA did not prescribe a timeline.

In fact, for two recalls, the firms did not initiate the recall of all potentially harmful products until 165 days and 81 days after the FDA became aware of the problem. The report states, “as a result, consumers remained at risk of illness or death for several weeks after FDA knew of potentially hazardous food.”

For example, the Salmonella outbreak linked to nSpired nut butters sickened at least 14 people. The FDA identified the potentially adulterated product, but it took 165 days for the company to initiate the recall. And in the Listeria monocytogenes outbreak linked to Oasis cheese, nine people were sickened, one infant died, and there were two fetal losses. There were 81 days from the date the FDA became aware of the problem and when the firm recalled the products. No one knows how many people may have been spared if the FDA had acted in a timely manner.

HHS says that the FDA revise its policies and procedures. Recall staff should set time frames for the FDA to request that firms voluntarily recall their products and for firms to initiate voluntary food recalls.

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