OIG: FDA recall process could put consumers at risk

By Joseph James Whitworth contact

- Last updated on GMT

Photo: FDA/Michael J. Ermarth. Salmonella bacteria in a petri dish
Photo: FDA/Michael J. Ermarth. Salmonella bacteria in a petri dish
The US Food and Drug Administration (FDA) has hit back at findings that it does not have an ‘efficient and effective food recall process’.

The HHS Office of Inspector General (OIG) said FDA did not have policies and procedures to ensure that firms or responsible parties made voluntary recalls promptly or did not instruct its recall staff to tell the firms a time and manner in which to start the voluntary recall.

It said 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.

The report recommended FDA consider the findings when implementing the Food Safety Modernization Act (FSMA) and follow its own procedures for monitoring recalls.

Under the FSMA, the agency has the authority to order a firm to recall certain food. It has used this twice.

Average time of less than a week

FDA said during the period reviewed by OIG it oversaw thousands of food recalls, with an average time for initiation of less than a week.

“A small number of these recalls fell well outside of that average, with months passing before all impacted products were taken off shelves, even though the FDA notified the companies involved of a contamination as soon as it had evidence.

“These delays are unacceptable. While some food recalls are more complicated than others due to the nature of the product(s), contamination, and investigation, the recall process should be as swift as possible and the FDA is already taking concrete steps to address the OIG’s concerns.

“These steps include the establishment of a rapid-response team made up of agency leaders, and the introduction of new technologies to make the process even swifter.”

The Strategic Coordinated Outbreak Response and Evaluation (SCORE) team has a number of roles including reviewing investigations that may have a link to specific foods or a facility when there is a serious human health risk.

OIG selected a sample of 30 imported and domestic voluntary human food recalls reported to FDA between October 1, 2012, and May 4, 2015.

It is a follow-up from a June 2011 report, which found FDA’s food recall program was inadequate because it did not have the authority to require firms to recall certain foods and did not always follow its own procedures.

Findings are preliminary and the audit is continuing. A draft report will be published when it is concluded and include comments and actions taken in response to this early alert, said OIG.

Recall start delay

For two recalls, the firms did not initiate the recall of all potentially harmful products until 165 days and 81 days after FDA became aware of the potential contaminations, it said.

“In a recall involving nut butter [nSpired Natural Foods​], at least 14 people became ill with a strain of Salmonella indistinguishable from or linked to the strain found at the firm’s manufacturing facility. 165 days passed from the date FDA identified the potentially adulterated product and the date the firm initiated a voluntary food recall.

“In a series of recalls involving various cheese products [Oasis Brands​], at least nine people became ill from Listeria monocytogenes, including one infant who died. According to FDA records, the Centers for Disease Control and Prevention also linked two fetal losses to these illnesses. 81 days passed from the date FDA became aware of the adulterated product and the date the firm had voluntarily recalled all affected products.”

Timeframes for voluntary action

Stephen Ostroff, FDA’s deputy commissioner for foods and veterinary medicine and Howard Sklamberg, deputy commissioner for global regulatory operations and policy, said facility and site inspections, surveillance sampling domestically and at the border, and laboratory and other analyses to help determine prevalence of foodborne risks contributes to safety every day.

They added the agency is looking at, in individual situations, specifying timeframes for voluntary action by the firm and, if necessary, enforcement action by the agency.

Ostroff and Sklamberg said actions have to be based in science and it goes where the evidence leads it.

“The scope of a contamination must be ascertained to determine how much of a product must be recalled. The time needed to collect evidence can vary, but to request a recall without evidence risks recalling the wrong product and leaving consumers vulnerable to contaminated food that is still on the market.”

The pair said they agree with the OIG that they must move quickly but there is not one rule for all.

“We also agree that timeframes should be set, but they must be done on an individual basis rather than by setting arbitrary deadlines. The complexities surrounding recall events make it difficult for the FDA to establish a single timeline applicable to all situations.”

Ostroff and Sklamberg said the preventive controls rules for human and animal food under FSMA, which require facilities to identify potential hazards and take steps to minimize or eliminate risks will strengthen protection.

Covered facilities are required to have a recall plan and compliance dates begin for certain firms in September 2016, they added.

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