FDA Draft Guidance Aims To Better Inform The Public Of Recalls

Federal health regulators released plans this week to improve how the public is notified about important food and drug recalls, putting much of the onus on manufacturers to make sure consumers are aware of the problems. 

On January 18, the FDA issued a draft guidance (PDF) that details the agency’s policies on public warning and notification of recalled products. The guidance comes a month after FDA Commissioner Scott Gottlieb announced that he would push the agency to give consumers better “actionable information” about recalled food products.

“Specifically, the draft guidance outlines circumstances when a company should issue a public warning about a recall, describes the general timeline for companies to issue such a warning, discusses what information should be included in a public warning, and describes situations where the FDA may take action to issue its own public warning should a company’s warning be deemed insufficient,” Gottlieb wrote in a public statement. “The draft guidance is a key step to enhance the recall process. It gives industry clear direction on how to navigate and work with the FDA to make sure that recalls are communicated promptly.”

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Gottlieb also said the agency is working on additional plans to better help consumers identify recalled food products. The agency currently tries to provide descriptions, lot codes, and photos of packaging, but Gottlieb said the agency intends to go further with plans later this year, such as providing additional geographic information, like specific stores where recalled products were sold.

The plans comes after a review of 30 FDA recalls from October 2012 to May 2015, including several several multi-state food poisoning outbreaks where identification of the source of the outbreak took months.

For example, a 2014 nut butter recall took 165 days to identify. A cheese recall linked to listeria contamination took 81 days  and ultimately resulted in nine illnesses and the death of a fetus in a pregnant woman.

The review identified several flaws in the recall process. It found that the FDA is not always able to identify the source of the contamination, and when a specific product is identified, the manufacturers and distributors can be difficult to identify due to lack of information.

According to the FDA’s information, manufacturers and the agency are best able to identify the source of an outbreak, allowing the manufacturer to issue a voluntary recall within three to four days. Last month, when announcing the new initiative, Gottlieb said the agency needs to remain steady in issuing recalls to protect the public and must always retain the authority to mandate recalls from manufacturers who decline to do so.

As part of recent efforts, the FDA established the Strategic Coordinated Oversight of Recall Execution (SCORE) team, which is comprised of senior leaders charged with reviewing complex and unusual food safety situations. They are responsible for determining the proper action to address the problem. In addition to overseeing complex recalls, the team also makes procedural recommendations that could better expedite the recall process.

The FDA is accepting public comment on the new draft guidance for 60 days. Electronic comments can be submitted to http://www.regulations.gov. Written comments should be sent to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments should be identified with the docket number FDA-2016-D-3548.


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