FDA Issues Final Guidance To Strengthen Public Recall Warnings And Notifications

Federal food regulators have outlined new steps that will help make sure the public is aware of recalls and warnings about issues that could represent a threat to public health and safety. 

In a statement issued on Thursday, FDA Commissioner Scott Gottlieb announced agency’s Public Warning and Notification of Recalls Guidance, which outlines additional steps the agency will take to improve public awareness and accuracy of food, medical device and drug recalls impacting the United States.

The FDA is tasked with protecting and promoting public health throughout the country, and controls the recall processes for food safety, tobacco dietary products, prescription and over the counter (OTC) medications, vaccines, biopharmaceuticals, medical devices, cosmetic products and veterinary products among various other fields.

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A draft guidance was issued by the FDA in January 2018, with plans to implement guidance for strengthening public warnings and notifications of recalls. This was the first of a series of actions that would develop into the most recent guidance issued this week.

The guidance details how company’s should issue a public warning about a voluntary recall, describes a general time frame for companies to issue such a warning, discusses what information should be included in a public warning, and details the situations where the FDA may take action to issue its own public warning should the impacted company warning be deemed insufficient.

The recommendations came 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.

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. In December 2017, 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.

The guidance also notes that the FDA will begin posting recalls in its Enforcement Report, which is a web listing of all recalls monitored by the FDA. This development could allow for quicker notification to the public, which could in return save lives and prevent illnesses, Gottlieb claims.

Gottlieb, also said new steps are being taken to improve technologies used to identify harmful bacteria and those used to notify consumers if they have purchased a product included in a recall.

The FDA has been testing new technology that can screen for multiple allergens simultaneously, and is also looking into ways to improve product traceability by using modern approaches such as blockchain technology and Whole Genome Sequencing, which is a form of DNA fingerprinting to relate strains of bacteria to the same source of contamination.

“Consumers should expect to continue to see more frequent communication on potential risks to their health. We’ll continue to seek out opportunities for improved processes, education and awareness,” Gottlieb wrote. “And we constantly strive to learn from every recall, and every issue, so that we can help to prevent future recalls and to work quickly with companies to remove the products from the market.”

The agency is accepting public comment on the guidance until March 20, 2019.


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