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FDA Aiming to Speed Up Recall Announcements

The Food and Drug Administration is aiming to alert members of the public faster when a product has been recalled, according to its official blog at FDA Voice. This move is being made to enhance the health of the public and increase the transparency of the agency.

The primary source for recall information is the FDA’s “Enforcement Report,” a web-based feature that is updated once a week. Previously, only recalls that were already classified in one of the three severity categories the FDA uses were included in the report. However, this has been causing a delay in getting the information about a potentially hazardous product out to the public as the classification process can take weeks or even months in some cases.

In response to the lag between classification and public notification, the FDA has opted to release recall information on the products it regulates as soon as possible, before the product is classified. From now on, recalls of human foods, drugs and veterinary products will be available in the Enforcement Report even if they have not yet been assigned a class. These classification-pending items will be shown as “not yet classified” in the report.

The FDA currently uses three classes to identify the danger level a product poses to the public. Class 1 is the highest risk and includes items such as defective pacemakers and food that is contaminated with salmonella, while Class 2 is intermediate and includes failure to declare an ingredient in a food product on its label. Class 3 is the lowest risk group, such as a sub-potent medicated shampoo.

In addition to alerting the public to a potentially dangerous product before it’s classified, the FDA is now also offering early summaries of removal or correction actions involving serious medical device issues on its Medical Device Recalls Database. This database also received an upgrade to its user search function to make finding information easier.

The FDA does note that recalls are usually voluntary. Sometimes, they are initiated by the company that makes the products. Other times, the company acts after being contacted by the FDA with a concern. Regardless of who discovers the issue, the FDA is still the agency that monitors the company’s recall strategy and evaluates its overall adequacy.

When a product is believed to pose a serious and immediate hazard, the FDA will act before its classification process is complete to publicize the recall as widely as possible. Its efforts for recalls may include advisory notices, updates to its website and press releases. The FDA also recommends consumers check its Enforcement Report for updated information on a “not yet classified” recall listing because more information will be added as it becomes available.

Unfortunately, dangerous products continue to be a threat to public health and safety, and with the volume of recalls the FDA sees on an annual basis, it’s no surprise the agency is working to notify the public faster. If you’ve been injured by a dangerous product, speak to an experienced defective product injury lawyer about your case.

 

Thanks to our friends and contributors from Richard J. Banta, P.C. for their insight into finding an attorney.


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