Dozens of speakers addressed FDA officials in a listening session on Sept. 30, and almost all of them said it is time for the agency to come out of the dark ages regarding its recall operations.
The speakers ranged from consumers whose children had been struck by foodborne illnesses to industry associations to non-profit consumer watchdog groups. All said, it is time for the Food and Drug Administration to standardize processes and use modern technology to improve the effectiveness of recalls.
The vast majority of speakers discussed food recalls, but a handful spoke on behalf of medical device users, and one spoke about the cosmetic industry. All of these topic areas fall under the jurisdiction of the FDA.
Kicking off the day-long “listening session” was Steve Mandernach of the Association of Food and Drug Officials. He spoke about food recalls and how ineffective they are.
“Consumers continue to get sick after recalls,” Mandernach said. “There is a lack of urgency, and it needs to be urgent.”
He called for using existing technology to make recalls more effective and timely.
FDA officials at the session did not respond to comments but took all information under advisement, carrying out the “listening” portion of the session as promised.
Here is a sampling of what speakers had to say.
Anthony Flood of the International Food Information Council said the FDA should offer timely recall information to better help consumers and the industry.
Susan Braymen of the Alliance to Stop Foodborne Illness said her daughter became ill after making cookie dough, but she did not find out about the recall until a month later. She called on the FDA to modernize its systems and train the industry on food safety.
Mitzi Baum of STOP Foodborne Illness said 30 years after the formation of the non-profit organization the FDA still has the same problems. “The recall system is not working.” The agency needs to use modern technology to act with a sense of urgency and do so in consumer-friendly language. She said the use of words and phrases such as “voluntary” and “abundance of caution” confuse consumers into thinking that recalls are not important.
Thomas Gremillion of the Consumer Federation of America said the FDA should post distribution lists. He said not doing so under the guise of Confidential Corporate Information is a disservice to the public and industry. “(Posting distribution lists) is a simple and easy step.”
Richelle Shields, whose son Chase became ill at age three and a half from drinking contaminated juice, said the FDA should do recalls quicker. She said there hasn’t been progress in the past 20 years like there should have been.
Monica Dudley-Weldon of Syngap1, an organization dedicated to working on rare diseases, said better recall communication should be accessible, considering the prevalence of technology in consumers’ hands. She said a 2022 survey showed 89 percent of households have computers and 96 percent of adults have smartphones. “We need to use technology to ensure transparency.”
Julie McGill of the non-profit AIM North America said her nephew had to have kidney and pancreas transplants after contracting an E. coli infection. She said the increased use of existing technology is crucial in reducing illnesses and deaths. She also suggested using unique identifiers on products to streamline traceability and transparency.
Scott Shields, whose son became infected with E. coli after drinking contaminated juice, said he is frustrated that there has been slight improvement in the recall structure in the more than 20 years since his son’s illness. “How many illnesses and deaths will it take to make changes?”
David Trosin of NSF said recall steps should be consumer-centered and user-friendly. He called for better use of social media platforms as one-way technology could help achieve this. He said the development of apps would help serve the public interest during recalls. He also said recall information should be available in multiple languages.
Josh Oyster, an attorney with the firm of Ropes and Gray LLP, said FDA-regulated entities are generally not required to notify the agency when they recall products, which is a disservice to the public. He also said there is a disconnect between the companies and the FDA recall coordinators and a lack of uniformity across those coordinators. For example, he said one form says not to omit any information when submitting it. Another says to submit information as it becomes available. He suggests revising all forms and making them accessible to the public.
Jared Rothstein of the Consumer Brands Association said there is a need for clarity and centralized operations for the recall process. He said the lack of consistency and standardization makes it difficult to get recall information to consumers.
Donna Garren of the American Frozen Food Institute said the FDA should develop a concise recall handbook and a standardized process for classifying recalls. She said the FDA should think beyond the recall press releases that companies provide.
Roberta Wagner of the International Dairy Foods Association said FDA processes are antiquated. She also said recall processes should address online sales and traditional sales venues. She called for the ongoing reorganization of the agency to combine all recall activities under one entity. Finally, she called on the agency to work more with industry rather than less.
Farida Mohamedshah of the National Confectioners Association said transparency and standardization of materials are vital in improving the recall process. He called for email forms and downloadable information to correct the current cumbersome process.
Gretchen Wall of the International Fresh Produce Association said FDA recall guidance and materials should include templates for the industry to use. She also said the FDA should reveal the root causes behind recalls.
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