Image by Gerd Altmann from Pixabay
The much anticipated unified Human Foods Program went into effect on October 1, 2024. With it comes big changes.
A U.S. Food and Drug Administration (FDA) reorganization that has been three years in the making. While information about the proposed shuffle of positions and creation of new ones has been in the news for a while now, the roles and responsibilities are locked into place with in inaugural day.
A press release on the FDA’s new program comes from those at the top of the organization. These include FDA Commissioner Robert M. Califf, M.D., Deputy Commissioner for Human Foods Jim Jones, and Associate Commissioner for Inspections and Investigations Michael Rogers.
The FDA is the regulatory body over, to put it simply, food and drugs. But it is so much more. They also regulate cosmetics, medical devices, veterinary drugs, and other related products. The United States Department of Agriculture (USDA) handles certain foods. Namely meat, eggs, and milk. However, the two organizations have some overlap when it comes to foodborne illness investigations.
The FDA has stood as “the oldest comprehensive consumer protection agency in the country.”
What worked over a century ago does not work in our modern world. And so it grows and changes as needed.
In the not so recent past, the agency has evolved over time to not only protect consumers from domestically produced foods, but those imported into our country as well. The same is true for medications and supplements (or collectively “drugs”) in the United States. New technologies, such as vape and medicinal use of cannabis have required additional consideration for some groups of the organization.
One organization was stretched across so many categories.
“The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA also provides accurate, science-based health information to the public.”
This worked for a long time. But recent events indicated that what we had was not working. Something needed to change. And soon!
The recent mishandling of whistleblower complaints, the inadequate response, and a need for a better sampling program prompted this radical change.
A June 2024 report with an evaluation of the agency’s response during the infant formula recalls in 2021 and 2022 published by the Office of Inspector General from the Department of Health and Human Services accelerated the timeline of this need for change.
In the report, titled, The Food and Drug Administration’s Inspection and Recall Process Should Be Improved To Ensure the Safety of the Infant Formula Supply, pointed out the weaknesses of the current system. It was long. Specific. And called for change.
Among the many criticisms of the agency’s role in the tragic contamination and recall event, the report points out that, “FDA had inadequate policies and procedures or lacked policies and procedures to identify risks to infant formula and respond through its complaint, inspection, and recall process.”
For example, complaints about the Abbott formula facility dating back to 15 months prior to any FDA action were discovered. One such whistleblower complaint sat stagnant for four months before the information made it to senior leadership. In that time, something could have been done. Any action may have lessened the blow that hit the marketplace and the tragedies of so many families.
Commissioner Robert Califf, who maintains that role in the new Human Foods Program agreed for the need to make significant changes in a statement for the proposed program in January 2023. A clear sign that the need was understood, and the organization was moving in the right direction to assess those deficiencies.
This new unified Human Foods Program is the “single largest reorganization in the agency’s modern history.”
According to the press release, changes impact more than 8,000 employees with this massive reshuffle and the changes touch nearly every facet of the organization.
A stronger emphasis on inspections and sampling to catch potential issues before they make it to the marketplace was one of the primary goals of the new organization. The Office of Regulatory Affairs has been restructured to the new Office of Inspections and Investigations A greater collaboration between field investigators, subject matter experts, and state and local partners allows for fluid share of information.
Some of the major points include:
While the FDA has always had a place for consumers to report issues and products, a new consumer complaint form serves two purposes. Efficiently handling consumer complaints and helping the FDA detect and respond to emerging public health risks.
With any major overhaul, some growing pains are expected. According to the press release, while the work has just begun, it too has room for improvement.
“We are hopeful this modernization and reorganization will enhance transparency and trust in the agency as we work together both inside and outside the FDA to better meet our country’s shared public health goals.”
If you’d like to know more about food safety topics in the news, like “FDA’s New Human Foods Program Went into Effect October 1st,” check out the Make Food Safe Blog. We regularly update trending topics, foodborne infections in the news, recalls, and more! Stay tuned for quality information to help keep your family safe, while The Lange Law Firm, PLLC strives to Make Food Safe!
By: Heather Van Tassell (contributing writer, non-lawyer)
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