FDA Reorganizes Agency To “Enhance Transparency And Trust”
Updated
The FDA has officially created the unified Human Foods Program as part of a larger restructuring effort that the agency says will help to “effectively deliver on our mission to protect and promote public health through science-based approaches to prevent foodborne illness, reduce diet-related chronic disease, and ensure the safety of chemicals in our food.”
According to the press release, this is the largest reorganization of the FDA in modern history, and it impacts “every facet of the FDA,” including 8,000 employees. The FDA announced they would craft a reorganization proposal in January 2023. The agency completed the proposal in December 2023 and has officially launched the new structure and reorganization of the FDA.
The press release states that the need to reorganize the agency was determined following an internal report after initiating a baby formula recall. The recall led to a shortage of infant formula in 2022. Dr. Califf initiated an investigation into areas where the agency could’ve been more efficient in protecting the public from harm while preventing shortages of important products.
The agency report provided 15 conclusions that ultimately led to the creation of the unified Human Foods Program. One of those findings is that infant formula is a critical product, and the agency should have weighed the risks of potential contamination versus the risks of product shortages. Another finding from the report is that “while the training process for FDA investigators is robust, investigators conducting inspections of infant formula manufacturing facilities receive limited infant formula-specific training.”
The HighWire reported about dangerous levels of toxic heavy metals in baby formula three years ago on the Jaxen Report. Zen Honeycutt from Moms Across America appeared on the show in July of this year to share the details from a new study about heavy metals in baby formula that shows several metals coming back significantly higher than the FDA considers safe. The FDA has yet to make any moves to regulate infant formula from these harms adequately. The agency is expected to publish a draft guidance for the industry in December to give details on action levels for lead in food intended for babies and infants. Honeycutt discussed several other metals in baby formula, including aluminum, cadmium, arsenic, and mercury.
Another concerning finding from the internal FDA report is that “Conditions observed at the Abbott Nutrition facility were not consistent with a strong food safety culture.” The agency has said it will provide a more accessible, streamlined way for consumers to issue complaints, which will be handled more efficiently by employees within the agency.
The press release states, “We are committed to building a stronger, more integrated and modernized agency. This is the goal across the agency and includes our laboratories, food safety and nutrition, medical products, tobacco products and cosmetics.The work has really only begun. 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.”
Jim Jones is the former EPA official who has been tasked to head the new program. Jones worked for the EPA for 19 years before moving to a role with the Household and Commercial Products Association, a group that lobbies the federal government regarding bills pertaining to chemical products. Jones has a Master’s degree in economics and worked for his own consulting firm for nearly five years before taking this new role at the FDA last year.
The FDA has been heavily criticized for conflicts of interest with pharmaceutical companies and large food manufacturers. Calley Means, who recently appeared on The HighWire, has called out the agency for accepting significant funding from pharma companies. Environmental Attorney Robert F. Kennedy Jr. stated that 50% of the FDA’s funding comes from pharma. The FDA issued a response to say that only 47% of funding comes from industry user fees.
There is a long history of FDA commissioners earning money from pharma stocks and working for pharmaceutical companies before and after working as the head of the federal regulatory agency. This includes Dr. Robert Califf, who has nearly a million dollars worth of stock in pharmaceutical companies. He has also worked as a consultant to the pharma industry.
Jones, with a background in pesticides and the EPA, also faces skepticism as his previous agency has been accused of covering up harmful environmental conditions to protect corporate entities like Norfolk Southern, which was responsible for the chemical disaster in East Palestine, OH last year.
The year that Jones left the Household and Commercial Products Association, the EPA announced that the lobbying group is a “Safer Choice Partner of the Year.” Clorox, Dupont, and BASF were also named partners of the year in 2020.
The HighWire has reported mixed messages from the FDA and CDC during the COVID-19 pandemic and the aftermath. An NPR report from 2021 showed that only 37% of Americans have a “great deal” of trust in the FDA. This reorganization is an attempt to build trust and transparency at a time when Americans are not happy with the work the agency is doing.