Any cooperation US consumer health product firms may anticipate from the Food and Drug Administration on improving access to OTC drugs and dietary supplements will have to come from a smaller agency.
As many as 700 employees reportedly were dismissed from their posts starting on 14 February as the culling of the federal workforce by the Trump administration’s Department of Government Efficiency reached the FDA. Many were still in their two-year probationary periods since joining the agency, a factor the DOGE, headed by key Trump ally Elon Musk, wielded in making the cuts.
In addition to the layoffs, a key figure in the FDA’s food safety programs has resigned. Jim Jones was appointed in 2023 as the agency’s first deputy commissioner to head all human foods programs in the massive agency-wide reorganization implemented in October.
Former commissioner Robert Califf, who stepped down in January, was critical of the White House’s FDA layoffs in a social media post.
“I am grieving for the many talented & dedicated FDA employees who have been mistreated & those left to do the work of protecting public health. Also for those who will be harmed by this among patients and the public. Those who are complicit in their silence will be judged harshly by history,” Califf said in a Blue Sky post on 16 February.
A former director of the FDA’s Center for Tobacco Products, Mitch Zeller, also anticipates harm to US public health from the cuts at the FDA.
“A well-structured and well-resourced FDA is essential to ensuring the dietary supplement marketplace is science-based and that requirements that protect consumer safety are effectively enforced.”
CRN
“This is absolutely going to harm the government’s ability to protect public health and advance consumer protection. That’s the inescapable direction that this is all headed, because what they’re doing is indiscriminate,” Zeller told HBW Insight.
Multiple sources told Citeline’s Medtech Insight newsletter that the layoffs apparently disproportionately impacted the Center for Devices and Radiological Health. The number is said to include about 200 device application reviewers, as well as some 40 statisticians and others in the CDRH’s research division.
Neither the FDA nor the Health and Human Services Department would provide the specific number of staff reductions at the FDA, although unofficial reports estimate the number at 600 to 700. It was unclear if the numbers also reflect staff who accepted the administration’s “deferred resignation” program, which closed before the cuts.
FDA Needs Resources To Conduct Regulation
The Council for Responsible Nutrition and the Consumer Healthcare Products Association were among the consumer health industry stakeholders to say they welcomed working with the FDA under Robert F. Kennedy Jr. as secretary of Health and Human Services.
Following news of the DOGE’s layoffs at the FDA, the CRN noted that staff cuts should be weighed against the agency’s responsibilities.
“While staffing changes can occur during any presidential transition, it is critical that the FDA maintains the resources, expertise and staffing levels necessary to ensure effective dietary supplement oversight that undergirds consumer confidence in the supplement market,” said Jeff Ventura, the CRN’s communications vice president.
“While we support efforts that lead to more government efficiency and have advocated for certain FDA reforms, the Consumer Healthcare Products Association is concerned by the recent reports of potential widespread job terminations at the US Food and Drug Administration,” the CHPA said in a statement.
“CHPA looks forward to engaging with the Administration to ensure that vital consumer health programs are not compromised.”
Ventura pointed out Kennedy has recognized supplements as a key component of integrative health care and emphasized the connection between better nutrition and better health.
“We’re excited to pursue this vision but realize it will require oversight and review of new ingredients, reasonable guardrails for the industry, and enforcement muscle to ensure a level playing field. We hope that reductions in FDA staff do not jeopardize that vision,” he said.
Venture also suggested Trump’s nominee for FDA commissioner, Martin Makary, has an opportunity to strengthen the role of supplements in preventative health care and recalibrate FDA’s regulatory approach to supplement manufacturing and marketing.
“A well-structured and well-resourced FDA is essential to ensuring the dietary supplement marketplace is science-based and that requirements that protect consumer safety are effectively enforced. CRN looks forward to working with the FDA and policymakers to advance a regulatory framework that supports both consumer safety and industry innovation.”
‘Not One Taxpayer Dollar’ Saved In CTP Cuts
Zeller, who resigned as CTP director in 2022 after nine years in the post as part of his career-long work in tobacco regulatory policy and to decrease tobacco-related death and disease, pointed out that the center, unlike all other FDA units, is funded entirely on user fees.
“It is 100% user-fee funded. Whatever the numbers turn out to be terms of the number of people that were fired, not one taxpayer dollar is going to be saved, because, at least for CTP, everything that that center does is funded by industry user fees,” he said.
Zeller also explained that the CTP must pay other FDA offices for staff support it receives.
“When I was center director, I assume that this has remained the case, we had to reimburse out of user fee dollars other parts of the agency for the work that they did on behalf of CTP. Like the work of the lawyers in the Office of Chief Counsel, the work of all the comms people in the press office, every year, we would basically have a memorandum of understanding with all those other parts of the agency,” he said.
Zeller suggested that while the potential impact of the FDA staff cuts likely isn’t understood by most consumers, drug and other manufacturers in industries regulated by the agency should be concerned.
“What’s it going to take for them to actually find that out? You know, the next crisis, whether it’s contaminated food, something goes wrong in the drug supply. I mean, what’s it going to take?” he said.
“But for now, I think it’s a fair question to ask where is the outrage?”
