CHPA’s Regulatory Scientific and Quality Conference featured the rare gathering of three new FDA center heads: George Tidmarsh, MD, PhD, director of the Center for Drug Evaluation and Research (CDER); Kyle Diamantas, J.D., deputy commissioner for the Human Foods Program (HFP); and Michelle Tarver, MD, PhD, director of the Center for Devices and Radiological Health (CDRH).
The session, moderated by CHPA President & CEO Scott Melville, touched on everything from transparency to safety to GRAS to DSHEA to yes, MAHA.
MAHA moments
Melville characterized the administration as having put the ‘F’ back in FDA, with more attention to food and nutrition than in previous years, driven largely by Secretary Robert F. Kennedy, Jr. and the Make America Healthy Again (MAHA) movement.
Diamantas, who has seven months under his belt as deputy commissioner for the HFP, described MAHA as a multifaceted, grassroots-to-state movement pushing greater FDA attention and food transparency, noting the 130 state bills aimed at food additives and food substances, efforts like front‑of‑pack labeling and RFIs on processed foods and the challenge of limited agency resources.
“There’s a famous quote that states have sort of been a laboratory for democracy and it’s true for MAHA,” Diamantas said. “States have really been that laboratory for federal rulemaking when it comes to at least the food sector of MAHA.
“The timing of the MAHA movement that’s been ushered in by Secretary Kennedy, there’s really never been more emphasis on foods and dietary supplements than there is right now. For better or worse, the food work at FDA and the portfolios have always sort of been a ‘stepchild’ to our user fee centers, devices and drugs and so food is sort of rebalancing itself with the agency.”
He added that the meaning of MAHA to him represents consumer education, with more educated consumers and parents dialed in on what they and their children are consuming.
“It’s an area where we’ve really focused on bringing greater transparency to the Secretary’s directive,” Diamantas said.
“We’re thinking about things like GRAS reform, front-of-pack labeling, putting out an RFI [Request for Information] to address social processed foods and see if maybe we can come up with a definition for that. It’ll probably be really difficult, but we’re going to try to do that.”
MAHA is really taking steps to address what a lot of people have perceived as long gaps in the regulatory framework, Diamantas said.
“We are a Human Foods Program, we don’t have user fees. we’re fully funded through appropriations from Congress, and we don’t have the type of money or resources historically that we should in order to really do the work,” he said. “So what we’re focused on are implementing incremental changes to address some of these systematic problems we’ve identified.”
Noting FDA commissioner Dr. Marty Makary’s criticism of the healthcare system for failing to address root causes of chronic illness, Diamantas said taking the appropriate steps to try to address and reverse chronic disease trends is the most important aspect of the MAHA movement in his eyes.
Drugs, supplements and DSHEA
Pointing to the drug preclusion provision in DSHEA, Mellville asked Diamantas to provide additional clarification and potential reform.
“We have a couple of citizen petitions outstanding, so I’ve got to be careful with what I say,” Diamantas said. “Of course, I can’t say too much, but I do think that when we respond to those, which will be very soon, it will hopefully provide greater insight and clarity into how we view that provision.”
Since joining the agency, the drug preclusion is something Diamantas said he and Dr. Tidmarsh has spent a lot of time talking about.
“I fully support the dietary supplement industry, as does Secretary Kennedy,” he added. “It goes back to that idea of finding ways to provide common sense reform where we’re not infringing on the drug industry. I think that there certainly is a way where you can provide that clear transparency without interrupting the work that goes on, because we do want to be respectful to that, but certainly we recognize the need for greater clarity.”
Authority and reform: ‘No longer a basic industry’
Emphasizing how the dietary supplement industry has grown tremendously over the past 30 years, Melville asked whether FDA has the regulatory authority to oversee today’s industry and what areas the FDA will be focused on.
“Certainly the industry has ballooned beyond what Senator Hatch probably anticipated when he started with the relevant statutory framework in 1994,” Diamantas said, adding that there’s no doubt dietary supplements play a role in millions of Americans’ health regimes and that FDA is actively looking for ways to reform the framework.
Diamantas said a few of the key issues FDA is working on is GRAS, pending citizens’ petitions, a product listing and how FDA might be able to resolve some of these issues while sidestepping Congress.
“But certainly some of those things would require Congress to act to give us authorities to take some of those steps we want to do,” he noted.
“The agency in years past has talked about the inability to regulate things like CBD and has asked Congress to step up in that regard. So we’re taking a look at a lot of these things to analyze whether in fact we might have that authority currently in our regulations or the ability to enact regulations.
“We understand that this is no longer a basic industry. It’s one that has outgrown the statute and statutory framework in a lot of ways, and we certainly support reform and welcome engagement from industries that are partners to the ideas that we can take.”
