FDA finally has a commissioner at the helm again. But can the dietary supplements industry expect that new FDA Commissioner Robert Califf will prioritize reforming and strengthening dietary supplement regulations—a lofty goal FDA’s leadership first set in 2019?
FDA finally has a commissioner at the helm again. But can the dietary supplements industry expect that new FDA Commissioner Robert Califf, MD, will prioritize reforming and strengthening dietary supplement regulations—a lofty goal FDA’s leadership first set in 2019?
Back in February 2019 when then-FDA Commissioner Scott Gottlieb, MD, was in charge, he made headlines by announcing a new agency initiative of “implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.”
Considering that Commissioner Califf, back at FDA as commissioner after more than five years, now has a pandemic on his hands, will supplement reform be a priority for him out the gate? Probably not.
“While we cannot predict exactly what the Commissioner’s priorities will be, there are much more significant issues that will require the new Commissioner’s more immediate attention,” says Michael McGuffin, president of the American Herbal Products Association (AHPA; Silver Spring, MD). “In the last two years, FDA shifted its focus to saving American lives from COVID-19, and that work is not done. COVID-19 will continue to be FDA’s highest priority. Dr. Califf’s background is mainly on the drug side, so we can assume he will focus on FDA’s Center for Drug Evaluation and Research (CDER) and bringing safe new drugs to market.”
One could argue that no concrete steps, in fact, have been taken toward significant supplement reform since Gottlieb first announced the goal in 2019. Discussions around topics like a mandatory product listing for dietary supplements have taken place among regulators and the industry, but after Gottlieb resigned from the agency in April 2019 shortly after announcing his intentions, not much has happened beyond talk.
“I don’t think there has been very much momentum,” says Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN; Washington, DC). After Gottlieb resigned from the agency, he says, “any of the momentum that was starting to build there I think we lost when he left.” Even before the pandemic happened, “I don’t believe FDA had made a lot of Dr. Gottlieb’s vision a priority after he left. I think a lot of what he wanted to do has just languished,” Mister says.
But there’s a lot the agency can do now even if the commissioner himself can’t personally focus on supplement matters immediately, says Mister. “There are those things that FDA can do by itself, and we are continuing to push that,” he says.
For instance, although each industry association’s specific regulatory wish list might look different, they all focus on core action items like having FDA move forward on improving supplement oversight, finalizing new dietary ingredient (NDI) guidance, and resolving the agency’s stance on N-acetyl-L-cysteine (NAC).
Mister says there is leadership within FDA “who are committed to making some real progress” in areas like reforming supplement regulations. For instance, he names Frank Yiannas, FDA’s deputy commissioner for food policy and response; Douglas Stern, deputy director for regulatory affairs at the Center for Food Safety and Applied Nutrition; and Greg Noonan, PhD, Cara Welch, PhD, and Gerie Voss at the Office of Dietary Supplement Programs.
Not having had a permanent commissioner in place may be why supplements progress has stagnated. “When there is no confirmed commissioner in that seat, there’s no place where the buck stops,” Mister says, “and so people are reluctant to do those kinds of broad initiatives because there’s nobody at the top who will have their back and push these things through.” Perhaps the agency will be more “empowered” to move forward on significant change now, he adds.
Quick progress is sorely needed on many fronts. For instance, on the issue of hemp cannabidiol (CBD), many industry leaders now believe that FDA will not act on its own to develop a legal pathway for the ingredient and that the issue depends on Congress. In other words, don’t look to Commissioner Califf to necessarily take the lead. “We have heard nothing from Dr. Califf that suggests he will promptly resolve the matter, even though we will continue to encourage the agency under his leadership to do so,” says McGuffin. “In the meantime, however, we will continue to maintain focus and support for legislative solutions.” Actions like getting FDA’s Office of Dietary Supplement Programs more funding to oversee the supplements industry, or creating a regulation for a mandatory product listing, also lie with lawmakers, not the agency itself.
There’s also an urgent need for finalized NDI guidance. The last the public heard on the matter was back in 2016 when FDA released its revised draft guidance. Here, the industry might have good news from FDA soon, according to McGuffin. “With regard to the possibility of finalizing NDI guidance, FDA recently published its list of Foods Program Guidance Under Development, indicating what guidances FDA expects to publish as draft or final policies by the end of 2022. On that list are two guidance documents with regard to NDIs, which clearly shows that FDA does plan to make progress on NDI guidance,” he says.
It’s not all about new reforms either, says Daniel Fabricant, PhD, executive director and CEO at the Natural Products Association (NPA; Washington, DC). NPA would like FDA and Commissioner Califf to renew focus on using the enforcement capabilities the agency has now under the Dietary Supplement Health and Education Act (DSHEA). “At the end of the day, FDA needs to demonstrate they’ve exhausted their powers in DSHEA and that there is a need, not a want, for regulatory reform,” Fabricant says. “It’s difficult for industry to comprehend why FDA would lobby for additional authorities when they’ve demonstrated to industry and Congress that they underutilize their current authorities.” Bad actors and illegal supplements are still on the market, he points out.
Fabricant continues: “The industry should expect Dr. Califf to follow through on his commitment to fully enforcing DSHEA. During his first go-around with the confirmation process, he committed to then-Senator Orrin Hatch that, under his leadership, the FDA would use the powers outlined in DSHEA to take significant steps to protect public health. Rather than regulatory reform like the mandatory product listing proposal, Dr. Califf should follow through with his previous commitments: working with the Department of Justice on civil and criminal actions such as injunctions and seizures.”
McGuffin says that while AHPA is interested in regulatory reform, the association is also encouraging taking a renewed look at the drug-exclusion provisions and regulations that impact the supplements industry. He says: “Modernization is also of interest to AHPA, but we would neither start nor stop with mandatory product listing. We would go back to that balance promised by DSHEA to ensure informed consumer access and appropriate FDA authority. In order to do so, we are advocating consideration of removing obstacles to the dissemination of truthful and not misleading information to consumers, and reconsideration of prior drug-exclusion provisions to establish a more equitable relationship between the drug and supplement industries.”
Making progress on bettering supplement oversight is a necessity, not a luxury, these industry heads agree. But what’s the best way for associations to push their agendas forward now that Commissioner Califf is here? Should they steamroll forward with requests, or should they wait as FDA first deals with other problems?
A little bit of both, perhaps. For instance, Mister says, even though the supplements industry might not be top of mind for the commissioner himself right now, CRN is still actively meeting with members of Congress and their staff to discuss its ongoing concerns. Now with Commissioner Califf in place, Mister says, “I think we are optimistic. We don’t want to be unreasonably optimistic about this, but we are optimistic now that there is a new commissioner there will be a renewed emphasis on some of the things that FDA promised.”
He adds: “I’m really hopeful that these people who are voices for progress within the agency, now that there is a commissioner, that they can start to move forward on some of these issues.”
McGuffin’s hope sounds similar. “My perception is that Dr. Gottlieb simply announced FDA’s initial interest in modernizing dietary supplement regulations, but that interest has not waned since his departure—including when Dr. [Stephen] Hahn was FDA Commissioner and when the position was vacant. FDA and industry are actively considering what improvements there could be to regulation of the dietary supplement category, which is what is driving FDA’s focus on mandatory product listing.”
It’s still a wait-and-see situation as industry watches whether Commissioner Califf injects change into the dietary supplement sector.