Editor’s note: This is part one of a two-part series about a recent FDA meeting between dietary supplement trade associations and FDA officials.
On Jan. 3, five dietary supplement trade groups met virtually with FDA officials, including Dr. Robert Califf, a medical doctor who almost a year ago began a second term as leader of the public health agency.
The nearly hour-long meeting represented a rare opportunity for industry executives to have the ear of top FDA officials.
The last meeting between industry trade associations and FDA brass—specifically then-FDA Principal Deputy Commissioner Joshua Sharfstein, M.D.—took place during the Obama administration and was focused on “tainted” products marketed as dietary supplements, some industry leaders recalled.
“We’ve all searched our memories and are quite certain there have not been any commissioner-level meetings with the [dietary supplement] industry in the last 30 years, if ever,” United Natural Products Alliance (UNPA) President Loren Israelsen and his group’s senior political advisors, Peter Reinecke and Patricia Knight, said in a joint statement.
Combined, Israelsen, Reinecke and Knight have well over a century (120 years) of legislative and industry experience, Israelsen said. All three of them were involved with the drafting and negotiations of the Dietary Supplement Health and Education Act of 1994 (DSHEA), either as an industry stakeholder (Israelsen) or as senior staff members to former Sens. Tom Harkin (Reinecke) and the late Orrin Hatch (Knight).
Israelsen, Reinecke and Knight said they were pleased to have the “opportunity to start a dialogue at the highest levels of FDA” and they “hope it can be the beginning of a productive and constructive dialogue.”
The principal purpose of the Jan. 3 meeting was to discuss a report facilitated by the Reagan-Udall Foundation, which was focused on recommendations and findings concerning the human foods program, leaders from several trade associations said.
The program has come under fire, including in the wake of a national infant formula crisis and scathing media coverage, including a POLITICO investigative report based on more than 50 interviews and published in April 2022, “The FDA’s Food Failure.”
The recently published Reagan-Udall Foundation report—a 38-page review of the human foods program and recommendations for changes to the program—specifically excluded dietary supplements.
That fact was not lost on dietary supplement trade groups who met with Califf to discuss the document.
However, the Jan. 3 meeting provided insights into the thinking of FDA concerning the human foods program and Reagan-Udall Foundation report.
It also afforded trade associations the chance to share with FDA leaders—including Califf and FDA Principal Deputy Commissioner Janet Woodcock, M.D.—specific issues of importance to the dietary supplement trade. People who attended the meeting said Califf offered the five trade groups a chance to discuss dietary supplement issues.
The trade organizations also had questions for FDA leaders, including perhaps most notably the agency’s justification for excluding dietary supplements in the human foods program report.
FDA’s answer to that question, several people who attended the meeting said, didn’t offer clarity or make a lot of sense. However, one industry leader offered an explanation for why supplements may have been omitted: Criticism of the human foods program, this person said, has focused on conventional food and infant formula, not dietary supplements.
FDA didn’t answer for this story why the Reagan-Udall Foundation report excluded dietary supplements. Instead, the agency issued a written statement in response to several questions.
“FDA Commissioner Califf has been meeting with a variety of stakeholders as he considers what steps to take in response to the Reagan-Udall Foundation independent panel of experts’ report on the agency’s human foods program,” an FDA spokesperson wrote. “While dietary supplements were not assessed as part of the report, potential changes to the overall human foods program could impact the Office of Dietary Supplements Program [ODSP], which sits in the Center for Food Safety and Applied Nutrition. As such, Dr. Califf felt it was important to engage dietary supplement associations.”
Califf and Woodcock did not say how potential changes to the human foods program could impact ODSP or supplements more generally, according to trade association executives who attended the meeting and spoke on background to describe their recollections of what FDA officials shared.
FDA officials “only talked in broad strokes that they were taking the report seriously [and] that there were changes coming to the agency, both structural in terms of how CFSAN operates and also dealing with the culture,” the head of a trade association said. The report poses a challenge for the supplement industry, another trade group executive who attended the FDA meeting said, since “the scope explicitly excludes us, but there’s a recognition that we … are still impacted.”
Woodcock also mentioned FDA’s plans to make an announcement on CBD, according to several trade association executives who attended the meeting. She was not specific about what the forthcoming CBD announcement would entail, these people said, though an FDA spokesperson recently shared a statement attributable to Woodcock that FDA planned to respond “soon” to three CBD-related citizen petitions.
During the meeting, Califf also emphasized “FDA’s internal processes” were inadequate, according to a trade association executive. The commissioner also discussed “matrix process … or organizational management,” this person said.
Some people who attended the meeting recalled Califf sharing that he fights back when FDA is treated unfairly.
But Califf “said, ‘With some of this report where it was critical, I couldn’t disagree,’” a trade association executive recalled. “He’s essentially acknowledging that some of the things that are pointed out in the report, [and] publicly available, the agency agrees with them. They think they should make some changes.”
Another trade association executive had a similar recollection of what Califf said.
“Ensuring that the agency has a strong human foods program that will protect the safety and nutritional quality of America’s food supply is a top priority,” an FDA spokesperson said in the written statement. “The agency remains committed to providing a public update on our new vision for the FDA human foods program at the end of January 2023. We’re focused on determining an approach for the human foods program that will facilitate effective navigation of challenges to our food supply from climate change, international strife and supply chain disruptions while delivering on our mission to protect the public health.”
In a Dec. 6, 2022, written statement at the time the Reagan-Udall Foundation report was released, Califf cited challenges facing the human foods program.
“America’s food supply is as safe as it’s ever been, and our foods program experts have significantly contributed to the availability of more safe and nutritious food options for consumers,” the commissioner stated, in part. “That said, over the past several years, the program has been stressed by the increasing diversity and complexity of the nation’s food systems and supply chain, the ongoing impacts associated with climate change and rapid advances in the science underlying many of the foods we eat today. Each of these factors points to the need to evolve our existing foods program leadership and structure and identify new ways to fund these mission-critical activities.”
Reactions from dietary supplement trade groups
Duffy MacKay is senior vice president of dietary supplements with the Consumer Healthcare Products Association (CHPA), one of the executives who attended the meeting with FDA officials.
Industry stakeholders agreed during the meeting that “dietary supplements should absolutely not be excluded, and if they’re going to be doing any major reforms of how they regulate food, they need to be thinking through exactly how they include, incorporate and integrate supplements into it,” MacKay said. “No matter which way you slice it...they have to regulate supplements as a category of food.”
Stakeholders want to ensure that if FDA is making changes to the human foods program, the agency is “integrating [supplements] and it’s not an afterthought,” he added.
American Herbal Products Association (AHPA) President Michael McGuffin also requested at the meeting that any restructuring to the human foods program not omit dietary supplements simply because the Reagan-Udall report did not address the category.
“I said, ‘We all want to support and engage with you as you figure out how to address dietary supplements in a reorganized human foods program at the Food and Drug Administration,’” McGuffin recalled.
Council for Responsible Nutrition (CRN) President and CEO Steve Mister said he appreciated the meeting with Califf. Mister said Califf invited industry stakeholders to follow up with further comment after the meeting if anything came to mind, and Mister said he would be discussing with CRN’s relevant committees whether to submit something to FDA in response to the Reagan-Udall Foundation report.
Another trade association executive viewed the FDA meeting in a different light.
“The purpose or understanding [of the meeting] was basically to grease the skids on, ‘Hey, we’re just going to fold ODSP into this reorg and you guys should be OK with that,’” said Natural Products Association (NPA) President and CEO Dan Fabricant, who oversaw FDA’s Division of Dietary Supplement Programs during part of the Obama administration. “That was the purpose of the call. Make no mistake.”
Fabricant added in a follow-up interview, “It’s disappointing that supplements were an after-thought to the report and reorg. Supplements should be subject to their own review. We deserve that. The 70% of Americans that use [supplements] daily deserve that.”