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CRN Leaders Chart Path for Dietary Supplement Industry as FDA and States Pursue Policy Goals

At Convergence ’25, Steve Mister and Bruce Brown urged industry collaboration and transparency amid shifting regulations and increased scrutiny.

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By: Mike Montemarano

Associate Editor, Nutraceuticals World

Photo: amazing studio | AdobeStock

The dietary supplement industry is facing plenty of challenges, including regulatory changes at the federal level, a patchwork of inconsistent state laws, and increased scrutiny and misinformation.

At CRN’s annual event, Convergence ’25, the trade association’s President and CEO Steve Mister and Board of Trustees Chair Bruce Brown discussed strategies for bolstering the industry’s potential to improve public health.

Gaining Footholds in the MAHA Era

Mister noted that, since the change in presidential administrations and development of the MAHA Commission, many in the industry were anticipating a “golden age” for dietary supplements, including clarification on a number of regulations, acknowledgement in public health strategies, and something more than “indifference and benign neglect” or “aggressive efforts to limit the industry” from the U.S. Food and Drug Administration.

He noted that, amid heightened skepticism, more proactive efforts need to be taken by the industry and trade groups to communicate transparency, accountability, and prioritizing consumer health, with some in the mainstream media characterizing the “supplements industry [as] behaving like big pharma and food, looking for special treatment.”

“When you think about our current requests of the administration and Congress, it’s still about protecting our consumers, not protecting ourselves. It includes getting supplements recognized as qualified medical expenses for FSAs and HSAs, so that more consumers can stretch their dollars and make their health ingredients more affordable. Or improving FDA’s inspection efficiency, creating a dietary supplement registry, directing investigation priorities toward facilities that impose the most risk, cracking down on unlawful products, all to ensure that consumers have these safe products … We’re much more aligned with the mission of making America healthy than we’re given credit for.”

Finding Common Ground

There is some perceived disconnect between industry desires and the MAHA movement, but common ground can be found in how FDA should address abuses of the self-GRAS pathway to market, ultra-processed foods, and removing certain artificial chemicals from the food supply, said Mister.

But, more importantly, “we need to focus on what people are missing, and what they can proactively do, not just what should be taken away,” he said.

Brown noted that the industry’s impact on public health often goes unsung. “No one thanks this industry for preventing illnesses that they never got … [including] every child whose eyes are impacted by simple vitamin A supplementation, or every mother whose folic acid supplementation helped manage a healthy pregnancy. These victories are silent, yet profound.”

“External forces, such as regulations, the media, and competition press on us … Right now, those pressures are intense. FDA is in the midst of a regulatory shakeup. States are experimenting with new restrictions. Media coverage often oversimplifies or misrepresents our science,” Brown said, and despite advances, an estimated 34 million Americans still live in food-insecure households. “The basics are still out of reach for many. That’s why I keep coming back to public health as our central purpose.”

It’s likely that the administration and the industry can find common ground in recognizing dietary supplements as a qualified medical expense, which is why CRN conducted a new economic analysis suggesting that previous estimates severely over-estimated the amount of tax revenue that would be lost.

“This change could be done administratively without even having to amend a statute,” said Mister. “The problem is that with previous administrations, we’ve never had the political support at the cabinet level to persuade the IRS to make that change on its own. Previously, the IRS even espoused that qualified medical expenses don’t include those that are merely beneficial for general health, like ‘vitamins or vacations.’”

Aside from direct government partnerships, industry shouldn’t lose sight of the impact that philanthropic efforts can play in making America healthy, Brown noted. This year, CRN began a philanthropic partnership with the National Association of Free and Charitable Clinics (NAFC), a provider of healthcare to underinsured and uninsured people.

“This challenge won’t end in one year’s turn … Access is not a side project, it’s our mission. We need to answer the question of whether we’re only here for those who can afford us.”

NAFC operates 1,400 clinics serving nearly 2 million patients, he noted. “They are described as the safety net beneath the safety net, helping those who are most in need. We sat with community health workers and the practitioners delivering primary care. They were inspired by the work we were doing, and the embrace they received from the community.”

By 2030, cutting nutrient deficiencies in half by providing every NAFC clinic in America with a steady supply of supplements is “within our reach,” and can “shift public health outcomes in a meaningful way,” Brown noted.

Challenges

It’s also important to make industry’s voice heard in areas where it isn’t aligned with the government, said Mister. 

“The administration’s original objective is to eliminate self-GRAS altogether … We formed a working group to address where the concerns with the self-GRAS process are. We’re proposing transparency and accountability in the process, including a public database of self-GRAS ingredients, more information about the scientific panels, and more thoroughness in the scientific review, to create a more transparent self-GRAS process rather than throwing the baby out with the bathwater,” Mister said.

“We’ve had to play defense at the state level, as well,” Mister noted. CRN’s efforts have helped to:

  • Exempt dietary supplements from legislation in Texas (Senate Bill 25) which would require warning labels on foods with certain additives;
  • Remove titanium dioxide from several state bills seeking to restrict certain ingredients;
  • Get clarification from California Governor Gavin Newsom that supplements wouldn’t be subject to testing and labeling requirements intended for baby food;
  • Secure amendments to a California bill requiring public disclosure of heavy metal test results for prenatal vitamins to allow for real-world context
  • Successfully oppose age restrictions for weight management and sports nutrition products

Self-Regulatory Efforts

CRN has also been campaigning to promote self-regulatory measures required of its membership, noted Mister, such as the Supplement Online Wellness Library (OWL), new voluntary guidelines such as child-proofing certain melatonin supplements, e-commerce guidelines, and more.

“If we’re going to accomplish our aspirations, we have to find common ground and meet in the middle with our opponents and detractors, policy makers and regulators, MAHA allies and fellow trade organizations, our members, and non-member companies,” Mister said.

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