The FDA held what could become one of the most consequential public meetings for the dietary supplement industry since passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994, signaling a renewed focus on how innovative ingredients are regulated.

As technologies such as precision fermentation, synthesis, cell culture, and recombinant production advance, regulators are increasingly grappling with whether the existing framework can keep pace.

That theme shaped a March 27 meeting titled “Exploring the Scope of Dietary Supplement Ingredients,” where agency officials invited input on ingredient definitions, new production methodologies, and emerging categories including peptides, proteins, enzymes, and microbials. FDA will accept comments on these topics and related questions through April 27.

Read More: Clause E Under the Microscope: FDA Reexamines the Boundaries of Dietary Ingredients

Market Growth Raises Regulatory Questions

Offering context for the meeting, FDA Deputy Commissioner for Human Foods Kyle Diamantas noted strong consumer demand and industry expansion.

More than three-quarters of American adults use dietary supplements, “reflecting a fundamental shift in how Americans approach their own health and wellness,” he said.  

The dietary supplement market itself has expanded from an estimated $2-4 billion in 1994 to over $60 billion today. The variety of products and ingredients available on the market has also increased substantially.

Diamantas said he believes healthy market growth is a testament to the product benefits in the dietary supplement category as a whole.

Innovation in ingredient development and manufacturing has accelerated significantly since DSHEA, creating new safety and classification questions for regulators.

“Against this evolving backdrop, the FDA has diligently worked to maintain an appropriate level of oversight within the balance of the authorities granted to us by Congress,” said Diamantas.

Pressure to Modernize

DSHEA was designed to balance consumer access with FDA’s authority to protect public health. But implementing that balance has become more complicated as the market has expanded and technologies have evolved.

“While the fundamental goals underlying the statute have not changed, the reality of implementing those goals has grown to a magnitude far beyond what it once was,” said Diamantas.  

It’s crucial that FDA be “nimble and adaptable” to keep pace with a rapidly growing market and scientific advancements, he added.

However, as the market has evolved, the regulatory framework has largely stayed the same, even though FDA has talked about its aspiration to modernize the system for years.

Diamantas reiterated his desire to address shortcomings “that have allowed unscrupulous actors to thrive, to the detriment of the overwhelming majority of players in this space who follow the law and regulations.”

While the Trump administration has prioritized deregulatory efforts, Diamantas said modernizing FDA oversight is not about stifling industry innovation or limiting consumer access. Instead, the intention is to confirm the rules serve their intended purpose: “to ensure a safe and thriving dietary supplement marketplace for all.”

Improving the regulatory framework is a “shared responsibility” between regulators and industry, he added.

“By working together, we can ensure that this industry continues to flourish while providing consumers with safe, high-quality products they can trust.”

NDI vs. GRAS in Focus

A central issue discussed during the meeting was the pathway for bringing new ingredients to market. Companies typically rely on either the New Dietary Ingredient Notification (NDIN) process, which involves submitting safety data to FDA, or the Generally Recognized As Safe (GRAS) pathway, which may or may not include agency notification.

The use of GRAS for supplement ingredients has drawn increased scrutiny from policymakers, including HHS Secretary Robert F. Kennedy Jr., who has questioned the transparency of the process.

At the same time, FDA hasn’t issued complete final guidance on NDIs, and pitfalls like drug preclusion and a race-to-market with drug companies have complicated ingredient launches.

Diamantas said FDA is seeking feedback on how companies navigate the intersection between GRAS determinations and NDIN submissions, and what challenges they face in choosing a regulatory pathway.

Balancing Oversight and Innovation

When discussing potential GRAS reforms, Diamantas said the agency’s goal is to ensure safe ingredients remain available for use in both conventional foods and dietary supplements.

“By ensuring appropriate oversight while at the same time removing unnecessary burdens and barriers to innovation, we can better support an industry that empowers consumers to take charge of their health,” he said.

FDA is seeking “concrete opportunities” to improve its processes and better support both public health and innovation.

What Comes Next?

Insights from the March 27 meeting, along with stakeholder comments, will inform FDA’s ongoing efforts to refine its approach to dietary supplement ingredients. The agency indicated that continued dialogue with industry will help shape how it evaluates novel ingredients going forward.

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