FDA Reassessing Dietary Supplement Framework, Ingredient Scope, Manufacturing Changes

April 15, 2026

Out with the Old? FDA Pushes to Modernize Dietary Supplement Regulation

Benjamin James, Samuel Jockel, Angela Spivey, Nicole Yapp Alston & Bird + Follow Contact LinkedIn Facebook X Send Embed The Food and Drug Administration (FDA) has signaled a reassessment of its dietary supplement regulatory framework, recently framing a public meeting around key questions on ingredient scope, identity, manufacturing changes, and regulatory pathways. Our Food & Beverage Group examines what these developments may mean for industry stakeholders.

• The FDA is reevaluating how “dietary substances” are defined, including novel ingredients and those produced through emerging technologies
• The agency is assessing when manufacturing changes may trigger new regulatory scrutiny or new dietary ingredient submissions
• The FDA is also considering updates to the generally recognized as safe (GRAS) pathway and how it intersects with dietary supplement regulation On March 27, 2026, the U.S. Food and Drug Administration (FDA) held a public meeting on dietary supplement innovation and the scope of dietary ingredients, signaling that the agency is questioning whether its regulatory framework for dietary supplements is keeping pace with an evolving industry. The agency centered the discussion on key questions aimed at testing the boundaries of that framework.

FDA Focus on Dietary Substance Identity

A central issue is the scope of “dietary substance for use by man [humans] to supplement the diet by increasing the total dietary intake” as used in the Dietary Supplement Health and Education Act of 1994 (DSHEA). The FDA is considering whether that definition should extend to substances not historically part of the human diet, as well as those produced through emerging production technologies such as synthesis, cell culture, precision fermentation, or recombinant methods.

The agency is examining whether changes in manufacturing may alter an existing dietary ingredient’s identity, composition, or safety profile sufficiently to trigger additional regulatory scrutiny or data submission. This includes how these changes should be addressed by new dietary ingredient notifications—particularly for byproducts, impurities, and structural or functional variations—to ensure adequate FDA assessment.

Evaluating Scientific Criteria

Closely related is the FDA’s focus on what scientific criteria the agency should use in evaluating ingredient identity. For complex substance types, such as peptides, proteins, enzymes, and microbials, the agency is assessing what determines whether two types of these substances are sufficiently similar to be considered the same dietary ingredient for regulatory purposes.

Feedback on these questions, along with other insights gathered at the meeting, will inform the FDA’s efforts to reform the dietary supplement regulatory framework to support innovation in the industry while ensuring the safety of substances used in dietary supplements.

“Nimble and Adaptable” Dietary Supplement Framework

In his opening remarks, Deputy Commissioner for Human Foods Kyle Diamantis emphasized the need for the FDA to remain “nimble and adaptable” in the face of a rapidly evolving marketplace and underscored the agency’s commitment to modernizing its oversight of substances used in dietary supplements. At the same time, he framed this effort as a shared responsibility, calling for collaboration with industry stakeholders.

Consistent with the agency’s push to modernize dietary supplement regulation, stakeholders in attendance advocated for expanding the definition of “dietary supplement” under DSHEA, asked for clarity on FDA’s regulation of dietary supplements, and emphasized the need for improving the regulatory framework as the industry expands.

Future of the GRAS Pathway

As we have previously discussed, the FDA is expected to propose a rule that could eliminate the regulatory pathway that allows companies to independently determine that a substance is generally recognized as safe (GRAS). Diamantis indicated that the agency is seeking feedback from stakeholders to better understand how potential changes to the GRAS framework would impact dietary supplements and to identify potential improvements to facilitate the safe introduction of new ingredients into the marketplace.

The FDA is seeking input on how potential regulatory changes could affect dietary supplement companies that currently navigate the overlap between self-affirmed GRAS determinations and new dietary ingredient submissions.

Next Steps for Industry

Industry stakeholders should prepare for changes to the FDA’s regulatory framework for the manufacture and sale of dietary supplements. Comments on the topics covered during the meeting are due by April 27, 2026.

Our Food & Beverage Team, which provides both regulatory and litigation services to our clients, will continue to monitor the FDA’s oversight of dietary supplements and assess implications for industry.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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