Industry Groups Urge FDA to Broaden Definition of Dietary Supplement Ingredients

A coalition of dietary supplement industry associations is calling on the FDA to revisit and broaden its interpretation of what qualifies as a “dietary substance.” The groups argue that the agency’s current approach may be restricting innovation while unintentionally reducing regulatory oversight.

The comments were submitted in response to the FDA’s March 27, 2026, public meeting,¹ “Exploring the Scope of Dietary Supplement Ingredients,” which sought stakeholder input on how the agency defines and regulates dietary ingredients under the Dietary Supplement Health and Education Act (DSHEA).

This issue has become increasingly urgent as novel ingredient categories, ranging from peptides to precision-fermented compounds, challenge traditional regulatory frameworks.

Why Are Industry Groups Pushing Back on FDA’s Interpretation?

At the center of the debate is FDA’s longstanding position that “dietary substances” must have a history of use in conventional foods. According to the Council for Responsible Nutrition (CRN), this interpretation is not supported by DSHEA’s statutory language or legislative intent.

In its formal comments,² CRN argued that this interpretation is not supported by DSHEA’s statutory language or legislative intent. CRN argued that Congress designed DSHEA to accommodate future innovation, not limit ingredients to those already present in the food supply.

The Natural Products Association (NPA) echoed this, analyzing the 17-word phrase in section 201(ff)(1)(E) regarding dietary substances.³ The association noted that the statute does not mention “food” in this clause, and that many established ingredients, such as Co-enzyme Q10 (CoQ10), glucosamine, and primrose oil, were not generally consumed as conventional food when they were first marketed.

In the eyes of the American Herbal Products Association (AHPA), FDA’s approach is particularly restrictive for botanicals and naturally derived compounds that have longstanding use in traditional systems but lack a clear history in conventional food.⁴

How Could the Current Framework Impact Safety Oversight?

While FDA’s approach is intended to ensure safety, CRN argues it may have the opposite effect in practice. By limiting which ingredients qualify as dietary ingredients, some substances may be blocked from entering the New Dietary Ingredient (NDI) notification pathway, which is designed to provide FDA with premarket safety data.

Essentially, CRN says that FDA’s current, narrow interpretation of “dietary substance” is inconsistent with the law and is limiting innovation, safety oversight, and consumer access. Without access to the NDI process, companies may be forced to pursue alternative regulatory routes, such as the GRAS (Generally Recognized as Safe) self-affirmation pathway.

Unlike the NDIN process, GRAS self-affirmation does not require notification to the FDA, essentially creating a "loophole" that reduces the agency's visibility into the market. The NPA noted that broadening the definition would result in more NDINs, providing the FDA with greater oversight and supporting the administration’s goal of "Making America Healthy Again" (MAHA) by ensuring a transparent, safe food and supplement supply.

In some cases, products may enter the market without undergoing appropriate FDA review. This creates what CRN describes as a regulatory gap, where oversight is diminished rather than strengthened.

What Changes Are Industry Groups Recommending?

In response, CRN and other associations are urging FDA to adopt a more flexible, science-based interpretation of “dietary substance” that aligns with DSHEA’s original intent.

Key recommendations include:

• Expanding the definition of dietary substances to include ingredients beyond those traditionally used in food
• Ensuring that qualifying ingredients can access the NDI notification process
• Evaluating ingredients based on identity and safety, rather than production method or food-use history
• Updating NDI guidance to reflect modern scientific tools, including non-animal safety assessment methods
• Strengthening enforcement mechanisms, including consideration of Mandatory Product Listing (MPL)

AHPA similarly emphasized the need for regulatory clarity that supports both consumer safety and responsible market innovation, particularly for botanical ingredients.

The industry also expressed frustration over the "drug preclusion" clause, which prevents ingredients from being marketed as supplements if they were first authorized for investigation as new drugs. NPA cited recent disagreements over N-acetyl-L-cysteine (NAC) and nicotinamide mononucleotide (NMN) as evidence of the uncertainty this causes.

During the March public meeting,¹ Daniel Fabricant, PhD, NPA’s president and CEO, asserted that the current system "tilts heavily in favor of pharmaceutical development." As a result, the NPA is requesting that the FDA update the list of precluded ingredients regularly to provide clarity for R&D investments; amend IND regulations to allow for limited disclosures regarding the existence of investigational new drug applications, preventing companies from investing in ingredients that may already be precluded; and recommend a technical amendment to Congress specifying that "dietary substances" do not have to originate from conventional food.

Which Emerging Ingredient Categories Are at Stake?

The outcome of this regulatory debate could have significant implications for several fast-growing ingredient categories. CRN specifically pointed to proteins, peptides, enzymes, and microbials as examples of ingredients that may not always have a documented history in conventional foods but are increasingly relevant to modern supplement formulations.

In addition, advancements in precision fermentation and biotechnology are enabling the production of compounds that are chemically identical to naturally occurring substances but lack a traditional food-use precedent. Industry groups argue that these innovations should not be excluded solely based on how they are produced.

How Could Evolving Definitions Impact Product Labeling?

Beyond ingredient qualification, stakeholders note that FDA’s interpretation of “dietary substance” could have downstream implications for product labeling, claims, and market positioning. If certain ingredients are excluded from qualifying as dietary ingredients, manufacturers may face uncertainty around how, or whether, those substances can be listed on Supplement Facts panels.

There has been emphasis on a narrow definition creating inconsistencies in labeling practices, particularly for novel ingredients that fall outside traditional food-use history but are otherwise safe and well-characterized. In such cases, companies may be forced to either exclude functional ingredients from labeling, reclassify products under different regulatory categories, or avoid commercialization altogether.

This uncertainty also raises questions about structure/function claims, as only legally recognized dietary ingredients can support claims within the dietary supplement framework. Without clear qualification, brands risk enforcement if claims are made on ingredients that FDA does not consider permissible dietary substances.

AHPA, in its comments, underscored the importance of regulatory clarity to ensure that labeling remains truthful, not misleading, and consistent across the marketplace, particularly as innovation accelerates in areas like botanicals, peptides, and fermentation-derived compounds.

“FDA should take steps to ensure that product labeling accurately differentiates ingredients produced using traditional techniques and sourced from agriculturally grown botanicals vs. similar ingredients produced using modern techniques to create compounds found in botanicals, AHPA wrote in its statement. “Ingredient labeling and associated implicit and explicit product and ingredient descriptive claims should retain such distinctions in manufacturing and sourcing as may best produce an informed marketplace.”

What’s Next for FDA and the Supplement Industry?

FDA has not yet indicated how it will incorporate stakeholder feedback from the public meeting into future guidance or policy. However, the volume and alignment of industry comments suggest that pressure is mounting for the agency to modernize its approach.

For finished product manufacturers, the outcome could shape the pipeline of new ingredients, the viability of emerging technologies, and the regulatory pathways available for bringing innovative products to market.

Ultimately, industry groups maintain that the FDA should act as a partner in innovation, ensuring that the "North Star" of consumer safety³ is met without creating unreasonable regulatory barriers.

References

1. Public meeting exploring the scope of dietary supplement ingredients. US Food & Drug Administration. March 27, 2026. Accessed May 4, 2026. https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meeting-exploring-scope-dietary-supplement-ingredients-03272026

2. CRN Comments – FDA Public Meeting. Council for Responsible Nutrition. April 27, 2026. Accessed May 5, 2026. https://crnusa.org/sites/default/files/pdfs/CRN_Comments_FDA_PublicMeeting_Scope_of_Dietary_Supplement_Ingredients_27April2026(final).pdf

3. Comments of the Natural Products Association. Natural Products Association. April 27, 2026. Accessed May 5, 2026. PDF delivered via email.

4. Comments of the American Herbal Products Association on exploring the scope of dietary supplement ingredients. American Herbal Products Association. April 27, 2026. Accessed May 5, 2026. https://www.ahpa.org/Files/Comments%20to%20FDA/26_0427_AHPA_Comments-to-FDA-re-Exploring-Scope-DI.pdf