FDA Public Meeting on What Counts as a Dietary Ingredient (2026)

Table of Contents

1. What the FDA Did
2. The Fourteen Words: What “Dietary Substance” Means in the Law
3. The FDA’s Current Reading, as Described at the Meeting
4. The Four Questions the FDA Asked
5. Session 1: The Debate Over Scope
6. Session 2: New Ways to Make Existing Ingredients
7. Session 3: Identity of Proteins, Enzymes and Microbes
8. The Open Public Comment Period
9. What the Meeting Does Not Do
10. Dates and Status as of 11 October 2026
11. How the Meeting Fits Earlier FDA Actions
12. Primary Documents
13. Key Research Papers
14. Connections

1. What the FDA Did

On 3 March 2026 the FDA’s Human Foods Program issued a constituent update announcing a public meeting for 27 March 2026, saying it “will help inform the FDA’s next steps regarding the meaning of the dietary ingredient categories defined in the Dietary Supplement Health and Education Act (DSHEA) of 1994.” A second update on 16 March 2026 announced that the agenda and a memo to the docket had been posted.

The meeting was organized by the FDA’s Office of Dietary Supplement Programs (ODSP) and ran from 9:00 a.m. to 3:00 p.m. Eastern Time in the Wiley Auditorium of the Human Foods Program, 5001 Campus Drive, College Park, Maryland, with virtual attendance by live stream. The agenda lists opening remarks by the FDA’s Deputy Commissioner for Human Foods, three expert panel sessions with question-and-answer periods, and a closing period of open public comment.

• Document type: a public meeting with a public comment docket. No Federal Register notice for the meeting was found in a check of FDA documents in the Federal Register from October 2025 to October 2026; the meeting was announced through the FDA’s own web pages.
• Docket: FDA-2026-N-2047 on regulations.gov. A docket is the public file the government keeps for one matter; anyone can read it and add a comment while it is open.
• Comment deadline: 27 April 2026, electronically through regulations.gov or in writing to the FDA’s Dockets Management Staff (HFA-305), 5630 Fishers Lane, Room 1061, Rockville, MD 20852, with the docket number on every submission.
• Materials posted afterwards: the meeting page, last updated 14 April 2026, lists the agenda, the memo to the docket, the full transcript and the slide deck, plus a recording.

The meeting page states that the FDA “will review input received at the public meeting and submitted to www.regulations.gov (docket number FDA-2026-N-2047) to determine next steps.”

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2. The Fourteen Words: What “Dietary Substance” Means in the Law

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines a dietary supplement partly by what it contains: one or more dietary ingredients. The list of dietary ingredients was written into the Act by DSHEA in 1994 and sits in section 201(ff)(1). As the ODSP Director walked through it at the meeting, most entries are familiar terms — a vitamin, a mineral, an herb or other botanical, an amino acid — and a final entry covers concentrates, extracts and other variations or derivatives of those.

One entry, section 201(ff)(1)(E), is open-ended. It covers:

“a dietary substance for use by man to supplement the diet by increasing the total dietary intake”

Speakers throughout the day called this phrase “the 14 words.” Several speakers from the supplement industry called it a “catch-all provision”. The meeting was about how far it reaches. Three kinds of ingredient were in question:

• Substances never part of the human diet. Whether a substance can count as a “dietary substance” if people have not eaten it in food.
• Known ingredients made a new way. The meeting page names precision fermentation (microbes engineered to produce a specific compound, which is then purified), cell culture technology (growing plant or other cells in tanks rather than harvesting whole organisms) and recombinant production (inserting the gene for a protein into a host organism so that it makes that protein). The agenda adds chemical synthesis.
• Ingredient types the list does not name. Proteins, enzymes and microorganisms, which the meeting page notes “are not specifically listed in section 201(ff)(1) of the FD&C Act.”

The answer matters because of how supplements reach the market. A firm planning to sell a supplement containing a new dietary ingredient sends the FDA a notification (an “NDI notification”) with its safety information; the ODSP Director noted that the agency has 75 calendar days to review one. A substance that does not count as a dietary ingredient at all cannot use that pathway.

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3. The FDA’s Current Reading, as Described at the Meeting

Opening Session 1, the ODSP Director described how the agency has read the phrase so far. The legislative history is short, she said, so the agency looked to ordinary dictionary meaning: a dietary substance is “a substance that is commonly used as human food or drink,” and the words “to supplement the diet by increasing the total dietary intake” reinforce that it is “meant to be foods and food components that humans eat as part of their diet.”

She added that the FDA does not accept that putting a substance into a supplement makes it part of the diet: “That would be a loophole.” She said this working definition served for a long time, but that developments in the supplement and food industries now raise the question of whether it is the full scope of the phrase.

The questions her staff put on screen included whether the source of a substance matters (made in a laboratory or taken from its natural source); whether it matters if a fermentation uses yeast or a bacterium; what happens to a microorganism isolated from a food or from the gut and then grown in a different medium, where “it’s going to adapt”; whether it matters if a microbe is in food on purpose (as in fermented foods) or only because of unsanitary conditions; and “Are there any limits to what this category can encompass?” — which she called “the question of the day.”

She also said that whatever the agency concludes has to be tied back to the statute’s wording: “the train tracks are always going to be the law.” Asked about what comes next, she said: “I don’t know. This is step one.”

In his opening remarks the Deputy Commissioner for Human Foods described the industry as having grown from an estimated $2–4 billion in 1994 to more than $60 billion, said that by FDA estimates more than three-quarters of American adults use dietary supplements, and described the agency’s aims as modernizing its oversight while removing what he called unnecessary barriers to innovation. He also asked supplement stakeholders how they currently navigate the overlap between GRAS conclusions and NDI notifications, in light of proposed reform of the GRAS framework.

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4. The Four Questions the FDA Asked

The memo the FDA placed in the docket lists four “Public Feedback Questions.” In the FDA’s words:

1. “What is your view on whether the phrase ‘dietary substance for use by man to supplement the diet by increasing the total dietary intake,’ as used in DSHEA, can include substances that have never been part of the diet?”
2. “When existing dietary ingredients are produced using emerging technologies such as synthesis, cell culture, precision fermentation, or recombinant production, at what point does a change in production methodology meaningfully alter the ingredient’s identity, composition, or safety profile—and therefore warrant additional regulatory scrutiny or data submission?”
3. “How should production technologies be characterized, e.g., in a new dietary ingredient notification—including potential byproducts, impurities, and structural or functional variations—to ensure that FDA can adequately assess the resulting ingredient?”
4. “For ingredient types such as peptides, proteins, enzymes, and microbials, what scientific criteria are important in determining the identity of a substance? For these ingredient types, what scientific criteria are important in determining whether two substances are sufficiently similar to be considered the same dietary ingredient for regulatory purposes?”

The memo also says the meeting would explore how new methods for producing existing ingredients “might be evaluated” and that the FDA would “seek input on emerging ingredient types and how they fit within the dietary supplement framework.”

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5. Session 1: The Debate Over Scope

The FDA chose two panelists for the first session, explaining that it wanted the conversation “held across the spectrum of stakeholders”: a lawyer for a consumer-advocacy organization and the head of a supplement-industry trade association.

The consumer-advocacy view. The organization’s regulatory counsel argued that dietary substances are limited to substances commonly used in human food or drink, matching the dictionary meaning of “diet” and, he said, the FDA’s position in its draft NDI guidance. He cited the Senate committee report on DSHEA as describing the term as covering substances from the food supply. He described the market as about 90,000 products, cited surveys finding that roughly half of adults overestimate how closely the FDA regulates supplements, and argued that a broader definition would enlarge a market the FDA already struggles to oversee. He raised a concern that a wider reading could reach substances such as tianeptine or phenibut, which the FDA has stated are not dietary ingredients, and said the GRAS pathway lets ingredients reach the market without FDA knowledge.

The trade-association view. The association’s chief executive, who said he had previously held the ODSP Director’s post, argued that DSHEA has worked as intended and that what has changed since 1994 is the science, not the need for new law. He described peptides as short chains of amino acids eaten in everyday foods such as eggs, milk and meat, and asked the FDA to keep “an open mind” on how peptides fit the definition; he noted that some view chemically modified peptides as drug ingredients, and said his organization disagrees. He said DSHEA does not define a probiotic, that some probiotic strains come from the human gut or breast milk rather than foods, and that the routes to market for them “aren’t always clear.” He also described the “drug preclusion” clause — under which a substance first studied as a drug can be barred from supplements — as a barrier to supplement research, because the date an investigational drug application takes effect is not disclosed.

Closing the session, the ODSP Director said clarity on what is meant by dietary substance would benefit both the agency’s review staff and companies trying to judge whether a substance qualifies.

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6. Session 2: New Ways to Make Existing Ingredients

The ODSP’s Director of Research and Evaluation framed the second session with a diagram of four overlapping production technologies: synthesis (making a compound through chemical reactions), cell culture technology (growing cells in a controlled environment), and precision fermentation and recombinant production, which he described as the same thing when a microorganism is genetically modified to act as a “cell factory” for an ingredient. The session’s key question, he said, was “what characteristics can equate or distinguish an ingredient made by different methods?”

Five panelists, from ingredient producers, a consumer health products trade association and a food-law firm, presented. Points made in their talks included:

• Plant cell culture. An ingredient scientist described how the chemical makeup of field-grown botanicals varies with growing conditions, giving saffron as an example: in one study he cited, a summer high temperature 2.5 °C higher went with about 30 percent less crocin, the pigment of interest. He described growing plant cells in liquid culture under controlled conditions so that the same composition is produced batch after batch.
• Synthesis and changes of source. A trade-association scientist gave examples of ingredients whose form or source changed after 1994: concentrated ethyl-ester forms of the fish-oil fatty acids EPA and DHA, and phosphatidylserine, which he said moved from a bovine-brain source to production from plant lecithin because of prion concerns while keeping its regulatory status. He also cited a 2014 FDA guidance on manufacturing changes for food additives as treating a change of manufacturing method as not, by itself, changing an ingredient’s identity or safety.
• Fermentation. A fermentation scientist described how enzymes and microbes are grown in a medium, concentrated, purified and dried, and noted that enzyme ingredients can be measured by their activity using compendial methods.
• Safety evaluation across methods. A food-law attorney said vitamins have been produced through microbial fermentation “for decades,” and outlined the elements of a safety evaluation: finished-product identity and specifications, characterization of any other material present (including fragments produced during fermentation), the manufacturing inputs and hazard controls, intended use and dietary exposure, and toxicology and allergen data. In his view, the method of manufacture need not matter once that evaluation has been done.
• Manufacturing and formulation. A manufacturing executive spoke on the downstream steps of turning ingredients into finished supplements.

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7. Session 3: Identity of Proteins, Enzymes and Microbes

The chief of the ODSP’s Identity and Status Branch opened the third session by saying that “without identity, we don’t know what it is,” and that identity comes before any discussion of safety. Proteins, enzymes and microbes, she said, “don’t have a home” in section 201(ff); they currently fit only when they are part of the usual human diet in food or drink. She added that peptides were left off the session title partly because the subject is “a little controversial right now.”

The identity attributes her branch asked about were, for proteins and enzymes, amino-acid sequence, molecular weight and any modifications, and for microbes, the strain, species-versus-strain differences, viability, metabolic profile and antibiotic-resistance factors. A second question was when a change in how something is made creates a new dietary ingredient — for example if a protein folds differently.

The five panelists were a university food-science professor, two ingredient-company scientists, a trade-association chief science officer and a microbiology consultant. Points made included:

• The professor explained that a protein’s biological activity depends on the order of its amino acids and the shape it folds into, and that an enzyme is a protein with a particular biological activity.
• The trade-association science officer argued that dietary substances are not limited to substances identical to those in conventional foods: “We are not meant to be frozen in time to what was innovated in 1994.”
• The microbiology consultant described a hierarchy of identity for microbes — genus, species, strain — and said whole-genome sequencing is the current industry benchmark, with quicker tests such as 16S ribosomal RNA sequencing giving only genus and species. He pointed to the recent renaming of many Lactobacillus species into new genera, and described master and working cell banks used to prevent genetic drift so that each production run matches the reference strain.
• A medical-affairs scientist raised the distinction between microbes eaten intentionally as part of the diet and those present only incidentally — an example the ODSP Director returned to in her closing remarks.

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8. The Open Public Comment Period

Seven registered commenters spoke during the open comment session, before a panel of four FDA staff. All seven spoke for industry organizations or from law practice, and six of them argued in some form for a broader reading of “dietary substance” than the FDA’s current one:

• A probiotics trade association asked for a regulatory solution recognizing microbial ingredients, probiotics and other biologics as dietary ingredients “regardless of what source they are isolated from,” for species-level recognition of food-supply presence, and for acknowledgment that manufacturing advances do not necessarily change a microbe’s identity.
• An attorney spoke in support of the meeting and of enforcement against firms that skip required NDI notifications.
• A supplement trade association’s general counsel argued that the statute’s plain language and legislative history support a broad reading, noting a change from “nutritional substances” in earlier drafts to “dietary substances” in the final law.
• An herbal-products trade association called the wording “forward looking and functional,” and said that ingredients chemically identical to botanical constituents but not extracted from plants “must not be labeled in a manner that may mislead consumers about their source or identity.”
• An attorney for the probiotics association argued, citing a 1995 Supreme Court rule of statutory interpretation, that because Congress used “present in the food supply” in the NDI section but not in the definition, the two phrases must mean different things.
• A food-additives trade association asked the FDA to reconsider its interpretation for live and heat-treated microbial ingredients through non-legislative means, and proposed that “chemical alteration” of a microbe mean only a change to its genetic makeup.
• A consumer health products trade association said the FDA’s interpretation had “at times drifted towards a narrower” view, argued that advances in manufacturing often improve purity and consistency, said GRAS “was never intended to serve as a workaround for dietary supplement ingredients,” and called the anticipated final NDI guidance an opportunity for the FDA to clarify its reading of section 201(ff).

The consumer-advocacy view was presented in Session 1 (section 5); no consumer group spoke in the open comment period. In closing, the ODSP Director said the agency’s goal is “to provide some clarity and some transparency” about how it reads the scope of dietary substance, and that the topic touches both removing barriers and ensuring “a strong, comprehensive, consistent review” when ingredients come in through the NDI pathway.

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9. What the Meeting Does Not Do

• No decision. The meeting issued no guidance, no rule and no new interpretation. The FDA’s stated purpose was to gather input “to determine next steps.”
• No change to the law. DSHEA and section 201(ff) are unchanged. The statute’s wording can be changed only by Congress; the FDA can change only how it interprets and applies that wording.
• No ingredient cleared or barred. No peptide, protein, enzyme, probiotic strain or fermentation-made ingredient was approved, accepted or excluded as a result of the meeting.
• Not a Federal Register action. No Federal Register notice for this meeting was found; it was announced on the FDA’s web pages and run through docket FDA-2026-N-2047.
• Speakers’ positions are not FDA positions. The views summarized in sections 5 to 8 are those of the outside speakers; the FDA’s own statements are its current reading (section 3) and its questions (section 4).

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10. Dates and Status as of 11 October 2026

• 3 March 2026 — meeting announced in an FDA constituent update.
• 16 March 2026 — agenda and memo to the docket posted.
• 27 March 2026 — meeting held in College Park, Maryland, and online.
• 14 April 2026 — meeting page last updated, listing the transcript, slide deck and recording.
• 27 April 2026 — comment period on docket FDA-2026-N-2047 closed.

Legal status: closed public meeting and closed comment period; no decision. The FDA documents on the meeting page record no guidance, proposed rule or other follow-up action on the scope of “dietary substance” as of 11 October 2026. The agency’s existing reading described in section 3 remains the one in use.

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11. How the Meeting Fits Earlier FDA Actions

2019: the first round. The ODSP Director told the meeting that the agency “actually started this discussion back in 2019,” at a May 2019 public meeting on innovation in dietary supplements whose first session was also on the scope of dietary ingredients under DSHEA. The 2026 meeting took that one session and expanded it into a full day.

The draft NDI guidance. The consumer-advocacy speaker pointed to the FDA’s draft guidance on new dietary ingredient notifications as setting out the agency’s current reading, and a trade-association commenter described the final version of that guidance as still anticipated.

2025–2026 actions named at the meeting. The Deputy Commissioner for Human Foods said the FDA had issued an enforcement-discretion letter in 2025 on the disclaimer required on supplement labels and expected rulemaking to adjust that requirement. He also cited the agency’s 2025 actions against concentrated 7-hydroxymitragynine (7-OH) products — warning letters and product seizures — as an example of coordinated work across its food-chemical offices; the later scheduling steps for those products are described on the site’s 7-OH kratom page.

The GRAS proposal (August 2026). GRAS means “generally recognized as safe,” a route by which a food ingredient can be used without FDA premarket approval. Several speakers described GRAS as being used as a route for supplement ingredients. On 11 August 2026 the FDA published a proposed rule that would make GRAS notifications mandatory; under that proposal, dietary-supplement ingredients are excluded from the “food additive” definition and so are not eligible for GRAS classification. That proposal is described on the site’s GRAS proposal page.

Peptides. Peptides came up repeatedly at the meeting but were left out of the formal session titles. The FDA’s separate 2026 handling of compounded peptides is described on the compounded peptides page.

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12. Primary Documents

1. U.S. Food and Drug Administration (2026). Public Meeting Exploring the Scope of Dietary Supplement Ingredients – 03/27/2026. FDA meeting page, last updated 14 April 2026. Docket No. FDA-2026-N-2047 — fda.gov meeting page
2. U.S. Food and Drug Administration, Human Foods Program (2026). FDA Announces Public Meeting on Dietary Supplement Innovation and the Scope of Dietary Ingredients. Constituent update, 3 March 2026, updated 16 March 2026 — fda.gov constituent update
3. U.S. Food and Drug Administration (2026). Agenda – Public Meeting on Exploring the Scope of Dietary Supplement Ingredients (March 27, 2026). Docket No. FDA-2026-N-2047 — agenda (PDF)
4. U.S. Food and Drug Administration (2026). Memo to the Docket (FDA-2026-N-2047) – Public Meeting on Exploring the Scope of Dietary Supplement Ingredients — memo to the docket (PDF)
5. U.S. Food and Drug Administration (2026). Transcript – Public Meeting on Exploring the Scope of Dietary Supplement Ingredients (March 27, 2026) — transcript (PDF)
6. U.S. Food and Drug Administration (2026). Slide Deck – Public Meeting on Exploring the Scope of Dietary Supplement Ingredients (March 27, 2026) — slide deck (PDF, 18.5 MB)
7. Public docket FDA-2026-N-2047 — regulations.gov FDA-2026-N-2047-0001
8. Food and Drug Administration, HHS (2026). Substances Generally Recognized as Safe; Proposed Rule. Federal Register 91:51834, 11 August 2026. Docket No. FDA-2025-N-3262 — FR Doc. 2026-16296

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Key Research Papers

1. Geller AI, Shehab N, Weidle NJ, Lovegrove MC, Wolpert BJ, Timbo BB, Mozersky RP, Budnitz DS (2015). Emergency department visits for adverse events related to dietary supplements. New England Journal of Medicine 373(16):1531-1540 — PubMed PMID: 26465986
2. Starr RR (2015). Too little, too late: ineffective regulation of dietary supplements in the United States. American Journal of Public Health 105(3):478-485 — PubMed PMID: 25602879
3. Hill C, Guarner F, Reid G, Gibson GR, Merenstein DJ, Pot B, Morelli L, Canani RB, Flint HJ, Salminen S, Calder PC, Sanders ME (2014). Expert consensus document. The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nature Reviews Gastroenterology & Hepatology 11(8):506-514 — PubMed PMID: 24912386
4. Zheng J, Wittouck S, Salvetti E, Franz CMAP, Harris HMB, Mattarelli P, O’Toole PW, Pot B, Vandamme P, Walter J, Watanabe K, Wuyts S, Felis GE, Gänzle MG, Lebeer S (2020). A taxonomic note on the genus Lactobacillus: description of 23 novel genera, emended description of the genus Lactobacillus Beijerinck 1901, and union of Lactobacillaceae and Leuconostocaceae. International Journal of Systematic and Evolutionary Microbiology 70(4):2782-2858 — PubMed PMID: 32293557
5. Teng TS, Chin YL, Chai KF, Chen WN (2021). Fermentation for future food systems: precision fermentation can complement the scope and applications of traditional fermentation. EMBO Reports 22(5):e52680 — PubMed PMID: 33908143

These papers are background to the topics discussed at the meeting (supplement safety surveillance, supplement regulation, the definition of a probiotic, microbial strain naming, and precision fermentation); none is cited in the FDA’s meeting documents.

PubMed Topic Searches

1. PubMed: dietary supplement regulation and DSHEA
2. PubMed: precision fermentation and food ingredients
3. PubMed: probiotic strain identification by whole-genome sequencing
4. PubMed: new dietary ingredient notification and safety

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Connections

• FDA and Regulation
• FDA Proposal to Make GRAS Notices Mandatory (2026)
• FDA Review of Compounded Peptides (2026)
• 7-OH Kratom Products: The 2026 Scheduling Steps
• FDA Reopens the DSHEA Innovation Door
• News
• Dangerous Supplements
• Contamination: Heavy Metals, Bacteria and Substitution
• Sedatives, Phenibut and Kratom
• How to Verify a Supplement
• Probiotics
• Enzymes: How They Speed Up Life

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