College Park, MD—In March, the U.S. Food and Drug Administration (FDA) announced “Exploring the Scope of Dietary Supplement Ingredients,” a public meeting on the evolving landscape of dietary supplement ingredients and recent scientific and technological advances shaping the industry. The goal: to help inform the agency’s next steps regarding the meaning of the dietary ingredient categories defined in the Dietary Supplement Health and Education Act of 1994 (DSHEA). The event featured presentations that provide background on:
The scope of the phrase “dietary substance for use by man to supplement the diet by increasing the total dietary intake” as used in DSHEA;
New methodologies to produce existing dietary ingredients;
Specific ingredient types, including proteins, enzymes, and microbials.
Defining a dietary supplement
Currently, the Federal Food, Drug, and Cosmetic Act (FD&C Act) defines “dietary supplement,” in part, as a product that contains one or more dietary ingredients, including “a dietary substance for use by man to supplement the diet by increasing the total dietary intake” (Section 201(ff)(1)(E) of the FD&C Act). The meeting will collect stakeholder input regarding that meaning.
What new ingredient types are being discussed?
FDA and stakeholders are discussing emerging dietary ingredient categories including proteins, peptides, enzymes, and microbials. These ingredients may be produced using modern technologies such as precision fermentation and other advanced manufacturing methods.
FDA set an April 27 deadline for industry stakeholders to submit comments on the topic, and trade groups in the natural products industry responded.
(Background: FDA Public Meeting Explores Scope of Dietary Supplement Ingredients)
AHPA: Clearer innovation pathways are needed
The American Herbal Products Association (AHPA) noted that FDA previously has interpreted a catchall clause of the definition, “a dietary substance for use by man to supplement the diet by increasing the total dietary intake,” to exclude any substance not already found in the conventional food supply–and this, AHPA said, has had the effect of stifling research and driving innovators to use Generally Recognized as Safe (GRAS) pathways and conventional food inclusions when bringing new ingredients such as probiotics and microbes to market.
In its comments, the trade group made it clear that, “contrary to FDA’s historical interpretation of DSHEA, a direct pathway to market must exist for innovative ingredients.” AHPA also emphasized that dietary supplement labeling must not mislead consumers regarding the origins of substances that have been produced using innovative technologies.
“Consumers deserve access to safe and beneficial new ingredients, but they also have a right to know where their products come from,” said AHPA President & CEO Graham Rigby. “We continue to support a facts-forward approach that clarifies the dietary ingredient landscape for consumer and regulator alike.”
AHPA also shared: “FDA has included industry guidance on new dietary ingredient safety and identity information in its set of 2026 priority deliverables. AHPA and the broader dietary supplement community eagerly await this timely yet long-awaited publication.”
CRN: Modernization of FDA interpretation is needed
The Council for Responsible Nutrition (CRN) submitted comments calling on the agency to modernize its interpretation of what qualifies as a “dietary ingredient.” CRN contends that FDA’s current interpretation of “dietary substance” is narrow, inconsistent with the law, and is limiting innovation, safety oversight, and consumer access. CRN says FDA’s historically take of limiting “dietary substances” to ingredients previously used in conventional foods is not supported by DSHEA’s plain language or legislative intent, which was designed to accommodate future innovation.
The problem, according to CRN, is that FDA’s approach has the unintended effect of reducing oversight, since ingredients that can’t enter the NDI pathway may bypass FDA review or be forced into less appropriate regulatory routes. As examples, CRN highlights emerging ingredient categories including proteins, peptides, enzymes, and microbials that should be able to qualify as dietary ingredients without prior conventional food use. Advancements in production technologies, including precision fermentation, can enhance the quality and consistency of existing ingredients while maintaining their identity and safety, CRN says. The trade group’s recommendations:
Align FDA’s interpretation of “dietary substance” with DSHEA’s broad, intended meaning
Ensure qualifying ingredients can access the NDI notification process
Evaluate ingredients based on safety and identity—not production method or food-use history
Update NDI guidance to reflect modern science, including non-animal safety methods
Strengthen enforcement and explore tools like Mandatory Product Listing
NPA: DSHEA remains flexible and effective
Presenting at the public meeting in March, Natural Products Association (NPA) President and CEO Daniel Fabricant, Ph.D., pointed out that DSHEA has successfully achieved its original goals:
Expanding consumer access to dietary supplements
Providing FDA with sufficient authority to police the marketplace
Supporting innovation while maintaining safety oversight
“In 1994, no one could have anticipated this growth in scientific advances for ingredients and production methods,” Dr. Fabricant said. “We know lawmakers had a bold vision to make supplements widely available to the American public because they said so. In defining a supplement, Congress intentionally covered a broad group of products.”
What’s changed the most in the last three decades since DSHEA became law in 1994 is the science, and not the regulatory structure, Dr. Fabricant emphasized, adding that FDA is “not fundamentally broken” and dietary supplements remain “one of the safest, if not the safest, commodity regulated at FDA.”
Dr. Fabricant said a key to this discussion is modernization and clarification—not major statutory overhaul. He stressed that the statutory language was designed with flexibility to accommodate scientific advances. He suggested that FDA should interpret DSHEA in a way that allows emerging technologies and ingredients to fit within the existing framework.
Dr. Fabricant also focused on DSHEA’s drug preclusion clause, maintaining that FDA’s handling of Investigational New Drug (IND) filings creates a “race to market” problem, and companies often can’t know when an IND filing has triggered drug preclusion because FDA does not disclose IND effective dates. This uncertainty discourages innovation and investment in new dietary ingredients, and those companies that do invest heavily in R&D and safety may later discover that an ingredient may be excluded from the supplement category. He emphasized these concerns are “not theoretical or hypothetical,” noting NPA has sued FDA twice over the issue.
Rather than rewriting DSHEA, Dr. Fabricant noted that FDA can already address many issues through enforcement discretion, guidance documents, and rulemaking, adding that forthcoming NAC rulemaking could establish an important precedent for handling future disputes involving the drug preclusion clause.
Dr. Fabricant also called for greater clarity, earlier disclosure of potential conflicts, and better coordination between FDA and industry around IND filings, as companies need to know about possible drug preclusion issues before investing heavily in research and commercialization.
Key points: FDA Examines DSHEA Dietary Ingredient Definition
Why is FDA reconsidering the definition of dietary ingredients?
FDA is reconsidering the definition because scientific and technological advances have changed how dietary ingredients are produced. The agency is evaluating whether current interpretations of DSHEA appropriately account for new ingredient types such as proteins, enzymes, and microbials, as well as modern production methods like precision fermentation.
What is the key regulatory tension?
Whether dietary ingredients must have prior conventional food use or can include new scientifically developed substances.
What is the industry concern?
Current interpretation may restrict innovation and complicate access to the New Dietary Ingredient (NDI) notification pathway.
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