March 27, 2026
Human Foods Program
U.S. Food and Drug Administration
Wiley Auditorium
5001 Campus Drive
College Park, MD 20740
Draft remarks of NPA President and CEO Daniel Fabricant, Ph.D., regarding FDA public meeting on “Dietary Supplement Innovation and the Scope of Dietary Ingredients”
Good morning. I’d like to thank the leaders of the Human Foods Program at FDA — specifically Dr. Welch and Deputy Commissioner Diamantas — for making this discussion a priority. In 2026, the Natural Products Association is celebrating its 90-year anniversary, which is a testament to the competence and professionalism of our member companies. Later today, you will hear from some of our members, including Kerry, Lonza and Novonesis. These companies and other members have collectively invested hundreds of millions of dollars in regulatory compliance, clinical science and new technologies to demonstrate the health benefits of dietary ingredients and finished products.
When we first approached FDA regarding this meeting, the focus was twofold. First, we wanted to discuss new technologies that are growing more relevant, specifically targeted microbial fermentation, peptides, synthetic biology, enzymes and “nature identical” copies of plant constituents. Second, we wanted to address regulatory definitions germane to those technologies to understand the array of interpretations and potential flexibility going forward.
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Once FDA announced the public meeting, a third discussion point came into focus: the current statutory framework. The Dietary Supplement Health and Education Act of 1994 works — and it works incredibly well.
DSHEA has effectively achieved its goals of promoting wide access to supplements while providing FDA the tools to effectively regulate the category and protect consumers from harmful products. FDA has managed to get the job done, and it’s a big job with one of the smallest offices at the agency. That’s due in no small part to the expertise and actions of Dr. Welch and her team at ODSP.
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Three out of four Americans take dietary supplements to promote their health, and these products when used responsibly contribute to Making America Healthy Again. Unfortunately, the plane landing safely doesn’t usually make the news. Despite the rhetoric you may have heard, more than 30 years after DSHEA was passed, dietary supplements remain one of the safest — if not the safest — commodities regulated by FDA.
Instead of dwelling on what’s wrong with DSHEA, it’s time to focus on how FDA can more effectively leverage its authorities and how industry can support the agency in regulating and policing the market. This form of dietary supplement modernization requires no act of Congress and aligns with the 2026 priorities of the FDA Human Foods Program.
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Now, I’d like to pivot to the future of our industry. In 1994 when DSHEA was passed, Congress could not have anticipated the last three decades of advances in ingredients and production methods. But we know that lawmakers had a bold vision to make supplements widely available to the American public because they said so in the preamble. In defining a dietary supplement, Congress intentionally covered a broad group of products, from minerals and botanicals to a category that FDA is focused on today, “a dietary substance for use by man to supplement the diet by increasing the total dietary intake.”
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The definition of a dietary supplement leads me back to one of the principal reasons that we requested public dialogue with FDA. What has changed the most in the last three decades since DSHEA’s enactment? The answer is the science, of course.
Let’s start with peptides, which are not explicitly called out in the definition of a dietary supplement. Recent media attention would have you believe that peptides are only found in medical spas, compounding pharmacies and court cases about weight loss drug intellectual property.
But the truth is we have been eating peptides our whole lives, which highlights the most important term in DSHEA that defines a supplement — the word, “dietary.” Peptides are short chains of amino acids, and the building blocks of proteins. They act as messengers in the body to regulate functions like skin repair, muscle growth and immunity.
Peptides are most often broken down into smaller peptide sequences (depending on the food matrix), residues or amino acids. However, technologies have emerged to ensure that peptides stay intact through the stomach so they can be utilized at their intended targets. In many cases, this is no different from when vitamins were originally isolated.
It’s critical that we explore how peptides fit into the definition of a dietary supplement because we are only beginning to fully appreciate and understand their essential role in health and wellness at a molecular level.
To have a physiological effect, certain peptides will likely need technological modifications, such as coatings or the addition of functional groups to the base molecule.
Some may view these modifications as establishing an active moiety or drug ingredient. We respectfully disagree. As the science evolves, we urge FDA to keep an open mind on how peptides can be delivered orally at safe doses and how these substances play a role in supplementing the human diet.
Similarly, DSHEA does not identify or define a probiotic or live microbial. The innovation in this space has been massive over the past 30 years, resulting in billions of dollars in food, beverage and supplement sales. Unfortunately, the regulatory pathways to market for probiotics aren’t always clear.
Probiotics have come into the diet through a variety of sources. Some come from yogurts and fermented cabbage, raw fruits and vegetables, and others come from the human intestine and breast milk. Probiotic companies attending this FDA public meeting are improving on existing genera, species and strains based on physiological targets that we didn’t understand 30 years ago.
How do we ensure these ingredients fit with the framework of DSHEA and have a lawful pathway to market? Although the universe of live microbials added to dietary supplements cannot be unlimited, how precisely or broadly should FDA define the category since probiotics represent a significant source of new dietary ingredient notifications to the agency because of our technological advancements in understanding the microbiome?
Those bright lines have not always been clearly delineated, and we have seen a migration to self-GRAS of live microbials to demonstrate safety or what some have termed the GRAS — or generally recognized as safe — loophole. This pattern is at odds with the current administration’s call for overhaul of the GRAS process to ensure there is more transparency and FDA oversight of food ingredients.
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I’d like to now discuss the challenges that our industry faces in the so-called race to market between dietary supplements and drugs.
The science of targeted fermentation, synthetic biology and other advances show new physiological effects of dietary ingredients on the structure or function of the body. But advancing science to promote health and wellness does not make a dietary ingredient a drug. And an investigational new drug application, or IND filed with FDA, should not thwart research and development of new dietary ingredients.
Unfortunately, the drug preclusion clause in DSHEA tilts heavily in favor of pharmaceutical development. Describing the clause as a race to market is inaccurate because in any race generally both participants know the starting line. FDA contends it cannot disclose the date that an IND takes effect, which triggers the race to market.
This lack of transparency creates a disincentive to innovate over concerns that an NDI could be excluded from the definition of a dietary supplement. These concerns are not theoretical or hypothetical. The Natural Products Association has sued FDA not once but twice in recent years over its application of the drug preclusion clause.
Fortunately, these cases have revealed that FDA has authorities, or the flexibility, to allow a dietary ingredient to be sold in a supplement, even if it’s determined that an IND predates the marketing of the supplement. For example, FDA can exercise enforcement discretion as it has done with NAC.
The other option is a notice-and-comment rulemaking. We request that FDA complete a proposed rulemaking for NAC since this would provide an important precedent and guidelines for future dietary ingredients that are subject to a previously filed IND.
But what else can be done to overcome challenges posed by the drug preclusion clause and a secret IND date? FDA and industry should work together to ensure there is greater clarity of process over substances that may be on a dual track as investigated drugs and new dietary ingredients. These disclosures must come to light before and not after supplement firms have invested in R&D and submitted safety dossiers to FDA. Otherwise, innovation will be stunted and protracted fights over the drug preclusion clause will continue to drain government and industry resources.
In summary, the notion that our industry is innovating and investing in what some would consider to be “pharma-like” research should not be an impediment to develop innovative ingredients used to supplement the diet and promote health.
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Finally, as a former dietary supplement regulator at FDA, I must stress that DSHEA is not fundamentally broken. To the contrary, the twin pillars or objectives of the statute have been realized. Consumers today enjoy wide access to a variety of science-based dietary supplements, and FDA has ample tools to protect the public from unsafe products. I used many of these authorities during the Obama administration while overseeing dietary supplement programs at FDA.
Whether it’s synthetic botanicals, probiotics or peptides, we believe these ingredients fit within the law’s broad definition of a dietary supplement. FDA may need to publish guidance to define the parameters, and our members are ready to provide technical and scientific input to the agency.
Simply put, FDA does not require structural reforms in the law to protect public health and provide a regulatory pathway for introduction of these new dietary ingredients and technologies. FDA can effectively regulate the 21st century dietary supplement market under the existing statute.
In conclusion, I am proud of the dietary supplement innovation led by our members because their scientific research and investments support a healthier America. We remain committed to ensuring that any new products are manufactured to FDA standards, safe for consumers and backed by rigorous science demonstrating their health benefits.
Thank you Dr. Welch and Deputy Commissioner Diamantas.
