Our Unique Opportunity

On September 3, 2026, FDA announced that as part of the Trump Administration’s initiative to streamline regulatory pathways and foster medical innovation the Agency is seeking public input to advance the development of botanical drugs.

As stated by Acting FDA Commissioner Kyle Diamantas, JD, “Under the Trump Administration, we are committed to modernizing regulatory frameworks to ensure promising, natural health options are evaluated through rigorous science.”

This is a welcome opportunity for constructive dialogue with the FDA on an issue that will impact the everyday health of millions of Americans.

We argue for a subcategory of botanical drugs designated as Traditional Herbal Drugs that may be registered based on the following seven elements, in recognition of the reality that traditional herbal medicines have been used for thousands of years, and for most of that time independent of government regulation:

• The drugs registered are truly traditional herbal drugs, formed from relatively unrefined herbal components, singly or in thoughtful combinations, based on documented traditional use of existing ingredients.
• The traditional herbal drug is intended for use without the supervision of a physician.
• A plausible mechanism of action can be attributed to the traditional herbal drug based on empirical use, and this mechanism may be explored further in modern basic science research.
• A review of the available scientific literature and traditional use literature does not highlight significant safety concerns.
• The labeling of the traditional herbal drug makes it clear that its use is based on traditional use, not evaluation of clinical trials by FDA.
• Monographs are created against which quality and labeling of Traditional Herbal Drugs can assessed.
• Adverse events related to Traditional Herbal Drugs are reported in alignment with the Dietary Supplement and Nonprescription Drug Consumer Protection Act.

A Regulatory Framework for Traditional Herbal Drugs

The regulatory framework for registration of “Traditional Herbal Drugs,” is best modeled after an existing registration option developed by the European Medicines Agency for Traditional Herbal Medicinal Products (THMPs).¹ 

This regulatory pathway in the EU is for herbal medicinal products designed for use without a prescription or oversight of a physician, based primarily on traditional use. By definition in the EU, a “medicinal product” (both herbal and pharmaceutical) is defined as “Any substance or combination of substances presented for treating or preventing disease in human beings.”² This corresponds to language defining a drug in US code as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.”³ While the framework we propose below is for a category of drug, it is a category of drug intended, like the EU regulatory category after which it is patterned, to provide standards of quality for traditional medicines that can be used without the supervision of a physician, and carry claims of traditional use based on authoritative review of available science that can be based on empirical use of herbal medicines over extended periods of time. 

In the EU system, an authoritative body within an EU member state reviews submitted literature regarding safety and efficacy of a medicinal product, as well as an associated expert report on safety covering available literature, before deciding whether the product may receive Traditional Use Registration.⁴ Plausible efficacy is identified in the reviewed literature, which may be based on empirical evidence, and documentation of quality in manufacturing must be submitted. There is also an important requirement regarding time of previous use, meaning that these are not new products, but truly traditional. To be considered for registration, a product must have been in use for 30 years, with at least 15 years in the EU. 

As individual competent authorities review submitted information, they are supported in referring to the work of the EU’s Committee on Herbal Medicinal Products, which publishes authoritative opinions on herbal substances and preparations. Much of this information is published in the form of monographs, which contain specifications for product quality, as well as information about product use and safety. The monographs also include statements of traditional use that are utilized to create labeling for the product.⁵ Upon approval of an application leading to a certificate of Traditional Use registration, the authoritative body may issue a concise and informative public report summarizing the basis for the approval within the regulatory framework. The report may delete sensitive commercial information. An example of such a report from Ireland’s authoritative body is cited, and may inform how such a document can be structured for Traditional Herbal Drugs here in the United States.⁶ It is important to understand that such a document need not, and should not, aspire toward a format used for the approval of pharmaceutical drugs; rather it serves its purpose within the unique regulatory framework established for Traditional Herbal Medicinal Products. The role of the public report is to document empirical use recognized as the basis for registration, including key information highlighting plausible mechanisms of action, and to screen for any safety issues that can be identified in the literature.

The regulatory approach to Traditional Herbal Medicinal Products in the EU has drawn reasoned praise for balancing patient autonomy and access to medicinal options with regulatory structure that fosters quality and provides reliable scientific information.⁷ 

Rational for the Regulatory Framework of Traditional Herbal Drugs

If the war against alternative medicine is over, it is time to openly consider the practical reality of traditional medicinal products that may be reasonably referred to here in the States as “Traditional Herbal Drugs.” The pragmatic foundational reality expressed by the EU directive on Herbal Medicinal Products is that products fitting in this category do not need the same level of clinical trial data as other medicinal products positioned for market authorization, which is corollary to a drug gaining approval through FDA’s Drug Development Process. As stated in EU directive 2004/24/EC specifically regarding traditional medicinal products: 

“The long tradition of the medicinal product makes it possible to reduce the need for clinical trials, in so far as the efficacy of the medicinal product is plausible on the basis of long-standing use and experience. Pre-clinical tests do not seem necessary, where the medicinal product on the basis of the information on its traditional use proves not to be harmful in specified conditions of use. However, even a long tradition does not exclude the possibility that there may be concerns with regard to the product’s safety, and therefore the competent authorities should be entitled to ask for all data necessary for assessing the safety.” 

This is important thinking that is critical to incorporate into creation of a regulatory pathway for Traditional Herbal Drugs here in the United States: 1) long-standing use is evidence of plausibility of some level of efficacy, and 2) traditional use without a history of safety concerns is in fact evidence of overall safety. These assumptions are based on reasonable tenets: 1) If no one or only very few people benefit from a traditional herb over an extended period of time, that medicine is replaced by better options for a particular use, based on empirical observation, and 2) over time, the safety of a traditional medicine also becomes reasonably well understood, again based on observation.

Further Considerations on Safety

Tenet 2, above, is not a cop-out regarding safety, which is a prime concern in the development of a “Traditional Herbal Drug” sub-category within the category of Botanical Drugs. Of course, it is true that any medicine can cause harm in some individuals. Estimates of nationally representative data suggest that harms from all kinds of medications, including what are currently regulated as drugs and herbal products, lead to emergency room visits for about six of every 1,000 people, per year. Products identified as herbal and homeopathic combined account for only about 1.4% of cases of medication harm in this context.⁸ Some of these cases likely come from products with highly refined or isolated herbal ingredients more akin to pharmaceutical drugs than traditional herbal medicines, such as some that have been marketed for the purpose of weight loss.

While exact comparisons of adverse events per unit of product-type consumed are difficult, we note that both pharmaceutical drugs (combined prescription and OTC forms) and the broad category of dietary supplements that currently include all herbal products, both enjoy robust use in the US population. About 62% of US adults have been estimated to use a drug within the last week while about 60% are estimated to have used a dietary supplement in the last 30 days.^9,10 Our recent search (September 2026) through the FDA Adverse Event Monitoring System (AEMS) Public Dashboard for Drugs and Biologics indicates that during the years 2020-2025, there were 7,065,252 serious adverse events reported for drugs and biologics. Accessing data available from the Human Foods Complaint System (HFCS-Quarterly-20260331-EXCEL), we see that between 2020 and 2025 there were 208 reports where dietary supplements specifically labeled as herbal were suspected of being associated with serious adverse events. While this does not mean that other dietary supplements in the data set did not contain herbal ingredients, this number provides some context in terms of products that clearly emphasize their branding as herbal and may thus more closely approximate a safety signal in a category of Traditional Herbal Drugs, vs dietary supplements as a whole. Further in this effort, we note that between 1991 and 2021 in the Netherlands, where herbal products can be registered as medicines, including since 2005 registration of traditional herbal medicines, there were 229 reports of adverse effects reported to the Pharmacovigilance Centre Lareb. Fourteen percent of the reports (32) associated with the herbal products were serious adverse events.¹¹ The number of reports related to herbal products over time is exceptionally small, compared to the overall total of about 30,000 reports of adverse drug reactions that Lareb receives each year.¹² The evidence available suggests that, overall, herbal medicines are less likely to be associated with serious adverse events than pharmaceutical drugs.

Still, those opposed to a regulatory framework for Traditional Herbal Drugs might protest that while the adverse effect rates for these herbal medicines might be low there are enough unknowns about their safety profile that fully informing the consumer about risks is not possible before use. To this point, we emphasize that in the current era since 1992 when the Prescription Drug User Fee Act was passed, 26.7 of 100 newly approved pharmaceutical drugs either receive a new boxed warning or are withdrawn after having been approved and entered the market.¹³ A process of pre-approval has not worked in the past to identify all drug risks before entering market, and to demand completeness of clinical safety profile for Traditional Herbal Drugs before they enter market is not only impractical, it places an unrealistic burden on a category of drug products that overall does not carry the same high level of risk carried by pharmaceutical drugs. Finally, a review of available literature on the safety of Traditional Herbal Drugs is adequate to identify most potential issues and to inform the creation of authoritative monographs that include quality standards to negate identified risks. For example, a review of the safety literature would easily identify the presence of pyrrolizidine alkaloids as a concern for comfrey products, and the monograph would require that any Traditional Herbal Drug Products produced from comfrey for internal use be verifiably free of these alkaloids. A review of the safety literature may also identify instances where both potential significant therapeutic benefit and toxicity occur, such as in the case of Nerium oleander. In such an instance FDA could determine that the herb is not fit to be marketed as a Traditional Herbal Drug and that further development may only take place as a botanical drug developed through other pathways available for botanical drugs to be used under the supervision of a physician. 

Though Traditional Herbal Drugs could enter the market based on a review of existing safety literature, this does not mean that further information is not needed. In fact, we argue that adverse effects of Traditional Herbal Drugs should be reported and monitored according to the Dietary Supplement and Nonprescription Drug Consumer Protection Act. Thus, while reasonable presumption of safety based on traditional use is given, pharmacovigilance signals are sought for and should be acted upon appropriately by the Agency.

Concluding the important discussion of safety, we hasten to articulate a difference between the composition of what should be considered Traditional Herbal Drugs and dietary supplements containing herbal components that have been highly refined or isolated. While methods of extraction creating tinctures and hot water extracts surely form a part of a part of traditional herbal medicine, highly isolated and purified herbal components are not a fit for the proposed category of Traditional Herbal Drug proposed. Indeed, we are concerned that the more concentrated and isolated herbal components become the more they can be expected to possess safety profiles similar to those of pharmaceutical drugs. We suggest that extracts be included in the Traditional Herbal Drug category only when the process of their manufacture captures a broad profile of plant phytochemicals, does not concentrate actives of safety concern, the extract has shown safe traditional use, and the safety data available in the literature for the Traditional Herbal Drug does not suggest a pattern of adverse events.

Considerations on Efficacy

In terms of efficacy, some would argue against a Traditional Herbal Drug Category because they feel that all drug categories should be supported by the same type of science. We argue that one size of scientific shoe is simply not the best fit for products with claims relegated to the domain of traditional use, based on long-term evidence of empirical use. However, to ensure that consumers understand the level of evidence used to support traditional use claims, transparency must be provided. For example, a Traditional Herbal Drug marketed with a statement that the formula is “Traditionally used for relief of joint pain*” could reasonably be tied to a standardized statement such as this: “*Based on traditional use, not FDA evaluation of clinical trials.” Such an approach allows traditional use claims consistent with traditional use and provides clarity in labeling that informs the consumer of the type of evidence supporting such a statement. Both pieces of information are important to consumers making informed decisions of use regarding products intended for use without supervision of a physician.

Considerations of Quality and Usage

The monographs provided in the EU carry important information regarding expectations of quality. EMA’s monograph on ginger, for example, directs that Medicinal Products for Traditional Use be made with certain forms (e.g. powdered herbal substance) and specific ratios of herbal substance to extraction solvent and stipulate the potency of the solvent used. Clear indications for use and duration of intake are also given. Such clear parameters for manufacture and use support efficacy according to what is described as effective in traditional use and also support safety by limiting the potential for over-exposure to the drug.

We wonder if either FDA’s Office of Dietary Supplements or the National Center for Complementary and Integrative Health would be reasonable sources for the creation of authoritative monographs for Traditional Herbal Drugs.

Concluding Thoughts

The United States has always wrestled with how to best balance providing safe, effective options to the American public while passing reasonable thresholds of safety and efficacy. A pragmatic, best-foot-forward approach with regard to traditional herbal medicines is to acknowledge that traditional herbal medicines exist and that a consumer’s reasonable decision to use them or not can be based on available empirical evidence combined with a review of available safety information. A regulatory category of Traditionally Used Drugs, intended for use without the supervision of a physician, can be a botanical drug category providing the greatest access with the least restrictive regulatory criteria, with claims based primarily on evidence of traditional use and efficacy found at a level of basic science. Because a Traditionally Used Drug Category would be new to the United States, but not to other areas of the world, such as Europe, it may be practical to give priority to registration to traditional herbal medicine products already registered in Europe and recognized in other authoritative sources such as the Chinese Pharmacopoeia.

Those readers who wish to comment regarding shaping of the regulatory framework for botanical drugs can make electronic comments by November 3, 2026. According to FDA’s instructions, comments can be made at https://www.regulations.gov by searching for Docket No. FDA-2026-N-9550, entitled “Advancing Development of Botanical Drug Products; Request for Information.”

References

1. https://www.ema.europa.eu/en/human-regulatory-overview/herbal-medicinal-products Accessed 10-Sept-2026.
2. Directive 2001/83/EC of the European Parliament and of the Council. https://eur-lex.europa.eu/eli/dir/2001/83/oj Accessed 10-Sept-2026.
3. 21 U.S. Code § 321(g)(1)(B).
4. European Commission Health and Food Safety Directorate-General. Health systems and products Medicinal products. Revision 11. Volume 2A Procedures for marketing authorization. Chapter 1 Marketing Authorisation. July 2019.
5. https://www.ema.europa.eu/en/human-regulatory-overview/herbal-medicinal-products/european-union-monographs-list-entries Accessed 10-Sept-2026.
6. https://assets.hpra.ie/products/Human/34895/Public_AR_TR23157-007-001_26022021164323.pdf. Accessed 22 Sept 2026.
7. Gatt AR, Vella Bonanno P, Zammit R. Ethical considerations in the regulation and use of herbal medicines in the European Union. Front Med Technol. 2024 Jun 14;6:1358956. Doi: 10.3389/fmedt.2024.1358956. PMID: 38948354; PMCID: PMC11211540.
8. Budnitz DS, Shehab N, Lovegrove MC, Geller AI, Lind JN, Pollock DA. US emergency department visits attributed to medication harms, 2017–2019. JAMA. 2021 Oct 5;326(13):1299–1309. doi:10.1001/jama.2021.13844. PMID: 34609453; PMCID: PMC8493432.
9. Green JL, Dailey-Govoni T, Kalidindi SD, Vosburg SK. Prevalence of Over-the-Counter and Prescription Medication Use in the US. JAMA Netw Open. 2026 Feb 2;9(2):e2559479. Doi: 10.1001/jamanetworkopen.2025.59479. PMID: 41697701; PMCID: PMC12910390.
10. Stierman B, Couch CA, Gahche JJ, Mishra S. Dietary Supplement Use: United States, August 2021-August 2023. NCHS Data Brief. 2026 May;(561):10.15620/cdc/252445. doi: 10.15620/cdc/252445. PMID:42214109; PMCID: PMC13223879.
11. van Hunsel FPAM, van der Kooi D, van de Koppel S, Kroes BH, Woerdenbag HJ. Analysis of Reports on Adverse Drug Reactions Related to Herbal Medicinal Products and Herbal Supplements in the Netherlands Received by the National Pharmacovigilance Centre Lareb. Drug Saf. 2022 Jun;45(6):651-661. doi: 10.1007/s40264-022-01180-5. Epub 2022 May 24. PMID: 35608783.
12. https://www.lareb.nl/en/pages/about-lareb Accessed 21 Sept 2026.
13. Frank C, Himmelstein DU, Woolhandler S, Bor DH, Wolfe SM, Heymann O, Zallman L, Lasser KE. Era of faster FDA drug approval has also seen increased black-box warnings and market withdrawals. Health Aff (Millwood). 2014 Aug;33(8):1453-9. doi: 10.1377/hlthaff.2014.0122. PMID: 25092848.