The landscape of natural health products is undergoing a significant shift, with botanical drugs emerging from decades of relative obscurity to capture the attention of legislators and regulatory bodies. This renewed focus, exemplified by the introduction of the Advancing Botanical Drug Development Act by Congresswoman Lauren Boebert (R-CO) in late August, signals a potential revitalization for a category long overshadowed by the booming dietary supplement market. The proposed legislation seeks to introduce crucial intellectual property (IP) protections, a move designed to incentivize research and investment in a sector that has struggled to gain traction since its framework was established by the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) in 2006.
While both botanical drugs and dietary supplements are derived from plant materials, their regulatory pathways and intended uses are fundamentally different. Dietary supplements are regulated as food products, intended to supplement the diet and support general well-being. Botanical drugs, conversely, undergo the rigorous drug approval process, akin to conventional pharmaceuticals, to diagnose, treat, or prevent specific diseases. The Advancing Botanical Drug Development Act proposes a 12-year market exclusivity period for developers of botanical drugs, a significant incentive aimed at overcoming the substantial financial and time investment required for clinical trials and regulatory approval. This initiative is not intended to lower the stringent scientific and clinical standards that define drug development. As Congresswoman Boebert emphasized in a press release announcing the bill, "Botanical drugs are FDA-approved medicines, not dietary supplements." This distinction is critical and underscores the bill’s objective to elevate, not dilute, the status of these plant-derived therapeutics.
The FDA has also signaled its engagement with the botanical drug sector. A week after the introduction of the congressional bill, the agency announced the opening of a public docket to gather insights and assess the current state of botanical drug development. This comment period, extending through November 3, 2026, follows a series of proactive steps, including a roundtable discussion hosted by the FDA’s Reagan-Udall Foundation. Furthermore, a joint workshop with the European Medicines Agency (EMA) is scheduled for September 25, 2026, to share knowledge and explore regulatory approaches to challenges faced in the European Union. Dr. Marta Sokolowska, Ph.D., Deputy Center Director for Substance Use and Behavioral Health at CDER, highlighted the potential of this sector, stating, "Given that many people use botanicals for self-treatment, botanical drug products represent an area where greater scientific development could create new opportunities for patients." This statement reflects an acknowledgment of the public’s interest in plant-based therapies and the FDA’s role in fostering scientifically sound advancements.
The Limited Landscape of Approved Botanical Drugs
The journey to FDA approval for botanical drugs has been notably arduous, with only four products successfully navigating the New Drug Application (NDA) or Biologics License Application (BLA) pathways in the United States. These include Veregen, a topical treatment for genital warts derived from sinecatechins found in green tea. Mytesi and Fulyzaq, both used to manage non-infectious diarrhea in HIV patients, utilize crofelemer, a compound extracted from the dragon’s blood tree. NexoBrid, a biologic derived from pineapple stems, aids in the removal of dead tissue in burn patients. Finally, Filzuvez, containing birch bark extracts, is indicated for the treatment of wounds associated with epidermolysis bullosa.
These approvals, dating back over a decade, highlight the slow pace of innovation in this category. For context, Qutenza, a topical capsaicin treatment for neuropathic pain, received marketing authorization from the EMA in 2009, predating some of the U.S. approvals. While other botanicals like psyllium and witch hazel have achieved over-the-counter (OTC) status under established monographs, these are typically for less complex indications and do not undergo the same level of clinical scrutiny as prescription botanical drugs.
Industry experts have voiced concerns about the limited number of approvals and the nature of the existing botanical drugs. Roy Upton, founder, president, and editor of the American Herbal Pharmacopoeia (AHP), commented, "Considering there are only four approved botanical drugs over 20 years of the category’s existence, I wouldn’t call that a lot of interest. None of these are really botanicals. These are botanical isolates approved for uncommon indications." This perspective suggests that the current approved products may not fully represent the broad potential of whole-plant or complex botanical extracts in treating a wider range of conditions.
European Precedents and Lessons Learned
The European Union, while offering a specific marketing authorization for plant-derived drugs, has seen limited uptake of this pathway. The high clinical requirements and associated costs present significant barriers, leading many companies to opt for the more prevalent food supplement and Traditional Herbal Registration (THR) schemes. Dr. Joerg Gruenwald, founder and chief scientific advisor of Analyze & Realize GmbH, a research and consulting firm, observed, "The supplement category is growing faster in Europe, with lots of new products and innovations. In comparison, herbal drugs are much more stagnant."
The stagnation in the EU’s botanical drug sector underscores the challenges inherent in developing plant-derived medicines. The rigorous demands of the drug pathway, coupled with substantial investment needs and lengthy registration processes, can deter potential developers. Gruenwald added, "I support all initiatives that try to develop better regulations for herbal drugs. The drug pathway has tough requirements, high investment costs, and a long process for registration. Whether in the US or EU, it will take a lot of money and government support to open an important avenue like this." This sentiment suggests that regulatory reform, coupled with financial and governmental backing, could be instrumental in stimulating growth.
Asymmetric Political Currents and the "Medicalization" Trend
The current legislative efforts in the U.S. indicate a growing governmental interest in supporting botanical drugs, positioning them favorably within the broader regulatory landscape. This development occurs against a backdrop of ongoing discussions within the dietary supplement industry concerning regulatory modernization. Key areas of focus for supplement stakeholders include mandatory product registration, expanded access to Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA), federal uniformity in regulation, and the process for self-affirmed Generally Recognized As Safe (GRAS) status.
The burgeoning attention on botanical drugs suggests that regulatory modernization efforts might extend to both the supplement and drug categories, particularly for ingredients that could potentially serve dual roles. A statement from Acting FDA Commissioner Kyle Diamantas during the Trump administration, cited in an FDA press release, articulated this sentiment: "Under the Trump Administration, we are committed to modernizing regulatory frameworks to ensure promising, natural health options are evaluated through rigorous science." Diamantas further stated, "Botanical drug products represent a critical area where greater scientific development can unlock new therapeutic opportunities for American patients while maintaining the highest safety standards."
The inherent complexities of botanical formulations—the variability of plant materials, batch-to-batch consistency challenges, and the intricate nature of multi-ingredient compounds—will continue to be significant hurdles regardless of whether they are pursued as supplements or drugs. However, the increased scrutiny from lawmakers like Rep. Boebert and the FDA’s active engagement could indeed catalyze innovation across both domains.
This evolving regulatory environment also reflects a broader trend toward the "medicalization" of certain aspects of the supplement industry. As specific botanical compounds and formulations gain attention for their potential therapeutic effects, the lines between supplementing the diet and treating medical conditions begin to blur. This raises fundamental questions about the definition and scope of dietary supplements. Are they intended as food ingredients offering synergistic benefits in small doses, or are they becoming high-potency isolates designed to exert more drug-like impacts on human health?
Leading industry trade associations have actively advocated for a more expansive definition of dietary supplements, one that moves beyond the traditional food-use requirements stipulated by the FDA. However, the ultimate resolution of these definitional debates remains uncertain. The potential for increased U.S. government support for botanicals, whether as drugs or supplements, is likely to further complicate and potentially blur these distinctions.
Roy Upton of the AHP points to a fundamental definitional challenge: "Unfortunately, in the US, there does not appear to be a threshold where a supplement crosses over into the drug world. Internationally, a traditional medicine is defined predominantly as a Galenic preparation, and relatively pure compounds are restricted to conventional drug categories. I don’t know if this is an emerging trend, but it is a foundational, definitional problem within DSHEA [Dietary Supplement Health and Education Act of 1994]." This highlights the ongoing debate about how to classify and regulate products derived from natural sources, particularly as scientific understanding and market demand evolve.
The Advancing Botanical Drug Development Act represents a significant legislative effort to address the long-standing challenges in the botanical drug sector. By proposing IP protections and fostering a clearer regulatory pathway, the bill aims to stimulate investment and research. This initiative, coupled with the FDA’s increased engagement, suggests a potential turning point for botanical medicines, offering a glimpse into a future where scientifically validated plant-derived therapies play a more prominent role in healthcare. The success of these endeavors will likely depend on sustained governmental support, robust scientific research, and a clear, consistent regulatory framework that acknowledges the unique characteristics of botanical products.
