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  AHPA submits comments on botanical drug development to FDA

  November 4, 2026 The American Herbal Products Association (AHPA) has submitted comments in response to a U.S. Food and Drug Administration (FDA) request for information regarding challenges and opportunities facing botanical drug development. In 2004, FDA published a botanical drug guidance intended to facilitate the approval of over-the-counter (OTC) and prescription drug products derived from or consisting of botanicals. Last updated in 2016, the guidance affords drug developers significant flexibilities, reflecting the complexities of botanical ingredients, including the opportunity to satisfy Phase 1 and 2 safety evidence requirements via a documented history of use. Since the release of this guidance, however, few botanical drugs have received new drug approvals. “The current botanical drug guidance provides a strong framework,” said AHPA President & CEO Graham Rigby. “But fulfilling the intended purpose of the guidance would require FDA to publicly communicate the availability and advantages of its approach to candidate botanical drug products. Further, realizing that purpose would require the agency to enhance institutional botanical expertise that can foster plant-based medicine candidates' progressing through the pipeline.” In its comments, AHPA emphasizes the utility of the current botanical drug framework and the distinct benefits of botanical drugs in the marketplace, while acknowledging that FDA could do more internally to support the pathway. AHPA's comments urge FDA to take further action to promote the pathway to candidate sponsors and potential investors, including by enhancing its internal expertise through hiring reviewers with botanical expertise, including qualified pharmacognosists. The comments also emphasize that botanical drugs ultimately serve a separate, complementary role in the health system alongside herbal dietary supplements.

  • Wednesday, November 4, 2026
  • | Posted by AHPA
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  AHPA, CRN, CHPA and UNPA Urge NIH to Preserve Independence of Office of Dietary Supplements

  October 26, 2026 Joint comments warn proposed reorganization could weaken scientific research, add bureaucracy and diminish an office Congress established to advance understanding of dietary supplements Four leading dietary supplement trade organizations are collectively urging the National Institutes of Health (NIH) to reconsider a proposed reorganization that would place the Office of Dietary Supplements (ODS) under the Office of Nutrition Research (ONR), warning that the change could undermine ODS's distinct congressional mandate, diminish its scientific reach, and create unnecessary bureaucratic barriers to advancing the science for dietary supplements. In joint comments submitted to NIH, the American Herbal Products Association (AHPA), Consumer Healthcare Products Association (CHPA), Council for Responsible Nutrition (CRN), and United Natural Products Alliance (UNPA) called for retaining ODS as a stand-alone office within NIH's Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), while pursuing stronger collaboration with ONR. The organizations emphasized that cooperation between the two offices is both desirable and achievable without reducing ODS's organizational standing or independence. The joint comments also connect the importance of sustained supplement research to the Administration's Make America Healthy Again (MAHA) priorities, which recognize the health benefits of select high-quality supplements as an area warranting scientific investigation. Congress established ODS under the Dietary Supplement Health and Education Act of 1994 (DSHEA) to advance scientific understanding of dietary supplements and their contributions to health. Its responsibilities also include serving as a principal advisor to senior federal health officials on dietary supplement issues. The associations expressed concern that placing ODS within ONR could narrow attention to the full range of scientific questions involving dietary supplements, particularly research involving botanicals, probiotics and other bioactive substances whose effects extend beyond conventional nutrient functions. They also emphasized the importance of protecting ODS's specialized scientific infrastructure, funding, and staffing to effectively fulfill its statutory mandate. The associations identified three central concerns with the proposed reorganization: Preserving ODS's congressional mandate. ODS was established to provide dedicated scientific leadership and advice on dietary supplements across the federal government. Adding another organizational layer could complicate those responsibilities and diminish its direct access to NIH leadership. Protecting the full breadth of supplement science. Research involving dietary supplements encompasses far more than nutritional deficiencies, including the biological effects of botanical ingredients and other substances, product quality, safety, efficacy and interactions with medications. Maintaining resources, accountability and scientific independence. The proposed restructuring raises unanswered questions about ODS's leadership authority, staffing, funding, research priorities and ability to coordinate scientific initiatives across NIH. Should NIH proceed with the proposed reorganization, the organizations urged the agency to first publish a detailed implementation plan for public comment that establishes clear safeguards for ODS's statutory mission, leadership authority, scientific priorities, funding, staffing, advisory responsibilities and public-facing resources. They also recommended a formal evaluation of the restructuring's effects within two years. The four associations concluded that strengthening collaboration—not diminishing ODS's standing—offers the most effective path forward. The full joint comments are available here. # # #   About the American Herbal Products Association (AHPA) Founded in 1982, the American Herbal Products Association (AHPA) is the national trade association and voice of the herbal products industry, representing growers, processors, manufacturers, and marketers of herbs and herbal products — including foods, dietary supplements, cosmetics, and non-prescription drugs — as well as companies providing expert services to the trade. AHPA champions the responsible and sustainable commerce of safe, high-quality herbal goods to ensure informed consumer access. Learn more at ahpa.org. About the Consumer Healthcare Products Association (CHPA) The Consumer Healthcare Products Association (CHPA), founded in 1881, is the national trade association representing the leading manufacturers and marketers of consumer healthcare products, including over-the-counter (OTC) medicines, dietary supplements, and OTC medical devices. CHPA is committed to empowering self-care by ensuring that Americans have access to products they can count on to be reliable, affordable, and convenient, while also delivering new and better ways to get and stay healthy. Visit www.chpa.org. About the Council for Responsible Nutrition (CRN) The Council for Responsible Nutrition (CRN), founded in 1973 and based in Washington, D.C., is the leading trade association representing the dietary supplement and functional food industry. Bringing together manufacturers, ingredient suppliers, and service providers, CRN unites its member companies around a shared commitment to science, transparency, and responsible business practices—advancing a strong, credible marketplace that supports consumer health and industry growth. In an increasingly complex regulatory and media environment, CRN serves as the industry's front line—shaping science-based policy, defending market access, and countering misinformation. Through strategic advocacy, self-regulatory leadership, voluntary guidelines, and evidence-based communications, CRN ensures that responsible companies are recognized, protected, and positioned to innovate and compete. Learn more at crnusa.org and follow @CRN_Supplements on X and LinkedIn. About the United Natural Products Alliance (UNPA) The United Natural Products Alliance (UNPA) is a premier trade association dedicated to advancing global natural health products. With a commitment to quality, science, and innovation, UNPA collaborates with industry leaders, government agencies, and stakeholders to promote responsible business practices and advocate for standards that ensure consumer safety, access to reliable health information and trained health practitioners. Through education, research, and advocacy, UNPA along with its members and partners foster industry excellence and leadership that drive growth and integrity in the natural health products community. UNPA serves as a unifying voice, to honor the dietary supplement industry's history, advance the science and protect the health freedom of our consumers. For more information, visit www.unpa.com.

  • Monday, October 26, 2026
  • | Posted by AHPA
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  Applications now open for inaugural Michael McGuffin Endowment awards

  October 20, 2026   The American Herbal Products Association (AHPA) is pleased to announce that applications for the inaugural cycle of Michael McGuffin Endowment points-based awards officially open today, October 20, 2026. The Michael McGuffin Endowment Fund was established to honor the legacy of herbal champion and longtime AHPA President Michael McGuffin and provide lasting financial support for critical AHPA initiatives, including advocacy, education, and research benefiting the herbal products industry. The fund is operated and managed by the AHPA Foundation for Education and Research on Botanicals (AHPA ERB Foundation), a 501(c)(3) nonprofit organization founded by McGuffin in 1997 and dedicated to advancing botanical education and research. Administered by the AHPA ERB Foundation, Michael McGuffin Endowment points-based awards provide financial support and opportunities for individuals, companies, and organizations working in, advocating for, or otherwise benefiting the herbal products industry. This launch marks the first of multiple award cycles that will be held periodically. Applications are evaluated using a structured points system based on project impact, feasibility, alignment with the Endowment's mission, and demonstrated need. For this initial points-based award cycle, it is estimated that one or more awards up to a total of $5,000 will be distributed. The AHPA ERB Foundation anticipates the availability of larger awards as the Endowment program matures. Funding is directed toward individuals, small businesses, growers, wild harvesters, manufacturers, researchers, educators, and emerging leaders who demonstrate financial need and a commitment to the botanical community. Eligible proposals and submissions should focus on projects that align with the Endowment's mission to support the future and long-term viability of the herbal community — including, but not limited to: Research or documentation projects Supply chain sustainability initiatives Regulatory or quality work Mentorship or training AHPA membership is not a requirement to apply. Applications for this cycle will be accepted through November 20, 2026. AHPA and the AHPA ERB Foundation extend our thanks to those who have contributed to the Michael McGuffin Endowment Fund, and we invite those who wish to honor Michael's legacy and help provide opportunities for future generations of herbal advocates to make a tax-deductible donation to the fund at any time.

  • Tuesday, October 20, 2026
  • | Posted by AHPA
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  FDA releases Identity & Safety section of NDIN guidance

  October 19, 2026 The U.S. Food and Drug Administration (FDA) has released a final guidance addressing the role of identity and safety information requirements in new dietary ingredient notifications (NDINs). This publication finalizes Section VI of the overarching FDA NDIN draft guidance, continuing a piecemeal approach the agency has used since issuing its last omnibus revision in 2016. AHPA submitted extensive comments to the 2016 draft guidance, including regarding several elements of Section VI. As it is focused on the elements required in an NDIN and not the circumstances giving rise to the overall NDIN requirement, this publication does not address underlying questions concerning the scope of “chemical alteration" which are a focus of material in Section IV and have yet to be finalized. AHPA staff are reviewing changes made in the final guidance and will communicate their findings to the broader membership. The contents of this final guidance section will be the subject of discussion at the upcoming AHPA Government Relations Committee meeting on Tuesday, October 27, being held in-person at SupplySide Global and virtually on Zoom. AHPA members interested in the ramifications of the final guidance and discussion of the potential comments and further advocacy on its subjects are encouraged to attend.

  • Monday, October 19, 2026
  • | Posted by AHPA