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  AHPA welcomes introduction of Dietary Supplement Innovation Act

  Newly introduced legislation modernizes drug preclusion framework to foster innovation and protect consumer access September 10, 2026 The American Herbal Products Association (AHPA) welcomes the introduction of the Dietary Supplement Innovation Act by Representative Diana Harshbarger (R-TN). This critical legislation clarifies and modernizes the drug preclusion provision of the Dietary Supplement Health and Education Act (DSHEA), establishing greater regulatory certainty while preserving consumer access to safe dietary supplement ingredients. Ambiguity surrounding the interaction between drug development and dietary supplements has long created unnecessary impediments to industry innovation. This new legislation addresses these challenges by clarifying when drug preclusion applies, ensuring that discontinued or inactive drug development programs do not permanently block ingredients from the dietary supplement market. It also ensures that the U.S. Food and Drug Administration (FDA) can never again attempt to use the provision to remove ingredients that existed in the dietary supplement market prior to DSHEA's enactment. Furthermore, the bill strikes an appropriate balance between protecting pharmaceutical research incentives and allowing consumer access to new dietary supplements, avoiding costly disputes while providing FDA a predictable pathway to resolve issues through an administrative order when appropriate. “Botanical dietary supplement innovation depends on clearly defined pathways that allow safe herbs and natural products to reach consumers,” said AHPA President & CEO Graham Rigby. “Representative Harshbarger's legislation would help restore the balance Congress intended under DSHEA and better ensure that drug development does not unnecessarily foreclose dietary supplement innovation. AHPA applauds Representative Harshbarger for her leadership and urges Congress to advance this important legislation as a key plank of modernizing the Federal Food, Drug, and Cosmetic Act's robust dietary supplement provisions.” Alongside the Consumer Healthcare Products Association (CHPA) and the Council for Responsible Nutrition (CRN), AHPA supports this legislation and will continue working closely with congressional leaders, regulatory agencies, and industry partners to advance a modern, science-based regulatory framework that fosters innovation, provides regulatory certainty, and preserves consumer access to trusted products.

  • Thursday, September 10, 2026
  • | Posted by AHPA
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  Dietary Supplement Trades Applaud Legislation to Modernize Drug Preclusion Framework

  September 10, 2026 The American Herbal Products Association (AHPA), Consumer Healthcare Products Association (CHPA), and Council for Responsible Nutrition (CRN) welcome today's introduction of the Dietary Supplement Innovation Act, by Rep. Diana Harshbarger (TN-01) to clarify and modernize the Dietary Supplement Health and Education Act's (DSHEA's) drug preclusion provision, providing greater regulatory certainty while preserving consumer access to safe dietary supplement ingredients. “Ambiguous FDA standards can leave manufacturers without guidance and consumers guessing about which products are available,” said Congresswoman Diana Harshbarger. “For decades, this broken drug preclusion process has allowed Washington bureaucrats to threaten lawful dietary supplements that have safely been purchased over the counter for years, stifling innovation and denying Americans access to products they already trust. My bill delivers the regulatory certainty manufacturers need to innovate and invest with confidence, while establishing transparency and predictability within the drug preclusion framework and preserving consumer access to dietary supplements.” “Botanical dietary supplement innovation depends on clearly defined pathways that allow safe herbs and natural products to reach consumers,” said AHPA President and CEO Graham Rigby. “Representative Harshbarger's legislation would help restore the balance Congress intended under DSHEA and better ensure that drug development does not unnecessarily foreclose legitimate dietary supplement innovation. AHPA applauds Representative Harshbarger for her leadership and urges Congress to advance this important legislation as a key plank of modernizing the Federal Food, Drug, and Cosmetic Act's robust dietary supplement provisions.” "We applaud Representative Harshbarger for introducing this important legislation, which modernizes an outdated provision of law, provides much-needed regulatory certainty, and helps ensure consumer access keeps pace with innovation," said CHPA President and CEO Scott Melville.  "Representative Harshbarger has introduced exactly the kind of thoughtful, balanced legislation this issue has needed for years," said Steve Mister, President and CEO of the Council for Responsible Nutrition. "This bill doesn't weaken FDA or undermine pharmaceutical innovation. Instead, it restores the balance Congress intended when it enacted DSHEA by creating transparent, predictable rules that allow both industries to innovate while protecting consumer access to safe dietary supplements. We commend Representative Harshbarger for her leadership and strongly urge Congress to advance this legislation."  The legislation would: Preserve access to ingredients that were marketed in foods or dietary supplements prior to Oct. 15, 1994. Clarify when drug preclusion applies, so ingredients involved in discontinued or inactive drug development programs are not blocked from the dietary supplement market forever. Provide greater regulatory predictability for manufacturers, researchers, and consumers. Help ensure that innovative ingredients are not unnecessarily excluded from the dietary supplement marketplace when no approved drug reaches the market. Strike an appropriate balance between protecting pharmaceutical research and allowing consumer access to new dietary supplements. Reduce costly and resource-intensive disputes by providing clearer rules regarding when drug preclusion applies. Streamline the pathway for FDA to allow both dietary supplements and drugs with the same ingredient at FDA's discretion under predictable rules and procedures. Recent consumer research found strong voter support for updating dietary supplement regulations and overwhelming agreement that dietary supplements positively impact health and wellness. The research also found broad support for reforms that strengthen innovation while maintaining consumer protections. The associations look forward to working with policymakers and stakeholders to advance a modern, science-based regulatory framework that fosters innovation, provides greater regulatory certainty, and preserves access to products that consumers trust.   ###   About American Herbal Products Association 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 Consumer Healthcare Products Association 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 consumer 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 Council for Responsible Nutrition 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.

  • Thursday, September 10, 2026
  • | Posted by AHPA
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  AHPA welcomes nomination of Dr. Heidi Overton for FDA Commissioner

  August 19, 2026 President Donald Trump has tapped Dr. Heidi Overton to serve as Commissioner of the Food and Drug Administration (FDA). Dr. Overton currently serves as Deputy Assistant to the President for Domestic Policy at the White House, focusing on health issues. She previously served as a White House Fellow during the first Trump administration and in leadership at the America First Policy Institute. She holds a medical degree from the University of New Mexico School of Medicine and a Ph.D. in Clinical Investigation from Johns Hopkins University. "AHPA supports Dr. Heidi Overton's nomination for FDA Commissioner,” said AHPA President & CEO Graham Rigby. “As a physician with a Ph.D. in Clinical Investigation, Dr. Overton has helped lead CBD policy at the White House Domestic Policy Council. In our engagement with her, AHPA has found her committed to strong scientific principles alongside a pro-innovation posture. When contributing to the development of policy for full-spectrum CBD products, she consulted not only scientific literature but also key industry resources, including the AHPA Hemp Lexicon. Her work on crucial hemp and CBD policy demonstrates a clear commitment to health, science, and patient access to health-promoting products. “We believe Dr. Overton's leadership will help protect consumer safety and foster innovation as the FDA considers industry input on critical issues — especially expanding the scope of dietary supplement ingredients, a topic on which AHPA and other industry representatives provided extensive comments at the agency's public meeting earlier this year,” Rigby added. AHPA looks forward to working closely with Dr. Overton and the agency on protecting consumer access to safe, high-quality dietary supplements and herbal products as well as advancing innovation backed by sound science.

  • Wednesday, August 19, 2026
  • | Posted by AHPA
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  FDA issues GRAS proposed rule; new substances would require notifications

  August 11, 2026 The U.S. Food and Drug Administration (FDA) has released a long-anticipated proposed rule to revise the pathway to market for food substances that qualify as Generally Recognized as Safe (GRAS). Per current regulations, a company may voluntarily notify FDA of a determination that a substance qualifies as GRAS under particular conditions of use, but FDA does not require submission of such notices. Under the new proposed rule, companies introducing a food substance into interstate commerce would be required to notify FDA of GRAS determinations and provide substantiation of GRAS status, generally in line with the current voluntary notification process. Among other proposed changes, FDA would have up to 360 days to respond to GRAS notices that the agency “files” after their submission. (FDA proposes to complete an initial “filing” determination within 45 days of submission.) FDA also proposes a time-limited, “streamlined” submission pathway for companies that previously introduced food substances pursuant to a self-GRAS determination. Available for a year from the effective date of any final rule, companies using this pathway would need to submit, among other elements, information on conditions of use along with evidence of presence in interstate commerce prior to the effective date of the final rule. The proposed streamlined pathway would not require submission of evidence substantiating that the subject substance qualifies as GRAS for its intended uses. FDA would include in a public database submissions made under both the proposed mandatory notification pathway and the transitional streamlined pathway. As of now, the comment period for the proposed rule will remain open through December 9, 2026. “AHPA welcomes FDA's embrace of GRAS as a pathway to market for food, including dietary supplement, ingredients with their publication of the proposed rule,” said AHPA President & CEO Graham Rigby. “Through continued engagement with FDA during this rulemaking process — including comment submission — AHPA will maintain its focus on ensuring the agency possesses the resources and specialized expertise necessary to ensure public access to herbal and botanical ingredients.”

  • Tuesday, August 11, 2026
  • | Posted by AHPA