Dietary Supplement Trades Applaud Legislation to Modernize Drug Preclusion Provision

September 9, 2026

WASHINGTON — The Consumer Healthcare Products Association (CHPA), American Herbal Products Association (AHPA), and Council for Responsible Nutrition (CRN) welcome today’s introduction 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.”

"We applaud Representative Harshbarger for introducing this important legislation, which modernizes an outdated provision of law, provides much-needed regulatory certainty, and helps ensure consumer access keeps pace with innovation," said CHPA President and CEO Scott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. 

“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.”

"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.

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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.

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 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.