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Trade groups welcome Dietary Supplement Innovation Act

The Dietary Supplement Innovation Act would revise federal rules on when drug-investigated ingredients can be marketed as dietary supplements.

Photo by Diana Polekhina / Unsplash

WASHINGTON — Three dietary supplement trade associations are backing newly introduced federal legislation aimed at changing how the Food and Drug Administration applies drug preclusion rules to dietary supplement ingredients.

The Consumer Healthcare Products Association (CHPA), American Herbal Products Association (AHPA) and Council for Responsible Nutrition (CRN) welcomed the introduction of the Dietary Supplement Innovation Act, H.R. 10336, by Rep. Diana Harshbarger of Tennessee. The bill would amend provisions governing when an ingredient investigated or approved as a drug can also be marketed as a dietary supplement.

The legislation would preserve access to ingredients marketed in foods or dietary supplements before Oct. 15, 1994, and clarify when drug preclusion applies to ingredients associated with discontinued or inactive drug development programs. It also would give FDA a pathway to permit both dietary supplements and drugs containing the same ingredient under specified circumstances.

“Ambiguous FDA standards can leave manufacturers without guidance and consumers guessing about which products are available,” said Harshbarger. “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.”

The trade groups said the changes could provide greater regulatory predictability for supplement manufacturers while maintaining protections for pharmaceutical research.

“We applaud Representative Harshbarger for introducing this important legislation, which modernizes an outdated provision of law, provides much-needed regulatory certainty, and helps ensure consumer access keeps pace with innovation,” said Scott Melville, CHPA president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

Graham Rigby, AHPA president and CEO, said clearer regulatory pathways are particularly important for botanical dietary supplements, while Steve Mister, CRN president and CEO, said the legislation seeks to establish more transparent and predictable rules for both the pharmaceutical and dietary supplement industries.

The associations said they plan to work with policymakers and other stakeholders as the legislation moves through Congress.

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