Harshbarger Introduces Legislation to Fix Outdated FDA Drug Preclusion Rules, Protect Access to Dietary Supplements
Washington, D.C. — Congresswoman Diana Harshbarger (R-TN) today introduced the Dietary Supplement Innovation Act, legislation that modernizes the Food and Drug Administration’s (FDA) drug preclusion provision to establish regulatory certainty, ensure pharmaceutical innovation, and support consumer access to dietary supplements.
“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.”
“Representative Harshbarger has introduced exactly the kind of thoughtful, balanced legislation this issue has needed for years,” said Steve Mister, President & 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 evenhanded, transparent, or 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.”
“We applaud Representative Harshbarger for introducing this important legislation, which modernizes an outdated provision of law, provides much-needed regulatory certainty, and helps ensure consumer access keeps pace with innovation,” said Consumer Healthcare Products Association (CHPA) President and CEO Scott Melville.
Secret investigational drug filings and indefinite preclusion based on abandoned pharmaceutical research have created significant uncertainty for manufacturers. The Dietary Supplement Innovation Act would establish clear standards for when preclusion applies, maintain incentives for pharmaceutical innovation, protect longstanding supplement ingredients from being retroactively pulled, and create a transparent, science-based process for FDA review.
Specifically, the bill:
Protects grandfathered ingredients: Preserves ingredients that were marketed in food or dietary supplements before relevant drug approval or clinical development milestones.
Ends perpetual preclusion: Allows preclusion to expire when Phase 2 or 3 clinical investigations have been inactive or withdrawn for at least seven years, or when drug development has been publicly discontinued.
Creates FDA exception authority: Allows FDA to approve the use of an otherwise precluded drug or biological product in food or dietary supplements through an administrative order.
Establishes science-based standards: Requires FDA to consider differences in route of administration, dosage, concentration or composition, and safety when determining whether a drug and dietary supplement contain the same “article.”
Provides judicial review: Makes FDA warnings and other statements asserting a violation of drug preclusion immediately reviewable by a court and places the burden of proof on the federal government.
ADDITIONAL INFORMATION: