Congresswoman Diana Harshbarger Introduces Legislation to Bring Transparency to Drug Preclusion

Congresswoman Diana Harshbarger (R-TN) introduced the Dietary Supplement Innovation Act, which seeks to address issues related to the drug preclusion provision of the Dietary Supplement Health and Education Act (DSHEA), which has been criticized heavily by the industry for many years.

Under DSHEA, the drug preclusion provision dictates that if a substance was first approved or authorized for investigation as a drug, and wasn’t already marketed as a dietary ingredient, it can’t be sold in dietary supplements.

Under current law, however, when a substance is approved as an investigational new drug (IND), the company that made the IND request isn’t required to notify the public, so brands have no way of knowing if a substance they’re marketing as a dietary ingredient is considered to be an investigational new drug by FDA.

Moreover, how FDA decides whether “substantial clinical investigations” have been conducted on an ingredient has drawn criticism in the cases of certain dietary ingredients that FDA has gone on to determine to be precluded.

  Because of these ambiguities, several ingredients have been declared by FDA to be precluded from use in dietary supplements after being marketed as dietary ingredients for many years. Some key examples include NMN, NAC, CBD, and red yeast rice.

Creating Certainty

The new legislation seeks to establish regulatory certainty, support pharmaceutical innovation, and maintain consumers’ access to dietary supplements, Harshbarger stated.

The bill would establish clearer standards for when preclusion applies, maintain incentives for pharmaceutical innovation, protect longstanding supplement ingredients from being retroactively pulled, and create transparency around FDA’s review process.

More specifically, the bill:

• Protects grandfathered substances that were marketed as dietary ingredients before specific drug approval and clinical development milestones.
• Allows preclusion to expire when Phase 2 or 3 clinical investigations have been inactive or withdrawn for at least seven years, or if drug development has been publicly discontinued.
• Gives FDA authority to make exceptions to the preclusion rule through an administrative order.
• Requires FDA to consider routes of administration, dosage, concentration, composition, and safety when determining if a drug and a dietary supplement are the same “article.”
• 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.

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

Resounding Endorsement

“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 evenhanded, transparent, and 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 Scott Melville, president and CEO of Consumer Healthcare Products Association (CHPA).

“Botanical dietary supplement innovation depends on clearly defined pathways that allow safe herbs and natural products to reach consumers,” said Graham Rigby, president and CEO of the American Herbal Products Association (AHPA). “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.”