DSHEA has long served as the legal foundation for safe access to dietary supplements and a clear separation between supplements and pharmaceutical drugs. But today, that framework is under increasing strain. From lawsuits challenging FDA authority to efforts that erode scientific boundaries, these emerging threats jeopardize consumer safety, research integrity, and lawful industry standards. Understanding these six critical issues is essential to defending the future of DSHEA.
Efforts to commercialize drug-researched ingredients as supplements threaten DSHEA’s drug exclusion clause, which preserves scientific integrity and protects innovation from being undercut.
Legal actions are being used to challenge FDA decisions under DSHEA, attempting to force policy reversals and set precedents that weaken regulatory enforcement and statutory clarity.
Some products are being sold as supplements without safety notification or FDA review, bypassing DSHEA’s premarket requirements and risking consumer trust and industry credibility.
Interest groups are urging FDA to allow exceptions beyond the law, pressuring the agency to abandon DSHEA’s legal structure in favor of politically driven enforcement discretion.
Attempts to blur the line between supplements and pharmaceuticals dilute DSHEA’s core protections, creating confusion and weakening oversight of health-related consumer products.
Allowing supplement claims on drug-researched compounds removes the incentive for companies to invest in rigorous drug development, risking long-term innovation and public benefit.
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The DSHEA Preservation Alliance is dedicated to defending the integrity of the Dietary Supplement Health and Education Act (DSHEA). We advocate for lawful FDA enforcement, protect the legal distinction between supplements and drugs, and promote regulatory clarity that supports innovation, safety, and consumer trust. Through education, outreach, and policy engagement, we work to preserve the framework that empowers responsible access to supplements and protects public health.
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