Born from one of the largest grassroots health movements in U.S. history, DSHEA preserves safe access to dietary supplements while upholding regulatory safeguards that protect consumers, science, and the future of health innovation.
In the early 1990s, a surge of public concern emerged as the FDA signaled its intention to regulate dietary supplements more stringently, potentially restricting access to familiar products such as vitamins, minerals, and herbal remedies. This apprehension galvanized a massive grassroots movement, resulting in over a million letters to Congress—a testament to the public’s demand for health freedom.
Responding to this outcry, Congress enacted the Dietary Supplement Health and Education Act (DSHEA) in 1994, championed by Senators Orrin Hatch and Tom Harkin. DSHEA established a distinct regulatory framework for dietary supplements, affirming consumer access while granting the FDA authority to act against unsafe or misbranded products.
A pivotal component, the “drug exclusion clause,” ensures that substances under active pharmaceutical investigation cannot be marketed as supplements, thereby safeguarding the integrity of scientific research and innovation. Today, as the supplement industry continues to evolve, preserving the Dietary Supplement Health and Education Act (DSHEA) remains crucial to maintaining a balance between consumer choice, public health, and scientific advancement.
More than two decades later, DSHEA remains the foundation of a $60 billion supplement industry that millions of Americans rely on every day. Yet this landmark law now faces mounting threats—from legal efforts to weaken FDA authority to attempts that blur the line between supplements and pharmaceutical drugs. If these boundaries are compromised, it would endanger consumers, undermine scientific research, and harm responsible industry innovation. At a time of rapid scientific advancement and growing interest in health and wellness, DSHEA is more critical than ever. The DSHEA Preservation Alliance is dedicated to protecting and strengthening this vital law for today’s needs and tomorrow’s breakthroughs.
Contrary to misconceptions, DSHEA does not eliminate regulation—it reinforces the FDA’s role in protecting public health. The law gives the FDA clear authority to take action against products that are unsafe, adulterated, misbranded, or sold without proper notification. Preserving DSHEA allows the FDA to focus on enforcement where it matters most, while resisting pressure from groups seeking to exploit legal gray areas or push unlawful ingredients onto the market.
We safeguard the integrity of DSHEA by defending its legal framework, preserving consumer access to trusted supplements, and protecting the boundary between dietary supplements and pharmaceuticals.
We inform lawmakers, regulators, the media, and the public about DSHEA’s purpose, its role in public health, and the risks of undermining its enforcement.
We work with policymakers and regulatory agencies to ensure DSHEA is lawfully upheld, FDA authority is respected, and science-based policy remains the foundation of supplement regulation.
The DSHEA Preservation Alliance, invites stakeholders from across the health, research, and regulatory communities to join us in preserving the Dietary Supplement Health and Education Act (DSHEA). Your partnership supports our efforts to defend the integrity of DSHEA, promote lawful FDA enforcement, and protect the boundaries between supplements and pharmaceuticals.
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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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