Dietary Supplement Safety: a 25 Year Retrospective Assessment

Oxford Conference Center - Auditorium

Passage of the Dietary Supplement Health & Education Act (DSHEA) in 1994 ushered in a new category of consumer products known as dietary supplements (DS). DSHEA’s definition of a dietary supplement encompasses a wide variety of products from multivitamins and single-ingredient botanical extracts, to “proprietary blends” of multiple botanical extracts and/or vitamins and minerals. Almost from their inception, safety concerns regarding certain categories of “proprietary blends” have plagued the DS industry. Most notable of these involved Ephedra-containing DS, whose questionable safety record led to their removal from the U.S. market in 2004 by the FDA after a 10-year period of public outcry and legal wrangling. Since that time other “proprietary blends” have come under scrutiny by the medical community for potential adverse health effects. While the vast majority of DS appear to have excellent safety profiles, others remain doubtful. Over the course of 25 years, much has changed in the DS industry. Today, thanks to internet marketing and easy access to a global supply chain, the once fledgling DS industry is now a multi-billion-dollar entity supplying tens of thousands of DS to the world market. The rapid evolution of the DS industry has brought with it a host of new concerns (e.g., adulteration, contamination, misbranding, drug interactions, toxicity from ill-advised proprietary blends, and others). The question now is, does DSHEA’s approach to safety, as written in its original form, remain a reasonable expectation for the DS industry, the FDA, and the consuming public? This panel will discuss DSHEA’s applicability in today’s rapidly evolving DS domain and examine what steps, if any, are necessary to render it more effective from a safety perspective.