FDA vs. Ephedra: Dietary Supplement Regulation Under DSHEA
Jones, Adam R.
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CitationFDA vs. Ephedra: Dietary Supplement Regulation Under DSHEA (2002 Third Year Paper)
AbstractThe Dietary Supplement Health and Education Act of 1994 (DSHEA) dramatically changed the way dietary supplements are regulated in the United States. DSHEA created a new category of products defined as â€œdietary supplements,â€ and altered the way in which these products are regulated in an attempt to promote consumer access to dietary supplements. By weakening the FDAâ€™s regulatory control of dietary supplements, DSHEA made it impossible for the FDA to insure the safety of dietary supplements sold in the United States. DSHEA allows most supplements to enter the market without first being tested for safety, and once on the market, DSHEA makes it very difficult for the FDA to remove potentially dangerous dietary supplements. The FDAâ€™s inability to insure the safety of dietary supplements under DSHEA is exemplified by its failed efforts to place tighter restrictions on the sale of dietary supplements containing ephedra alkaloids (ephedra or ephedrine). Despite mounting evidence that supplements containing ephedra alkaloids may be responsible for serious injury and death, the well-funded and politically-connected ephedra industry has successfully fought off all FDA efforts aimed at imposing tighter regulations on ephedra supplements. Changes to existing law, including pre-market testing, mandatory reporting of adverse events, and accurate content labels are necessary if the FDA is to fulfill its goal of policing consumer safety.
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