February 14 , 2006
"Appeal On Ephedrine Ban Is Limited"
After a decision by the Food and Drug Administration to ban the drug ephedrine, a federal appeals court will allow manufacturers to challenge the FDA's ban. These lawsuits brought on by manufacturers were filed in New Jersey, Florida and Utah.
Ephedrine is a drug that has been used in popular dietary supplements and for weight loss aides. Serious effects included cardiac arrests, permanent brain damage, strokes, and hypertension. In 2004, the FDA found that these products posed “unreasonable risk” to consumers and were later linked to deaths among athletes. After the FDA prohibited distribution of products that contained ephedrine alkaloids, or ephedra, a ban was decided.
Following this ban, manufacturers quickly challenged the FDA, claiming that it was exceeding its powers according to the Dietary Supplement Health and Education Act. After a long running dispute about how strictly dietary supplements should be regulated, congress passed the DSHEA and later established that the manufacturers' lawsuits are governed by the deferential standards of the Administrative Procedures Act.
The manufacturers argued that the FDA could easily avoid judicial review resulting in more regulations on dietary supplements rather than bringing individual enforcement actions. For the first case in New Jersey, U.S. District Judge Joel Pisano refused to issue an emergency injunction to lift the ban.
The appeals litigation will continue into the Florida and Utah cases with the cases limited to a review of the FDA's proceedings including their administrative record so that no additional evidence is presented. Also, in the new appeals litigation, the manufacturers are not entitled to present their own expert witnesses nor gather and present additional evidence.
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