A district court in Utah today challenged part of the Food and Drug Administration's (FDA) ban on ephedra dietary supplements, telling the agency to revise its rulemaking as it applies to low-dose ephedra. The challenge to the FDA ban, brought by Nutraceutical International Corporation and its subsidiary Solaray, Inc., successfully argued that FDA could not use a risk/benefit approach under the Dietary Supplement Health and Education Act of 1994 (DSHEA) and that FDA's evidence did not support a ban on daily doses of ephedra dietary supplements containing 10 milligrams or less of ephedrine alkaloids.
It appears that at least temporarily, pending potential legal action by FDA in other districts, and including an appeal, that sales of low-dose ephedra dietary supplements of 10 milligrams would be permitted.
This ruling does not, however, alter laws established in some states prohibiting or restricting the sale of ephedra that were not repealed after FDA published its final rule. Therefore, a careful review of state and local laws must be considered prior to risking a national launch.
“I think it's important to remember that this decision does not undo state laws, nor does it alter the ban established by FDA in the federal rule against dosages in excess of 10 milligrams,” said David Seckman, NNFA's executive director and CEO. “It also requires FDA to act before there is a final determination that 10 milligrams is safe for use.”
FDA has the ability to appeal, and continues to have the authority to sue other companies in other districts under the existing final rule, which currently remains unchanged.
“An important effect of this decision is that it does challenge FDA's risk/benefit safety analysis as it was first applied in the case of ephedra. This has significant ramifications, as most in the industry agreed that such a test was inappropriate under DSHEA,” said Seckman.NNFA will continue to keep its members apprised of any developments as a result of this case and will publish a more detailed analysis in a future issue of NNFA Today.