NPA To Supreme Court: Risk-Benefit Standard Would “Unravel” DSHEA
This article was originally published in The Tan Sheet
The National Products Association filed a brief with the Supreme Court April 6 in support of Nutraceutical Corp.'s petition for review of an appellate court decision upholding FDA's use of a risk-benefit standard to determine product adulteration
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Challenges to the risk-benefit analysis FDA applied in banning the use of ephedra will continue following the Supreme Court's May 14 refusal to hear Nutraceutical Corp.'s appeal, according to the firm's attorney and to industry trade groups
"Nutritional supplements are not drugs and should not be regulated as such," Rep. Chris Cannon, R-Utah, said in response to inquiries about the possible review of the risk-benefit standard by the Supreme Court
An appellate court decision upholding FDA's ban of ephedra "will embolden FDA to challenge products that have a bad safety profile," according to Scott Bass, a food and drug law expert and partner at Sidley Austin (Washington, DC)