07.01.07
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…The firm appealed FDA’s application of a risk-benefit standard in banning the use of ephedra because such a standard is not included in the Dietary Supplement Health and Education Act, which created FDA’s regulatory scheme for supplements.
Because a risk-benefit approach is primarily used in the evaluation of pharmaceuticals and not for supplement products, it may become a key area for challenges on possible future FDA regulatory action regarding supplements, [Nutraceutical’s attorney Jonathan] Emord [of Emord & Associates] said…Council for Responsible Nutrition president Steve Mister said applying this standard in a decision on another ingredient could set the stage for more challenges, but FDA is unlikely to apply it.
“I can’t rule out that they would never do it, but the margin for safety of our products for the most part is quite large. Ephedra is sort of a unique issue,” Mister said…The Natural Product Association (NPA) had filed an amicus brief with the Supreme Court to support Nutraceutical’s argument against FDA’s use of a risk-benefit standard, but pointed out it did not contest the agency’s ban of ephedra. The association continues to oppose FDA’s use of a risk-benefit standard in the ephedra ruling and is concerned the agency will apply the standard when considering the safety of other dietary supplement products.
—Robert Mitchell, The Tan Sheet, 5/21/07
Because a risk-benefit approach is primarily used in the evaluation of pharmaceuticals and not for supplement products, it may become a key area for challenges on possible future FDA regulatory action regarding supplements, [Nutraceutical’s attorney Jonathan] Emord [of Emord & Associates] said…Council for Responsible Nutrition president Steve Mister said applying this standard in a decision on another ingredient could set the stage for more challenges, but FDA is unlikely to apply it.
“I can’t rule out that they would never do it, but the margin for safety of our products for the most part is quite large. Ephedra is sort of a unique issue,” Mister said…The Natural Product Association (NPA) had filed an amicus brief with the Supreme Court to support Nutraceutical’s argument against FDA’s use of a risk-benefit standard, but pointed out it did not contest the agency’s ban of ephedra. The association continues to oppose FDA’s use of a risk-benefit standard in the ephedra ruling and is concerned the agency will apply the standard when considering the safety of other dietary supplement products.
—Robert Mitchell, The Tan Sheet, 5/21/07