Absent in the debate over FDA reform is reform of DSHEA.
Yesterday, the Supreme Court rejected an appeal from a unit of Nutraceutical International Corp. to overturn a Food and Drug Administration ban on its ephedra dietary supplements.
Nutraceutical sued the FDA in 2004 to block the agency's action on ephedra, arguing it was abusing its authority and misusing federal regulations in order to take action on the dietary supplement, which is generally regulated more like a food than a drug.
A U.S. district court sided with Nutraceutical, Salt Lake City, but the 10th Circuit overturned that ruling.
"This case offers a key test of whether the FDA will be required to observe the statutory boundary between foods and drugs," Nutraceutical said in its appeal, arguing that the FDA never met the "burden of proof" necessary to force the supplements off the market. The company
This ruling is good news for the public health -- but it raises the issue of why so-called "supplements" are regulated as food in the first place.
The answer -- DSHEA. And it's time for a change.
Yesterday, the Supreme Court rejected an appeal from a unit of Nutraceutical International Corp. to overturn a Food and Drug Administration ban on its ephedra dietary supplements.
Nutraceutical sued the FDA in 2004 to block the agency's action on ephedra, arguing it was abusing its authority and misusing federal regulations in order to take action on the dietary supplement, which is generally regulated more like a food than a drug.
A U.S. district court sided with Nutraceutical, Salt Lake City, but the 10th Circuit overturned that ruling.
"This case offers a key test of whether the FDA will be required to observe the statutory boundary between foods and drugs," Nutraceutical said in its appeal, arguing that the FDA never met the "burden of proof" necessary to force the supplements off the market. The company
This ruling is good news for the public health -- but it raises the issue of why so-called "supplements" are regulated as food in the first place.
The answer -- DSHEA. And it's time for a change.
