Here’s the media headline:
“The Food and Drug Administration told the makers of one of the country's most popular cold medications, Zicam, to stop selling its nasal spray and swabs. In the last ten years, about 130 consumers have filed complaints, saying they permanently lost their sense of smell after using Zicam.”
Here’s the public health headline – It’s time to reform DSHEA.
In May 2007, 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
That ruling was good news for the public health -- but it raises the issue of why so-called "supplements" are regulated as food in the first place.
It was a good question in May 2007; it’s a crucial public health question in June 2009. As an advisor to President Obama’s FDA transition team I raised the issue of DSHEA and at a recent meeting with Drs. Hamburg and Sharfstein I raised it again.
Oftentimes it takes an event (such as the Zicam action) to drive legislative change. Hopefully this will be one such opportunity.
DSHEA -- It's time for a change.
“The Food and Drug Administration told the makers of one of the country's most popular cold medications, Zicam, to stop selling its nasal spray and swabs. In the last ten years, about 130 consumers have filed complaints, saying they permanently lost their sense of smell after using Zicam.”
Here’s the public health headline – It’s time to reform DSHEA.
In May 2007, 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
That ruling was good news for the public health -- but it raises the issue of why so-called "supplements" are regulated as food in the first place.
It was a good question in May 2007; it’s a crucial public health question in June 2009. As an advisor to President Obama’s FDA transition team I raised the issue of DSHEA and at a recent meeting with Drs. Hamburg and Sharfstein I raised it again.
Oftentimes it takes an event (such as the Zicam action) to drive legislative change. Hopefully this will be one such opportunity.
DSHEA -- It's time for a change.
