Tuesday, March 3, 2009

Environmental attorney Sanders says GAO's latest report hammers FDA's inept handling of dietary supplements; FDA needs strong reform measures.

Add dietary supplements to the growing list of products the struggling Food and Drug Administration is failing to regulate. The Government Accountability Office reported to Congress that the FDA does not have even the most fundamental information to protect the public from hazardous supplements.

The factual bases for GAO’s report against FDA on this subject matter are simply astonishing to the reader. For example, the FDA does not have an accurate inventory of the supplement ingredients on store shelves. FDA doesn't have information on the potential serious adverse reactions to dietary supplements.

More appalling, the GAO found that the FDA does not have a list of the names and locations of herbal supplement manufacturers. And several substances banned overseas are readily available on the Internet and in retail stores all over the U.S. even though the supplements are variously linked to kidney damage, liver damage, seizures, and death.

It is well past time to reform the FDA. Its mission is apparently too complex and too burdensome for the agency to handle. Perhaps more concerning to us is FDA’s openly cozy relationship with the regulated community. In short, FDA is not competently carrying out its true mission of protecting the American public. Hello Washington, we have a problem.

GAO's report can be read at http://cspinet.org/new/pdf/final_gao_dietary_supplements_report.pdf.