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A few months ago, I consulted on the medical case of a young man with an extremely low platelet blood cell count. The problem, which could have caused life-threatening bleeding, was suspected to be a medication side-effect. The patient had been diagnosed with inflammatory bowel disease and recently started on a standard and widely-used medication for that condition. But the issue was not so straightforward. At the same time that the treating doctors prescribed the drug, the patient also began self-medicating with a Chinese, multi-herbal preparation. Read More
"When it comes to herbal
"When it comes to herbal products, however, the FDA is severely impeded in what it can do to protect the public. This is no error of omission, but rather thanks to a specific piece of disenabling legislation, the Dietary Supplement Health and Education Act passed by Congress in 1994. Until that legislation is reversed, there is little proactively that the FDA can do."
Dr. Blanc,
Respectfully, I must disagree with the above statement, and inform you there is a clear disconnect in your facts. The FDA has, since December of 2008, had a serious adverse event reporting (sAER) system in place for supplements, thanks to the insistence of the dietary supplements industry and its trade groups and lobbying efforts. All manufacturers of dietary supplements are required by law to submit AERs they receive to the FDA via the MedWatch system. Doctors, practitioners and consumers all also have access to this system.
The FDA uses this system just as they do the one in place for drugs - as a signal generator. If there are several instances of reports regarding any substance, the FDA can determine an appropriate action based on this "signal".
DSHEA is only a problem when adequate enforcement is not conducted by the FDA. Though you are certainly entitled to your opinion, as a doctor and arguably someone who is perceived by many as an "expert" as such, it would be helpful and, more so, appropriate, for you to include facts with such charged statements as the one above.
FDA role
Adverse event reporting alone, unfortunately, is only one part of protection. Dietary supplements are exempt from a whole series of pre-marketing requirements.
DSHEA is not the problem
Dietary supplements have a long history of safe use. DSHEA was enacted to assure continued access to products that Americans have taken for decades. To classify them under the present drug model with pre-approval requirements for safety and efficacy would have removed them from the market with no adequate means for their approval. Neither appropriate expertise among the regulators or drug development money would be available to ensure their appropriate continued use.
DSHEA allowed products with no known safety issues to remain on the market while new ingredients have applicable regulations as a result of DSHEA. Supplements are not regulated as drugs nor should they be. FDA is on record stating that they have adequate tools at their disposal under DSHEA to take action when action is needed.
You may not like DSHEA Dr. Blanc, but it isn't right for the public to be deprived of the supplements that they have safely consumed for decades. It in disingenuous to characterize DSHEA as impeding FDA when it in fact created a category and provided FDA with adequate enforcement capabilities for it.
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