Most are familiar with those commercials on television promoting prescription drugs that supposedly offer relief from a variety of ailments, if one would only pressure ones doctor to obtain them. They have become a source of great entertainment and amusement to some, the kicker coming at the end of each commercial when the FDA-approved medications obligatory litany of warnings and dangerous side effects is recited: Tell your doctor if…. and Side effects may include….. Some of the warnings are mild like diarrhea and constipation, some list serious effects like cancer or tuberculosis, and others admit that sometimes even death can result.
The point here is that these are all FDA-approved drugs being advertised and used extensively. Drugs that can cause serious diseases like lymphoma. Drugs that can kill. The FDAs dismal safety record is well documented; even PBS ran a Frontline special that investigated and exposed the FDAs unsafe drug record, the influence of Big Pharma inside the FDA, and lack of long-term testing and medical review of many, many dangerous drugs. The FDA seldom removes a drug from the market even after it proves to be harmful or deadly, however they do post quarterly reports with details of the latest potentially dangerous side effects of drugs currently under investigation.
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Nonetheless, Senator John McCain (R-Ariz.) wants this same FDA, with its dismal safety record, to regulate dietary supplements. The Dietary Supplement Safety Act (DSSA), S. 3002 (text of this bill posted on Senator McCain’s website), that McCain has introduced with one cosponsor, would repeal key provisions of the Dietary Supplement Health and Education Act (DSHEA) to more effectively regulate dietary supplements that may pose safety risks unknown to consumers.
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Under attack by the DSSA is the once-protected field of supplements, as they have always been considered food. Potencies would have to be reduced to comply with what appears to be a plan modeled after the European Food Safety Authority. A new list of Accepted Dietary Ingredients would be prepared, published, and maintained by the Secretary, in the future. Thats a bit like being handed a blank check and told to fill it out later as one wishes. It could certainly be used to severely limit access to, and even production of, hundreds of life-sustaining and essential mineral, herb, and vitamin products.
All ingredients contained in each supplement would have to be disclosed at the time the company registers all of its manufactured, packaged, held, distributed, labeled or licensed, products with the FDA. An onerous burden would be placed on the shoulders of suppliers and retailers of dietary supplements, as they would have to obtain written evidence from the seller that the product is registered as required by law, and keep that documentation on file. Monetary penalties for non-compliance may, in addition to other penalties imposed in this section, be fined not more than twice the gross profits or other proceeds derived from the manufacture, packaging, holding, distribution, labeling, or license of such dietary supplement. Those are very broad dictates and most likely subject to even broader interpretation.
February 26, 2010