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"Beware of McCain's Freedom - Destroying Dietary Supplement Regulatory Bill
Published:
Is McCain the pharmaceutical conglomerate's latest sock puppet?
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The Codex Alimentarius Commission, organized by the United Nations in the 1960s, is charged with “harmonizing” food and supplement rules between all nations of the world. Under Codex rules, even basic vitamins and minerals require a doctor’s prescription. The European Union already has adopted Codex-type regulations, regulations that will be in effect across Europe later this year. This raises concerns that the Europeans will challenge our relatively open market for health supplements in a WTO forum. This is hardly far-fetched, as Congress already has cravenly changed our tax laws to comply with a WTO order.
Like WTO, CAFTA increases the possibility that Codex regulations will be imposed on the American public. Section 6 of CAFTA discusses Codex as a regulatory standard for nations that join the agreement. If CAFTA has nothing to do with dietary supplements, as CAFTA supporters claim, why in the world does it specifically mention Codex?
Unquestionably there has been a slow but sustained effort to regulate dietary supplements on an international level. WTO and CAFTA are part of this effort. Passage of CAFTA does not mean your supplements will be outlawed immediately, but it will mean that another international trade body will have a say over whether American supplement regulations meet international standards. And make no mistake about it, those international standards are moving steadily toward the Codex regime and its draconian restrictions on health freedom. So the question is this: Does CAFTA, with its link to Codex, make it more likely or less likely that someday you will need a doctor’s prescription to buy even simple supplements like Vitamin C? The answer is clear. CAFTA means less freedom for you, and more control for bureaucrats who do not answer to American voters.
Pharmaceutical companies have spent billions of dollars trying to get Washington to regulate your dietary supplements like European governments do. So far, that effort has failed in America, in part because of a 1994 law called the Dietary Supplement Health and Education Act. Big Pharma and the medical establishment hate this Act, because it allows consumers some measure of freedom to buy the supplements they want. Americans like this freedom, however – especially the health conscious Baby Boomers.
This is why the drug companies support WTO and CAFTA. They see international trade agreements as a way to do an end run around American law and restrict supplements through international regulations.
The largely government-run health care establishment, including the nominally private pharmaceutical companies, want government to control the dietary supplement industry – so that only they can manufacture and distribute supplements. If that happens, as it already is happening in Europe, the supplements you now take will be available only by prescription and at a much higher cost – if they are available at all. This alone is sufficient reason for Congress to oppose the unconstitutional, sovereignty-destroying CAFTA bill."
July 19, 2005
Dr. Ron Paul is a Republican member of Congress from Texas.
http://www.lewrockwell.com/paul/paul261.html
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"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 one’s 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 medication’s 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 FDA’s dismal safety record is well documented; even PBS ran a Frontline special that investigated and exposed the FDA’s 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.
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.”
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. That’s 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.
The McCain bill would change existing mandatory serious adverse reporting regulations, requiring minor adverse effects to be reported as well so that the FDA could arbitrarily pull supplements off the shelves or reclassify them as drugs. This immediate recall authority would be granted to the “Secretary upon determination,” that there is a “reasonable probability” that the product is “adulterated” or “misbranded.” Adulterated in this bill takes on a whole new expanded definition: “A dietary supplement which contains a new dietary ingredient shall be deemed adulterated under section 402(f) unless there is a history of use or other evidence of safety.” The development of new products that contain newly discovered nutritional components may be entirely quashed.
The hypocritical contrast between the regulation of drugs that can kill and the proposed hyper-regulation for food products -- vitamins, minerals, herbs -- is as plain as the nose on everyone's face.
A Pandora’s box of intended and unintended legal complications and government harassment of nutritional supplement manufacturers and sellers could very well be unleashed if this bill is passed. There are already existing laws on the books that protect consumers from misbranded, fraudulent, or contaminated products. Granting the FDA additional regulatory authority over nutritional supplements seems a bit suspicious, especially considering the influence the enormous pharmaceutical industry has wielded over the research, development, and approval process inside the FDA. Let’s face it, the FDA has been no friend and often has been positively antagonistic toward the nutritional supplement industry. Therefore one wouldn’t set the wolf to guarding the sheep without dire consequences.
In this perverted overly-regulated country, food is now toxic, and drugs and chemicals are safe for ingestion, no matter the harm that results. This inversion should remind us that those who best have the consumers health and safety interests at heart are the consumers themselves. It is big government that has a proven track record of not protecting the public. And it is big government that is seeking to take away yet another individual freedom, the right to choose one’s own treatment. (Where is the pro-choice crowd on this one; the ones that claim, “my body, my choice?”)
Contact your federal legislators and urge them not to cosponsor, support, or vote for such a power-grabbing, bill. Let them know Americans want unrestricted access to nutritional supplements, and the government out of their health choices.
Sen. McCain described his bill as a “no brainer.” For constitutionalists it’s a “no brainer” that it should be rejected for the dictatorial, power-grabbing, choice-limiting attack on the nutritional marketplace and individual freedoms that it is."
http://www.jbs.org/health-care-freedom-blog/5957-proposed-dietary-supplement-regulatory-bill
Comments
Boy, that McCain sure is a mavericky-get-big-gov't-out-of-our-lives kind of fellow, isn't he?
Couple more sources of the bill -- in case it gets 'disappeared' from Mc-Ought-To-Be-Ashamed's page:
http://www.opencongress.org/bill/111-s3002/text
http://www.govtrack.us/congress/billtext.xpd?bill=s111-3002
After all they have major drug companies whispering $weet nothing$ in their pocket$$$$.
Squeaky wheel gets the most grease .... and you make a pest out of yourself with your polite messages telling them you oppose it, so what.
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