I am very concerned about what is happening right now within the UK re dietary supplements.The MCA (Medicines Control Agency) (their FDA) is pushing very hard to harmonize to an extremely harsh European Economic Community Directive (EEC 65/65) under which any substance having any sort of physiological effect can be regulated as a "medicine" with the MCA being "judge, jury, and executioner" and no appeal.(See excerpt from the debate in the House of Commons, excerpted below.)
This threatens to force manufacturers out of business in droves. MCA could force them to go through an utterly impossible licensing procedure which only the pharmaceutical giants could afford.... but that, of course, is the drug cartel's game plan, and its what they're trying to do world wide. In the UK right now, though, this feces sandwich has been stuck out there in people's faces by the MCA, which doesn't give a damn if they like it or not because they intend to shove it down people's throats. If the cartel takes England...they'll be at our throats next, and I really question IADSA's resolve to do what must be done while simultaneously urging IADSA to establish an alliance with IAHF, because we do have the necessary resolve - if need be, we will lay physical siege to the FDA's Parklawn Building in Rockville, Maryland- we've done it before, and urge IAHF UK to do the same if necessary to the MCA- jam their fax machines- fax them en masse for a whole day, and let your MPs know why you're doing it.
The only way this thing can be monkeywrenched is in the US Congress, and I hope IADSA comes to realize this fact because as an NGO, IADSA has no power, it can't even vote. We can't win by playing the drug cartel's game, and they have the deck stacked at CODEX. The UN must be destroyed. The United States must pull OUT of the UN so it will collapse of its own weight. Ron Paul has introduced a bill that NNFA must push: The American Sovereignty Restoration Act. Gets us OUT of the UN. NNFA must get behind it, but first they must boot all drug companies including AHP,BASF, Rhone Poulenc, Novartis, and others OUT, or they won't be able to do the right thing. (And as long as that's the case, IAHF will continue growing as consumers world wide get more and more involved, because IADSA's hands are tied in too many ways.)
This UK move constitutes CODEX harmonization-- a big push in the direction the drug cartel is trying to push the whole WORLD. It is from this awareness that I am greatly angered by Novartis, and other drug companies not only being on NNFA's Board, but they shouldn't even be MEMBERS of NNFA. NNFA has been BLOCKING me from getting an oversight hearing on CODEX.FDA is lying through their teeth when they try telling us that our domestic laws can't be harmonized to Codex standards. The sanitary/phytosanitary measures agreement which goes along with both NAFTA and GATT requires us to harmonize our laws, and the International Council on Harmonization was established to oversee that process. The amendment that I worked so hard to get to get dietary supplements exempted from the harmonization language of the FDA Modernization Act of 1997 could be very easily repealed by slipping a few strategic words into some telephone book pending legislation somewhere were we'd never think to look for it, and the other side knows it too.
Please read the following which I excerpted from the Hansard, from a
debate in the House of Commons re vitamin regulation in England which
occurred on March 10th (to see the whole debate go to
I pointed out during the Adjournment debate on vitamin B6 that, whereas medicines and foodstuffs are closely regulated, the group of products that we are discussing this morning fall into a regulatory no man's land and attempts to use medicines law or foodstuffs law to regulate them will cause and have already caused problems.
MLX 249, which is partly causing the present controversy, is a proposed amendment to the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994.
It was issued recently by the Department of Health. A consultation letter was sent out on 6 November last year by the Medicines Control Agency and responses were requested by 31 December 1998. Note the very short time for consultation over one of the busiest holiday periods of the year. I shall come back to that in a moment. The proposal was to put the regulation in place by statutory instrument by 1 April. The MCA claims that it wants to make the decision-making process more transparent and put the classification process for medicinal products on a statutory basis.
MLX 249 relies for its existence on European directive 65/65, which was incorporated in UK law in 1995. That led to MAL 8, which is the MCA's interpretation--I underline that word--of the directive. Other countries have interpreted the same directive differently. Although the directive excludes foodstuffs, it has produced a broad definition of a medicine, which supersedes that given in the Medicines Act 1968, causing panic throughout the health food industry.
The definition is:
"Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying"--
I underline the next word--
"physiological functions in human beings or animals is likewise considered to be a medicinal product" according to directive 65/65. Note the use of the word "physiological" instead of "pharmacological". The definition could classify water as a medicine, along with many other substances.
In a court action last year, the MCA used directive 65/65 and MAL 8 to remove melatonin from the shelves of health product stores and supermarkets. The industry is very worried that many other products will follow suit.
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