ACT NOW TO CONTACT YOUR REPRESENTATIVES TO STOP THIS
Natural Health News has been covering CODEX now for more than a decade. For KEY information on this issue check our posts here from 2005 and the main resources on this concern, Alliance for Natural Health (ANH) and IAHF
LEF is monitoring the legislation and they sent this comment 29 April: The threat of a regulatory stranglehold over dietary supplements has intensified.More from LEF, 3 April - Here is a link to the exact text of HR 4173, along with a link discussing of the implications of Waxman's proposal. http://www.govtrack.us/congress/bill.xpd?bill=h111-4173 If you have any additional questions, please e-mail us or call the advisor helpline at .
Earlier this year, Sen. John McCain introduced a bill that would have given the FDA draconian new powers. A citizen’s revolt ensued that caused that bill to be sidelined. We are being watchful that Sen. McCain does not try to slip some of his oppressive original proposals into another Senate bill. SEE UPDATE ON THIS BILL
The urgent issue we face today is language Rep. Henry Waxman snuck into the already passed Wall Street Reform Bill (H.R. 4173) that he hopes to get into the Senate bill. This language would give unelected FTC bureaucrats arbitrary authority to impose crippling requirements that will drive up the costs of supplements or remove them from the market entirely.
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Related article: Lovaza ShuffleCongressman Waxman Slips Obscure Anti-Supplement Measure into Wall St. “Reform” Bill Passed by the House; Please Take Action to Prevent Same Thing Happening in the Senate!
Similar issues surround the biologically active form of pyridoxine (vitamin B6 or P5P) and B9 (folic acid). Make sure you are connecting the dots.
Posted By ANH-USA On April 27, 2010 @ 6:34 pm In Attacks on Integrative Medicine, Food Safety, The Dietary Supplement Health & Education Act of 1994 (DSHEA)
The American public is becoming fed up with “sneak” provisions tacked onto largely unrelated bills that are likely to pass. A glaring recent example was tacking onto the Healthcare bill a complete change to student loans. Often the “sneak” provision is so buried that hardly anyone is aware of it.
The Wall Street Reform and Consumer Protection Act of 2009 (H.R. 4173), recently passed in the House of Representatives, includes language going far beyond finance inserted by Congressman Henry Waxman (D-CA). This language could be used for an end run around the Dietary Supplement Health and Education Act (DSHEA), the legislation that governs dietary supplement regulation by the FDA.
The Senate is expected to vote on its finance “reform” bill as early as this weekend. We need your help to ensure that it is not amended to include a similar provision going far beyond finance that could be used against supplements. Please take action now.
Congressman Waxman is well known as an opponent of the dietary supplement industry. This is somewhat ironic: his district includes Hollywood and presumably many of his closest supporters are health store shoppers and supplement users. Most of these people simply don’t know what Waxman is doing in this area.
This powerful Congressman, chair of the House Energy and Commerce Committee (which includes health as a subcommittee), would appear to want supplements regulated like drugs, a step that would effectively eliminate them. He is determined and has stated: “One enduring truth about Washington is that no issue is ever settled for good.”
ANH-USA has been on alert to see how Waxman would use his committee chairmanship to strike at DSHEA. He is very clever and we knew a covert attack was a possibility.
A direct attack on supplements would take the form of an amendment to DSHEA, since that legislation governs FDA regulation of supplements. In this case, Waxman has left DSHEA alone, and has instead inserted language in the Wall St. “reform” bill that gives the Federal Trade Commission (FTC) important new powers that could be used to circumvent key supplement protections in DSHEA.
To see how this would work, let’s see how the FTC operates today. Its chief mission is to combat commercial fraud. It has full authority to pursue companies making fraudulent claims. But the FTC can’t go beyond that, can’t set other regulatory requirements, without advance approval of Congress. The FTC once had this regulatory “rule-making” authority. It lost it in the 1980’s because Congress thought the Agency was abusing it.
At the present time, if the FTC moves against a dietary supplement company for false or misleading advertising, the FTC typically requires the company, as part of a consent decree agreed to by both parties, to back up its claims by undertaking at least two random controlled human trials. This is done on a case-by-case basis and is legal because the targeted company has agreed to it.
If the FTC had general rulemaking authority, which Waxman’s language reinstates, the Agency would be expected to create a new legal requirement for all supplement companies. Such companies would have to perform at least two of these human studies before making any claims for their products.
Why should we care whether supplement companies are required to perform two random controlled human trials for each product? Because such trials take a long time and would be beyond the financial means of most supplement companies. Even if the companies could find the money, the FTC could require more and more costly versions of these studies, or more of these studies. At each stage, fewer supplements would be available, and those available would cost more and more, until they became as costly as drugs.
Supplements are not drugs. In most cases, drugs are non-natural and therefore patentable substances. Why patentable? Because no company will spend a billion dollars on studies and FDA approval trials without the monopoly provided by the patent. To insist that supplements be treated like drugs is really to sound the death knell for the supplement industry, something that drug companies would be delighted to see, because they know that supplements are their chief potential competition, are often more effective than drugs, are often less toxic, and are always much less expensive.
Supplements are already regulated by the FDA under DSHEA. If the Waxman provision is included in the final Wall St “reform” bill, the FTC will gain the power to override the limited protections for supplements that already exist under DSHEA. The FDA would still have to respect DSHEA, but the FTC would not be so constrained.
Five unelected FTC commissioners would issue binding regulations in a wide range of areas, including the regulation of dietary supplements. And companies that did not comply with the new FTC rules could effectively be put out of business.
According to renowned constitutional attorney Jonathan Emord, “The provision removing the ban on FTC rulemaking without Congressional preapproval contained in H.R. 4173 invites the very same irresponsible over-regulation of the commercial marketplace that led Congress to enact the ban in the 1980s. FTC has no shortage of power to regulate deceptive advertising; this bill gives it far more discretionary power than it needs, inviting greater abuse and mischief from an agency that suffers virtually no check on its discretion.”
The bottom line is that FTC would be given power to regulate areas they don’t understand, and their first order of business would likely be to regulate supplements, an area far outside their area of expertise.
The Senate Wall St “reform” bill, the Restoring American Financial Stability Act of 2010 (S. 3217), doesn’t contain the Waxman provision yet. But we know that Senator Rockefeller (D-WV) may offer an amendment including Waxman’s language. Please help us stop this. Please take action now to help us maintain access to low cost, high quality supplements. Tell your senators not to support any amendments that give FTC unchecked power to over-regulate areas they don’t understand, including dietary supplements.
Copyright © 2010 Alliance for Natural Health - US. All rights reserved.
And now from Orthomolecular Medicine -Multivitamins Dangerous?From CP -
Latest News from the World Headquarters Of Pharmaceutical Politicians, Educators and Reporters
(OMNS, Apr 29, 2010) The following purports to be a transcript of a recent meeting at the World Headquarters Of Pharmaceutical Politicians, Educators and Reporters [WHOPPER]:
"All right, all right! Please come to order, ladies and gentlemen. We know how excited you all are over the recent flood of anti-vitamin news coverage. But please have a seat! Thank you.
"First of all, congratulations on a job well done. We now have the public totally flummoxed about vitamins. We have persuaded the media that high doses of supplements are dangerous, and that low doses are also dangerous. We have scared the people away from taking any nutrients at all. Why, we have even sold the idea to the press that a once-daily multivitamin is dangerous. Nice work, everyone!
"Funny thing about multivitamin supplements: if you look at each individual nutrient in a multivitamin, it is of course good for you. Thousands upon thousands of research studies confirm the body's absolute need for each and every vitamin. So, we urge people to eat a "balanced diet" to get all their various vitamins from food . . . while simultaneously convincing them that a balanced multivitamin supplement is bad! Essential vitamins from foods are good; essential vitamins from pills are not. Then, truly a stroke of marketing genius, we push processed foods devoid of vitamins, advertising day and night.
"We hardly have to spell it out, now do we? The fewer nutrients people consume, the more sick they will become. The more illness, the more drugs the public will have to take. After all, if vitamin therapy is "dangerous," what's left? Us, that's who. Our pharmaceutical plants running 24/7 can produce millions of pills a day, for pennies apiece, to retail at ten dollars per tablet. Ching-ching!
"Even better, the government will pay for it all. "National health care," as you already know is really "national pharmaceutical insurance." The Feds will pay all right. After all, we sold them on the flu vaccine, didn't we? Even when it was shown that the vaccine was worthless at best? (1)
"You can see other ways that the Feds listen to us. We have set it up so that Food Stamps cannot be used to buy vitamins. (2) A bag of cookies or a box of donuts, yes. But not vitamins. The ban includes supplemental vitamin D, which is widely known to prevent bone diseases in children and the elderly, and to prevent lung cancer, colon cancer, prostate cancer, breast cancer, and a dozen other cancers. (3)
"Is it just me, or have you noticed how hot it is in here? Well, at any rate, you have all done one Hell of a nice job. Our Boss is proud of you."
The FDA is once again considering banning a safe, affordable nutritional supplement. Last year, a pharmaceutical company convinced the FDA to outlaw supplements of pyridoxamine—a form of vitamin B6 known to stop the damaging process called glycation—so that the company could sell them as a prescription drug. Now another pharmaceutical company has petitioned the FDA asking that pyridoxal-5-phosphate (P5P), another form of vitamin B6, be banned so that the company can turn this supplement into an expensive drug.
I urge you to contact your senators and representatives to ask them to stop this theft of P5P from the public domain.
After all, what’s next? The FDA banning the sale of safe, natural foods like walnuts?
As a matter of fact, that’s exactly what’s next as the FDA recently sent a warning letter to Diamond Foods, Inc. proclaiming that walnuts sold by the company cannot be legally marketed because the walnuts “are not generally recognized as safe and effective” for the medical conditions mentioned on Diamond Foods’ website. The FDA warned the company that these walnuts are now classified as “drugs” and could be subject to government “seizure or injunction.”
The good news? Within weeks, Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA) are expected to introduce the Dietary Supplement Full Implementation and Enforcement Act of 2010. The bill will ensure that the FDA will fully fund and implement the Dietary Supplement Health and Education Act (DSHEA), the legislation that regulates dietary supplements. The new bill is intended to fund all DSHEA regulatory provisions, serving as a rebuttal to the argument by supplement opponents that the industry isn’t really regulated due to a lack of funding.
Although there is a chance the legislation will backfire and that the FDA will misuse the funds to persecute supplements, the more hopeful option is that for the first time some FDA employees will consider their jobs as being funded by supplements. If supplements disappear, their jobs would disappear.
I will keep you updated on this bill when it is introduced.