FDA ANNOUNCES PLAN TO ELIMINATE VITAMIN COMPANIES
By Byron J. Richards, CCN
Go To OriginalThe FDA, emboldened by its transformation into a drug company, has embarked upon an anti-American plan of interfering with business and intentionally eliminating various dietary supplement companies from the market. The FDA announcement came on Friday, June 22, 2007 under the guise of a final rule for dietary supplement good manufacturing practices (CGMPs). Within this 800 page rule the FDA states, "We find that this final rule will have a significant economic impact on a substantial number of small entities.... Establishments with above average costs, and even establishments with average costs, could be hard pressed to continue to operate. Some of these may decide it is too costly and either change product lines or go out of business.... 140 very small [less than 20 employees] and 32 small dietary supplement manufacturers [less than 500 employees] will be at risk of going out of business.... costs per establishment are proportionally higher for very small than for large establishments....The regulatory costs of this final rule will also discourage new small businesses from entering the industry."
This FDA rule will directly raise the price of dietary supplements for all consumers. The FDA acknowledges this and says "We expect that the majority of these costs will be borne by consumers of dietary supplements, who will likely respond to the increase in prices by reducing consumption." Thus, the FDA is intentionally seeking to shrink the size of the dietary supplement industry and reduce the influence of safe and effective options to improve the dreadful trend in the health of Americans. The goal is to leave toxic drugs as the primary health option.
Independent analysis of this FDA rule has placed cost of compliance at 10 fold what the FDA estimates with as many as 50% of small companies unable to comply.
The gutless cowards of Congress, a majority of whom are on the Big Pharma payroll or will be on it once they leave Congress, have delegated their lawmaking powers granted by the U.S. Constitution to a bunch of Big Pharma-friendly unelected bureaucrats at the FDA, who are in turn using this power to undermine free commerce and help Big Pharma eliminate competition from the market. This is the behavior of a government in tyranny, inviting a revolution by the people. It is noteworthy that fascist governments of the past have eliminated health freedom and health options as a necessary condition to enslave and brainwash a population. Congress has delegated its responsibility to the people to such an extent that over half the laws in this country are now concocted by unelected bureaucrats with vested interests.
A Vehicle for Unprecedented Harassment
Any company that can afford to comply with the costs and regulations of this new FDA rule can be targeted and eliminated at will by the FDA. In essence, the FDA is seeking to make the dietary supplement industry document every phase of production, including expensive testing at multiple points in the production process. Massive recordkeeping will be required, including all customer complaints and returns for any reason! This is utterly draconian and unnecessary interference and burden to free commerce. It is completely Anti-American. No doubt, the FDA will impose user fees as an additional charge so that FDA agents will have the funding required to enforce the regulations. Under the new rule any flaw in bookkeeping can result in a company's products being declared adulterated, allowing the FDA to remove them from the market even though nothing is wrong with them! A company can then be forced out of business because they won't be able to sell any products to raise the money to comply. The rules are so complex and vague that the FDA can selectively target any company it chooses, even those attempting to comply in good faith.
The FDA is doing this under the pretense of improved consumer safety. Consumer safety could readily be guaranteed by simply having all companies test their final products for purity and potency. Instead of this simple approach the FDA has gone to the extreme of burdening the dietary supplement industry with regulations in excess of the drug industry! Supplements are foods, not drugs. The food industry couldn't begin to comply with these FDA rules, even though food contamination is far more dangerous to health than dietary supplements.
The FDA intends to phase this rule in over the next three years. This means that within five years half the industry and many of the health options individuals rely on will either be gone or significantly more expensive.
Even more chilling is that forces within the dietary supplement industry itself are in no small part responsible for this FDA final rule.
Trade Groups and their Big Companies Turn on America
The Natural Products Association (formerly the National Nutritional Food Association – NNFA) and the Council for Responsible Nutrition (CRN) have been instrumental in forcing these drug-like rules on dietary supplements. These globalist organizations are selling out America, destroying American jobs, undermining the U.S. Constitution, and working in conjunction with pharmaceutical companies to usher in Codex and the New World Order. Consumers of dietary supplements should learn who these companies are before buying their products and helping to inadvertently fund the destruction of health freedom in this country.
When DSHEA was passed in 1994 part of that law required the FDA to establish current good manufacturing practices (CGMPs) for the dietary supplement industry. During a period of FDA outreach to the industry the FDA was surprised to learn that CRN and NPA were in favor of drug-like CGMPs for the dietary supplement industry. These trade groups, working closely with Senators Orin Hatch (R-UT) and Tom Harkin (D-IA), have intentionally taken the supplement industry down a slippery slope. It is noteworthy that Hatch takes in more money from Big Pharma than he does from dietary supplement companies. Not only is Hatch a big supporter of the Medicare Part D drug rip off of Americans he has saved Big Pharma billions by protecting them from generic competition, as he is currently attempting to do with his legislation for new biologic drugs. Hatch also has a son working for NPA and another son that lobbies for NPA and the dietary supplement industry. When Hatch leaves the Senate he will be first in line for a six or seven figure Big Pharma salary.
The CRN has been taken over by multinational drug and food companies. Key players are the nutritional divisions of Bayer, BASF, Cargill, Monsanto, Wyeth, and Archer Daniels Midland. Nutrition companies that participate are in most cases owned by pharmaceutical companies, heavily invested in pharmaceutical companies, or jockeying for position in the international market as part of the New World Order. Key names include Mannatech, Shacklee, Herbalife, GNLD International, The Vitamin Shoppe, and GNC. These companies are glad to eliminate competition from small companies and start up ventures.
Carrying on the general theme of Big Pharma ownership and a globalist agenda are the companies that control the NPA. One need only look at the new NPA China board to understand who these key players are. Jarrow Formulas, Now Foods, GNC, and Herbalife top the list. At the end of 2006 Jarrow and Now helped lead the charge with Senators Hatch and Harkin to burden the dietary supplement industry with bizarre Adverse Event Reporting legislation (AER) which insisted that dietary supplement companies keep extensive records on any type of consumer complaint. Aspects of this AER law are now implemented in the FDA final rule on CGMPs. Of course, NPA was quick to offer expensive training to its members to indoctrinate them into how to comply with the rules that NPA, working on behalf of the FDA, just forced on its own members. Are their member companies really this stupid? Or are they all working together? I would recommend that any NPA member that believes itself to be a true American company that values our constitution immediately withdraw from NPA membership – consumers will be looking to see who you are.
The picture is now crystal clear for any person who cares to look. Numerous dietary supplement companies are anti-American and actively selling out our country and our constitution, working hand-in-glove with the FDA and Big Pharma. The majority of such companies can be found as members of CRN and NPA. It will be up to the American consumer to save the dietary industry from itself and preserve their own access to safe and effective natural health remedies. This is a relatively simple task. Quit buying products from or quit being a distributor in these fascist organizations. Support the small companies that are the backbone of America, otherwise they will soon be extinct.
Update on S.1082 Threat to Dietary Supplements
Many of you have been following the extreme threat to dietary supplements posed by S.1082. Similar legislation has now cleared the House Energy and Commerce Committee and is headed for the floor of the House in the next week or two. The House version of this bill now contains the "food and food ingredients" language that the FDA can use to apply drug-related risk/benefit analysis to dietary supplements and have them removed from the market at their whim.
It is noteworthy that both CRN and NPA have posted on their websites information stating that S.1082 is not a threat to dietary supplements. Both organizations are flat out wrong. They cite a colloquy by Hatch, Harkin, Kennedy, and Enzi as their evidence. This colloquy was a direct result of our grassroots campaign to alert the American consumer to this major threat. In no way does this colloquy protect dietary supplements. UNTIL THE LANGUAGE IN THE BILL IS CHANGED THE THREAT EXISTS AND IS VERY REAL.
CRN and NPA also tell their members that the Codex initiative to scare consumers into thinking that dietary supplements are unsafe above miniscule amounts and need to be regulated by international laws is also no big deal. It is clear that CRN and NPA, again working hand-in-glove with the FDA, are a major part of the problem and are actively engaged in forwarding the globalist agenda of the New World Order. While pretending to represent the dietary supplement industry these organizations are in fact shooting the industry in the back and undermining health options for Americans.
The FDA is Out of Control
The FDA is a tyrannical organization that is now emboldened and completely out of control. It is not surprising that the FDA is seeking to eliminate competition to Big Pharma, they have been doing that for much of the past century. What is surprising is that they are openly stating in their final rule a plan that directly eliminates small businesses from existence. This fascist organization believes itself to be above the rule of law and is actively working against America and the rights of Americans. It must be stopped.
© 2007 Truth in Wellness, LLC - All Rights Reserved
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Byron J. Richards, Founder/Director of Wellness Resources, is a Board-Certified Clinical Nutritionist and nationally-renowned health expert, radio personality, and educator. He is the author of Mastering Leptin, The Leptin Diet, and Fight for Your Health: Exposing the FDA's Betrayal of America.
Richards encourages individuals to take charge of their health, stand up for their health rights, and not blindly succumb to propaganda from the vested-interests who profit from keeping Americans sick. As founder of Wellness Resources, Inc. of Minneapolis, MN, an independently-owned fine-quality dietary supplement company since 1985, he has personally developed 75 unique nutraceutical-grade nutritional formulas. www.wellnessresources.com
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E-mail: byron@truthinwellness.com
NUTRICIDE: CRIMINALIZING NATURAL HEALTH
CODEX: HOW THE WTO IS TAKING AWAY YOUR HEALTH FREEDOM
Support Ron Paul's Health Freedom Protection Act, H.R. 2117
Tell Your Congressmen and Women to Co Sponsor the Health Freedom Protection Act, H.R. 2117
The FDA is on a rampage against dietary supplements. Preventing reasonable and factual health claims, the FDA is using its immense power to fuel the pharmaceutical profit picture at the expense of the lives and health of hundreds of thousands of Americans each year. The rights of Americans to learn about natural products through truthful, science-based health claims is routinly stifled to the detriment of health and health freedom in the United States.
This bill shifts the burden of proof onto the FDA whenever the agency wants to deny the public the benefit of health claims information about Dietary Supplements.
H. R. 2117 allows reasonable health claims, with proper disclosure language, "unless the Secretary determines that -- `(i) there is no scientific evidence that supports the claim; and `(ii) the claim is inherently misleading and incapable of being rendered non misleading through the addition of a disclaimer." Thus, even "a scintilla" of scientific evidence would allow the making of claims that Dietary Supplements may be of benefit to individuals. The requirements of the bill are consistent with the law that already governs the agency's position, announced in 2004, "FDA intends to apply a standard for substantiating claims for dietary supplements that is consistent with the Federal Trade Commission's (FTC's) standard for dietary supplements and other health related products of 'competent and reliable scientific evidence'."
Current FDA policy, in violation of US Case Law, is to deny truthful claims which do not relate to either structure or function. All other truthful health claims are currently forbidden by the FDA. This bill would greatly enhance public access to truthful and
not misleading health information, in keeping with the US Supreme Court's dictum in Thompson v. Western States Medical Centers and presents a clear opportunity to enhance legal
protections for Dietary Supplements and natural remedies.
Urge your Congressmen/women to press for passage of H. R. 2117 which would would shift FDA resources from over-regulation of safe food substances to what should properly be considered their main task, protecting people from dangerous drugs and
medical devices.
Please use this opportunity to encourage your Representatives to work with other congresspeople to join as cosponsors and get behind the Health Freedom Protection Act.
Yours in health and freedom,
Dr. Rima
Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
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