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Letters to the Editor Issue 138

by Letters(more info)

listed in letters to the editor, originally published in issue 138 - August 2007

US FDA Announces Plan To Eliminate Vitamin Companies

by Byron J Richards CCN
The 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.

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 record keeping 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 pretence 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 (NPA) (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 US 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 favour 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. 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. 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 National Products Association (NPA). At the end of 2006 key players 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.

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. 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 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!

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