FDA Issues Dietary Supplements Final Rule

[Guest guest]

By Byron J. Richards, CCN

 

June 27, 2007

 

NewsWithViews.com

 

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.

 

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 -