Health Guardian Newsletter--Prepare For War!

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Sent: 7/31/2011 4:14:03 P.M. Central Daylight Time

Subj: Health Guardian Newsletter--Prepare For War!

Volume 6 Issue 2

July 2011

The Battle Will Soon Begin

Everyday we Americans take for granted our freedom to go out and

purchase nutritional support for our bodies in the form of dietary supplements.

But that may soon come to an end if our FDA and our elected politicians can

have any say. In this newsletter I will expose what is secretly happening

behind the scenes to remove this freedom and what we as Americans can do

about it if we unite with one voice!

A Victory In 1994

Back in 1994, the FDA tried to classify all nutritional products as drugs

after Time Magazine came out with an article saying what great results

vitamins and minerals were having fighting heart disease and cancer. When

this information became public knowledge, the American people united and

bombarded the phones of their representatives in Congress with complaints,

which

ultimately led to the passage of the DSHEA Act of 1994. The Dietary

Supplement Health & Education Act (DSHEA) prevented the FDA from power grabbing

and stripping the American people with the freedom to purchase

nutritional supplements without a prescription.

But that is about all to change...unless we, the American people, do

something to prevent this travesty from taking place.

Sneak Attack

On July 1st, right before Congress broke for the holiday weekend (how

convenient), Illinois Senator, Dick Durbin, introduced bill S.1310 the Dietary

Supplement Labeling Act of 2011.

Tricky Dick is selling this bill as his latest gobbly goop (he has tried

unsuccessfully before) that will protect consumers of dietary supplements

by heaping on yet more FDA regulations.. He says that this will guarantee

that consumers will have the information they need to distinguish between

products that are safe and others that contain potentially dangerous

ingredients (i.e., not approved by the FDA). As usual, Durbin is wrong and his

solution will only harm the industry and consumers.

This bill is nothing more than an attempt to impose more FDA control over

dietary supplement manufacturers, their marketing, and consumer access to

supplements. By piling yet more costly regulations onto the backs of

companies, it will also favor the mega companies, which can afford the lawyers

and specialists to deal with such useless nonsense, at the expense of the

medium and small sized companies which cannot. This is all part of the

Durbin political agenda that pushes the " consumer safety " issue as a thin cover

for pure greed and power...as he protects his campaign contributions which

he receives from drug companies by protecting the drug companie's

monopoly over cures.

BUT IT ONLY GETS WORSE!!!

By coincidence, on this same day, July 1st, as Tricky Dick launched his

legistrative initiative, the FDA issued its own notice for its draft

" Guidance for Industry: Dietary Supplements: New Dietary Ingredient

Notifications

and Related Issues. " This is a proposed guidance for supplement

manufacturers and not a regulation that mandates industry compliance.

When you read these new guidelines you will see it is an all out effort of

the FDA to utterly destroy the supplement industry and turn vitamin

company founders into wanted criminals!

Let's take a peak at these new guidelines:

• Every nutritional supplement company will be forced to submit

comprehensive NDI (New Dietary Ingredient) documentation for EACH ingredient

used in

EACH product they currently sell. This will amount to hundreds of

thousands of NDI applications flooding the FDA offices. This is a clever FDA

scheme

to place a huge burden of research and paperwork on every dietary

supplement company in the USA. In the FDA's own words:

" The statute places the obligation for submitting the notification on

each manufacturer or distributor. Any other manufacturer or distributor who

wishes to market its own dietary supplement containing the same NDI should

submit a NDI notification to FDA explaining its own basis for concluding that

this new product containing the NDI will " reasonably expected to be safe "

under the conditions recommended or suggested in the new product's

labeling. "

• All supplement companies must REMOVE their products from " interstate

commerce " for the 75 days after the FDA receives their NDI applications. No

product containing an NDI application ingredient may be sold in the United

States or it will be considered " adulterated " by the FDA and thereby

subjected to confiscation.

• While the NDI provisions of the 1994 DSHEA act merely required dietary

supplement companies to notify the FDA of new ingredients, the FDA is now

distorting this into a de facto supplement approval process. Without the

FDA's new approval, nutritional supplements will all be labeled " adulterated "

and potentially confiscated at gunpoint by the FDA (see FDA raid links

below).

• The FDA does not support electronic filing for NDI applications. All

applications must be done on paper and then mailed to the FDA (yes, as in

dropped in a metal mailbox with a paper envelope). The 75 days of waiting does

not begin until the FDA says it receives your application.

• While a few ingredients that were in widespread use before 1994 are

exempted from these new requirements, the FDA refuses to publish any list of

" grandfathered " ingredients. Instead, it requires each supplement company to

figure it out for themselves. In addition, even pre-1994 ingredients must

receive new approvals from the FDA if they are " altered " in any way,

including changing the particle size, increasing the amount per serving, using

a

super-critical extraction process, baking the substance or even harvesting

it from a plant at a different life stage of the plant. In other words,

nearly all ingredients use in dietary supplements today are considered

" adulterated " by the FDA.

• As a result of the point above, nearly all dietary ingredients will be

required to receive new approval by the FDA due to the agency's broad

definition of " adulterated. " Note that changing the mg per serving of the

nutrient makes it " adulterated, " as does altering the target market. So if you

sell vitamin C to senior citizens, and it's approved by the FDA as a dietary

ingredient, you will need a NEW application and approval if you now sell

that same vitamin C to children.

• The requirements for " proving " the safety and efficacy of dietary

ingredients is entirely unreasonable. FDA says it requires companies to submit

peer-reviewed scientific journal articles, clinical trial test results and

even, in the case of botanicals, to provide the name of the scientist who

originally gave the plant its Latin name. (Seriously? Is it a trick

question?)

• The FDA has no obligation to " approve " any NDIs in a timely manner. It

merely says it will acknowledge receipt of the NDI application within 75

days.

• If one company receives approval for a specific dietary ingredient

(resveratrol, for example), that approval does NOT apply to any other company.

EVERY company must independently apply for approval of resveratrol, and

each company must independently supply all the research and documentation

required to support the safety and efficacy of that ingredient in the amounts

used in its products, and in the context of the marketing of that product.

• Companies that sell dietary supplements containing ingredients that have

not been approved under these new FDA regulations will be accused of

selling " adulterated " ingredients and can have their inventory seized by

federal marshals or have their company founders arrested for selling

" adulterated

drugs " even though they might only be vitamins or herbs.

• These proposed regulations are NOT a law under the control of Congress.

Neither the House nor the Senate has any control over this. The FDA can

simply issue these regulations on its own, regardless of what publicly

elected officials want the agency to do. The FDA is run by unelected

bureaucrats

who answer to no one and write their own " laws. " (See attorney

Emord's book The Rise of Tyranny to learn more.)

• The FDA can simply choose to DENY all applications and thereby outlaw

virtually all nutritional supplements. There is no obligation by the FDA to

honestly and accurately review any applications whatsoever. It can simply

rubber stamp 'DENIED' on every one of them. In the FDA's own words: " FDA's

failure to respond to a NDI notification does not constitute a finding by

the agency that the NDI or the dietary supplement containing the NDI is safe

or is not adulterated. "

• The real kicker in all this? Synthetic molecules that mimic dietary

supplements (i.e. those used in pharmaceuticals) are EXEMPTED from all these

requirements! So synthetic molecules need no approval from the FDA, while

the natural ones do! This conveniently exempts the pharmaceutical vitamin

companies who use synthetic vitamin chemicals rather than natural,

full-spectrum nutrients.

FDA's " End Game " Strategy

Remember, this is the FDA's " end game " strategy to utterly destroy the

supplements industry and thereby hand Big Pharma a complete monopoly over

nearly all forms of medicine in the USA. If this regulation is put into

practice, it would cause:

• The complete wipe out of nearly all nutritional supplement companies in

the USA.

• The bankruptcy of most health food stores and vitamin retailers,

including on-line retailers.

• A loss of millions of jobs currently supported by the supplements

industry. How does this come to millions of jobs? Add up all the jobs related

to

the importing, manufacturing and transportation of nutritional supplements

and super-foods. Include all the jobs related to marketing, advertising,

promoting, distributing and publicizing these supplements. Then include all

the jobs of workers in health food stores, fulfillment centers and

supplement formulators. On top of that, you have all the jobs which are

supported

by successful nutritional supplement companies, including accounting,

legal, graphic design and technology jobs. The Natural Products Foundation

conservatively says that dietary supplements contribute $61 billion to the

U.S. economy and support 450,000 jobs. The FDA's new regulations, however,

impact not just dietary supplements but also super-foods and functional

foods which are part of an even larger market. In all, millions of jobs will be

impacted by the FDA's proposed new regulations. In addition, nutritional

supplements boost job performance across all industries because they help

employees work better and reduce sick days. So removing their access to

these supplements will suppress the productivity of workers across ALL

industries. This is one of the ways in which these proposed new regulations

could

destroy millions of jobs across the U.S. economy.

• Skyrocketing rates of chronic degenerative diseases such as cancer,

heart disease, diabetes and Alzheimer's disease, because nutritional

supplements are practically the only thing keeping these diseases in check

right now.

• A worsening of infectious disease and viral outbreaks due to weakened

immune systems across the U.S. population. (The CDC will respond by saying

we need " more vaccines! " )

• Huge increases in health care costs due to more patients having more

disease and yet having fewer alternatives available for preventing or

treating that disease. This will lead to a complete meltdown of the US

financial

system.

Finally, let's remember this is a federal agency that monitors drug

approvals and is doing such a good job...with only 120,000 Americans dying

each

year of properly prescribed, FDA approved drugs. And this number, by all

estimates, only represents 10% of the actual deaths because of the

inadequacy of the FDA's own drug report monitoring system.

Compare these numbers with the fact that in a recently revised analysis by

the US Poison Control Center, there have been no deaths, whatsoever, in

the last 27 years from a vitamin supplement...none at all, in the 27 years

that such reports have been available!

Are you willing to fight to prevent losing your freedom to choose how you

wish to implement your own wellness program and not leave it up to

bureaucrats which are only concerned about their next election. If you are

then

join me and other like minded individuals as we do whatever is necessary to

preserve this freedom.

Dozens of health freedom organizations are participating and agreed to

coordinate a massive consumer revolt.

The official start date of this uprising is Thursday, September 8, 2011,

but you can take preliminary action today to thwart the FDA’s latest

attempt to steal your supplements and make them the exclusive domain of Big

Pharma.

We ask that you forward this e-mail to everyone you know so they can

understand the precarious state their health will be in when the FDA bans their

most effective dietary supplements.

Then, use our convenient website to e-mail letters to the White House,

your Representative and two Senators by clicking on the links below:

_Send a letter to your Representative and two Senators_

(http://click.icptrack.com/icp/relay.php?r=1075623458 & msgid=31344872 & act=TSGT & c=\

89834 & destinati

on=http://www.capwiz.com/lef/issues/alert/?alertid=51641606 & type=CO)

demanding the FDA immediately withdraw their oppressive proposed guidelines

pending rational discussions with those who depend on dietary supplements to

protect their health and livelihood. _Send a letter to the President’s

Office of Management and Budget_

(http://click.icptrack.com/icp/relay.php?r=1075623458 & msgid=31344872 & act=TSGT & c=\

89834 & destination=http://www.lef.org/featur

ed-articles/0719_Letter-to-the-White-House.htm) as the FDA’s proposed

guidelines on new dietary ingredients directly conflict with an _Executive

Order issued July 11, 2011_

(http://click.icptrack.com/icp/relay.php?r=1075623458 & msgid=31344872 & act=TSGT & c=\

89834 & destination=http://www.lef.org/featured-ar

ticles/0719_Executive-Order-Letter.htm) , that orders the FDA to

streamline and repeal burdensome regulations that interfere with job creation,

economic growth, and innovation.

Remember back to the beginning of this article about the success of the

American people from preventing the FDA from taking control of the vitamin

industry...and that was when only a handful of consumers were purchasing

supplements and the was no Internet and very few used emails. Today there is

an estimated $26,000,000 in supplement sales in the US and the Internet

has become a powerful weapon in keeping people informed. So get ready to go

to war my fellow wellness patriots!

Your fellow warrior,

Dr Harry

Harry Elwardt, N.D., Ph.D.

The Health Guardian, LLC

President/CEO

Naperville, IL

630-961-5145 © The Health Guardian, 2011

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