RED ALERT: FDA SET TO BAN YOUR SUPPLEMENTS

The word on the street is that apparently Americans are beginning to awaken to the tyranny being enforced upon them. Many more are questioning the powers that are clamping down on the very freedoms and rights upon which this formerly great nation is based.

I have written extensively about Codex Alimentarius and Agenda 21, two genocidal acts that have been signed into law that are guaranteed to lower health standards and increase mortality upon the average person. Basically, while nutritional healthy foods will disappear and be replaced by inferior unhealthy creations full of chemicals, stripped of all that is wholesome.

Another aspect of this attack took place in 1994 and how it is up for review in the Halls of Tyranny once again. Please read below. This is what is behind the irrational arrests of those selling raw milk, for example. Please read the three articles below, which explain the situation, and offer insight of the long term effects of this idiocy in terms of human and economic costs. Then take action if you are American. These draconian regulations have been defeated before; it is time to flex your civil muscles yet again to defend your right to eat properly.

Consider the following (not even the tip of the proverbial iceberg) and then please read on:

A review of 2009 information for adverse events reported to the national control center’s data system shows that:

No major adverse events or deaths were reported for botanical supplements like St. John’s wort, ginseng, and Echinacea; 

No major adverse events or deaths were reported for hormone supplements like DHEA, melatonin, and pregnenolone; 

No major adverse events or deaths were reported for phytoestrogen supplements; 

No major adverse events or deaths were reported for the joint- and cartilage-support supplements glucosamine and chondroitin; 

No major adverse events were reported for vitamins A and E, and only one adverse event each was reported for vitamin B6 and C. 

In total, 41 major adverse events were reported for the entire spectrum of supplements including botanicals, amino acids, and vitamins, and one death. 

In contrast, MORE THAN 7,000 MAJOR ADVERSE EVENTS WERE REPORTED FOR PHARMACEUTICAL DRUGS, INCLUDING A TOTAL OF 496 DEATHS. And based on previous studies, we know the overall death rate for physician prescribed drugs to be far higher.

SNIPPITS AND SNAPPITS: NUTRICIDE ~ U.N. GENOCIDE ~ CODEX ALIMENTARIUS

.

ARTICLE ONE 

FDA UNLEASHES END GAME SCHEME TO OUTLAW

VIRTUALLY ALL DIETARY SUPPLEMENTS FORMULATED AFTER 1994

By Mike Adams, the Health Ranger
Natural News
July 6, 2011

In the wake of hundreds of dietary supplements recently being outlawed across the EU, the U.S. Food and Drug Administration has quietly unleashed a regulatory scheme that, if fully implemented, could ban virtually all dietary supplements in the USA that were formulated after 1994.

That means nearly all superfoods, multivitamins, detox supplements, and medicinal herbal products we have all come to depend on to prevent disease and boost our immune health could soon be stripped from store shelves and outlawed across the nation.

I call it the "End Game" of the FDA's war against humanity:

PHASE ONE was the enforcement of nutritional ignorance by threatening and raiding companies that dared to make truthful health claims on their own websites (http://www.naturalnews.com/021791.html).

PHASE TWO involves "nuking" the entire dietary supplements industry by simply denying the use of nearly all the ingredients presently used in supplement products.

AN EFFORT TO DESTROY NEARLY ALL MODERN SUPPLEMENTS?

 .

The discovery of this new End Game strategy by the FDA to outlaw virtually all dietary supplements comes to us from the Alliance for Natural Health, the leading health freedom non-profit group in America, and the group that consistently reports fact-based information on how the FDA and FTC are squashing health freedom in America. Their most recent announcement, entitled FDA's New Sneak Attack on Supplements (http://www.anh-usa.org/fda-new-snea...) explains how this new assault on your freedom is being engineered by the FDA.

Here's the brief story of where this comes from and how the FDA is now waging a new war on our vitamins, herbs and supplements:

In 1994, after years of armed raids, oppression and censorship by the FDA, Congress passed a law known as DSHEA. This is the law that essentially forced the FDA to stop regulating dietary supplements out of existence, and groups such as the Life Extension Foundation (www.LEF.org) were instrumental in helping get this law passed in 1994.

But one of the little-known sections of the law required dietary supplement manufacturers to "notify" the FDA any time they used a new ingredient in their formulations. However, the details on how supplement companies were supposed to abide by these notification guidelines (called "NDI" or New Dietary Ingredient rules) were never published by the FDA, and since 1994, this entire section of DSHEA has remained essentially unenforced (or selectively enforced).

Now, suddenly, the FDA has decided it wants to enforce NDI, and its enforcement of this technicality would essentially amount to the FDA denying permission to use nearly all dietary supplement ingredients introduced since 1994.

So last Friday, the FDA proposed its new rules on NDI ~ on the Friday before a long weekend, no less, which is a common tactic government uses when it wants to do something that nobody notices ~ and these new rules run the risk of being adopted as active regulations, threatening virtually the entire dietary supplement industry with an eventual shutdown.

(ED: This subversive timing tactic was also used to slip in the Federal Reserve Act over the Christmas season of 1913 when most of the Senate and Congress were already home with their families. It is an old technique.)

Why did the FDA wait 17 years to take action on NDI rules? Believe it or not, this was mandated under the new Food Safety Bill (S.510 remember?) that Congress passed into law late last year without even reading the bill (http://www.naturalnews.com/030789_F...). So now, the FDA has been forced into issuing these new guidelines, and it obviously is going to take every opportunity it can to destroy the nutritional supplements industry (and thereby protect the profits of Big Pharma).

FDA GOES FUKUSHIMA ON DIETARY SUPPLEMENTS
.

Importantly, nearly all vitamin and supplement ingredients could soon be banned under the FDA's new NDI rules because very few supplement ingredients can be conclusively shown to have been widely used BEFORE 1994. As the ANH points out, the FDA recently banned a common form of vitamin B6 by claiming the vitamin was a "drug" that was never "approved" for use in supplements (http://www.anh-usa.org/when-is-a-vi...).

That story is also covered here on NaturalNews: http://www.naturalnews.com/025606_v...

The upshot of all this is that by issuing new guidelines on the NDI requirements, the FDA can now essentially disallow the use of virtually all supplement ingredients that exist in the market today. As ANH warns:

"We fear that they will use this power to ban any supplement innovation unless the supplement is turned into a drug and brought through the drug approval process. Since nobody can afford to pay for the new drug approval process if the substance is not patented, and supplements generally already exist in nature and cannot therefore be patented, to require full new drug approval is to ensure that there will be no new supplements. This should suit the drug industry very well and, based on past behavior, the FDA as well."

SUPPLEMENT COMPANIES WOULD NEED TO SEEK FDA APPROVAL FOR ALL THEIR FORMULATIONS
.

Through this clever trick with NDI rules, the FDA can now position itself as the gatekeeper for all supplement approvals. Far from merely being a requirement to "notify" the FDA of the use of new ingredients, NDI rules essentially subject supplements to approval from the FDA.

As the FDA has proven time and time again, it can simply refuse to approve anything used in natural products. Even today, the FDA refuses to approve walnuts for preventing heart disease, or vitamin C preventing scurvy.

The FDA won't even admit that vitamin D can prevent rickets!

Imagine the difficulty of trying to get the FDA to approve cherry extracts, or Chinese medicine herbs, or glucosamine for that matter. Nearly all the top supplements you've come to enjoy and value over the last two and a half decades are now threatened with being utterly outlawed and stripped off the shelves.

The FDA, in other words, is now gearing up to gut the natural products industry, bankrupt vitamin retailers and enslave the American people in a system of failed chemical medicine where they now have zero options for natural nutritional therapies.

This, of course, would cause chronic disease rates to explode across the nation, greatly enriching the pharmaceutical industry and cancer treatment centers, all of which must be cheering these proposed new rules as a great way to recruit new patients who can then be milked for profits.

BUT SYNTHETIC DRUGS NEED NO NOTIFICATION APPROVAL!
.

Amazingly (or maybe not, if you know the FDA), the new NDI rules state that synthetic copies of natural molecules are exempted from any new reporting requirements.

Thus, drug companies that commit biopiracy and steal molecules from nature then turn them into chemical drugs are exempted from this whole thing.

But natural product companies offering safe, effective and full-spectrum nutrients made by Mother Nature are suddenly put out of business.

These rules are selectively applied, in other words, only to natural products, not synthetic chemicals. It is yet another monopolistic betrayal of the American people by the FDA, an agency that has consistently and maliciously taken every opportunity to protect the drug companies while destroying the natural products industry. (http://www.naturalnews.com/021952.html)

"In these proposed rules, the FDA has effectively created a de facto pre-market approval system" 

for nutritional supplements, says the ANH. And the FDA will, of course, routinely deny virtually all supplement ingredients from ever being approved.

Because the FDA is already on the record with its position that there is no such thing as any vitamin, nutrient, herb or food that has any biological effect whatsoever that could prevent, cure or reverse any disease or health condition.

That's the FDA's official position! With that kind of distortion, it is impossible for this agency to ever recognize the innate ability of any natural ingredient to actually produce a health benefit.

TAKE ACTION NOW
.

Help us oppose the FDA's proposed new rules by signing this online petition.

Click here for the petition.

Once again, your representatives in Washington need to hear from you ~ pronto! ~ if you hope to maintain your right to purchase vitamins and supplements in the USA.

Lest you think this is an exaggerated warning, keep in mind that hundreds of dietary supplements have just been banned across the EU (http://www.naturalnews.com/032302_h...). Regulators in the USA are gunning for the same kind of wipeout of the supplements industry as a way to lock in decades of disease profits for Big Pharma and the greed-driven cancer industry (which cares far more about treating cancer than preventing it).

If these new FDA regulations go into effect, your access to dietary supplements could simply disappear before the end of this year, turning vitamin sellers into "criminal dealers" and "smugglers" (much like raw milk retailers today).

Armed FDA raids would be conducted on vitamin and supplement companies, and the founders of those companies would be rounded up and sent to prison for their "crimes" of selling unapproved ingredients

 
This is the FDA's end game.

Even if the FDA only partially enforces this new rule, it would still place a heavy compliance burden on small nutritional supplement companies. As the ANH says,

"The bottom line is that when new and unreasonable burdens are placed on supplement manufacturers, it immediately becomes a financial increase for consumers. And if the pressure becomes too great, the nutritional supplements on which you rely may simply become unavailable."

That's exactly what the FDA wants, of course:

To put dietary supplement companies out of business, leaving the field open only to those pharma-chemical vitamin companies largely owned by the drug companies themselves. They use synthetic chemicals which are NOT subjected to these new FDA rules. Many of those synthetic vitamins are, in essence, poisons. Isn't it interesting that the FDA says companies need no approval to use poisons in their formulations, but they need FDA permission to use natural substances that actually prevent disease?

Learn more at the ANH: http://www.anh-usa.org/fda-new-snea...

And please consider supporting this outstanding group with a donation so that it can continue its mission of staying on top of legislative and regulatory issues that impact our health freedoms. NaturalNews is a long-time ANH supporter, and we honor the work this group is doing.

Stay tuned to NaturalNews.com for more reporting on this latest FDA assault on health freedom.

READ THE FDA RECOMMENDED REGULATIONS YOURSELF
.

You can view them at:

http://www.fda.gov/Food/GuidanceCom...

ARTICLES RELATED TO THIS ARTICLE:

FDA Running Extortion Racket: Natural Supplement Companies Threatened with Arrest if They Don't Pay Up

The FDA Exposed: An Interview With Dr. David Graham, the Vioxx Whistleblower

Mercury Fillings Shattered! FDA, ADA Conspiracy to Poison Children with Toxic Mercury Fillings Exposed in Groundbreaking Lawsuit

Ending the Atrocities of the FDA; Life Extension Urges Immediate Petition Action for Health Freedom

NaturalNews exclusive: FDA wages secret war on raw milk farmers using KGB-style spying and infiltration techniques

Tyranny in the USA: The true history of FDA raids on healers, vitamin shops and supplement companies

ARTICLE TWO:

FDA'S SCHEME TO OUTLAW NEARLY ALL
NUTRITIONAL SUPPLEMENTS CREATED AFTER 1994

WOULD DESTROY MILLIONS OF JOBS AND DEVASTATE ECONOMY

By Mike Adams
Natural News 
July 7, 2011 

Yesterday we reported on the FDA's new scheme for outlawing nearly all nutritional supplements formulated after October, 1994  

(http://www.naturalnews.com/032912_F...). 

That was just the beginning of this story, because a detailed analysis of the proposed new regulation reveals extremely disturbing revelations that would absolutely gut the nutritional products industry if these regulations are put into practice.

Below are the highlights of the most offensive and onerous portions of these proposed new FDA regulations. The source of all this information is the FDA itself, which proposes its new rules in a rather lengthy post at: http://www.fda.gov/Food/GuidanceCom...

~ 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 Jonathan 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.

THE FDA'S PLAN TO KILL THE SUPPLEMENT INDUSTRY WITH A THOUSAND PAPER CUTS
.

This is all revealed on the FDA's own proposed regulation page:

http://www.fda.gov/Food/GuidanceCom...

A sample form for requesting NDI "approval" is available at:

http://www.fda.gov/downloads/Food/G...

Remember, the FDA will receive hundreds of thousands of these applications if it adopts this regulation. Under that mountain of paperwork, guess what we'll see next? The FDA begging Congress for "more money" to handle the work load!

The FDA also provides a decision chart to help you decide whether your ingredient needs to seek FDA approval:

http://www.fda.gov/downloads/Food/G...

Notice that nearly ALL ingredients lead to the conclusion of "NDI notification required." And even for those ingredients that the FDA says don't require notification, it recommends voluntary notification (bottom right corner of the chart).

Note carefully, too, that merely altering the intake level of a nutrient is enough to require new FDA notification and approval! So merely increasing the level of omega-3s in a supplement will require a manufacturer to seek a new approval from the FDA.

THE FDA WILL TURN VITAMIN COMPANY FOUNDERS INTO WANTED CRIMINALS

Also note: All products made with ingredients that are not APPROVED by the FDA under these new rules will be called ADULTERATED. The FDA has a long history of engaging in armed raids against companies that it accuses of selling "adulterated" products

(http://www.naturalnews.com/021791.html).

Owners of these companies will be hunted down like common criminals and accused of "dealing drugs" ~ a label that can earn them a red flag on Interpol

(http://www.naturalnews.com/027750_G...).

This is exactly what happened to Greg Caton, who was kidnapped from Ecuador by the FDA after manufacturing and selling anti-cancer salves that actually worked quite well to eliminate skin cancer tumors.

Caton's listing on Interpol said he was wanted for "drugs, related crimes, fraud." That's the official Interpol listing.

What drugs? The skin cancer salves.

What fraud? The "fraud" of selling anti-cancer products.

What "related crimes?" The "crime" of refusing to bow down to the FDA's outrageous censorship and tyranny.

In this way, the FDA can simply fabricate fictitious accusations against sellers of nutrients and herbs then use either U.S. marshals to arrest them at gunpoint in the USA, or invoke Interpol to have them kidnapped from other countries, in complete violation of expatriation agreements between nations.

THE FDA NOW SEEKS TO UTTERLY DESTROY THE NUTRITIONAL SUPPLEMENTS INDUSTRY

 .

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 wipeout of nearly all nutritional supplement companies in the USA.

~ The bankruptcy of most health food stores and vitamin retailers, including online 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 superfoods.

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 (http://naturalproductsfoundation.or...).

The FDA's new regulations, however, impact not just dietary supplements but also superfoods 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.

THE END OF THE SUPPLEMENTS INDUSTRY WOULD SPELL THE END OF AMERICA

Because of these reasons, I believe this FDA regulation, if fully enforced, would destroy what remains of America's economy and, within just a few years, cause a total collapse of the health care system which is already burdened under a rising wave of degenerative disease (diabetes rates have doubled in just one generation, thanks to the utter failure of western medicine).

In this proposed FDA regulation, I believe we are looking at a deliberate effort to destroy America, engineered by the unelected criminals and tyrants who run the FDA and answer to no one.

They are writing their own new laws, in essence, with zero oversight from Congress and no responsibility whatsoever to the People they are supposed to serve. This is what happens when we allow runaway Big Government to trash our economies, mandate failed health care treatments (Obamacare) and nullify the U.S. Constitution.

Obama says he is not engaged in a war against Libya (yeah, right!), but it's clear the FDA has declared war on the American people.

And where does the FDA even claim it has the right to deny the use of dietary ingredients?

The Commerce Clause, of course! It's the catch-all clause that Big Government always uses to claim supreme power over the people. And yet it's all a misinterpretation of the original intent of the Commerce Clause!

The U.S. Constitution was written to LIMIT the power of government in order to protect the People from precisely the kind of tyranny being unleashed against us by the FDA.

WHERE YOU CAN READ MORE:
.

Ralph Fucetola, the Vitamin Lawyer, shares his thoughts on this issue at: 

http://www.healthfreedomusa.org/?p=9875

Also, the Alliance for Natural Health, which originally broke this story, offers an excellent analysis along with an online petition I encourage you to sign:

http://www.anh-usa.org/fda-new-snea...

Alert your local health food stores about this FDA assault on so-called NDIs. Share this article. Make sure your friends know the FDA is trying to destroy the supplements industry.

We must not let them succeed. In fact, I say that in a just society, we would ask the U.S. Department of Justice to lead a citizens' march into the FDA offices and arrest the criminals there, charge them with crimes against humanity ~ plus fraud, racketeering, and conspiracy to commit murder ~ then hold public trials where all the evidence against the FDA is made public so that the entire population can see the full extent of the crimes this agency is committing against the People of this great nation.

We are not just dealing with bureaucrats here, my friends... we are dealing with murderers who absolutely do not value human life in any way ~ and who are committed to causing more disease, more suffering, and more death as long as they can protect the profits of the pharmaceutical industry.

These FDA bureaucrats are in the same evil class as Nazi war criminals, and it's time that we subjected them to the full force of common law powered by the People.

The sooner that day comes the safer our nation will be from tyrants. We are now quite literally fighting for our lives.

ARTICLE THREE:

RED ALERT: FDA SET TO BAN YOUR SUPPLEMENTS

Mercola.com
By Dr. Mercola

 

The FDA has issued a proposed mandate that represents the greatest threat to dietary supplements since 1994. Back in the early 1990s, consumers were so alarmed by FDA bullying that they staged a massive revolt.

The result was that Congress passed a law prohibiting the FDA from banning popular nutrients (as the agency had threatened to do).

There was, however, a loophole in the 1994 law. The FDA was given authority to regulate ingredients introduced after October 15, 1994.

It has been 17 years, but the FDA just issued draconian proposals as to how it intends to regulate what it now calls “new dietary ingredients”. You can find the FDA Draft Guidance on New Dietary Ingredients (NDI’s) here.

If implemented, some of the most effective nutrients you are taking will be removed from the market. This includes many fish oil formulas and natural plant extracts. A detailed analysis of the FDA Draft Guidance is available here.

These oppressive rules are exactly what the 1994 law (DSHEA) sought to prevent. The FDA is using its authority in direct violation of Congressional intent.

In order for these ingredients you are using today to return to the market, the FDA will require manufacturers to conduct outrageously expensive studies using absurdly high doses, in some situations multiplied by a “safety factor” up to 2,000-times the recommended dosage on a per product basis.

The FDA defines dietary supplements as being “new” if they were introduced after October 15, 1994. That means that even certain nutrients that have been safely used over the course of three decades will be subject to the FDA’s oppressive policies that mandate costly animal testing.

THE FDA VIEWS SUPPLEMENTS IN SAME LIGHT AS SYNTHETIC FOOD PRESERVATIVES

According to the new guidelines, the FDA believes that “new dietary supplements” must be regulated similarly to synthetic food preservatives. The FDA guidelines have modeled the outrageous safety thresholds after those in place for food additives.

This appears to be in direct violation of DSHEA, the law enacted in 1994 to protect consumer access to dietary supplements, which classifies dietary supplements as foods, not food additives.

The FDA proposes that new dietary supplement ingredients should adhere to aggressive safety margins, which are typically reserved for chemical compounds known to be dangerous in all but the most miniscule concentrations.

Since food additives or preservatives such as aspartame, monosodium glutamate, and sodium nitrate are known to cause cancer or other severe health problems, the FDA has implemented safety guidelines which limit allowable concentrations of these food additives to levels that are supposed to be physiologically inert.

The fact that the FDA is trying to impose the same limits upon dietary supplements seems to be arbitrary and completely unfounded.

In fact, when someone takes a dietary supplement, their intent is to positively affect the structure or function of their bodies in some way ~ limiting dosages of dietary supplements to physiologically inert levels defeats the entire purpose of supplementation with health-sustaining nutrients.

The FDA’s new guidelines are so flawed that even nutrients shown to be completely safe in hundreds of human clinical studies would fail to accommodate the unreasonable safety margins.

To give you an example, each manufacturer of certain fish oils would have to conduct a one year study where animals would have to consume the human equivalent of 240,000 milligrams each day of fish oil.

Another option under the FDA’s proposed mandates is to conduct a 90-day, 1,000 ~ fold safety margin study in which two species of animals, one being non-rodent ~ likely young beagle dogs, will theoretically consume the equivalent of 2.4 million milligrams of fish oil daily.

We know of virtually no species can tolerate this high dose, so by default, FDA guidelines will make it impossible for certain omega-3 supplements to be sold. (Note typical dose of EPA/DHA people take each day is around 2,400 mg ~100 times less than what the FDA proposes must be tested.)

Since these are not patented drugs, no supplement maker will be able to afford these “safety” studies, which means that many of the nutrients you now purchase at low prices will convert into high-priced drugs.

PHARMACEUTICAL INDUSTRY PROFIT THREATENED BY LOW COST SUPPLEMENTS

It appears that the FDA is claiming that dietary supplements are unsafe, and in order to “protect consumers” the agency must place a stranglehold on the dietary supplement industry by requesting exorbitant safety testing.

These ludicrous safety thresholds are in excess of those required by pharmaceutical drugs despite studies showing supplements are far safer than drugs.

According to the 2001 report of the American Association of Poison Control Centers (AAPCC), of the substances implicated in fatal poisonings in 2001, 84.6 percent were pharmaceutical drugs, with analgesics being implicated as the primary cause of death in 32 percent of fatalities or 341 deaths.

This compares with 0.8 percent for all dietary supplements combined, even including substances such as dinitrophenol, a dangerous (and illegal) substance banned in 1938, as well as the central nervous system stimulant Ma Huang (Ephedra). Interestingly, the anti-asthma drug theophylline alone was responsible for 15 deaths, 66 percent more than all the available dietary supplements combined.

There is, however, a massive economic benefit for the drug industry if the proposed guidelines are enforced by the FDA. Health conscious Americans who properly supplement slash their risk of degenerative disease. The FDA’s new rules, if enacted, will force the price of many supplements to surge upwards, while removing many effective ones altogether.

That means that more aging people will have to rely on side effect laden prescription drugs to treat the degenerative diseases they will contract because they will be denied access to health-promoting nutrients.

WHAT YOU CAN DO TO STOP THIS IMPENDING CARNAGE!

No one can sit on the sidelines with an emergency of this magnitude about to befall everyone who depends on dietary supplements. As citizens, we have the constitutional right to petition the government to redress our grievances. In this case, the FDA proposals pose a direct threat to our health and longevity.

We therefore have to take extraordinary measures to defend our right to continue using supplements that our very lives depend on, and to gain access to new natural ingredients that demonstrate efficacy in scientific studies.

I ask each one of you contact your representatives by following this link:

Contact your local representative now!

Recall how Consumers revolted back in 1994 and the result was a glorious victory over FDA tyranny!

Let your voice be heard by exercising your right to petition the government against these serious violations of the law and scientific principle.  

PLEASE BE SURE TO CALL, FAX,

OR SEND A CERTIFIED LETTER TO YOUR REPRESENTATIVE

EMAILS CAN BE EASILY DISMISSED.

Here is a set of talking points for your consideration:

My name is [Name] and I am a constituent of [Congress Member’s name].

I am very concerned about the new FDA draft guidance on dietary supplements and new dietary ingredients.

I request that Congress hold hearings and take action to review the FDA’s draft guidance and stop their overreach of power.

The FDA’s draft guidance flies in the face of the original congressional intent of the Dietary Supplement Health Education Act: The guidance turns what was meant to be a simple notification system for new dietary ingredients into a preapproval scheme that Congress did not intend to create.

Congress recognized that dietary supplements are natural ingredients and therefore inherently safer than drugs and chemical food ingredients. It did not intend that the FDA would have the power to approve or reject dietary supplements.

The FDA’s draft guidance creates unnecessary regulations that limit my access to dietary supplements I rely on. The expensive and burdensome process will force between 20,000 and 42,000 dietary supplements to be removed from the market and will increase the cost of those supplements that remain.

The draft guidance hurts our economy. Expert analyses show that this guidance will cause a total economic loss of $21.2 billion to $39.8 billion annually.

Thank you for your time.

TIPS:

Be courteous and respectful.

Keep your comments brief and focused on the facts.

Always thank the staff member for their time taking your call.

Find Your U.S. Representative

Zip code: +

Powered by CQ Press

Get this widget

SAMPLE LETTER TO CONGRESS:

The Honorable _________________________ Washington, DC

In direct violation of the law, the FDA is threatening to ban my access to new dietary supplements.

The FDA defines dietary supplements as being “new” if they were introduced after October 15, 1994. 

That means that nutrients that I have been safely using over the course of three decades will be subject to FDA’s oppressive policies that mandate costly animal testing, which translates into forced withdrawal from the market, and higher prices for me if the supplement is ever allowed to be sold again.

The Dietary Supplement Health and Education Act of 1994 states that:

“The Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers.”

It says that Congress finds that:

“Dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare.”

And it says that:

“Legislative action that protects the right of access of consumers to safe dietary supplements is necessary in order to promote wellness.”

This draft guidance does the exact opposite of what Congress intended. It imposes unreasonable barriers that limit and slow the flow of safe products and accurate information to consumers. I call upon Congress to: 

1. Uphold the landmark legislation it passed seventeen years ago, and to direct the FDA to revise its New Dietary Ingredient draft guidelines to reflect DSHEA’s (and Congress’s) stated values and goals.

2. Vote against the newly introduced Dietary Supplement Labeling Act as this would give the FDA even greater arbitrary powers to remove safe dietary supplements from the market, and will profoundly impact this nation’s health in a negative way.

All of these proposals result in wasteful federal spending while at the same time impose a massive new “regulatory tax” on consumers and the vitamin industry.

Kindly let me know what actions you are taking in response to the urgent issues raised in this letter.

Sincerely,

Name________________________________________
Address______________________________________
City______________________ST____ Zip__________ 

 

THE FDA ATTEMPTS TO TAKE AWAY YOUR RIGHTS TO NATURAL THERAPIES, HERBS, AND ORGANIC FOOD

STAND FOR THE RIGHT TO LIFE, LIBERTY, AND THE PURSUIT OF HAPPINESS (HEALTHY WELLBEING) BY WRITING TO YOUR REPRESENTATIVES AND SENATORS, AND LIVING OUR RIGHTS

ACT BEFORE THE FDA Guidelines Commenting Deadline of APRIL 30, 2007 through www.treeoflife.nu/healthrights

A HEALTHY PEOPLE IN TOUCH WITH NATURAL HEALING AND ANCIENT/MODERN HEALTH SCIENCES DOES NOT NEED THE DRUGS AND MEDICAL PARADIGM OF A CULTURE OF DEATH.

SUCH A PEOPLE MAKES A CULTURE OF LIFE! A CULTURE OF LIFE IS A THREAT TO THE CULTURE OF DEATH OF THE GLOBAL ECONOMIC AGENDAS.

THIS IS A FULL-ON ATTACK IN WAVES aimed at making the People dependent on pharmaceutical drugs, taking away all choices except for genetically modified, irradiated-lifeless, mineral-depleted, biochemically adulterated, non-nutritive food, leaving the People undernourished and unhealthy, and the economically powerful in control.

IMMORAL, UNCONSTITUTIONAL, SPIRITUALLY BANKRUPT. 

THE FDA'S ALIGNMENT WITH MONOPOLIZING DRUG COMPANIES AND CODEX ALIMENTARIUS OVERSTEPS BOUNDS AND IS ECONOMICALLY MOTIVATED. 

IT MUST BE 100% STOPPED NOW 

BY A SUSTAINED OUTCRY.

STAND AGAINST ANY outlawing of YOUR NUTRITION AND HEALTH RIGHTS

We Are Not Fooled by False Claims of "Food Security" and "the Need for Regulation."

NUTRIENTS ARE OF THE EARTH, OF THE DIVINE, AND OUR NATURAL RIGHT.

NATURAL FOODS, HERBS, MINERALS, ENZYMES, FASTING, TOUCH, ENERGY, AND OTHER THERAPIES HAVE BEEN USED FOR 5000+ YEARS TO KEEP PEOPLE WELL.

NATURAL HEALING REMAINS THE HOPE FOR MILLIONS OF PEOPLE TODAY.

COMPROMISING THAT WOULD BE AN EXCUSE FOR A MORE VICIOUS POLITICAL PLAN:

We the People challenge the ego of economic globalism's culture of death and desire to dominate food and nutrition, control health, and enslave us into being a sick and depleted people whose minds, bodies, & pocketbooks become too weak to fight for our rights.

WE CONTROL OUR HEALTH AND NUTRITION ~ 

DRUG COMPANIES DO NOT. BACK OFF!

784,000 Annual Deaths in U.S.A. by Modern Medicine. Costs $282 Billion (Carolyn Dean, M.D.)

Deaths by Supplements, Herbs, and Natural Therapies: Fewer Than Deaths by Bee Stings!

GROW FOOD. SUPPORT ORGANIC, LOCAL, & FAIR TRADE.

SEEK NATURAL HERBS, MINERALS, BODYWORK, & ENERGETIC HEALING MODALITIES.

TALK TO EVERYONE YOU KNOW ABOUT THIS.

FARM LOCAL REGIONAL & NATIONAL LEADERSHIP AND ORGANIZATION

INFORM YOUR SENATORS AND REPRESENTATIVES: 

The FDA should keep the drug companies in check ~ not collude with them!