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donnay
09-14-2011, 09:08 AM
FDA New, Stealth Dirty Trick To Take Your Supplements

The FDA's war on our health includes trickery.


http://www.youtube.com/watch?v=CA3LY0M_gI8

donnay
09-14-2011, 09:11 AM
FDA Set to Ban Your Supplements (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 You can find the FDA Draft Guidance on New Dietary Ingredients (NDI's) here.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 A detailed analysis of the FDA Draft Guidance is available here.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.

http://articles.mercola.com/sites/articles/archive/2011/09/13/fda-to-ban-new-supplements-and-classify-them-like-food-preservatives.aspx?e_cid=20110913_DNL_art_1

donnay
09-14-2011, 09:13 AM
FDA's scheme to outlaw nearly all nutritional supplements created after 1994 would destroy millions of jobs and devastate economy

(NaturalNews) 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.

Stay tuned to NaturalNews.com for more reporting on this developing issue.

Learn more: http://www.naturalnews.com/032924_dietary_supplements_FDA_approval.html#ixzz1 XwLXZFc7

donnay
09-14-2011, 09:15 AM
Alex Jones - ‪Mike Adams: FDA's End Game scheme to outlaw all nutritional supplements 1_3!


http://www.youtube.com/watch?v=Nc8B8MZ11P4

linusPAULing
09-15-2011, 08:11 AM
Below is another article on the proposed FDA ban on supplements. Please consider contacting Congress via this site

http://www.anh-usa.org/vitaminwar/

to request that they stop this assault on our access to supplements.


On the Friday before the Fourth of July weekend, the FDA published a 47-page document, that would ban all nutritional and supplemental ingredients by requiring them to file documentation involving multi-million-dollar testing and the regulations would be retroactive to 1994!

This will destroy the manufacturers of these products because most are small companies that could not afford such costs. It’s not like there is a vast body of information that demonstrates any threat to health from vitamins and minerals. Quite the contrary. There is ample information on their benefits. There are libraries filled with books devoted to this.

Who would benefit from such regulation of the natural supplement industry? Big Pharma. The same pharmaceutical companies that have a long record of putting forth FDA-approved medications that later prove to be lethal are looking to use the regulatory powers of FDA to literally increase levels of illness.

In the same way Obamacare has been demonstrated to not only be unconstitutional, but also a threat to the health of millions—especially senior citizens—this callous administration now threatens to remove from the shelves of stores that sell nutritional supplements, from pharmacies, and from supermarkets and other outlets, the vitamins, minerals, and herbal supplements on which millions depend for wellness.

This constitutes a criminal conspiracy and Congress, which has ceded its law-making authority to the FDA, must hear from everyone in order to stop this assault on everyone’s health.

http://canadafreepress.com/index.php/article/39686

drpaulsince76
09-20-2011, 08:39 AM
What would Ron Paul Do?

If anybody wants to do anything about this I post here on 8/16/11
Right to Know About the Science Behind Dietary Supplements!

Please go and tell others about this site Citizen for Health.
www.citizens.org/?page_id=2095

There are two Ron Paul bills:
HR 3394, the Freedom of Health Speech Act
HR 3395, the Health Freedom Act

Main site Citizens.org go to Supplements and see some the other good and bad legislation Senetor Durbin (D) Illinois is trying to do.

The FDA is trying to take our rights and supplements away. I was involved back in early 1990's helping get the word out for our rights to be able to choose and even have dietary supplements available. The biggest letter writing, calling and faxing campaign to congress took place. Today that cause was and still is the biggest out cry to Congress about ANY issue ever! OUR rights to choose to have dietary supplements access or not. This was bigger than protesting the congress about the Vietnam War. Help spread the word...thanks