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LISTMATES:  PLEASE TAKE THE TIME TO ACT ON THIS!!

 

*RED ALERT*

FDA Set to Ban Your Supplements 

Posted By Dr. Mercola, September 13, 2011

Dear Friends, 

The current actions against nutrition require we invest a little time and

determine 'do I want to act on this'?  The threat is genuine.

Comments should be submitted by October 3, 2011.  Please read the enclosed and

act as you see fit.      

 

 

 

Story at-a-glance

 

·  The FDA's new Draft Guidance on New Dietary Ingredients threatens to remove

some of your most commonly used supplements from the market

·   Manufacturers of supplements will be forced to conduct expensive safety

studies using absurdly high doses, which will force many out of

business-effectively eliminating competition to high-priced pharmaceuticals

·   The FDA guidelines have modeled the outrageous safety thresholds after those

in place for food additives, which is in direct violation of DSHEA, which

classifies dietary supplements as foods, not food additives, in order to protect

consumer access to dietary supplements

·   Defend your right to continue using supplements by taking action now!   

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find  the FDA Draft Guidance on New Dietary Ingredients (NDI's) here.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 A detailed analysis of the FDA Draft Guidance is available here.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 

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.