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Re: Please fight corrupt Big Pharma!

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Dr. McCandless,

I think we also need provide the evidence that children with autism may

suffer from cell-mediated immunity defects which is a contraindication

to many vaccines according to the CDC. Children with autism as reported

in the Low natural killer cell cytotoxic activity in autism

<http://www.ncbi.nlm.nih.gov/pubmed/18929414> that you worked on showed

that 45% of a group of over 1,000 children with autism suffer from low

natural killer cell activity. It has been very well documented in

immunology literature that one of the functions of Cell-Mediated

Immunity involves the activation of natural killer(NK) cells.

Autism According To SCIA (search for CDC to jump to the vaccine

contraindication paragraph)

https://stopcallingitautism.org/content/pdf/AutismAccordingToSCIA.pdf

<https://stopcallingitautism.org/content/pdf/AutismAccordingToSCIA.pdf>

Let's show the data, Stop Calling It Autism! is putting all this

together, the only way we can make the difference is providing the

evidence in forms of data. We need to get every single child with

autism tested for immune function.

SCIA Realtime Medical Disease Registry Statistics

https://stopcallingitautism.org/sciastudytracker/sciastudystats.html

<https://stopcallingitautism.org/sciastudytracker/sciastudystats.html>

Stop Calling It Autism!

>

> 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 · The FDA's new Draft Guidance on New Dietary Ingredients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.

>

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