Fw: Supplements the FDA Wants to Ban

[Guest guest]

Dear Listmates, friends, colleagues, and family:  For those of you who have the

time, PLEASE act now and post on your websites - this is all a ruse by Big

Pharma which hates people using nutrients; their goal is to have everyone on at

least 4-7 expensive (and often dangerous) prescription drugs forever if

possible.  Too many of us are doing well with nutrients, and cutting a bit into

their billion-dollar profits!  Dr. JM

Subject: Supplements the FDA Wants to Ban

Urgent request for your help again since supplements will not just become

terribly expensive but, unless you act now, many will be gone forever.

The FDA has had this regulation on the books for 17 years, now they have figured

out a way without any new laws to make most supplements unavailable without

millions of dollars of studies per item. This is always in the name of

protecting the public whereas the fact is there are VIRTUALLY NO DEATHS FROM

SUPPPLEMENT USE. According to the Poison Control Centers, there were zero deaths

due to supplements in 2008. In 2009, there was one. Please go to the bottom of

the attached and complain, as enough voices being heard by our representatives

might stop the FDA from implementing these onerous regulations.

Garry F. Gordon MD,DO,MD(H)

President, Gordon Research Institute

www.gordonresearch.com

Please find below a special message from Advanced Bionutritionals. They have

some very important information to share with you about the latest attempt by

the FDA to ban supplements.  Read the shocking news below.

Sincerely,

J. Rowen, MD

Dear friend,

I know I've sent you a lot of emails about the new FDA rules. Sorry to keep

bothering you. But this is a critical issue. The deadline to comment is December

2. That's tomorrow!

Some of our customers have heard back from their Congressmen. That's good.

What's not good is that some of them are misinformed.

For example, Senator Mark Warner writes:

" This guidance, when finalized, does not create new regulations or law.

According to the FDA, the industry can use an alternative approach if the

approach is consistent with the applicable provisions under an existing law, the

Dietary Supplement Health and Education Act of 1994 (DSHEA). "   True, it doesn't

create a new law. ly, that would be easier to fight! Instead these new

regulations interpret existing law to wipe out 17 years of safety and

innovation.

And Senator Cantwell writes:

" In its new guidance the FDA recommends that a manufacturer should include

information explaining the composition of the ingredient, why the ingredient is

considered new, recommended usage by consumers, and why the ingredient is

considered safe. "   Senator Cantwell glosses over what kind of proof the FDA

will

require to consider a " new " ingredient safe. I put " new " in quotes because these

nutrients really aren't new. They come from nature. But under these proposed

guidelines, the FDA will consider any ingredient " new " if a different extraction

process is used, if a different " life stage " (like ripe instead of unripe) is

used, or even if a supplement uses more of an ingredient than was used 17 years

ago.  Bear in mind, that people have been safely taking these ingredients for

years — even decades!

Yet the FDA will require companies to conduct prohibitively expensive studies on

every ingredient in a product and on every product a company sells.

It is true that the DSHEA of 1994 directed the FDA to define " New Dietary

Ingredients. " But the FDA did nothing for 17 years. In that time, hundreds —

even thousands — of " new " ingredients have been introduced.

Now the FDA wants to ignore nearly two decades of innovation and turn back the

clock. Dr. Rowen made a good comparison. What if someone from the

government came along and replaced your current computer with a model from 1994?

Or swapped your smart phone for a clunky early model cell phone? That's what the

FDA wants to do.  This is not hysteria. This is not a mis-reading of the FDA's

proposed guidelines. This information comes directly from the FDA's own

website.  If enacted, these rules will enable the FDA to ban many of the

supplements you are now taking.

Think I'm exaggerating? Then please listen to the full story ...

Back in the early 1990s, the FDA tried to make many supplements illegal.

Consumers were so alarmed by the FDA's bullying that they staged a massive

revolt. The result was that Congress passed the Dietary Supplement Health and

Education Act (DSHEA). That law protected supplements from the FDA unless the

FDA could prove a supplement wasn't safe.

There was, however, a loophole in the 1994 law. The FDA was given the authority

to regulate new ingredients introduced after October 15, 1994.

So what happened? Nothing at first. For 17 years, the FDA took no action, gave

no guidance, and launched no enforcement of these " New Dietary Ingredients. "

And that's been a good thing. Because for 17 years, the dietary supplement

industry has enjoyed tremendous innovation. These innovations have allowed us to

extract and concentrate the most effective natural ingredients. As a result,

millions of consumers have benefitted. They've protected their hearts and

arteries ... found relief from their joint pain ... boosted their memory ... and

more.

And during this time, supplements have enjoyed a remarkable safety record.

Statistics show that supplements are safer than prescription drugs, cosmetics,

medical devices, and even food!

According to the Poison Control Centers, there were zero deaths due to

supplements in 2008. In 2009, there was one.

Meanwhile, pathogens like e. coli in food kill at least 2,000 people each year.

Acetaminophen in drugs like Tylenol kills 450 people every year. And more

powerful prescription drugs kill many more. Even the FDA now says Vioxx likely

killed over 26,000 people before they finally took it off the market!

Supplements the FDA Wants to Ban

But now the FDA wants to act like the last 17 years never happened. The agency

has drafted a proposal to regulate what it calls New Dietary Ingredients. If

this proposal is implemented, some of the most effective nutrients you take will

be pulled from the market. Nutrients like resveratrol ... ubiquinol CoQ10 ...

bacopa ... strontium ... and more.

But that's not all. Under these guidelines, the FDA can define almost anything

as a " new " dietary ingredient. For example:

•  If a supplement includes more of an ingredient than was used 17 years ago

—

even something like vitamin C — it's " new. "

•  If an ingredient uses a different extraction process — like baking or

fermentation — it's " new. "

•  If a supplement uses an ingredient at a different " life stage " — such as

using ripe rather than non-ripe apples — it's " new. "

•  If a supplement duplicates an ingredient in a laboratory rather than

extracting it from the food — even though it's chemically identical — it's

" new. "

•  And if a probiotic formula includes a strain of bacteria that wasn't found

in

yogurt 17 years ago, it's " new. "

So what would happen to all these " new " ingredients? The manufacturers would

have to take them off the market until they could prove the ingredients are safe

— even if those ingredients have been safely used for 17 years!

Why It's Nearly Impossible to Comply

What kind of proof is the FDA demanding? According to the guidelines, many

companies would have to conduct animal studies using a dosage that's 1,000 times

the typical dose.

I'm not kidding you. It's right there in black and white on the FDA's website.

The FDA wants vitamin makers to do studies for a full year, at 1,000 times the

typical dose.

So a fish-oil manufacturer would have to conduct a one-year study where animals

are force-fed the human equivalent of 240,000 milligrams of fish oil each and

every day! This outlandish dose would injure the animals and give the FDA an

excuse to outlaw the product.  But wait, it gets even better. If one fish-oil

manufacturer performs such a study and it passes, it doesn't mean the other

fish-oil makers can use the same data. No sir. They are still required to go out

and do their own studies before they're allowed to sell their product.

And these studies are very expensive. A study like the one above typically costs

about $100,000-$200,000 to perform. Multiply that by several ingredients in

several products, and you get an idea of the cost.

Say a company carries 6 products containing 6 ingredients each. It would cost

between $3.6 and $7.2 million in studies before that company could even offer

the products for sale. For a larger company offering 50 products or more, the

costs would be astronomical.

Few supplement makers will be able to afford these studies, and many will be put

out of business. And the ones that remain would still be at the mercy of the

FDA's whim. That's because there are no requirements for the FDA to approve

anything. They can approve or reject anything they want. And in the past, they

have rejected the majority of ingredients submitted to them.

That means most of the nutrients you buy today will be pulled from the market

and never return. Those that do return will be a lot more expensive — or may

only be available as prescription drugs!

A Blatant Abuse of Power

This is a blatant abuse of power. What the FDA is doing here is performing an

end-run around the existing law. According to the law, the FDA has to prove a

dietary supplement is unsafe for it to be taken off the market. These new

guidelines turn that on its head. They are clearly not what Congress intended.

Fortunately, these FDA guidelines have not yet been finalized. All federal

agencies are required to give the public an opportunity to comment on a draft

before it is made final. In this case, the FDA has given interested parties

until December 1st to comment on the draft. That means there's a small window of

opportunity for you to voice your disapproval.

ly, I wouldn't bother commenting to the FDA. The process is cumbersome, and

those unelected bureaucrats don't care what you think anyway.

What You Can Do

The best way to defeat these new rules is to talk to the people you do elect —

your congressman and your two U.S. senators. They have the power to reign in the

FDA — and they have done so in the past when enough voters complained.  Back

in

the 1970s, the FDA tried to require " warning labels " on vitamins. Angry voters

called and wrote letters, and Congress responded with the Proxmire Amendments

which limited the FDA's power.

Then in the 1990s, the FDA went on the warpath again. When voters complained,

Congress passed the Dietary Health Supplement Education Act, which once again

limited the FDA's power. But like a monster killed in a horror movie, the FDA

keeps coming back. And so once again, it's time for us to step up and call the

folks who rely on our votes.

HERE'S WHAT YOU NEED TO DO:

Go to http://www.usa.gov/Contact/Elected.shtml and look up the phone numbers of

your U.S. Senators and your Representative (congressman). Then give them a

call.  Don't be shy and don't worry. No one is going to bite you, no one is

going to argue with you, and no one is going to quiz you to see how well you

know the issues. The job of the staffers who answer is to listen politely and to

relay what you say to their boss. So please do call. And please be polite and

respectful of the staffers' time.

Here are some talking points to use when you call:

•Hello, my name is [name] and I am a constituent of [name of Senator or

Representative].

•I am very concerned about the new FDA draft guidance on dietary supplements

and

new dietary ingredients.

•[Feel free to tell them about the supplements you take and/or the benefits

you

get from those supplements. Then feel free to make as many of the following

points as you like:]

1.Supplements have an unrivaled safety record. Statistics show they're safer

than drugs, safer than medical devices, safer than cosmetics, and even safer

than food.

2.The FDA cannot define New Dietary Ingredients so broadly. According to these

guidelines, almost everything is a New Dietary Ingredient. This will strangle

innovation and deprive consumers of the supplements they depend on for their

health.

3.The FDA did nothing about new dietary ingredients for 17 years. Now they want

to wipe out 17 years' worth of innovation and 17 years' worth of benefits to the

consumer.

4.When the Dietary Health Supplement Education Act was passed, Congress intended

a simple notification process for new dietary ingredients. The FDA is turning

this into a pre-approval scheme, which goes against the intent of the law.

5.The FDA already has ample regulatory authority to take action against a

product if it's unsafe. They don't need to have this pre-approval power, too.

6.These could be disastrous to public health. At a time when preventative

measures are even more important to health care costs, the FDA is limiting

access to preventative health care.

7.The cost of complying with these guidelines would be astronomical. Experts

estimate that the studies required would cost between $100,000 and $200,000 per

ingredient notification. That adds up to millions of dollars per supplement

company. Smaller companies would not be able to afford this and would go out of

business.

The economy is already hurting and we have high unemployment. Experts estimate

that this could cost the economy tens of billions of dollars and result in the

loss of tens of thousands of jobs.

8.The government's resources are already stretched. We have record budget

deficits and record debt. Why enact more regulations when there are no safety

issues here?

•I request that Congress direct the FDA to carefully review their draft

guidance. If they do not amend the guidance to reflect my concerns, I request

that Congress call hearings at the end of the review process. I also call on

Congress to write legislation that would " grandfather " all supplements currently

on the market.

•Thank you for your time.

After the phone call, send a letter to your senators and reps, making the same

points. Make sure the letter is in your own words (form letters tend not to work

as well). You can find the e-mail and physical addresses at the same website,

http://www.usa.gov/Contact/Elected.shtml.

Then send the same letter to President Obama. (His address and phone number are

on the website, too.)

Please, please, please don't make the mistake of thinking that the FDA won't

take your supplements away. Similar regulations were passed in other countries,

and the result was disastrous. Many supplements were taken off the market

forever. In some instances, the entire supplement industry was decimated. Don't

let that happen here.

Take action now! You only have a small window of opportunity to make your voice

heard. Get started by going to http://www.usa.gov/Contact/Elected.shtml.

Sincerely,

Garret W. Wood

President

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