OK guys, time to wake up and take this matter into hand. Write your congressman, your senators, contact all blog sites you communicate with . We've got to move on this issue ASAP

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

Fight FDA Fascism - Deadline: Dec.1

I'd like to share an email I just received from the President of a Nutraceutical company that makes professional level vitamins and supplements.

Here is the content:

This is the most serious message I've ever had to write to you.

Why? Because the FDA has issued new rules that, if enacted, will enable them 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.

Frankly, 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 https://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:]
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.

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.

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.

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.

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.

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.

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.

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, https://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 https://www.usa.gov/Contact/Elected.shtml.

Sincerely,

Garret W. Wood
President
Advanced Bionutritionals, LLC

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Thank you for the heads up!

Im going to be bumping this thread quite a bit over the next month. Please take action.

I already didn't like the FDA. This really seals the deal.

Thanks for posting!

I just e-mailed my senator.

Dido and representative.

This is the message I am sending:

Please vote NO on the upcoming power grab the FDA is attempting to make on behalf of pharmaceutical companies and the laboratory animal industry. The FDA is attempting to require that all health supplements be “proven safe” through a ridiculous model of animal testing (1,000 times normal human dose). This model is contrived to produce a biased result. Animals are much smaller than humans. 1,000 times normal human dose is actually 2,000-3,000 times larger than a normal dose for an animal, depending upon size of the animal.

No testing of food supplements (including herbals), which have been available to the American people since 1994, is needed. These dietary supplements have already been proven safe through many years of actual use. It is the mission of the FDA to prove that substances are unsafe. The FDA does not have the authority to require manufacturers to do testing.

Is there a Senate or House bill number? Many representatives do not research by topic. They only care about how their party is going to vote on a specific bill. The lazy oafs.

Thanks for the message verbiage hints. That helps a lot.

__________________
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- Jim
That which does not kill us makes us stronger. -Friedrich Nietzsche

It is called The Dietary Supplement Safety Act of 2010

Here is an article about it:
https://www.lef.org/featured-articles...ct-of-2010.htm

Thanks. That's good enough.

Here is a response from one of my senators.

So Senator Hutchinson said essentially nothing on her position. Typical politician.

Yes. Just politics. She is notorious for changing her position, right before a vote, to whatever her party tells her to do.

OK, this is why they put fluoride in your water, and mercury in your fillings and vaccines.

This is like a magic trick... you make the people look over here while you make something happen over there.

Put it this way... the FDA and their banker bosses know that the people won't stand for their supplements to be taken away... they know this because its been tried before and it backfired on them, but there is a reason why they are doing it again, its the magic trick...

We'll get all the people involved with saving their supplements, and saving the whales, and trying to slow down global warming, and trying to remove fluoride from water, and getting rid of vaccines, etc., while they steal all the money from the global economy. These are the greediest bastards on the planet, they want it all.

Greece is the pivot point. What happens there will also happen in Spain, and Italy, and I have a very strong hunch that the people of Greece will not give in to these greedy buggers, and that will cause riots beyond anything we have seen so far. They will not tolerate the corrupt government, and will start removing them from power... permanantly.

Getting back to the FDA, remember...they want us to look over here..

__________________
Let Food Be Your Medicine And Medicine Be Your Food.(Hippocrates)

I got the same typical form letter response from my senator and house representative.
Although I have heard nothing form our other state senator, but then I am not in his district. However that does not mean no one else can send him a letter and considering that he is the one pushing for this legislation everyone should be flooding him with letters.


Senator Durbin�s Stealth Move against Supplements

October 25, 2011
Since he�s having trouble getting his own bill passed, he�s trying a different approach to get the same results. New Action Alert!

For weeks we have been telling you about Sen. Dick Durbin�s disastrous Dietary Supplement Labeling Act, which attempts to impose harsh limits on supplement availability by giving the FDA major new powers to make arbitrary standards and rules that will curtail supplement sales.
Initially it orders the FDA to compile, with help from the Institute of Medicine, a list of dietary ingredients (read: supplements) that could lead to adverse events or are otherwise deemed risky in some way. But creating lists of �bad� ingredients or �bad� doses based on completely arbitrary or non-existent standards is a slippery slope.

Now Sen. Durbin has proposed an amendment to an appropriations (budget) bill, which is a sneaky way of getting controversial laws passed without too much attention. The amendment would have the Government Accountability Office (GAO) assess the effectiveness and utility of the FDA�s adverse event reporting (AER) system, and report to Congress on what actions FDA is taking to ensure that dietary supplement manufacturers are reporting adverse events; how the AER system �informs the public� of FDA�s efforts to protect consumers; and, most especially, whether FDA has implemented the recommendations GAO made in its 2009 report on dietary supplements.

Buried in the GAO�s recommendations in its 2009 report are some of the same provisions that are also in Durbin�s unpopular Dietary Supplement Labeling Act. In our article on the report, we noted that the GAO recommended:

• increased supplement labeling regulations�one of the Durbin bill�s main goals;
• a clear delineation to be made between food and supplements�a first step toward treating supplements as drugs�this is also in the Durbin bill, and it�s the particular clause we feared he would slip into the appropriations bill; and
• an increase in AER requirements: currently only severe adverse events must be reported, but this would force AERs to be filed even for the most minor events.

The GAO undermined its own recommendation in the report by acknowledging that �FDA officials told us that the current regulatory framework is sufficient to identify and act on safety concerns regarding foods with added dietary ingredients.� This supports ANH-USA�s assertion that the FDA is already well equipped and needs no additional authority to do its job.

Furthermore, the number of supplement AERs is quite low�only 1,080 in 2008. And keep in mind that over half the US population (at least 154 million individuals) take nutritional supplements, according to data from 2007 National Health Interview Survey. The supplement AER figure is even lower when compared to the 526,527 prescription drug AERs in 2008. In other words, for every adverse event from supplements, there are 488 adverse events from prescription drugs!
Remember that it took the deaths of 55,000 Americans before FDA considered pulling Vioxx off the shelves.

The fact that Sen. Durbin has suggested this appropriations amendment indicates that he no longer has high hopes for the Durbin bill. Thanks to all the messages you�ve been sending Congress, he is having a difficult time gaining support for it�he has only been able to find one senator so far who is willing to co-sponsor his bill�and so he�s trying to pressure FDA into implementing the bill�s goals via the regulatory system. We believe it is also an attempt to lay stronger groundwork to push his bill through legislatively, once he gets the ball rolling and FDA starts to treat supplements more like drugs.
We should also note that Sen. Durbin was the architect of the current AER system, but he was unhappy with the political compromise that was struck when the law was passed originally�Sens. Hatch and Harkin agreed to a reporting system so long as it was only for severe events. Now we see Durbin pushing a requirement to have all adverse events be reported, no matter how minor.

What Sen. Durbin clearly wants is for every supplement to be approved by the FDA before it is sold. Everything he does is intended to move things in that direction.

There are fundamental objections to this. First, the FDA is biased in favor of drugs, probably because drugs pay the FDA�s bills. Since the agency sees supplements as competition for drugs, not many will be approved. Second, the agency will demand supplement trials just like drug trials�which is not appropriate for supplements. Supplements are like food: it is the combination and balance of what you take that matters, not just the effect of one pill. Third, the cost of complying with the pre-approval process will make supplements, already beyond many people�s budget, too expensive for all but the rich.

If this powerful senator can�t win using the direct approach, he�ll try an end-run. It may be politics as usual, but when it affects your family�s health, it�s time to fight back. We�ll keep you posted on the maneuvering around appropriations bills.

In the meantime, if you haven�t yet sent a message to Congress about the Durbin bill, please do it now!But just as important, the appropriations bill is scheduled to be voted on by next Monday, October 31, at which time Sen. Durbin will try to add his amendment. Please write your senators today and stop this language dead in its tracks!

Wonder what happened.