Showing posts with label dietary supplements. Show all posts
Showing posts with label dietary supplements. Show all posts

Thursday, March 11, 2010

LATEST NEWS ON LEGISLATION INVOLVING REGULATIONS ON NATURAL SUPPLEMENTS

By: Jenny Thompson - HSI

In the David vs. Goliath world of the vitamin and herbal supplement industry vs. Big Pharma, the medical mainstream and the FDA, you can put away your slingshot--for now. But don't put it too far out of reach, because you'll need it again...sooner than you may think.

Yes, it's hunting season...on supplements, that is.

We'll start in Congress. It seems like every couple of years light bulbs blink on and some congressmen get the brilliant idea that the supplement industry should be more severely regulated. Of course, on the surface that might sound reasonable. Why not make sure something that millions of Americans are putting in their bodies every day is as safe as possible?

The problem: That isn't how regulation works.

First of all, the FDA can't manage and adequately enforce supplement regulations already in place. How in the world will they cope with excessive new layers of bureaucracy? That's exactly how regulators bog down the whole system. They pile on layers of needless red tape at unmanageable expense and, at the end of the day, the results for the consumer are rarely any better.

And make no mistake...if the ideas currently pending actually come to life, supplement companies will be forced to shut their doors or raise their prices so high that it would put them out of reach for most of us.

So while some of the proposals seem harmless on the surface, I promise you they are anything but.

Your right to buy the supplements of your choice at a reasonable price is under attack by a Congress that sees an easy target and an administration looking to cross things off its "to do" list.

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McCain Failin'
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A bill, titled the Dietary Supplement Safety Act of 2010, was recently introduced by Senators John McCain and Byron Dorgan. McCain is the big gun here, obviously, so the bill is widely referred to as "the McCain bill."

Yet, in a surprise move, Senator McCain withdrew his support of the bill late last week. (I don't remember THAT in the Schoolhouse Rock song.) A new "compromise" bill is reportedly in the works.

As originally submitted, the bill would have been disastrous. In fact, a statement on the website for the Alliance for Natural Health USA spells out the chilling details: "Under current law, the FDA cannot arbitrarily ban a supplement that was sold prior to October 15, 1994, the date that the Dietary Supplement Health and Education Act (DSHEA) was passed. McCain's bill wipes out that protection."

In addition, the bill would have authorized the FDA to keep a list of legal supplements. "The FDA would have arbitrary power to choose permitted supplements and (importantly) supplement doses."

That means that the FDA could have decided vitamin C could be sold in doses only of 60 mg or that CoQ10 couldn't be sold at all.

So, of course, supplement takers, makers and marketers alike are rejoicing in what they are declaring a victory.

But it's not quite time to pop the champagne and laugh in Goliath's face just yet.

One thing we know about Senator McCain is that he doesn't walk away from a fight. We'll soon see another version of his bill, and the changes may or may not be to the average supplement user's advantage.

In any case, Congress isn't the only looming threat...

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All Noisy on the Western Front
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Over at the FTC, someone appears to be cooking up such strict new requirements for supplement product claims that many supplement makers would simply be driven out of business.

According to Todd Harrison--a Washington, D.C., attorney and columnist for Nutraceuticals World--the FTC plans a new regulation that would require two human trials on the actual products to provide scientific support of supplement products. (Right now, most supplement companies rely on scientific studies about individual ingredients or combinations when developing formulations.)

Again, on the surface that might sound like a good idea. But clinical trials like that are extremely expensive-- like, drug company expensive. In other words, it would effectively prevent most new supplements from entering the market or put the natural medicine industry squarely in the hands of the Big Pharma companies that could afford to comply.

Around the country, there are foxes guarding henhouses who are saying, "Wow...that's a really bad idea!"

In addition, the FTC would be able to use third-party studies to refute a supplement maker's claims, but the supplement maker would not be allowed to use third-party studies to support the claims.

Here's the real kicker: IF the supplement company did two human trials AND their research proved a substantial benefit BUT the prevailing body of evidence doesn't support their research, they still can't use their study results.

So they will have invested years and hundreds of thousands of dollars and proven the value of their products and then the FTC can still disallow their results.

We still don't know the true scope of this threat. The FTC is not quite as predictable or transparent as Congress. But if we do get an opportunity to comment on this before the agency makes a final ruling, I'll make sure you're the first to hear about it so we can let FTC officials know they're way off track on this one.

Sunday, July 8, 2007


The following article was authored by United States Congressman Ron Paul and Presidential candidate, a truly heroic individual who takes on big government, pharmaceutical drug companies, corruption and greed, including that demonstrated by agencies, such as the FDA and FTC.

DIETARY SUPPLEMENTS AND HEALTH FREEDOM

By: Congressman Dr. Ron Paul, U.S. Presidential Candidate

Millions of Americans take dietary supplements every day, and the numbers are growing as the Baby Boom generation ages. More and more Americans understandably are frustrated with our government-controlled health care system. They have concluded that vitamins, minerals, and other supplements might help them stay healthy and less dependent on the system. They use supplements because they can buy them freely at stores and research them freely on the internet, without government interference in the form of doctors, prescriptions, HMOs, and licenses. In other words, they use supplements because they are largely free to make their own choices, in stark contrast to the conventional medical system.

But we live in an era of unbridled government regulation of both our personal lives and the economy, and Food and Drug administration bureaucrats burn to regulate supplements in the same manner as prescription drugs.

The health nannies insist that many dietary supplements are untested and unproven, and therefore dangerous. But the track record for FDA-approved drugs hardly inspires confidence. In fact, far more Americans have died using approved pharmaceuticals than supplements. Not every dietary supplement performs as claimed, but neither does every FDA drug.

The FDA simply gives people a false sense of security, while crowding out private watchdog groups that might provide truly disinterested consumer information. It fosters a complacent attitude and a lack of personal responsibility among people who assume a government stamp of approval means a drug must be safe, and that they need not study a drug before taking it.

The FDA, like all federal agencies, ultimately uses its regulatory powers in political ways. Certain industries and companies are rewarded, and others are punished. No regulatory agency is immune from politics, which is why the FDA should not be trusted with power over our intimate health care decisions.

The real issue is not whether supplements really work, or whether FDA drugs really are safe. The real issue is: Who decides, the individual or the state? This is the central question in almost every political issue. In free societies, individuals decide what medical treatments or health supplements are appropriate for them.

Over the past decade the American people have made it clear they do not want the federal government to interfere with their access to dietary supplements. In 1994, Congress bowed to overwhelming public pressure and passed the Dietary Supplements and Health and Education Act, which liberalized the rules regarding the regulation of dietary supplements. Congressional offices received a record number of comments in favor of the Act, which demonstrates how strongly Americans feel about health freedom.

The FDA simply has thumbed its nose at Congress and ignored the new rules in many instances, by attempting to suppress information about health supplements. But in 1999 a federal appellate court affirmed that the American people have a First Amendment right to such information without interference from the FDA. However, members of Congress have had to intervene with the FDA on several occasions to ensure that they followed the court order.

My regular listeners already know about another looming threat to dietary supplement freedom. The Codex Alimentarius Commission, an offshoot of the United Nations, is working to “harmonize” food and supplement rules between all nations of the world. Under Codex rules, even basic vitamins and minerals will require a doctor’s prescription. As Europe moves ever closer to adopting Codex standards, it becomes more likely that the World Trade Organization will attempt to force those standards on the United States. This is yet another example of how the WTO threatens American sovereignty. By cooperating with Codex, the FDA is blatantly ignoring the will of Congress and the American people.

To learn more about how the government is threatening your freedom to use health supplements, please take 30 minutes and watch the video "We Become Silent: The Last Days of Health Freedom".