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.
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…
All Noisy on the Western Front
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.
Jenny Thompson is the Director of the Health Sciences Institute and editor of the HSI e-Alert. Through HSI, she and her team uncover important health information and expose ridiculous health misinformation, most notably through the HSI e-Alert.
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