when legal loopholes run wild…

Over the last 16 years, DSHEA has been a massive giveaway to alt med and snake oil peddlers, doing far more harm than good.

Imagine a law which allows anyone to sell you pretty much anything without having to follow any standards or testing the wares being sold for safety provided they wink and tell you that what you’re buying isn’t intended to cure of diagnose any disease and that their claims haven’t been evaluated by anyone. Then, say that you really should buy it to lose weight, feel better, boost your immune system or help you deal with an illness, ensuring that nowhere do they explicitly say the two words they’re not allowed to mention in their product pitch. Is it just me, or does that sounds like a loophole for people to sell whatever they want without consequences and any kind of oversight or regulation, hoping that no one gets hurt and sues them for selling something dangerous, at which point their questionable claims would be brought up in a court of law and taken apart by experts?

Well as odd as it may seem, the U.S. has such a legal loophole. It’s called the Dietary Supplement Health and Education Act, or DSHEA, and it basically places the burden of making sure that anything marked as a dietary supplement on the manufacturer rather than on the FDA, so all reports on product safety or efficacy depend solely on the sellers’ good will or lawsuits by angry customers. On top of that, the FDA can’t just yank products off the market. It has to prove they’re unsafe before that happens so if you’re selling bottled water you claim is rich with miracle minerals and antioxidants that will help your customers live longer, you’ll never be hauled to court or get your products pulled since your product isn’t actively harmful.

This is the same law which allows homeopaths to sell sugar pills sprinkled with water they say has magical properties, radiating special mystical energies best explained by rambling technobabble, or a horrendous mangling of physics. Claiming that it’s holistic medicine that treats the whole body, not just the disease (whatever that means), lets them sell whatever they want and make tens of billions of dollars a year doing it. And they’re so good at hiding this lack of regulation in 3 point font of barely legible scrawl on their products, a third of the people buying them don’t even know they’re not FDA approved and aren’t required to be.

And that brings us to the Quack Miranda by which all those pitching “natural cures and treatments” abide. You probably saw it more times than you can count on commercials for diet pills and vitamins flashing a standard template which we outlined with our introduction to the DSHEA. So all those homeopaths and makers of odd, questionable supplements they claim are being suppressed by Big Pharma say that they’re going to cure you in ways that the FDA would never allow because it would cost pharmaceutical companies money and yet, they also warn that the product you’re taking isn’t actually intended to cure any disease.

So which one is it? Will the mysterious pill they want you to take cure you or do absolutely nothing? The general response of the quacks is to bombard you with testimonials, which is how pseudoscience and quackery generally spreads according to a scientific study on the subject. But the fact remains, they just sold you something they say can cure some sort of malaise. You know it. They know it too. And so they concoct elaborate conspiracy theories and rely on the good, old fashioned image of a rebel thumbing his nose at the stogy Establishment to convince you that their sly tactics are really for the best. Hell, many of them have been chanting this so long, they’ve bought their own argument hook, line and sinker. Meanwhile, the FDA just looks the other way.

But here’s the big problem. There are thousands of outfits and pseudo-doctors making medical claims which are not subject to any clinical trial or any oversight whatsoever, relying on folksy testimonials and rambling on and on about the virtues of “natural medicine” and “being open-minded.” Instead of freeing up the FDA to keep its eye on Big Pharma and its partners, DSHEA also unleashed a swarm of charlatans selling the modern day version of snake oil. Obviously having the already overburdened, understaffed and under-budgeted FDA also spend time on evaluating millions of placebos isn’t a very good solution to the dilemma.

Trying to turn the agency’s focus solely on quacks is also not realistic since Big Pharma are no angels and someone has to be there to make sure they don’t cut corners to bring a product to market and catch their mistakes when they do. But it seems that DSHEA is in dire need of modification which would ban any supplement maker from trying to make medical claims when selling their products unless they submit clinical studies showing their claims to be accurate. Is it placing an expensive burden on the supplement makers? Yes. But if they should never play with people’s lives. Instead of whining about Big Pharma’s sins, they should thrive to be better than them.

People have been harmed and killed by quackery and we have a duty to stop those who profit from promising treatments and cures they haven’t bothered to back up with anything more than rants about the little guy vs. Big Pharma. When you rake in more than $30 billion a year in revenues, you’re not entitled to pretend you’re a little group of healers who just want to make people feel better because that’s lying, plain and simple.

You’re an industry, same as those pharmaceutical giants you want to hold accountable for their mistakes. All I ask is that you’re willing to hold yourself to similar standards you want placed on the likes of Pfizer, Merck and GSK. Or of course you could fight it tooth and nail, claiming a Big Pharma conspiracy to put you out of business while in reality, it’s just a ploy used to inspire an outburst of alt med populist rage and freeing you from being held accountable for your actions…

# health // alt med / dshea / fda / government

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