FDA - Money, Politics, Power-Brokering and YOU!

Anyone who's ever seen or read an ad for a nutritional supplement is familiar with the legal disclaimer stated above. Personally, I've always found it a bit of a joke, as if Roger Federer told you something about his tennis racket and then had to say "these statements have not been evaluated by my golf pro".

Though I have no doubt that there are honest and serious and good people working at the FDA, the whole idea that the FDA can seriously evaluate vitamin research and should be the final word on what consumers should take has always struck me as kind of ridiculous.

A recent disclosure in the New York Times illustrates how much deeply both "scientific" research and FDA approval can be influenced by money, politics, power brokers and economics.

Here's what happened: a knee-repair device called Menaflex which is supposed to cushion stress in the joint and encourage regeneration of tissue was tested in a clinical trial in the 1990's where it was found to be no better than standard surgery; not only that, there were some concerns about safety.

So the company- ReGen Biologics of Hackensack NJ-applied for "fast-track" FDA approval which bypasses the need for proof of safety or efficacy. All that's required for approval is a finding that the device is "substantially equal" (no worse than) others on the market.

Problem is, the FDA scientific reviewers found no such thing.

But that didn't stop the company. They complained of unfairness and applied pressure to New Jersey lawmakers to "lean" on the FDA.

Which the lawmakers did. And before long, the FDA ruled that the device was indeed "substantially equivalent" to others on the market. This decision was made by a panel of outside experts, but ReGen was able to prevent those experts from hearing direct testimony from the scientific reviewers.

Nice work if you can get it.

The FDA now acknowledges that it received "extreme" pressure from four members of the New Jersey Congressional delegation who clearly influenced a decision that was supposed to be made on scientific grounds. (The FDA is now reviewing its decision to approve Menaflex.)

I can't prove it but I think this stuff goes on all the time.

There are deep biases in much of the "research" conducted on vitamins, and profound economic reasons why drug companies do not want the public to hear positive reports about "natural", non-patentable alternatives to pharmaceuticals. And these folks have connections and deep pockets.

"What the research shows" can be so easily influenced by what research you choose to present, who winds up hearing (and evaluating it), who did the research in the first place, and what they stand to gain by it.

Please try to remember that the next time you read (or hear) an alarmist headline like "multivitamins kill" or "vitamin E shortens lives".

It's time we look a little more closely- and listen a little more critically- to what we hear about vitamins and supplements (and yes, drugs!) from the media.

Oh by the way- these statements have not been evaluated by the FDA.

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FDA Warning about Tainted Weight Loss Products

A continuing investigation by the FDA has prompted consumer warnings and recalls by some distributors of dozens of so-called "weight loss supplements", many of them imported from China. According to the FDA- which I don't always agree with, but is on the money with this one- many of these supplements contain hidden and potentially harmful drugs. To which I would add- and most of them aren't even effective.

I was personally delighted to see "Star Caps" on the warning list. This overpriced, ridiculous product was aggressively marketed by one Nikki Haskel. Who is Nikki Haskel and what does she know about nutrition? Glad you asked. Back when I lived in NY, Nikki Haskell was an "in-crowd" wannabe, a perpetual hanger on at all the "in" clubs, and the host of a low-rent cable TV show where she interviewed B list celebrities and pretended to be part of the "in crowd". Next thing you know she turns up as a "diet guru" marketing a pill whose ingredients were basically papaya and garlic for 100 bucks a pop.

And people bought it- at least until recently, when it was revealed that Star Caps also contains a substance on the "banned" list of the NFL. But Star Caps isn't the only culprit. The FDA now lists 72 tainted weight-loss supplements. "A large percentage of these products either contain dangerous undeclared ingredients or they might be outright fraudulent on the ingredients and have no effect at all", said Michael Levy, the director of the FDA's division of New Drugs and Labeling Compliance.

Now I'm no fan of the FDA. But it's worth pointing out that many of the ingredients on their warning list do in fact have a lot of serious problems associated with them, including high blood pressure, tachycardia (rapid hearbeat), palpitations and even stroke.

One of the controlled substances found in many of the listed products is Sibutramine, the same ingredient in the prescription drug Meridia, only at an even higher dosage. Fenproporex, another controlled substance found in many of the products, can cause arrhythmia and possible sudden death.

Here is a partial list of the products on the FDA's list of "tainted" weight loss products:

• 3 Day Diet
• 7 Day Herbal Slim
• 21 Double Slim
• 24 Hours Diet
• Fatloss Slimming
• Perfect Slim
• Royal Slimming Formula
• Slim 3 in 1 Extra Slim Formula
• Starcaps
• Super Fat Burner

There's nothing wrong with using products to help with weight loss- particularly safe, effective products like Green Tea Extract, Super Citrimax, CLA-Tonalin and the like.

But they're not magic.

Used in conjunction with a lower calorie, low-carb diet and a sensible exercise program, they can give you an edge.

Best of all, they're completely safe. And- unlike Star Caps and others like it- they don't cost a fortune, promise the moon and deliver substances that may seriously harm your health.