ICEBERGS AHEAD

Health Sciences Institute e-Alert 

March 12, 2003 

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Dear Reader, 

Last week the FDA made what appeared to be one of its boldest efforts to place tighter regulations on the herbal and dietary supplement industry. 

In presenting the publication of a "proposed rule" (in reality, a large set of rules, designed to ensure accurate labeling information and to put uniform controls on the manufacturing of supplements), FDA representatives announced it as if the cavalry had FINALLY arrived to rescue an imperiled public from the evils that lurk in impure supplements. 

So...is it actually much ado about nothing? Or is there a hidden agenda? 

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How smooth is your ceiling? 
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The proposed rule is referred to as CGMP, an acronym for "Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements." 

Most of the 547-page CGMP is as dry as dust, including mundane bureaucratic requirements such as "adequate lighting in hand-washing areas," and a very strict insistence that manufacturing plants should have "floors, walls and ceilings that are of smooth and hard surfaces." If these rules become formal regulations, we'll be able to finally take great comfort in knowing that our daily supplements are produced in facilities with smooth, hard ceilings. 

The CGMP document is open to public comment for the next 90 days, so the tone of the wording is somewhat differential - almost meek - as if to say, "These are just some ideas we came up with. We guess they're okay. What do you think?" And the FDA press release that accompanied the announcement stated that the goal was to implement rules, "without imposing unnecessary regulatory burdens." 

All that was missing was a blushing FDA rep kicking the dirt with his toe while saying, "Aw shucks - we're just doin' our job, folks." 

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Speaking with two voices 
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But the hangdog tone of CGMP doesn't quite match the more strident and accusatory public statements that accompanied the publication of the document. One FDA spokesperson warned that there were "many" cases in which pesticides, bacteria, lead and even glass had been discovered in supplements. And FDA commissioner Dr. Mark B. McClellan called the supplement industry a "buyer beware market" - making it sound as if the typical bottle of vitamin C is manufactured haphazardly in open-air facilities with no ceilings or walls. 

(As a side note, by the way: ALL markets are buyer beware markets. Whether you're purchasing a bottle of diet soda or a Concorde jet, a smart buyer should always beware, ask questions and do research before making a purchase. In fact, one of the functions of HSI e-Alerts, Members Alerts, and the Forum is to offer a resource for those who desire to make informed healthcare decisions.) 

The curious reality of CGMP, however, is that this is an attempt to create regulations where regulations already exist. Robin Gellman (spokesperson for the American Herbal Products Association) pointed out to the New York Times that it's currently illegal to market a product that's adulterated, noting that the FDA has removed such products in the past. She adds that the FDA is being irresponsible when they insinuate that supplements aren't regulated. 

So if these 547 pages represent redundant regulations, what's really going on here? 

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New top dog 
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Dr. McClellan took over as FDA commissioner only four months ago. Perhaps this proposed rule reflects a new regime asserting itself with the first of what may very well turn into a barrage of regulations to be imposed on the supplement industry. That's certainly reflected in a statement in the introduction of the document that describes the proposed rule as "one of many actions related to dietary supplements that we (FDA) are taking to promote and protect the public health." 

Commissioner McClellan also described the new set of standards proposed in this rule as a tool to assist researchers attempting to determine the health benefits of supplements. 

Ah! There we go! Now we're seeing what is perhaps the real intent behind these new rules: To set the stage for a more aggressive questioning of the health benefits of supplements. 

I hope I'm wrong, but if I were a betting woman, I'd bet the farm that this somewhat mundane set of proposed rules is just the tip of a very large iceberg. 

...and another thing 

As a side bar to today's e-Alert I want to take a quick look at one of the barometers that measures the safety of herbal and dietary supplements. After all, when the FDA starts talking about impurities and protecting the public health, what they're really talking about is safety. So let's look at some numbers that will put safety into perspective. 

Between 1989 and 1998 the number of deaths per year associated with dietary supplements averaged a little more than six per year. Let's round that up to seven per year, for a total of 63 deaths over nine years. I don't mean to make light of this. After all, that's 63 unfortunate tragedies - good people who only wanted to improve their health. 

During that same period ('89-'98) those who attempted to improve their health with pharmaceuticals fared quite a bit worse, however. The average number of pharmaceutical related deaths was approximately 227,000 per year. That places deaths associated with pharmaceuticals as the third leading cause of death in the U.S. - right behind heart disease and cancer. 

But of course, while the supplement industry is large, the pharmaceutical industry is truly gigantic. So naturally we would expect to see a higher rate of deaths. But 227,000 PER YEAR!? 

Previously, when I offered a similar sort of comparison, someone pointed out that the numbers weren't comparable because the pharmaceutical industry is easily 10 times larger than the supplement industry. So let's imagine that the supplement industry is not just 10, but 20 times larger than it currently is. Then, if we extrapolate the numbers, we would get a death toll from supplements of 140 per year. 

140 avoidable deaths per year is unacceptable. 7 avoidable deaths per year is unacceptable. 227,000 avoidable deaths per year is an epidemic out of control - no matter how you do the math. 

To Your Good Health, 

Jenny Thompson Health Sciences Institute

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