Guest guest Posted January 30, 2004 Report Share Posted January 30, 2004 > Seeing Double Standards > > Health Sciences Institute e-Alert > > January 29, 2004 > > ************************************************************** > ************************************************************** > > Dear Reader, > > Emboldened by their recent move to ban ephedra, FDA officials > are chomping at the bit. Now they have three more supplement > ingredients in their sights - all marked for official > extinction. > > Speaking last week at the University Mississippi School of > Pharmacy, FDA commissioner Mark McClellan said that the agency, > " will be doing more work in the coming months to more closely > evaluate the potential safety risk of these products, and we > could take further action to remove unsafe dietary supplements > from the market. " > > Mr. McClellan said he was " concerned " about several dietary > supplements, specifically mentioning three that are used in some > weight-loss formulas: bitter orange, aristolochic acid and usnic > acid. > > >From what I've read, those who use any of these supplements > should be careful with them and certainly only take them as > directed. But outlawing their sale with an FDA ban is like > killing mosquitoes with a bazooka. Is the fuss really worth it? > > Don't bet on it. Something else is going on here. > > ----------------------------- > No contest > ----------------------------- > > Should bitter orange, aristolochic acid and usnic acid be > banned? > > Problems have been reported with all three of these botanicals - > mostly due to their misuse. But unlike ephedrine (the synthetic > form of ephedra that has caused most of the problems for which > ephedra has been blamed), these three have not been associated > with the deaths of any high-profile athletes or teenage boys, > prompting emotional scare headlines. > > In fact, bitter orange, aristolochic acid and usnic acid may not > have contributed to any deaths at all. (In Belgium, several > kidney failures were associated with aristolochic acid, but they > were erroneously reported as deaths.) But of course, a > supplement that has the potential to cause kidney failure or, in > the case of usnic acid, severe liver problems should be used > with the greatest care. > > Which brings us once again to acetaminophen. Just last week, in > the e-Alert " Flick of the Wrist " (1/19/04) I told you how easy > it is to overdose on acetaminophen, prompting liver failure that > results in more than 100 deaths each year. From what I've read > (there's not much out there on this topic) usnic acid has been > cited as " playing a role " with one death due to liver failure, > and nine cases of liver problems from which patients recovered. > > So let's check our scorecard here: > > * Acetaminophen: Multiple deaths yearly. > * Usnic acid: One death, maybe. > > And yet, the day the FDA calls for a ban on acetaminophen will > be the same day that pigs fly south for the winter. But somehow > the FDA has decided that usnic acid is so dangerous that it > needs to be classified as a forbidden poison. > > ----------------------------- > Planting the seeds > ----------------------------- > > What's really going on here? > > For ten years, FDA officials have been frustrated by the Dietary > Supplement Health and Education Act (DSHEA), which limits the > agency's power to regulate food supplements in the same way > drugs are regulated. In the e-Alert " Under the Gun " (11/10/03) I > told you about congressional efforts to give the FDA greater > latitude over supplements, but for the moment those efforts seem > to have stalled. > > So the ephedra ban was a sweet victory for the FDA (provided the > ban survives a court challenge, which it probably will). > Finally, FDA officials got to have things their way. But more > than that, they helped their efforts to pass legislation for > more regulatory control by sending a message to congressmen and > the public: The safety of dietary supplements is unreliable. > > The fact that this message is untrue is beside the point. The > point is to get the message out there and repeat it until people > believe that legislation to increase FDA powers is absolutely > necessary. Is the public really in grave danger when products > that contain bitter orange, aristolochic acid and usnic acid are > on the shelves? That's very unlikely. But with the announcement > that there are three more reckless culprits out there, the idea > is planted again. And it appears that as the year goes along the > idea will be repeated and planted again and again and again. > > ----------------------------- > And more to come > ----------------------------- > > In his Mississippi speech, Mr. McClellan stated that new dietary > supplement regulations for manufacturing and labeling will be > announced sometime in 2004. He said, " When these regulations are > finalized later this year, the public will not be faced with > 'buyer beware' any longer. " > > But I disagree. The public will be faced with a much more > serious " buyer beware. " Buyer, beware: Your health care choices > are being stripped away. > > ************************************************************** > Quote Link to comment Share on other sites More sharing options...
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