[Acupuncture-students] FDA ban goes into effect Monday
bob at bluepoppy.com
Fri Apr 9 10:56:28 EDT 2004
Hopefully, readers of this forum understand by now that their right to prescribe, dispense, sell, and even personally use
ready-made Chinese medicines may disappear as early as Monday, Apr. 12, 2004. That is the date the FDA has set for
the ban on all dietary supplements containing any amount of ephedra alkaloids from any and all herbal sources, including
Ephedra, Pinellia, and Sida Cordifolia. All ready-made Chinese medicines (i.e., patent medicines), those manufactured in
Asia and those manufactured in the U.S., are legally sold in the U.S. under DSHEA (Dietary Supplement Health &
Education Act) as "dietary" or "herbal" supplements. This has absolutely nothing to do with our legal scope of practice. While the FDA ban does not effect the prescription, dispensation, sale, and use of bulk-dispensed,
water-based decoctions, very few U.S. practitioners prescribe and dispense Chinese herbs in this form. Already, at least one well known company has had an entire shipment of powdered Chinese herbal extracts embargoed by Customs
on the order of the FDA. Not only will the FDA not allow companies to import and sell any products containing any ephedra alkaloids, but product liability insurers will not cover any product which has been banned by the FDA.
This creates simply too much legal liability for companies to disregard or flout this ban.
Including products that contain Ma Huang and/or Ban Xia, we are talking about over 900 ready-made Chinese medicinal
products. If these are truly forced off the market, many herb companies will go out of business as will book publishing and
distributing companies and schools. It costs approximately $5000 to produce a single run of a single formula/product,
including labelling and packaging. Since approximately 40% of all Chinese medicinal products contain one of these
ingredients, this ban effectively guts our formulary. What's even worse, if this ban is allowed to stand, the next set of
ingredients on the FDA chopping block is all the citrus medicinals due to their containing synephrine. This includes Chen Pi, Qing Pi, Zhi Ke, Zhi Shi, and Fo Shou.
If you have any desire to practice Chinese herbal medicine either now or in the future and you intend to prescribe and/or
sell or even simply personally use any ready-made Chinese herbal medicines, it is imperative that you contact your
Congressional representatives and the FDA ASAP. You can easily do so with a pre-prepared letter, addresses, e-mail
addresses, etc. by going to www.bluepoppy.com.
If you have been lulled into complacency by the recent AT article on this issue, please wake up. The AT article was simply misinformed and wrong. Act now or you will have no one to blame but yourself. Based on CCs sent to
various herbal companies so far, your co-professionals are not responding en masse to this threat, and we only have three days left till this ban goes into place.
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