Guest guest Posted September 20, 2004 Report Share Posted September 20, 2004 Ephedra sinica and The Fear and Death Administration JoAnn Guest Sep 19, 2004 19:26 PDT Ephedra sinica and The Fear and Death Administration Toj-@a... I send this in case any of you do not understand the far reaching significance of FDA's decision to ban Ephedra. They obviously do not worry about 110,000 annual deaths from in hospital use of approved drugs, but really want to control the dietary supplement industry. There are at most 2-3 deaths that appear to have a significant relationship, and in those cases, abuse of recommended dosages was a major contributor to the outcome. So to " protect " the public they would make EVERY dietary supplement go through MAJOR toxicity studies to drive the cost out of sight! If they really cared to " protect the public " , they would check a real percentage of all cattle for mad cow disease. But it is important to understand that sometimes you LOSE if you fight too hard about saving ephedra - this is NOT simple. Garry F. Gordon MD, DO, MD(H) President, Gordon Research Institute www.gordonresearch.com In my opinion, allowing this latest ruling by the FDA to go unchallenged will open the industry to attack on almost any basis. The industry should oppose the ruling if for no other reason than it sets a precedent for one of the most obvious double standards in my recollection. The following are a few points of interest that should not be ignored. Ephedra contains ephedrine. It stands to reason that an isolated, purified form of the active is potentially more hazardous than a plant containing lower levels. If Ephedra is considered so hazardous, why are a majority of allergy/decongestant medications being sold over the counter " contaminated " with ephedrine HCL or Ephedrine Sulfate? Why are 75mg dosages of Ephedrine HCL administered to elementary children for ADD? How likely is it that other stimulants are completely avoided in all of these instances? Clearly Ephedra is one supplement that competes with a burgeoning pharmaceutical market niche. If you believe that the FDA would not participate in such a political market showdown, consider the following. I attended a seminar (Focus on the Future) where an FDA employee stated that any supplement that acts like a drug and has physiological activity should be regulated as a drug. (His fist was closed and softly pounding on the table for added emphasis.) This was not in regards to Ephedra, but SAW PALMETTO! Incidentally, I know of no adverse events even remotely attributed to this supplement. However, I am aware that within a period of five years, Saw Palmetto stole nearly 50% of the pharmaceutical market for Proscar. I could go on, but perhaps the best defense of my position comes from a matter of public record. A quotation from the FDA Dietary Supplement Task Force Report, page 2, June 15, 1993, deserves careful reading. " The [FDA] Task Force considered various issues in its deliberations; including ... what steps are necessary to ensure that the existence of dietary supplements on the market does not act as a disincentive for drug development. " I rest my case. David Parish President Designed Nutritional Products DSHEA permits FDA to declare an ingredient or product to be declared " adulterated " if it presents a significant or unreasonable risk under conditions of use described in labeling (paraphrase). The term " unreasonable risk " is not defined, but must logically be definable and was clearly intended by the framers of the law to have some meaningful impact. We have not yet seen FDA's rationale for the action they plan to take, and the details will be important. I don't believe we can reject out of hand the potential for developing a reasonable rationale and definition of the term. As for the argument that this opens the door to a wholesale attack on other ingredients, that assumes a level of potential risk or even physiological activity for those other ingredients that I for one am not aware of. Let us be thoughtful about this issue, because it is huge. By its advance notice, FDA has created an opportunity for frenzy to build, as everyone speculates about worst-case scenarios, in the absence of solid information about the agency's actual arguments. I know this useful dialogue within the industry will continue and will raise valuable points to be considered, but I hope we won't let the momentum push us into assuming we " must " oppose any and all efforts to define and implement the " unreasonable risk " provision of DSHEA. As Senator Hatch has pointed out, the fact that FDA is choosing to act by implementing DSHEA is a potentially powerful demonstration that the law works when FDA decides to make it work. Annette Dickinson, Ph.D. President Council for Responsible Nutrition 1828 L Street, N.W., Suite 900 Washington, D.C. 20036 202 776 7951 direct line 202 776 7929 CRN main line 202 204 7980 FAX anne-@c... _________________ JoAnn Guest mrsjo- DietaryTi- http://www.geocities.com/mrsjoguest/Beans.html Quote Link to comment Share on other sites More sharing options...
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