Guest guest Posted December 30, 2003 Report Share Posted December 30, 2003 if the term traditional chinese herbal remedy is meant to apply to products other than home-brewed teas, what would be the actual meaning of this category? 1. would it mean only products made in china 2. products only made with herbs grown in china 3. products only made with herbs listed in TCM materia medica 4. products mostly made with herbs listed in mm and/or grown in china 5. products containing or made solely from a single herb grown in china and/or listed in std. mm's exemptions from laws must be made in easily identifiable categories such as whether one is a licensed practitioner or whether a product is regulated as a food or dietary supplement. it is almost impossible to see how one would separate prepared chinese herb products from prepared products made from other western herbs or vitamins. what if you add vitamin c or echinacea to an herbal product, is it any longer a chinese herb formula. I am sure the FDA has no intent to do this type of micromanagement, which would literally force them to scrutinize every product in the US to determine which ones were exempt or not. since this rule gives no practitioner exemption, there is no simple way to enforce that products claiming to be chinese remedies are indeed such. This would result in hundreds of lawsuits. As their information specialist told me, the only way to enforce this rule as written is with an across the board ban on prepared products containing ephedra and pinellia, regardless of where they are sold. I am amazed that pinellia was included in this ban without raising any alarms anywhere. Anyone hear about pinellia being banned before today. I am hardly outside the loop on these matters. BTW, if this ban was not also directed at chinese prepared products containing ephedrine, why include pinellia in the banned list. As far as I know, pinellia is not used in any weight loss products or by any manufacturer as an ephedrine source. It has far too little to make it useful. We will see what is what in the next 2 weeks, but it certainly appears to me that the intent of this rule is much broader than merely banning self-medication with ephedra. If so, why not clearly state it as such. Chinese Herbs FAX: Quote Link to comment Share on other sites More sharing options...
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