Guest guest Posted March 30, 2004 Report Share Posted March 30, 2004 1. why have no FDA letters been sent to TCM patent suppliers 2. why did an FDA rep respond to my student's email by telling her that the rule did not apply to her. Chinese Herbs FAX: Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 30, 2004 Report Share Posted March 30, 2004 , wrote: > 1. why have no FDA letters been sent to TCM patent suppliers > > 2. why did an FDA rep respond to my student's email by telling her > that the rule did not apply to her. It seems that there are only 2 possibilities: 1. The FDA is playing a game with us and wants us to think we are safe so that when the ruling become effective, they can drop the hammer on us. 2. The FDA really intends for us to be exempt, but they, for some reason, were unable to word it correctly in the ruling. Brian C. Allen Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 30, 2004 Report Share Posted March 30, 2004 Tood, > 1. why have no FDA letters been sent to TCM patent suppliers IMO, A. Because they now realize that they've screwed up. They didn't really think out the details of the ruling and the fact that ready-made Chinese herbal medicines are sold under DSHEA. Remember in the ruling they actually said that DSHEA has nothing to do with Chinese herbal medicine. (Wrong!) From what the manufacturers and distributors have been told by AHPA, there is confusion and consternation high up at the FDA over all this. On the one hand, we're using this law is a self-serving dishonest way to sell a class of medicines they don't have a category for. After all, we are using a loophole in DSHEA. On the other, they know they have to appear sensitive to the cultural traditions of Asians who tend to be big political contributors. They also have their relationship with the PRC to consider. So my guess is that they're scrambling to come up with some politically correct solution to the mess they have gotten themselves into by not doing their homework in the first place and for trying to regain control of the herbal-dietary supplement marketplace. CYA. B. Chinese ready-made manufacturers and distributors are not registered with or by the FDA. So the FDA does not have a list of all us companies to send a letter to. That'd take some leg-work on their part. Since they tend to be a complaint-driven department, they would not assign person-power to this kind of " investigation " or research until or unless it became necessary, which to them, at this point in time, it probably does not appear to be. > 2. why did an FDA rep respond to my student's email by telling her > that the rule did not apply to her. Again IMO, she didn't write a clear set of questions. She did not inform the FDA spokesperson that traditional Asian herbal medciines are being sold legally in the U.S. under DSHEA. She did not specifically make the distinction between traditional bulk-dispensed decoctions and ready-made " dietary supplements. " If she had, I think she would've gotten a different answer. Try it. That way you/we'll know one way or the other. Bob Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 30, 2004 Report Share Posted March 30, 2004 I'd like to think that it's a bit of the 2nd. By to clearly defining the ruling they open the doors for a loophole that others can exploit. Perhaps by keeping it low-key we, as TCM people, are so under the radar that they can enforce the ban as they see fit. And hopefully keeping their hands off us. doug , " bcataiji " <bcaom@c...> wrote: > , wrote: > > 1. why have no FDA letters been sent to TCM patent suppliers > > > > 2. why did an FDA rep respond to my student's email by telling her > > that the rule did not apply to her. > > It seems that there are only 2 possibilities: > 1. The FDA is playing a game with us and wants us to think we are > safe so that when the ruling become effective, they can drop the > hammer on us. > 2. The FDA really intends for us to be exempt, but they, for some > reason, were unable to word it correctly in the ruling. > > Brian C. Allen Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 30, 2004 Report Share Posted March 30, 2004 Dear colleagues, I just had a conversation with Robert Moore at FDA. He works for Susan Walker in CFSAN. The best address for ALL concerned parties to email FDA is : cephedra We think any & all emails to Congress & FDA are useful but this NEW address should be added to your practitioner Call for Action letters and is the most important address! Has anyone heard of CC numbers to AOMAlliance or CSOMA or AAOM? Robert Moore did mention that he could not comment on the litigation (NJ company vs FDA which Michael McGuffin@AHPA characterizes as a joke)) or the AHPA Citizen Petition. There is a small working group at CFSAN working on the Ephedra Ruling. Obviously, it is VERY important to get everyone (practitioners, patients, schools, companies) communicating how they will be be impacted by the ambiguity in the FDA Final Ruling. Thanks, Bill Egloff On Mar 30, 2004, at 2:23 PM, Bob Flaws wrote: > Tood, > >> 1. why have no FDA letters been sent to TCM patent suppliers > > IMO, > > A. Because they now realize that they've screwed up. They didn't > really think out the details of the ruling and the fact that > ready-made > Chinese herbal medicines are sold under DSHEA. Remember in the ruling > they actually said that DSHEA has nothing to do with > Chinese herbal medicine. (Wrong!) From what the manufacturers and > distributors have been told by AHPA, there is confusion and > consternation high up at the FDA over all this. On the one hand, we're > using this law is a self-serving dishonest way to sell a class of > medicines they don't have a category for. After all, we are using a > loophole in DSHEA. On the other, they know they have to appear > sensitive to the cultural traditions of Asians who tend to be big > political contributors. They also have their relationship with the PRC > to > consider. So my guess is that they're scrambling to come up with some > politically correct solution to the mess they have gotten > themselves into by not doing their homework in the first place and for > trying to regain control of the herbal-dietary supplement > marketplace. CYA. > > B. Chinese ready-made manufacturers and distributors are not > registered with or by the FDA. So the FDA does not have a list of all > us > companies to send a letter to. That'd take some leg-work on their > part. Since they tend to be a complaint-driven department, they > would not assign person-power to this kind of " investigation " or > research until or unless it became necessary, which to them, at this > point in time, it probably does not appear to be. > >> 2. why did an FDA rep respond to my student's email by telling her >> that the rule did not apply to her. > > Again IMO, she didn't write a clear set of questions. She did not > inform the FDA spokesperson that traditional Asian herbal medciines > are being sold legally in the U.S. under DSHEA. She did not > specifically make the distinction between traditional bulk-dispensed > decoctions and ready-made " dietary supplements. " If she had, I think > she would've gotten a different answer. > > Try it. That way you/we'll know one way or the other. > > Bob > > > > Chinese Herbal Medicine offers various professional services, > including board approved continuing education classes, an annual > conference and a free discussion forum in Chinese Herbal Medicine. > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 30, 2004 Report Share Posted March 30, 2004 Or an additional ( & likely) reason: 3. FDA is a government organization, & is as screwed up as every other gov't org. The right hand probably doesn't know what the left hand is doing. I agree with Todd though, regardless of intention, the rule as it stands would allow for them to tighten the screws at any point in the future. This brings up another point. When writing letters to congress, etc, we need to be sure to clarify we know that the FDA ruling's preamble claims exemption for us, otherwise our protests may be regarded as unfounded as was the case with Todd's student. The ambituity needs to be pointed out. Hopefully that student sent a follow up. We could take the position that clearly the FDA's intent was to exempt us, but the rule was worded poorly. Perhaps we would meet with less resistance if we don't appear to be supporting a contrary position. Tim Sharpe bcataiji Tuesday, March 30, 2004 12:46 PM , wrote: > 1. why have no FDA letters been sent to TCM patent suppliers > > 2. why did an FDA rep respond to my student's email by telling her > that the rule did not apply to her. It seems that there are only 2 possibilities: 1. The FDA is playing a game with us and wants us to think we are safe so that when the ruling become effective, they can drop the hammer on us. 2. The FDA really intends for us to be exempt, but they, for some reason, were unable to word it correctly in the ruling. Brian C. Allen Quote Link to comment Share on other sites More sharing options...
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