Guest guest Posted March 11, 2004 Report Share Posted March 11, 2004 This message came via Jake Fratkin, John Scott and John Chen according to the headers. They seem to share my concern over the implications of the FDA ban for both raw herbs and patents. I think John Chen got it exactly right. Please note that Mr. Chen consulted with FDA attorneys in formulating his opinion. I would submit that John Chen is also in a good position to comment, with his Pharm.D. degree. I have recently been informed that at least one company that had planned to pull their ban xia containing products has now decided to continue selling them while they try and get some sort of official clarification from the FDA. They may also try and get some sort of injunction or exception (similar to exceptions for xi xin if tests show undetectable AA). Mayway sent a letter to PCOM about a month ago informing us that they planned to continue selling their ma huang and ban xia containing products as the ban did not apply to them. This was prior to AHPA taking their position that it probably does apply, so I don't know what Mayway's current plan is. there is a lot of confusion around this matter and it remains unclear where the dust will settle. The exception based upon lab analysis seems the only course that is viable and serves the spirit of the rule. american ephedra species are exempt because they have no ephedrines, so why not ban xia that tests clean. hopefully that will be an acceptable compromise. However it still might entail the destruction of huge amounts of existing stock that cannot pass the test. This is currently the case for xi xin as well. Springwind cannot find any AA free xi xin. So if you have suppliers who claim they can, they should provide you the documentation to prove it. whoever is left holding the bag when the final decision is made will eat the herbs. So one has to decide whether to stock up or stop making purchases. but it will be unreasonable to expect suppliers to accept returns of ban xia containing products that were purchased prior to 4/12 and made in full foreknowledge of this information. > Dr. Jake Fratkin <info > Thu Mar 11, 2004 8:39:46 AM US/Pacific > John Scott <gfch > Cc: " " < > Fwd: Urgent: Status of Ma Huang (Ephedra) and Ban Xia > (Pinellia) > > > > > > Drjohnchen > March 10, 2004 4:37:14 PM MST > Drjohnchen > Urgent: Status of Ma Huang (Ephedra) and Ban Xia (Pinellia) > > To the entire TCM community, > > > > I am writing to inform you something quite disturbing that I have just > learned. Over the past week, I have had extensive conversations with > four FDA attorneys, a government personnel, and a few other sources, > and they have all confirmed that while FDA’s intention is to remove > unsafe products from the market, the implication is that the FDA has > banned the use of any product that contains Ma Huang (Herba Ephedrae) > and Ban Xia (Rhizoma Pinelliae) altogether. > > > > As you may be aware, on February 11, 2004, the FDA published a final > regulation to ban over-the-counter sales of products that contain > ephedrine alkaloids (21 CFR Part 119). In this regulation, it stated > that products that contain ephedrine alkaloids cannot be sold as > “food” because it is unsafe as food. Further, it stated that it will > “ban all products marketed as dietary supplements that contain any > amount of ephedrine alkaloids.” If these products cannot be sold as > “food” or “dietary supplement,” the only other place where it can be > classified is as a “drug.” This essentially will be the end of any > product that contains ephedra or pinellia (it costs about 900 million > dollars R & D to get a drug approved by the FDA). > > > > The FDA did state in this regulation the following: > > “This final rule does not affect the use of Ephedra preparations in > traditional Asian medicine, although we considered the comments' views > and information on the use of Ephedra in traditional Asian medicine in > the context of their possible relevance to the risks of dietary > supplements containing ephedrine alkaloids. This rule applies only to > products regulated as dietary supplements (See 62 FR 30678 at 30691). > Traditional Asian medicine practitioners do not typically use products > marketed as dietary supplements.” > > > > “Several Ephedra species (including those known as ma huang) have a > long history of use in traditional Asian medicine. These products are > beyond the scope of this rule because they are not marketed as dietary > supplements. The use of ephedrine alkaloids in traditional Asian > medicine is discussed in more detail in section V.B.5 of this > document. As we describe there, this rule does not change how these > products are regulated under the act.” > > > > This is not correct because all Chinese herbal products are regulated > as dietary supplement – according to the law, this is the only place > they can be classified. We may think of them as Chinese herbs or > herbal medicine, but they legal classification is “dietary > supplements.” Chinese herbs are not food, and they are definitely not > drugs. So the only way for traditional Asian medicine to be exempt is > they have to literally be approved and classified as “medicine.” And > even this is were the case, acupuncturists would not be able to use it > because we are not licensed to prescribe “medicine” or “drugs.” > > > > This regulation will be in effect on April 12, 2004. I know we need > to do something and we need to do it quickly. I am hoping that above > information above will be a catalyst to bring the TCM community > together, and hopefully, we can fight to preserve our right for > continued access to our medicine. > > > John K. Chen, Ph.D., Pharm.D., O.M.D., L.Ac. Chinese Herbs FAX: Quote Link to comment Share on other sites More sharing options...
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