Guest guest Posted May 7, 2007 Report Share Posted May 7, 2007 Dear All, I send this to our community, just want to let everyone know that the AAAOM is in the correct position... Thanks for everyone's support.. update GMP Currently the majority of the herb suppliers used in the US are from countries like Japan, China and Taiwan. All of them have exercised pharmaceutical-grade GMP for the TCM products. The FDA's proposed GMP guideline on dietary supplement However, will not impose additional cost to the suppliers who comply to pharmaceutical GMP in their countries. The result is that companies who are suspected of supplying ingredients with lower quality to this US market will be filtered out. Based on the purview and resources of FDA, I highly doubt that they will target small-scale pharmacies. Practitioners are exempt from the GMP regulation, which stands for Good " Manufacturing " Practice. The dietary supplement market totals 20 billion dollars. TCM practitioners are only 3% of the market value, and they each have different regulatory systems , for example: TCM School pharmacy: accrediting agency (ACAOM) TCM Practitioners: licensing board Manufacturing company : FDA The risks are not as great as some would say. Christine W Chang, DAOM, LAc., BOD & Chair of Herbal Medicine Committee (AAAOM) American Association of Acupuncture and Oriental Medicine 310-951-8698 (cell) " I think, therefore I am. " convergentmedical <kailin Saturday, May 5, 2007 2:07:30 PM Re: FDA Proposed Rule on cGMP for Dietary Supplements Dear Dr. Waldrope, You had requested more information on how to approach OMB with respect to the FDA proposed rule on cGMP for Dietary Supplements. This is not an approach that should be undertaken by individual proponents of any measure under OMB review. This avenue is more appropriate for national organizations that pack some clout. Largely in response to my urging, the Council of Colleges of Acupuncture and Oriental Medicine (CCAOM) did submit an excellent letter to OMB on February 28, 2007. CCAOM (unlike AAAOM) understands that individual herbalists and acupuncture colleges will be sorely impacted by the proposed rule. Let me emphasize that approaching OMB is a small but important action in the campaign that is needed. But if AAAOM, as the national practitioners organization, is not on board, then the campaign is probably over and lost before it has been begun. The most pressing question then is how AAAOM members can move AAAOM to reverse its policy and effectively protect the interests of Oriental Medicine herbal practitioners. That does not seem like too much to ask of a dues-charging national association. Best Regards, David Kailin, Ph.D., M.P.H., L.Ac. Author, Quality In Complementary & Alternative Medicine http://www.converge ntmedical. com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 8, 2007 Report Share Posted May 8, 2007 On 5/7/07, Christine Chang <panasiaintl wrote: > > Based on the purview and resources of FDA, I highly doubt that they will > target small-scale pharmacies. Practitioners are exempt from the GMP > regulation, which stands for Good " Manufacturing " Practice. > Ni Hao, Christine. The full name of the propose rule is: " Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements. " I don't manufacture, but I do pack and hold dietary ingredients and supplements when I give them to my patients. So perhaps this does apply to individual practitioners. My question to you is this: why does the AAAOM believe that private practitioners who are repackaging imported herbs are exempted from this rule? Xie xie. -al. -- Pain is inevitable, suffering is optional. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 8, 2007 Report Share Posted May 8, 2007 Dear Al, here is the answer for you " Given the purview and resources of FDA, it is highly unlikely that they will target small-scale pharmacies. Practitioners are generally exempt from 'Good Manufacturing Practices' regulation since they are not typically engaged in manufacturing. If however, a practitioner is making an out of state purchase, their supplier needs to comply with the GMPs. Further, the FDA has neither the resources nor desire to pursue the individual practitioner that is, unless they are engaged in egregious activities. The dietary supplement market totals 20 billion dollars. TCM practitioners represent only 3% of the market value... " How much money involve and do you have any tax reports?? hope this can help , talk to you later Christine W Chang, DAOM, LAc., BOD & Chair of Herbal Medicine Committee (AAAOM) American Association of Acupuncture and Oriental Medicine 310-951-8698 (cell) " I think, therefore I am. " Al Stone <al Monday, May 7, 2007 11:13:41 PM Re: update GMP On 5/7/07, Christine Chang <panasiaintl@ > wrote: > > Based on the purview and resources of FDA, I highly doubt that they will > target small-scale pharmacies. Practitioners are exempt from the GMP > regulation, which stands for Good " Manufacturing " Practice. > Ni Hao, Christine. The full name of the propose rule is: " Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements. " I don't manufacture, but I do pack and hold dietary ingredients and supplements when I give them to my patients. So perhaps this does apply to individual practitioners. My question to you is this: why does the AAAOM believe that private practitioners who are repackaging imported herbs are exempted from this rule? Xie xie. -al. -- Pain is inevitable, suffering is optional. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 8, 2007 Report Share Posted May 8, 2007 Dear Christine Chang, You state that AAAOM is in the correct position on the cGMP issue. AAAOM has denied that the proposed rule applies to individual practitioners and colleges pharmacies engaged in herbal compounding for patients. I have quoted FDA's statement that individual herbal practitioners are not exempt from the proposed rule. Your denial flies in the face of the reality of what the FDA has clearly stated. On what do you base your words? You say that you " highly doubt that they will target small-scale pharmacies. " If small scale pharmacies are exempt, then they couldn't be targeted. If small scale pharmacies (such as individual herbalists) are not exempt, then AAAOM is in the wrong. You imply that FDA does not have jurisdiction over TCM school pharmacies and over TCM practitioners. In fact, FDA has jurisdiction over devices and dietary supplements used in both these settings. TCM schools and practitioners operate under the jurisdiction of State and Federal laws and regulations, in addition to the standards of professional associations. Yes, the proposed rule does have some positive influences on quality, particularly as applied to large manufacturing entities. But its provisions are draconian as applied to small entities such as individual herbalists. It should be clear to anyone who has read and understood the proposed regulation that AAAOM has failed to comprehend it. Those AAAOM members who want AAAOM to attempt to protect in-office herbal compounding should contact AAAOM at once and make their wishes known in no uncertain terms. If in-office herbal compounding isn't important to the profession, then don't bother. At best, we have only a slim chance of being able to change or defeat the proposed regulation at this point. If AAAOM is not willing to lead the fight, we have no chance at all. David Kailin, Ph.D., M.P.H., L.Ac. Author, Quality In Complementary & Alternative Medicine http://www.convergentmedical.com , Christine Chang <panasiaintl wrote: > > Dear All, > > I send this to our community, just want to let everyone know that the AAAOM is in the correct position... > > Thanks for everyone's support.. > > > update GMP > > Currently the majority of the herb suppliers used in the US are from countries like Japan, China and Taiwan. All of them have exercised pharmaceutical-grade GMP for the TCM products. The FDA's proposed GMP guideline on dietary supplement However, will not impose additional cost to the suppliers who comply to pharmaceutical GMP in their countries. The result is that companies who are suspected of supplying ingredients with lower quality to this US market will be filtered out. > > Based on the purview and resources of FDA, I highly doubt that they will target small-scale pharmacies. Practitioners are exempt from the GMP regulation, which stands for Good " Manufacturing " Practice. > > The dietary supplement market totals 20 billion dollars. TCM practitioners are only 3% of the market value, and they each have different regulatory systems , for example: > > TCM School pharmacy: accrediting agency (ACAOM) > TCM Practitioners: licensing board > Manufacturing company : FDA > > The risks are not as great as some would say. > > > Christine W Chang, DAOM, LAc., > BOD & Chair of Herbal Medicine Committee > (AAAOM) > American Association of Acupuncture and Oriental Medicine > 310-951-8698 (cell) > > " I think, therefore I am. " > > Quote Link to comment Share on other sites More sharing options...
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