Guest guest Posted April 13, 2004 Report Share Posted April 13, 2004 Please forward to as many members as you see fit. I have 'blind copied' my list. Thank you, Pam Price - Drjohnchen needledoc Monday, April 12, 2004 4:42 PM Re: FDA & Ephedra April 12, 2004 John K. Chen, Ph.D., Pharm.D., O.M.D., L.Ac. PO Box 90878 City of Industry, CA 91715-0878 U. S. Department of Health and Human Services U. S. Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Nutritional Products, Labeling and Dietary Supplements Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 To Whom It May Concern: I am a licensed acupuncturist who practices traditional Asian medicine in the State of California. I am writing to request clarification and/or amendment on 21 CFR Part 119 “Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids,†published on February 11, 2004. The reason for this request is because the current regulation (21 CFR Part 119) is unclear and ambiguous. Though the FDA stated that “This final rule does not affect the use of Ephedra preparations in traditional Asian medicine†and that this rule “applies only to products regulated as dietary supplements (See 62 FR 30678 at 30691),†it is my understanding that these “traditional Asian medicine†products that I use in my practice are in fact classified and regulated as dietary supplements. In this regulation, the FDA stated that “dietary supplements containing ephedrine alkaloids are adulterated under the Federal Food, Drug, and Cosmetic Act (the act) because they present an unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in labeling, under ordinary conditions of use.†These products generally refer to ones misused and abused for weight loss, energy, or to enhance athletic performance. While I support FDA’s action to protect the general public, I am deeply concerned that an indiscriminate ban of these products marketed as dietary supplements will deprive responsible acupuncturists and their patients valuable tools necessary for optimal healthcare. Use of these products by a licensed acupuncturist, in the words of the FDA, is definitely not “under ordinary conditions of use†because they are properly used and supervised. Acupuncturists have received proper medical training and understand how to use these herbs safely and effectively. In fact, the FDA had acknowledged in this regulation that there is no “recorded adverse events with the use of Ephedra in traditional Asian medicine.†Use of these products by licensed/certified traditional Asian medicine practitioners do not “present an unreasonable risk of illness or injury†as stated by the FDA. All adverse reactions are associated strictly with products that abuse and misuse these herbs for weight loss, athletic performance enhancement, and others. Ma Huang (Ephedra) and Ban Xia (Pinellia) are two Chinese herbs that will be directly affected by this regulation. These are two of the most important herbs in the Chinese Materia Medica. Furthermore, these two herbs are vital ingredients in approximately 20% of Chinese herbal formulas. Not having access to these herbs (and hundreds of such formulas) will have a tremendous-deleteriously effect on the entire profession of traditional Chinese medicine (approximately 14,000 acupuncturists, 10,000 students, 53 acupuncture schools, and not to mention all the patients). In conclusion, I would like to request the FDA to consider clarifying and/or amending the current regulation to specifically allow licensed/certified traditional Asian medicine practitioners to use dietary supplements that contain ephedrine alkaloids only within their scope of practice. This request is not novel, nor unique. The State of California adopted such a policy last year in banning products containing ephedrine alkaloids, but specifically allowed licensed healthcare practitioners to sell and dispense such products, except for weight loss, energy or any such purposes. An amendment mimicking the California Legislation will protect the general public and also allow the safe and responsible use of these products through licensed/certified healthcare providers. Respectfully yours, John K. Chen, Ph.D., Pharm.D., O.M.D., L.Ac. PO Box 90878 City of Industry, CA 91715-0878 E-mail: drjohnchen CC: Dr. Christine Taylor, Director, FDA CFSAN Dr. Robert Moore, Branch Chief, FDA CFSAN Dr. Susan Walker, Acting Director, FDA CFSAN American Association of Oriental Medicine (AAOM) Acupuncture and Oriental Medicine Alliance (AOMA) California State Acupuncture and Oriental Medicine Association (CSOMA) California Acupuncture Board National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM) The Accreditation Commission for Acupuncture and Oriental Medicine (ACAOM) Council of Colleges of Acupuncture and Oriental Medicine (CCAOM) American Herbal Products Association (AHPA) Senator Barbara Boxer Senator Dianne Feinstein Governor Arnold Schwarzenegger Representative David Dreier ---------------------------- April 12, 2004 Dear Senator and Congressman, I am a Licensed Acupuncturist in your voting district and would like to voice my opinion regarding the final FDA ruling 21 CFR Part 119 declaring Dietary Supplements containing Ephedrine alkaloids adulterated. Through this ruling, the FDA bans the use of Ephedra (“Ma Huangâ€) and Pinellia (“Ban Xiaâ€) in the dietary supplements used by licensed professionals such as Acupuncturists because they contain ephedrine alkaloids. Although the FDA appeared to give Acupuncturists and makers of Traditional Asian Medicines an exemption from this rule, it did not because the formulas used by Acupuncturists are usually sold as dietary supplements. I use the herbs Ephedra (“Ma Huangâ€) and Pinellia (“Ban Xiaâ€) regularly in my practice, including dietary supplements that contain such, and they are administered safely according to my extensive traditional Chinese herbal training and national certification. We believe and support the public policy behind the current FDA ruling in so far as it is to keep Ephedra out of weight-loss products. However, we believe that this public policy and allowing Traditional Asian Medicine practitioners to use dietary supplements containing ephedrine alkaloids can co-exist using a learned intermediary model, with licensed health care practitioners to use such products such as under California Health and Safety Code Section 110423.100-110423.101. There are no Adverse Event Reports for products sold as dietary supplements containing the herb Ma Huang as used by Traditional Asian Medicine practitioners. Based on hundreds of years of tradition and use of Ma Huang and Ban Xia in formulas to assist people with respiratory problems instead of weight loss, we believe the herb is safe to use for the above stated purposes. The FDA did not state previously that their final ruling would include Pinellia and has not produced any evidence in its ruling that Pinellia is unsafe. In other words, the FDA has not followed due process with this herb. Please communicate to the FDA on my behalf, that the FDA should add an additional section to the ruling that clearly states that Traditional Asian Medicine Practitioners can use and sell in their practice dietary supplements that contain ephedrine alkaloids as used in traditional formulas and for traditional uses. Sincerely, John K. Chen, Ph.D., Pharm.D., O.M.D., L.Ac. PO Box 90878 City of Industry, CA 91715-0878 CC: American Association of Oriental Medicine (AAOM) Acupuncture and Oriental Medicine Alliance (AOMA) California State Acupuncture and Oriental Medicine Association (CSOMA) California Acupuncture Board National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM) The Accreditation Commission for Acupuncture and Oriental Medicine (ACAOM) Council of Colleges of Acupuncture and Oriental Medicine (CCAOM) American Herbal Products Association (AHPA) President George Bush Senator Barbara Boxer Senator Dianne Feinstein Governor Arnold Schwarzenegger Representative David Dreier Dr. Christine Taylor, Director, FDA CFSAN Dr. Robert Moore, Branch Chief, FDA CFSAN Dr. Susan Walker, Acting Director, FDA CFSAN Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 13, 2004 Report Share Posted April 13, 2004 Pam, With all due respect to you and John.... this all is a waste of time and effort ... the rule is in effect ... and no letters to anyone is going to change that. David At 09:25 PM 4/12/2004, you wrote: >Please forward to as many members as you see fit. I have 'blind copied' my >list. Thank you, Pam Price > >- >Drjohnchen >needledoc >Monday, April 12, 2004 4:42 PM >Re: FDA & Ephedra > > >April 12, 2004 > > > >John K. Chen, Ph.D., Pharm.D., O.M.D., L.Ac. > >PO Box 90878 > >City of Industry, CA 91715-0878 > > > > > >U. S. Department of Health and Human Services >U. S. Food and Drug Administration >Center for Food Safety and Applied Nutrition >Office of Nutritional Products, Labeling and Dietary Supplements > >Food and Drug Administration, 5600 > >Fishers Lane, Rockville, MD 20857 > > > > > >To Whom It May Concern: > > > >I am a licensed acupuncturist who practices traditional Asian medicine in >the State of California. I am writing to request clarification and/or >amendment on 21 CFR Part 119 “Final Rule Declaring Dietary Supplements >Containing Ephedrine Alkaloids,†published on February 11, 2004. The >reason for this request is because the current regulation (21 CFR Part >119) is unclear and ambiguous. Though the FDA stated that “This final >rule does not affect the use of Ephedra preparations in traditional Asian >medicine†and that this rule “applies only to products regulated as >dietary supplements (See 62 FR 30678 at 30691),†it is my understanding >that these “traditional Asian medicine†products that I use in my >practice are in fact classified and regulated as dietary supplements. > > > >In this regulation, the FDA stated that “dietary supplements containing >ephedrine alkaloids are adulterated under the Federal Food, Drug, and >Cosmetic Act (the act) because they present an unreasonable risk of >illness or injury under the conditions of use recommended or suggested in >labeling, or if no conditions of use are suggested or recommended in >labeling, under ordinary conditions of use.†These products generally >refer to ones misused and abused for weight loss, energy, or to enhance >athletic performance. > > > >While I support FDA’s action to protect the general public, I am deeply >concerned that an indiscriminate ban of these products marketed as dietary >supplements will deprive responsible acupuncturists and their patients >valuable tools necessary for optimal healthcare. Use of these products by >a licensed acupuncturist, in the words of the FDA, is definitely not >“under ordinary conditions of use†because they are properly used and >supervised. Acupuncturists have received proper medical training and >understand how to use these herbs safely and effectively. In fact, the >FDA had acknowledged in this regulation that there is no “recorded >adverse events with the use of Ephedra in traditional Asian >medicine.†Use of these products by licensed/certified traditional >Asian medicine practitioners do not “present an unreasonable risk of >illness or injury†as stated by the FDA. All adverse reactions are >associated strictly with products that abuse and misuse these herbs for >weight loss, athletic performance enhancement, and others. > > > >Ma Huang (Ephedra) and Ban Xia (Pinellia) are two Chinese herbs that will >be directly affected by this regulation. These are two of the most >important herbs in the Chinese Materia Medica. Furthermore, these two >herbs are vital ingredients in approximately 20% of Chinese herbal >formulas. Not having access to these herbs (and hundreds of such formulas) >will have a tremendous-deleteriously effect on the entire profession of >traditional Chinese medicine (approximately 14,000 acupuncturists, 10,000 >students, 53 acupuncture schools, and not to mention all the patients). > > > >In conclusion, I would like to request the FDA to consider clarifying >and/or amending the current regulation to specifically allow >licensed/certified traditional Asian medicine practitioners to use dietary >supplements that contain ephedrine alkaloids only within their scope of >practice. This request is not novel, nor unique. The State of California >adopted such a policy last year in banning products containing ephedrine >alkaloids, but specifically allowed licensed healthcare practitioners to >sell and dispense such products, except for weight loss, energy or any >such purposes. An amendment mimicking the California Legislation >will protect the general public and also allow the safe and responsible >use of these products through licensed/certified healthcare providers. > > > > > >Respectfully yours, > > > > > > > >John K. Chen, Ph.D., Pharm.D., O.M.D., L.Ac. > >PO Box 90878 > >City of Industry, CA 91715-0878 > >E-mail: drjohnchen > > > > > >CC: > >Dr. Christine Taylor, Director, FDA CFSAN > >Dr. Robert Moore, Branch Chief, FDA CFSAN > >Dr. Susan Walker, Acting Director, FDA CFSAN > >American Association of Oriental Medicine (AAOM) > >Acupuncture and Oriental Medicine Alliance (AOMA) > >California State Acupuncture and Oriental Medicine Association (CSOMA) > >California Acupuncture Board > >National Certification Commission for Acupuncture and Oriental Medicine >(NCCAOM) > >The Accreditation Commission for Acupuncture and Oriental Medicine (ACAOM) > >Council of Colleges of Acupuncture and Oriental Medicine (CCAOM) > >American Herbal Products Association (AHPA) > >Senator Barbara Boxer > >Senator Dianne Feinstein > >Governor Arnold Schwarzenegger > >Representative David Dreier > > > >---------------------------- > > > >April 12, 2004 > > > >Dear Senator and Congressman, > >I am a Licensed Acupuncturist in your voting district and would like to >voice my opinion regarding the final FDA ruling 21 CFR Part 119 declaring >Dietary Supplements containing Ephedrine alkaloids adulterated. Through >this ruling, the FDA bans the use of Ephedra (“Ma Huangâ€) and Pinellia >(“Ban Xiaâ€) in the dietary supplements used by licensed professionals >such as Acupuncturists because they contain ephedrine alkaloids. > > > >Although the FDA appeared to give Acupuncturists and makers of Traditional >Asian Medicines an exemption from this rule, it did not because the >formulas used by Acupuncturists are usually sold as dietary supplements. I >use the herbs Ephedra (“Ma Huangâ€) and Pinellia (“Ban Xiaâ€) >regularly in my practice, including dietary supplements that contain such, >and they are administered safely according to my extensive traditional >Chinese herbal training and national certification. > > > >We believe and support the public policy behind the current FDA ruling in >so far as it is to keep Ephedra out of weight-loss products. However, we >believe that this public policy and allowing Traditional Asian Medicine >practitioners to use dietary supplements containing ephedrine alkaloids >can co-exist using a learned intermediary model, with licensed health care >practitioners to use such products such as under California Health and >Safety Code Section 110423.100-110423.101. > >There are no Adverse Event Reports for products sold as dietary >supplements containing the herb Ma Huang as used by Traditional Asian >Medicine practitioners. Based on hundreds of years of tradition and use of >Ma Huang and Ban Xia in formulas to assist people with respiratory >problems instead of weight loss, we believe the herb is safe to use for >the above stated purposes. > > > >The FDA did not state previously that their final ruling would include >Pinellia and has not produced any evidence in its ruling that Pinellia is >unsafe. In other words, the FDA has not followed due process with this herb. > > > >Please communicate to the FDA on my behalf, that the FDA should add an >additional section to the ruling that clearly states that Traditional >Asian Medicine Practitioners can use and sell in their practice dietary >supplements that contain ephedrine alkaloids as used in traditional >formulas and for traditional uses. > > > >Sincerely, > > > > > >John K. Chen, Ph.D., Pharm.D., O.M.D., L.Ac. > >PO Box 90878 > >City of Industry, CA 91715-0878 > > > > > >CC: > >American Association of Oriental Medicine (AAOM) > >Acupuncture and Oriental Medicine Alliance (AOMA) > >California State Acupuncture and Oriental Medicine Association (CSOMA) > >California Acupuncture Board > >National Certification Commission for Acupuncture and Oriental Medicine >(NCCAOM) > >The Accreditation Commission for Acupuncture and Oriental Medicine (ACAOM) > >Council of Colleges of Acupuncture and Oriental Medicine (CCAOM) > >American Herbal Products Association (AHPA) > >President George Bush > >Senator Barbara Boxer > >Senator Dianne Feinstein > >Governor Arnold Schwarzenegger > >Representative David Dreier > >Dr. Christine Taylor, Director, FDA CFSAN > >Dr. Robert Moore, Branch Chief, FDA CFSAN > >Dr. Susan Walker, Acting Director, FDA CFSAN > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 13, 2004 Report Share Posted April 13, 2004 Pam, With all due respect to you and John.... this all is a waste of time and effort ... the rule is in effect ... and no letters to anyone is going to change that. David At 09:25 PM 4/12/2004, you wrote: >Please forward to as many members as you see fit. I have 'blind copied' my >list. Thank you, Pam Price > >- >Drjohnchen >needledoc >Monday, April 12, 2004 4:42 PM >Re: FDA & Ephedra > > >April 12, 2004 > > > >John K. Chen, Ph.D., Pharm.D., O.M.D., L.Ac. > >PO Box 90878 > >City of Industry, CA 91715-0878 > > > > > >U. S. Department of Health and Human Services >U. S. Food and Drug Administration >Center for Food Safety and Applied Nutrition >Office of Nutritional Products, Labeling and Dietary Supplements > >Food and Drug Administration, 5600 > >Fishers Lane, Rockville, MD 20857 > > > > > >To Whom It May Concern: > > > >I am a licensed acupuncturist who practices traditional Asian medicine in >the State of California. I am writing to request clarification and/or >amendment on 21 CFR Part 119 “Final Rule Declaring Dietary Supplements >Containing Ephedrine Alkaloids,†published on February 11, 2004. The >reason for this request is because the current regulation (21 CFR Part >119) is unclear and ambiguous. Though the FDA stated that “This final >rule does not affect the use of Ephedra preparations in traditional Asian >medicine†and that this rule “applies only to products regulated as >dietary supplements (See 62 FR 30678 at 30691),†it is my understanding >that these “traditional Asian medicine†products that I use in my >practice are in fact classified and regulated as dietary supplements. > > > >In this regulation, the FDA stated that “dietary supplements containing >ephedrine alkaloids are adulterated under the Federal Food, Drug, and >Cosmetic Act (the act) because they present an unreasonable risk of >illness or injury under the conditions of use recommended or suggested in >labeling, or if no conditions of use are suggested or recommended in >labeling, under ordinary conditions of use.†These products generally >refer to ones misused and abused for weight loss, energy, or to enhance >athletic performance. > > > >While I support FDA’s action to protect the general public, I am deeply >concerned that an indiscriminate ban of these products marketed as dietary >supplements will deprive responsible acupuncturists and their patients >valuable tools necessary for optimal healthcare. Use of these products by >a licensed acupuncturist, in the words of the FDA, is definitely not >“under ordinary conditions of use†because they are properly used and >supervised. Acupuncturists have received proper medical training and >understand how to use these herbs safely and effectively. In fact, the >FDA had acknowledged in this regulation that there is no “recorded >adverse events with the use of Ephedra in traditional Asian >medicine.†Use of these products by licensed/certified traditional >Asian medicine practitioners do not “present an unreasonable risk of >illness or injury†as stated by the FDA. All adverse reactions are >associated strictly with products that abuse and misuse these herbs for >weight loss, athletic performance enhancement, and others. > > > >Ma Huang (Ephedra) and Ban Xia (Pinellia) are two Chinese herbs that will >be directly affected by this regulation. These are two of the most >important herbs in the Chinese Materia Medica. Furthermore, these two >herbs are vital ingredients in approximately 20% of Chinese herbal >formulas. Not having access to these herbs (and hundreds of such formulas) >will have a tremendous-deleteriously effect on the entire profession of >traditional Chinese medicine (approximately 14,000 acupuncturists, 10,000 >students, 53 acupuncture schools, and not to mention all the patients). > > > >In conclusion, I would like to request the FDA to consider clarifying >and/or amending the current regulation to specifically allow >licensed/certified traditional Asian medicine practitioners to use dietary >supplements that contain ephedrine alkaloids only within their scope of >practice. This request is not novel, nor unique. The State of California >adopted such a policy last year in banning products containing ephedrine >alkaloids, but specifically allowed licensed healthcare practitioners to >sell and dispense such products, except for weight loss, energy or any >such purposes. An amendment mimicking the California Legislation >will protect the general public and also allow the safe and responsible >use of these products through licensed/certified healthcare providers. > > > > > >Respectfully yours, > > > > > > > >John K. Chen, Ph.D., Pharm.D., O.M.D., L.Ac. > >PO Box 90878 > >City of Industry, CA 91715-0878 > >E-mail: drjohnchen > > > > > >CC: > >Dr. Christine Taylor, Director, FDA CFSAN > >Dr. Robert Moore, Branch Chief, FDA CFSAN > >Dr. Susan Walker, Acting Director, FDA CFSAN > >American Association of Oriental Medicine (AAOM) > >Acupuncture and Oriental Medicine Alliance (AOMA) > >California State Acupuncture and Oriental Medicine Association (CSOMA) > >California Acupuncture Board > >National Certification Commission for Acupuncture and Oriental Medicine >(NCCAOM) > >The Accreditation Commission for Acupuncture and Oriental Medicine (ACAOM) > >Council of Colleges of Acupuncture and Oriental Medicine (CCAOM) > >American Herbal Products Association (AHPA) > >Senator Barbara Boxer > >Senator Dianne Feinstein > >Governor Arnold Schwarzenegger > >Representative David Dreier > > > >---------------------------- > > > >April 12, 2004 > > > >Dear Senator and Congressman, > >I am a Licensed Acupuncturist in your voting district and would like to >voice my opinion regarding the final FDA ruling 21 CFR Part 119 declaring >Dietary Supplements containing Ephedrine alkaloids adulterated. Through >this ruling, the FDA bans the use of Ephedra (“Ma Huangâ€) and Pinellia >(“Ban Xiaâ€) in the dietary supplements used by licensed professionals >such as Acupuncturists because they contain ephedrine alkaloids. > > > >Although the FDA appeared to give Acupuncturists and makers of Traditional >Asian Medicines an exemption from this rule, it did not because the >formulas used by Acupuncturists are usually sold as dietary supplements. I >use the herbs Ephedra (“Ma Huangâ€) and Pinellia (“Ban Xiaâ€) >regularly in my practice, including dietary supplements that contain such, >and they are administered safely according to my extensive traditional >Chinese herbal training and national certification. > > > >We believe and support the public policy behind the current FDA ruling in >so far as it is to keep Ephedra out of weight-loss products. However, we >believe that this public policy and allowing Traditional Asian Medicine >practitioners to use dietary supplements containing ephedrine alkaloids >can co-exist using a learned intermediary model, with licensed health care >practitioners to use such products such as under California Health and >Safety Code Section 110423.100-110423.101. > >There are no Adverse Event Reports for products sold as dietary >supplements containing the herb Ma Huang as used by Traditional Asian >Medicine practitioners. Based on hundreds of years of tradition and use of >Ma Huang and Ban Xia in formulas to assist people with respiratory >problems instead of weight loss, we believe the herb is safe to use for >the above stated purposes. > > > >The FDA did not state previously that their final ruling would include >Pinellia and has not produced any evidence in its ruling that Pinellia is >unsafe. In other words, the FDA has not followed due process with this herb. > > > >Please communicate to the FDA on my behalf, that the FDA should add an >additional section to the ruling that clearly states that Traditional >Asian Medicine Practitioners can use and sell in their practice dietary >supplements that contain ephedrine alkaloids as used in traditional >formulas and for traditional uses. > > > >Sincerely, > > > > > >John K. Chen, Ph.D., Pharm.D., O.M.D., L.Ac. > >PO Box 90878 > >City of Industry, CA 91715-0878 > > > > > >CC: > >American Association of Oriental Medicine (AAOM) > >Acupuncture and Oriental Medicine Alliance (AOMA) > >California State Acupuncture and Oriental Medicine Association (CSOMA) > >California Acupuncture Board > >National Certification Commission for Acupuncture and Oriental Medicine >(NCCAOM) > >The Accreditation Commission for Acupuncture and Oriental Medicine (ACAOM) > >Council of Colleges of Acupuncture and Oriental Medicine (CCAOM) > >American Herbal Products Association (AHPA) > >President George Bush > >Senator Barbara Boxer > >Senator Dianne Feinstein > >Governor Arnold Schwarzenegger > >Representative David Dreier > >Dr. Christine Taylor, Director, FDA CFSAN > >Dr. Robert Moore, Branch Chief, FDA CFSAN > >Dr. Susan Walker, Acting Director, FDA CFSAN > > > > > Quote Link to comment Share on other sites More sharing options...
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