Guest guest Posted May 26, 2000 Report Share Posted May 26, 2000 > The Food and Drug Administration (FDA) has requested that we communicate > > to our members a continuing concern regarding the toxicity of plants > > containing aristolochic acids and the possible adulteration of various > > botanicals with species of Aristolochia. > > Adulteration of several specific Chinese herbs with Aristolochia has > > been occasionally observed over the past decade. The consequences of > > such substitution can be severe and in some cases could be fatal. All > > species of Aristolochia contain aristolochic acids (AA), known to be > > both carcinogenic and nephrotoxic. AA is also found in other plants, > > including Asarum canadense (wild ginger, or Canada snakeroot). > > In its correspondence dated May 16, 2000, FDA provided AHPA, CRN and > > other organizations with “lists of plants known to contain aristolochic > > acid and of plants which may become adulterated with Aristolochia spp.” > > The first list included many species of Aristolochia as well as Asarum > > canadense and Bragantia wallichi (probably actually a species of > > Thottea). The second list includes species of Akebia, Clematis, > > Cocculus, Diploclisia, Menispermum, Sinomenium, and Stephania. > > FDA advised that herbal product manufacturers take the following > > actions: > > § Test products that “contain ingredients that may be contaminated with > > aristolochic acid…to confirm the absence of aristolochic acid.” > > § Collect adverse events, “especially adverse events that may include > > renal system disorders” and associated with an herbal ingredient on the > > lists provided by FDA, i.e., with a species known to contain > > aristolochic acid or known to be adulterated with species of > > Aristolochia. FDA further advised that firms “promptly notify FDA’s > > MEDWATCH program” of any such reports. > > FDA also stated its intention to issue “in the very near future, an > > import alert that will provide for the automatic detention without > > physical examination of any product containing a plant listed in the > > enclosure to this letter. Detained product will be released when the > > responsible party can provide direct analytical evidence that it is free > > of aristolochic acid.” The agency further stated that it would consider > > any product containing aristolochic acid “to be unsafe and to be > > adulterated.” > > Several species of Aristolochia, known by such common names as birthwort > > and Dutchman’s pipe, were formerly employed for a number of therapeutic > > uses. Virginia snakeroot (A. serpentaria, also know as serpentaria) > > was listed in the National Formulary as late as 1950. > > Although the use of Aristolochia species as ingredients is now quite > > uncommon, the adulteration issues to which FDA refers in its > > correspondence are well documented. Reported incidents of substitution > > are apparently related to confusion between herbs that have similar > > Chinese names. In a case reported in Belgium in 1993, the root of > > Stephania tetrandra, known as “fang ji” or “han fang ji” was found to be > > adulterated with the root of Aristolochia fangchi, known as “guang fang > > ji.” In more recent incidents reported in Britain, the stem of > > Aristolochia manshuriensis, known as “guan mu tong,” may have been > > substituted for the stem of Clematis armandii or “chuan mu tong,” or > > that of one of the medicinal species of Akebia, known simply as “mu > > tong.” The Belgian event resulted in over 100 reports of nephrotoxicity, > > and the later British case in at least two reports of end-stage renal > > failure in which kidney transplants were prescribed. > > In a Member Alert dated August 31, 1999, AHPA members were informed that > > Britain’s Medicine Controls Agency (MCA) had placed an emergency 3-month > > ban, effective July 28, 1999 on the import and sale of Aristolochia. In > > the meantime, this ban has been extended to June 30, 2001, and new > > restrictions have been authorized by MCA, similar to those now being > > proposed by FDA, against the import and sale of herbal ingredients at > > risk of confusion with Aristolochia species. Restricted plants include: > > stephania (presumably Stephania tetrandra); Clematis armandii; Clematis > > montana; Akebia quinata; Akebia trifoliata; three species of Cocculus; > > and products labeled as fang ji or mu tong. Also, Canada’s Health > > Protection Branch has issued a consumer warning against using products > > that contain Aristolochia or that are labeled to contain mu tong. > > AHPA established a trade recommendation in July 1997 that all member > > companies who use Stephania tetrandra root test each lot to assure the > > absence of Aristolochia fangchi root. The Member Alert of August 31, > > 1999 further advised that the same precaution be taken for any material > > identified as the stem of Clematis armandii or Akebia. FDA has now > > stated its intention to use its regulatory authority to take a position > > that is consistent with these self-regulatory precedents. > > All AHPA and CRN members who trade in any species of Aristolochia, > > Akebia, Clematis, Cocculus, Diploclisia, Menispermum, Sinomenium, or > > Stephania or Asarum canadense are urged to take this communication from > > FDA seriously. Please contact the AHPA or CRN office for a copy of the > > full list of species prepared by FDA. > > Our scientific staffs will be working closely the American Herbal > > Pharmacopoeia to evaluate and/or develop testing methods for > > determination of such identification, and will make these available as > > soon as this work is completed. > > > > Michael McGuffin, President > > American Herbal Products Association > > > > John B. Cordova, President > > Citizens for Responsible Nutrition Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 26, 2000 Report Share Posted May 26, 2000 We need to do a lot more than let the AHPA provide help. We ned to organize now and work to get the ban halted asap. Here is a quote from their letter. " Regardless of the reason for the presence of aristolochic acid in different products, it is important that products that contain aristolochic acid not be allowed to enter the U.S. marketplace.....FDA considers and FDA regulated product containing aristolochic acid to be unsafe and to be adulterated.” David Molony In a message dated 5/26/00 2:15:41 AM, herb-t writes: << All AHPA and CRN members who trade in any species of Aristolochia, > > Akebia, Clematis, Cocculus, Diploclisia, Menispermum, Sinomenium, or > > Stephania or Asarum canadense are urged to take this communication from > > FDA seriously. Please contact the AHPA or CRN office for a copy of the > > full list of species prepared by FDA. > > Our scientific staffs will be working closely the American Herbal > > Pharmacopoeia to evaluate and/or develop testing methods for > > determination of such identification, and will make these available as > > soon as this work is completed. > > > > Michael McGuffin, President > > American Herbal Products Association > > > > John B. Cordova, President > > Citizens for Responsible Nutrition Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 26, 2000 Report Share Posted May 26, 2000 A passionate yes!! It is also each and every practitioner's responsibility to educate and descriminate herbal quality and sources!! purchase only from reliable suppliers such as spring wind, and know to identify, for example, Mu tong from Guang Mu tong. Rudimentary, Holmes...Eti Quoting acuman1: > We need to do a lot more than let the AHPA provide help. We ned to organize > > now and work to get the ban halted asap. > Here is a quote from their letter. > " Regardless of the reason for the presence of aristolochic acid in > different > products, it is important that products that contain aristolochic acid not > be > allowed to enter the U.S. marketplace.....FDA considers and FDA regulated > product containing aristolochic acid to be unsafe and to be adulterated.” > > David Molony > > In a message dated 5/26/00 2:15:41 AM, herb-t writes: > > << All AHPA and CRN members who trade in any species of Aristolochia, > > > > > > Akebia, Clematis, Cocculus, Diploclisia, Menispermum, Sinomenium, or > > > > > > Stephania or Asarum canadense are urged to take this communication from > > > > > > FDA seriously. Please contact the AHPA or CRN office for a copy of the > > > > > > full list of species prepared by FDA. > > > > > > Our scientific staffs will be working closely the American Herbal > > > > > > Pharmacopoeia to evaluate and/or develop testing methods for > > > > > > determination of such identification, and will make these available as > > > > > > soon as this work is completed. > > > > > > > > > > > > Michael McGuffin, President > > > > > > American Herbal Products Association > > > > > > > > > > > > John B. Cordova, President > > > > > > Citizens for Responsible Nutrition > > > > ------ > Old school buds here: > http://click./1/4057/9/_/542111/_/959366165/ > ------ > > Chronic Diseases Heal - Chinese Herbs Can Help > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 26, 2000 Report Share Posted May 26, 2000 Perhaps we can invite Dr. John Chen (Pharm.D, Ph.D, and OMD) of Lotus Herbs online here on CHA to inform us as to what the current status is in the process of chinese herb species identification, detection and prevention of incorrect species being improperly substituted for desired species, what testing procedures are being used to detect toxicity, contamination and adulteration, and what further steps are planned for the future to help deal with this problem. Might also be helpful to invite Michael McGuffin to join us from time to time to discuss this as well. Between Michael and John we would have a truly excellent source of knowledge, and of up to date information on how this problem, and process is shaping up, and what we can do as a profession to protect our patients, and our practices. Bruce (original message follows)-- << Subj: aristolochic acids update herb-t (Todd) Reply-to: <A HREF= " " > @</A> (cha) > The Food and Drug Administration (FDA) has requested that we communicate > > to our members a continuing concern regarding the toxicity of plants > > containing aristolochic acids and the possible adulteration of various > > botanicals with species of Aristolochia. > > Adulteration of several specific Chinese herbs with Aristolochia has > > been occasionally observed over the past decade. The consequences of > > such substitution can be severe and in some cases could be fatal. All > > species of Aristolochia contain aristolochic acids (AA), known to be > > both carcinogenic and nephrotoxic. AA is also found in other plants, > > including Asarum canadense (wild ginger, or Canada snakeroot). > > In its correspondence dated May 16, 2000, FDA provided AHPA, CRN and > > other organizations with “lists of plants known to contain aristolochic > > acid and of plants which may become adulterated with Aristolochia spp.†> > The first list included many species of Aristolochia as well as Asarum > > canadense and Bragantia wallichi (probably actually a species of > > Thottea). The second list includes species of Akebia, Clematis, > > Cocculus, Diploclisia, Menispermum, Sinomenium, and Stephania. > > FDA advised that herbal product manufacturers take the following > > actions: > > § Test products that “contain ingredients that may be contaminated with > > aristolochic acid…to confirm the absence of aristolochic acid.†> > § Collect adverse events, “especially adverse events that may include > > renal system disorders†and associated with an herbal ingredient on the > > lists provided by FDA, i.e., with a species known to contain > > aristolochic acid or known to be adulterated with species of > > Aristolochia. FDA further advised that firms “promptly notify FDA’s > > MEDWATCH program†of any such reports. > > FDA also stated its intention to issue “in the very near future, an > > import alert that will provide for the automatic detention without > > physical examination of any product containing a plant listed in the > > enclosure to this letter. Detained product will be released when the > > responsible party can provide direct analytical evidence that it is free > > of aristolochic acid.†The agency further stated that it would consider > > any product containing aristolochic acid “to be unsafe and to be > > adulterated.†> > Several species of Aristolochia, known by such common names as birthwort > > and Dutchman’s pipe, were formerly employed for a number of therapeutic > > uses. Virginia snakeroot (A. serpentaria, also know as serpentaria) > > was listed in the National Formulary as late as 1950. > > Although the use of Aristolochia species as ingredients is now quite > > uncommon, the adulteration issues to which FDA refers in its > > correspondence are well documented. Reported incidents of substitution > > are apparently related to confusion between herbs that have similar > > Chinese names. In a case reported in Belgium in 1993, the root of > > Stephania tetrandra, known as “fang ji†or “han fang ji†was found to be > > adulterated with the root of Aristolochia fangchi, known as “guang fang > > ji.†In more recent incidents reported in Britain, the stem of > > Aristolochia manshuriensis, known as “guan mu tong,†may have been > > substituted for the stem of Clematis armandii or “chuan mu tong,†or > > that of one of the medicinal species of Akebia, known simply as “mu > > tong.†The Belgian event resulted in over 100 reports of nephrotoxicity, > > and the later British case in at least two reports of end-stage renal > > failure in which kidney transplants were prescribed. > > In a Member Alert dated August 31, 1999, AHPA members were informed that > > Britain’s Medicine Controls Agency (MCA) had placed an emergency 3-month > > ban, effective July 28, 1999 on the import and sale of Aristolochia. In > > the meantime, this ban has been extended to June 30, 2001, and new > > restrictions have been authorized by MCA, similar to those now being > > proposed by FDA, against the import and sale of herbal ingredients at > > risk of confusion with Aristolochia species. Restricted plants include: > > stephania (presumably Stephania tetrandra); Clematis armandii; Clematis > > montana; Akebia quinata; Akebia trifoliata; three species of Cocculus; > > and products labeled as fang ji or mu tong. Also, Canada’s Health > > Protection Branch has issued a consumer warning against using products > > that contain Aristolochia or that are labeled to contain mu tong. > > AHPA established a trade recommendation in July 1997 that all member > > companies who use Stephania tetrandra root test each lot to assure the > > absence of Aristolochia fangchi root. The Member Alert of August 31, > > 1999 further advised that the same precaution be taken for any material > > identified as the stem of Clematis armandii or Akebia. FDA has now > > stated its intention to use its regulatory authority to take a position > > that is consistent with these self-regulatory precedents. > > All AHPA and CRN members who trade in any species of Aristolochia, > > Akebia, Clematis, Cocculus, Diploclisia, Menispermum, Sinomenium, or > > Stephania or Asarum canadense are urged to take this communication from > > FDA seriously. Please contact the AHPA or CRN office for a copy of the > > full list of species prepared by FDA. > > Our scientific staffs will be working closely the American Herbal > > Pharmacopoeia to evaluate and/or develop testing methods for > > determination of such identification, and will make these available as > > soon as this work is completed. > > > > Michael McGuffin, President > > American Herbal Products Association > > > > John B. Cordova, President > > Citizens for Responsible Nutrition ------ Failed tests, classes skipped, forgotten locker combinations. Remember the good 'ol days http://click./1/4053/9/_/542111/_/959321697/ ------ Chronic Diseases Heal - Chinese Herbs Can Help ----------------------- Headers -------------------------------- Return-Path: <sentto-201013-1169-959321697-GRCanning=aol.com (AT) returns (DOT) > Received: from rly-zd02.mx.aol.com (rly-zd02.mail.aol.com [172.31.33.226]) by air-zd04.mail.aol.com (v73.13) with ESMTP; Fri, 26 May 2000 02:15:41 -0400 Received: from jj. (jj. [208.50.144.82]) by rly-zd02.mx.aol.com (v74.10) with ESMTP; Fri, 26 May 2000 02:15:12 -0400 X-eGroups-Return: sentto-201013-1169-959321697-GRCanning=aol.com (AT) returns (DOT) Received: from [10.1.10.37] by jj. with NNFMP; 26 May 2000 06:14:57 -0000 Received: (qmail 2267 invoked from network); 26 May 2000 06:14:56 -0000 Received: from unknown (10.1.10.27) by m3.onelist.org with QMQP; 26 May 2000 06:14:56 -0000 Received: from unknown (HELO mx.spiritone.com) (205.139.108.5) by mta2 with SMTP; 26 May 2000 06:14:56 -0000 Received: (qmail 27455 invoked from network); 26 May 2000 06:14:55 -0000 Received: (ofmipd 206.129.88.61); 26 May 2000 06:14:33 -0000 Message-ID: <392E1644.7CCF3195 X-Mailer: Mozilla 4.7 (Macintosh; I; PPC) X-Accept-Language: en,pdf,zh herb-t MIME-Version: 1.0 Mailing-List: list ; contact -owner Delivered-mailing list Precedence: bulk List-Un: <-> 25 May 2000 23:14:29 -0700 aristolochic acids update Content-Type: text/plain; charset=ISO-8859-1 Content-Transfer-Encoding: 8bit >> Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 28, 2000 Report Share Posted May 28, 2000 Here is an article John Chen submitted for the AAOM American Accupuncturist on Aristolochia. David Nephropathy associated with the use of Aristolochia westlandi (guan fang ji) and Aristolochia manshuriensis (guan mu tong) by John K. Chen, Ph.D., Pharm.D., O.M.D., L.Ac. The issue of nephropathy associated with the use of Chinese herbal remedies was first reported in Belgium in the early 1990's in a group of women taking a slimming preparation which contained fenfluramine, diethylpropion, cascara powder, belladonna extract, acetazolamide, Stephania tetrandra (han fang ji) and Magnolia officinalis (hou po). Of all who ingested this preparation, 33 cases of nephropathy were reported initially. To date, more than 100 cases of nephropathy have been reported. The cause of nephropathy was attributed to the substitution of Aristolochia westlandi (guan fang ji) for Stephania tetrandra (han fang ji). Aristolochia westlandi (guan fang ji) contains a substance called aristolochic acid, which is a known nephrotoxin . All cases of nephropathy can be traced to the ingestion of the herbal preparation prepared by the same clinic containing the incorrect herbal ingredient of Aristolochia westlandi (guan fang ji). This unfortunate incidence of nephropathy occured because there was a poor handling of Chinese herbs. In this case, the prescribed herb was Stephania tetrandra (han fang ji), but was incorrectly substituted with Aristolochia westlandi (guan fang ji). These are two different herbs with distinct physical appearances and laboratory presentations. Aristolochia westlandi (guan fang ji) root is round, 8-15 cm in length, and 1.5-4.5 cm in diameter. The root has a thick and rough outer layer that is greyish-brown in color. In contrast, Stephania tetrandra (han fang ji) root is round or cylindrical, 3-5 cm in length, and 3.5-5 cm in diameter. The outer layer of the root is dirt-brown in color with numerous pores. In August 7, 1999, The Lancet reported two additional cases of end-stage renal failure associated with the use of Chinese herbal remedies. Case one was a 49 year-old white female who took a Chinese herbal remedy for her eczema for 2 years. After complaining of headache and hypertension, she was screened for renal function and was found to have acute renal failure. She began dialysis immediately and subsequently received a cadaveric renal transplant. Case two was a 57-year-old white woman who was took a Chinese herbal remedy for her eczema for 6 years. After a 6-month history of anorexia, lethargy, nausea, and weight loss, she was admitted to the hospital with end-stage renal failure. She began dialysis immediately and is currently on the waiting list for renal transplant. In both cases, Aristolochia manshuriensis (guan mu tong) was the common ingredient in the herbal remedies. The Lancet reported that the investigation for other causes of renal failure were negative. In this case, nephropathy occured because there was a lack of verification resulting in the inadvertent use of Aristolochia manshuriensis (guan mu tong). According to the Pharmacopoeia of the People's Republic of China, the herb mu tong may be derived from the following species of plants: Clematis armandii (chuan mu tong), Clematis montana (chuan mu tong), or Aristolochia manshuriensis (guan mu tong). , Due to the toxicity associated with aristolochic acid in Aristolochia manshuriensis (guan mu tong), Clematis armandii (chuan mu tong) or Clematis montana (chuan mu tong) are now used as the preferred sources of mu tong. In regards to visual inspection, Aristolochia manshuriensis (guan mu tong) is long and round, approximately 1 m in length and 1.5-3 cm in diameter. The outer layer is greyish-yellow or light brown in color. It has enlarged joints in between parts of the plant and a distinct camphor-like odor. In contrast, Clematis armandii (chuan mu tong) or Clematis montana (chuan mu tong) long and round, 50-100 cm in length, and 2-3.5 cm in diameter. The outer layer is light to dark yellow/brown in color. It has no joints and no odor. Nephropathy associated with the use of Aristolochia westlandi (guan fang ji) and Aristolochia manshuriensis (guan mu tong) is not an isolated incidence. It has been documented in China, Belgium and England. Proper cautions must be taken to avoid such adverse reactions. Correct identification of the herb is imperative toward safe and effective use of the herbs. Physical inspection is the most commonly used used method of identification. It, however, is not 100% accurate or reliable. In the Belgium incidence, an incorrect substitution was used. In the England incidence, there was a lack of verification for the safest herb used. Therefore, it can be concluded that visual inspection is not sufficient for correct identification of the herbs as physical appearance of the herbs are often indistinguishable. Laboratory techniques such as High Performance Liquid Chromatography (HPLC), Thin-Layer Chromatography (TLC), and Liquid-Column Chromatography (LCC) must be used to confirm qualitative and quantitative analyses. Furthermore, such examinations must be performed on each and every batch of the herbs as random examinations will not ensure the safety of the herbs. It is the duty of the herbal manufacturer to instill the most stringent quality control measures to ensure the safety of the herbs, and it is the duty of the practitioners to purchase and dispense herbs from manufacturers who meet such criteria. Note: Figure 1 and 2 are sample certificates of analysis of Stephania tetrandra (han fang ji) and Clematis armandii (chuan mu tong). Certificate of analysis offers documentation on the safety and purity of the herbs. Items examined include heavy metal content, bacterial content, purity and positive identity of the herb. Figure 1. Stephania tetrandra (han fang ji). Figure 2. Clematis armandii (chuan mu tong). About the Author: Dr. John Chen is the president and founder of Lotus Herbs, Inc. He is a recognized authority on western pharmacology and Chinese herbal medicine. He graduated from the University of Southern California (USC) School of Pharmacy and South Baylo University of Oriental Medicine. He also received extensive post-graduate training in China specializing in herbology and internal medicine. He currently teaches herbal medicine and pharmacology at USC School of Pharmacy, South Baylo University, Yo San University and Emperor's College. He is a member of the Herbal Medicine Committee for the American Association of Oriental Medicine (AAOM) and a consultant for the California Association of Acupuncture and Oriental Medicine (CAAOM). Dr. Chen co-authored " Sixty-Five Herbal Formulas for the Stateboard Exam, " and published many articles, and given numerous seminars at universities, state and national organizations. In 1998, he was invited as a guest speaker by USC to present the continuing education seminar " Where Do Herbal Remedies Fit? Counseling the Patients on the Use of Herbal Remedies " at the Bergen Brunswig annual convention where more than 400 pharmacists and medical doctors attended. Dr. John Chen is the president and founder of Lotus Herbs, and is available for medical consultations through the Lotus Herbal Consultation Line at telephone: (626) 916-1070 and fax: (626) 917-7763. Herbal Information: Lotus Herbs offers full-spectrum standardized herbs to ensure safety and efficacy of the herbal extracts. State-of-the-art technology such as High Performance Liquid Chromatography (HPLC), Thin-Layer Chromatography (TLC), and Liquid-Column Chromatography (LCC) are used for qualitative and quantitative analyses. Active ingredients are identified, analyzed and compared to an established standard to ensure accuracy and consistency of the final products. Only with these tests can it be confirmed that the extracts are genuine. Our herbs are manufactured in Taiwan under the most stringent GMP (Good Manufacturing Practice) guidelines which meet or exceed the standards of Western pharmaceuticals. Reference: 1 Depierreux M, Van-Damme B, Vanden-Houte K, Vanherweghem JL. Pathological aspects of a newly described nephropathy related to the prolonged use of Chinese herbs. American Journal of Kidney Diseases, (1994 Aug) vol. 24(2):172-80. 2 Vanherweghem JL, Depierreux M, Tielemans C, et al. Rapidly Progressive interstitial fibrosis in young women: association with slimming regimen including Chinese herbs. Lancet 1993; 341:387-91. 3 Vanherweghem JL. Misuse of herbal remedies: the case of an outbreak of terminal renal failure in Belgium (Chinese herbs nephropathy). J Altern Complement Med 1998; 4:9-13 4 Chinese Herbal Botany, December 1974 5 Lord GM, Tagore R, Cook T, Gower P, Pusey CD. Nephropathy caused by Chinese herbs in the UK. The Lancet August 7, 1999; 354:481-482,494 6 Goshi T, ed. Pharmacopoeia of the People's Republic of China 1992; 16-17 and 304-05. 7 Zheng HZ, Dong ZH et al. Modern Study of . October 1997. Vol 1. 936:954 8 Zhejiang Journal of , 1965;12:32 Zheng HZ, Dong ZH et al. Modern Study of . October 1997. Vol 1. 936:954 9 Zheng HZ, Dong ZH et al. Modern Study of . October 1997. Vol 1. 936:954 10 Lotus Herbs, Inc. Certificate of analysis for Stephania tetrandra (han fang ji) and Clematis armandii (chuan mu tong). 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