FDA Recall of Herbs and Herbal Products
Aristolochic acid, a chemical constituent of the aristolochia species and some asarum species of herbs, was the impetus behind the FDA import alert of May 2000. This alert called for the “detainment without physical inspection, of herbs suspected to be composed, in whole or part, of any Aristolochia species, or other herbs that may be substituted for it.”
Beginning in September of 2000, the FDA visited several Chinese herb distributors requesting the voluntary recall of herbs and herbal products believed to contain aristolochic acid. On December 14, 2000 at the request of the FDA, Mayway issued a national recall of Ma Dou Ling (Aristolochia debilis fruit) and Qing Mu Xiang (Aristolochia debilis root) in whole, powder, and extract powder form. We were not asked to recall, hold, or discontinue the sale of any of our finished products.
Correct Species Identification and Testing for Aristolochic Acid
Since 1997, herbs used in the Min Shan® and Plum Flower® Brand pills, which might possibly be adulterated with species of Aristolochia, have been tested prior to production using TLC (Thin Layer Chromatography) to verify species. This testing is conducted in-house at the manufacturer’s lab to ensure that our products do not pose a safety risk.
Our manufacturers are exceptionally diligent in the selection of herbs used to make the herbal products we distribute. For formulas containing Mu Tong, Chuan Mu Tong (Clematis armandii stem) or San Ye Mu Tong (Akebia Trifoliata stem) is used depending upon which herb is in season. These two types of Mu Tong have the same functions and are considered to be interchangeable. For formulas calling for Fang Ji, we use Han Fang Ji (Stephania tetrandra root).
Plum Flower® Brand unsulfured bulk herbs come from Mayway Anguo, our own processing facility in Hebei, China. There, herbs are acquired from the source and transported directly to our facility for processing. Of our five herbalists on staff, two are on-site to handle purchasing and quality control, and one to oversee herb processing. Their combined experience totals over 65 years in the art and science of identifying and grading herbs. In verifying species, microscopic examination is done and compared with the standards in the PRC Materia Medica. For more difficult to identify species, samples are sent to outside labs for TLC (Thin Layer Chromatography) or HPLC (High Performance Liquid Chromatography).
In response to the national recalls in 2000, we re-tested all of our pills, extracts, and herbs containing Mu Tong, Fang Ji and Xi Xin using LCMS (Liquid Chromatography Mass Spectrometry) with a detection level of 0.1 ppm to ensure once again that our products were safe and in compliance with current FDA guidelines on aristolochic acid. These and subsequent tests of new batches were conducted at the research lab of the Institute for the Advancement of Chinese Medicine (IACM) at the world-renowned Hong Kong Baptist University.
Injuries linked to Aristolochic Acid-Containing Species in Belgium
The incorrect identification and misuse of Aristolochia species have resulted in severe consequences. In Belgium in 1993, 70 people suffered kidney failure after taking a slimming product in which Guang Fang Ji (Aristolochia) had been used instead of Han Fang Ji (Stephania). The regimen also consisted of many prescription drugs including Phenfen, but as Guang Fang Ji contains aristolochic acid, a known nephrotoxin, it has become the alleged culprit. The Guang Fang Ji was taken in relatively large doses over an average of one year, and the regimen was not prepared or administered according to traditional Chinese medicine standards. The deaths and injuries from these cases eventually lead to the banning of not only all Aristolochia species, but even suspected species such as Asarum, Clematis, and Akebia in most of Europe.
The Need for Better Understanding
Guang Fang Ji has been in use in traditional Chinese medicine for several hundred years. It had always been used as a water decoction. The Merck index states that aristolochic acid is insoluble in water, which could explain why there have not been reported cases of toxicity in TCM decoctions or products made from traditional water decoctions. As the Belgium slimming regimen used the Guang Fang Ji in raw powdered form, the Aristolochic Acid was present and absorbed by the patients, and may have, along with the prescription drugs, caused kidney failure. Although the clinic thought that what it was administering was Han Fang Ji (Stephania tetranda) and not Guang Fang Ji, it is evident that the clinic was not using or preparing the herb in a traditionally prescribed manner.
As a company, we feel that this situation underscores the need for more research and a better understanding on the part of regulating agencies, industry and practitioners. Many herbs containing toxic substances have therapeutic merit and have been used safely and effectively throughout Chinese medicinal history through correct processing, preparation, administration, dosage and diagnostics. With the growing use of traditional Chinese medicines worldwide, comes the inevitable growth in research and use of Chinese herbs outside the realm of TCM. Although TCM itself is an ever-changing art and science, it is essential that correct identification of species and traditional processing and use must be taken into account. In our efforts to “modernize” and to make TCM more scientific or find new applications for it, we must also be diligent in our efforts to maintain a complete understanding of traditional Chinese herbal medicine.
Mayway Corporation and the FDA
We continue to work with the California Dept. of Health Services (CADHS), Food & Drug Branch (FDA) to better understand issues, and to help prevent potential problems related to Chinese herbs. We hope that by working with the CADHS and the FDA on issues such as Aristolochic acid that we can foster a greater amount of confidence in traditional Chinese medicine and trust in our industry by both regulatory agencies and the public.
For more information see:
U.S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Nutritional Products, Labeling and Dietary Supplements
“Aristolochic Acid: A toxicological review”, by Pokhrel, P. and Ergil, K. Clinical Acupuncture and Oriental Medicine (2000)
“Urothelial carcinoma associated with the use of a Chinese herb (aristolochia fangji)” by Nortier, J. et al., NEJM Vol.342, No. 23 6/8/2000
“Chinese Herbs and Urothelial Cancer” by Ming Li, Y, NEJM letter to the editor Vol.343, No.17 10/26/2000