Jake Paul Fratkin, OMD
Chinese patent medicines have drawn recent attention due to concern of contamination with heavy metals, pharmaceuticals, pesticides and preservatives. Preliminary reports in the California Food and Drug Branch (FDB) article Important Information for Sellers of Asian Patent Medicines (October 10, 1991) raised concerns of widespread use of toxic contaminants. Serious allegations were also raised in the New England Journal of Medicine (September 21, 1995). In 1998, the California Food and Drug Branch (FDB), California Department of Health Services, under the leadership of Dr. Richard Ko, issued their 1997-1998 Compendium Of Asian Patent Medicines, which included analysis on samples of 260 products from mainland China, Taiwan, Hong Kong and Singapore. They are now preparing for publication an expanded list of 505 samples, which I have had access to.
Dr. Ko is to be commended for leading an excellent investigation. The laboratory tests the California FDB used were performed with atomic absorption and high speed gas chromatography mass spectrometry analyses, which are state of the art techniques for discovering heavy metals and chemicals. His investigation cannot be a completely accurate record, due to the fact that he took isolated samples of products that did not follow strict batch controls. At best, they represent a general survey of probability of contamination. In this light, however, one can make inferences about product contamination in general for the Chinese products available in the United States.
In my forthcoming book, CHINESE HERBAL PATENT MEDICINES, we are describing about 1000 products from mainland China available in North America. Of these, 450 are made at Australian certified GMP (Good Manufacturing Practice) factories, and are guaranteed not to contain any heavy metals or chemical contaminants. They also do not contain pharmaceuticals. The companies offering Chinese-made GMP level products are:
Plum Flower Brand
Herbal Times Brand
Bio Essence Brand
Minshan Brand, Lanzhou Foci Herb Factory
Pangaoshou Pharmaceutical Co, Ltd, Guangzhou.
Qixing Pharmaceutical Factory; Guangzhou
Tanglong Brand, Gansu Medicines & Health Products I/E Corp.
Of the remaining 550 products, we are including 261 of the 505 products that Dr. Ko made analysis on samples of. The other 244 products in the FDB list are not included in the book for the following reasons: either a) they were made outside mainland China in Taiwan, Hong Kong, Singapore or Korea; b) the product is no longer found in North America; or c) the product did not list their ingredients, and was therefore not included in my book.
What are the standards of contamination? The United States Pharmacopoeia (USP) for dietary supplements allows a total of 10 to 20 ppm (parts per million) of heavy metal content within a product. The Australian Therapeutic Goods Administration (TGA) considers unacceptable levels for heavy metals to be greater than 5 ppm for lead, greater than 3 ppm for arsenic and greater than 3 ppm for mercury. As you can see, the USP has a more flexible standard, looking at combined heavy metal contamination. If we accept the Australian TGA standards, the more rigid of the two, we can then sum up Dr. Ko’s material as follows.
Total number of non-GMP products in book: 550
Total number of non-GMP products examined: 261
Percentage of non-GMP products examined: 47.4 %
Of the examined products:
Those that are clean without contaminants or heavy metals: 183
Percentage of examined products: 70.1%
Those with heavy metals at Australian TGA levels: 79
Percentage of examined products: 30.2%
Percentage of total products, including GMP: 0.8%
Those with heavy metals levels > 100 ppm: 29
Percentage of examined products: 11.1%
Percentage of total products, including GMP: 0.3%
Those with preservatives or pesticides: 31
Percentage of examined products: 11.8%
Percentage of total products, including GMP: 0.3%
Those with prescription drugs: 10
Percentage of examined products: 3.8%
Percentage of total products, including GMP: 0.1%
The implications of these summations are as follows: probably 30% of medicines from China that are not from a GMP factory may have some heavy metal contamination. There are mitigating circumstances a practitioner should keep in mind. First, total amounts of heavy metals need to be seen against length of time of ingestion. A product having up to 50 ppm of toxic metals is probably not damaging if taken within a five day course. Most of the products listed as contaminated have less than 50 ppm total of heavy metals.
Secondly, products with extremely high metal contamination (between 100 ppm and 82000 ppm) number 29, or 11% of the products examined. This is high, admittedly, but when one accuses all Chinese products as being contaminated, one can respond that about 11% of non-GMP products are so. Many factories that have these levels of heavy metal contamination put them in there intentionally, usually to combat life-threatening bacteria and viruses. They are not commonly used or available, but the public needs to be informed. My book will list which products are contaminated, and which factories have the greatest incidence of heavy metal contamination.
It is obvious that the future of Chinese patent medicines in this country will be with those products manufactured at GMP level factories. However, there are many products that are not made at GMP factories that are both beneficial and safe. When the press attacks Chinese patent medicines as polluted with heavy metals, pharmaceuticals and pesticides, you now have some data to validate or challenge those assumptions.
JAKE PAUL FRATKIN, OMD is a Doctor of Oriental Medicine in practice since 1978. After seven years basic training in Japanese acupuncture and Chinese herbal medicine in this country, he went to Beijing for one year to do advanced hospital training in herbal internal medicine, pediatrics and medical qi gong. He is the author of CHINESE HERBAL PATENT MEDICINES, (2001), a respected reference work of 1200 Chinese herbal products available in this country. In 1999 he received the national award, Acupuncturist of the Year, from the American Association of Oriental Medicine, and 2006 he received the award as Acupuncture Teacher of the Year. He is a recognized expert in the treatment of leaky gut syndrome, chronic respiratory and digestive disorders. Jake lives and practices in Boulder, Colorado
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