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The Truth about Contamination In Chinese Patent Medicines

By Lorenzo Puertas

In the last two years there have many reports about the supposed dangers of Chinese ready-made (patent) formulas. Newspaper, magazine, and television reports have scared many people away from Chinese herbs, and from Chinese medicine as a whole. According to these articles, some Chinese patent formulas are contaminated with lead, arsenic, mercury or pharmaceuticals.

Many of these stories in the press are loosely based on a study done in 1998 by the California Department of Health Services, Food and Drug Branch (California FDB). Under the guidance of Dr. Richard Ko, the California FDB laboratory screened hundreds of Chinese products and published the results in the 1997-98 Compendium of Asian Patent Medicines. Though this report is often used against Chinese herbs, a careful look at the California FDB report shows a very different picture. Dr. Ko himself has said, "I feel that my research has often been misused."

The truth is that many instances of supposed contamination are not problems at all ≠ and they can be explained by examining the history of Chinese patent formulas, the chemical constituents of their ingredients and the traditional Chinese medical uses of each formula.

Patent Formulas

Ready-made or patent medicines are as old as Chinese medicine itself. Many formulas still in production today are taken directly from the Shang Han Lun, another early text that is nearly 2,000 years old.

Since the late 1950s, the government of China has made serious efforts to guarantee the quality and safety of patent medicines. In 1985, the Drug Control Regulations Act went into effect, specifying rules for the ingredients, manufacturing procedures, and labeling of patent formulas. Today, most herb factories in China are safe, clean, and well run. Chinese herb manufacturers are regulated as pharmaceutical factories, with stringent requirements for safety and procedure.

In recent years, several Chinese factories have gone beyond Chinaπs regulations and voluntarily adopted Australian standards of Good Manufacturing Practice (G.M.P.). These factories are some of the best herb manufacturers in the world, making products to the worldπs highest standard of quality. Australian G.M.P. regulations mandate careful adherence to proper procedure, detailed record keeping, and laboratory testing of each batch to assure the safety of the products. Purchasing G.M.P. products from China guarantees freedom from worries of contamination.

Even non-G.M.P. Chinese products are overwhelming safe and free from contamination, as a careful look at the California F.D.B. report reveals. nte

Interpreting FDB Laboratory Testing

An analysis of the California FDB report shows that the problem of contamination in Chinese patent formulas is far less widespread than portrayed in previous reports. Many instances of supposed contamination disappear when examined more carefully:

  • Eight of the products tested by the California FDB are over-the-counter pharmaceuticals, not herbal formulas: Diaformin Tablets, Fenfluramini Tabellae, Fuchingsung-N (neomycin sulfate), Phenformini HydrochlorideTabs, Saridon (propyphenanzone), Sumalin, Tegafuri (Florouracil), and Tetrahydropalmatine Sulphate. These products are clearly pharmaceutical products, not traditional herbal preparations. They should not be included in any discussion of the safety of Chinese herbal medicine.
  • The presence of certain chemicals (such as modern pharmaceuticals) in herbal products can only be determined by comparison of test results with an existing library of analytical peaks. Unknown herbs can make it very difficult to accurately determine the presence or absence of known compounds. Some of the FDBπs positive results for drugs may not be accurate, due to the limitations of the FDBπs database.
  • FDB staff conducting the tests and publishing the reports are not trained in Chinese medicine. This makes it difficult for them to interpret laboratory results. Scientists untrained in traditional Chinese medicine cannot know if a chemical detected in the laboratory is an accidental contaminant, a deliberate adulteration, or simply an ingredient.
  • Many medicinal items used in patent formulas are substances that may wrongly be considered contaminants in the United States. Even if properly identified in the laboratory, unexpected ingredients are often incorrectly considered contaminants. Some of these ingredients may include camphor, realgar (arsenic disulfide), borneol, cinnabar (mercury sulfide), lead, borax, and magnetite.

    In the introduction to the Compendium, Dr. Ko and his staff at the FDB acknowledge many of these limitations. It is essential that the FDBπs laboratory results be properly interpreted by those trained in Chinese medicine. It is impossible to distinguish safe products from unsafe ones without this interpretation.

Distinguishing Contaminants from Ingredients

The chemicals detected by the FDB fall into three categories, seen in the tables accompanying this article.

  1. Traditional Ingredients In most cases, chemicals detected by the FDB are simply the chemical constituents of traditional ingredients in the formula.
  2. Contaminant: naturally occurring This category includes naturally occurring chemicals that can be considered contaminants because their presence in the formula is not intentional. This category also includes accidental contaminants such as the heavy metals lead, mercury, and arsenic which may be leached from mineral-rich soil by herbs.
  3. Contaminant: deliberate adulteration Some of the products analyzed by the FDB were found to contain modern pharmaceutical ingredients. As stated above, several of these are clearly over-the-counter drugs, not traditional herbal formulas. Excluding those products, there remain several products that appear to be herb/drug combinations.

The Use of Toxins in Traditional Chinese Medicine

Much of the concern about Chinese herbal formulas has focused on the presence of toxic chemicals in these preparations. Mercury, arsenic, lead and several highly toxic plants are used as ingredients in some of these formulas, causing concern about accidental poisonings.

These substances have proven their value over centuries of use, and thus have a place in the Chinese Pharmacopoeia. While some require great care in their use, they are no more dangerous than most modern pharmaceuticals. The potential toxicity of a medicine is not, in itself, an argument against its use.

The issue of toxic ingredients in Chinese herbal formulas must still be addressed. Some, like Dr. Ko, have proposed that we voluntarily limit these formulas to prescription use. Others feel that they have no place in our materia medica. It is for us to decide, keeping the best interests of our patients and our medicine in mind always.

The Safety of Chinese Patent Formulas

The vast majority of Chinese herbal formulas are safe, effective, and free of contaminants that may harm patients. The work done by the California FDB has started a serious and necessary discussion of the safety of our herbs and formulas, but as Dr. Ko has said repeatedly, it was never his intention to pass an indictment on Chinese herbal medicine.

A careful look at the FDBπs laboratory work shows that these products pose little danger to our patients. While herbal manufacturers, national associations, and government agencies are doing much work to improve the safety of our herbal medicines, little is being accomplished by exaggerated warnings in magazines, newsletters and websites.

Chinese herbs are safe and effective, and we do ourselves great harm by raising unwarranted fears among ourselves and among the patients we seek to treat.


Lorenzo Puertas is Director of Quality & Safety at Nuherbs and a member of the Herbal Medicine Committee at the American Association of Oriental Medicine. He is also an assistant editor of the California Journal of Oriental Medicine.


References

    1997 ≠ 1998 Compendium of Asian Patent Medicines, California Department of Health Services, Food and Drug Branch 1998.

    Bensky, Dan, and Gamble, Andrew, Chinese Herbal Medicine: Materia Medica. Seattle: Eastland Press, 1986.

    Flaws, Bob, 160 Essential Patent Formulas. Boulder Colorado: Blue Poppy Press, 1999.

    Hsu, Hong-yen et al, Oriental Materia Medica, A Concise Guide. New Cannan, CN: Oriental Healing Arts Institute, Keats Publishing, 1986.

    Naeser, Margaret, Outline Guide to Chinese Herbal Patent Medicines in Pill Form. Boston MA: Boston Chinese Medicine Press, Boston MA, 1998

    Puertas, Lorenzo, "Ingredients vs. Contaminants", California Journal of Oriental Medicine, Vol. 11, No.4, Fall 2000.

    Yeung, Him-Che, Handbook of Chinese Herbal Formulas. Rosemead, CA: Institute of Chinese Medicine, 1983.

    Yeung, Him-Che, Handbook of Chinese Herbs. Rosemead, CA: Institute of Chinese Medicine, 1983.

 


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