Issues of Safety and Quality of Chinese Herbs
The safety of Chinese herbal products is an important question and one taken seriously by herbalists in the West. From infant formula to pet food and toys with toxic lead-based paint, there have been several newsworthy cases of contaminated products manufactured in China that have rightly caused a great deal of concern.
Problems of safety regarding herbs have not been common, but do occur. Along with the U.S. Food and Drug Administration (FDA), the Chinese medicine community has worked diligently to minimize these problems and create protocols that ensure high quality standards. Potential concerns generally fall into four major categories: bio-toxin contamination, excessive heavy metal concentration, inclusion of unlabeled ingredients, and incorrect species identification.
Below is a discussion of these issues and the measures that have been taken by the Oriental medicine community in the U.S. in order to ensure high quality herbal products that are both safe and effective.
The FDA requires strict regulation of all imported herbs and herb products that enter the U.S. in order to ensure they do not contain contaminants. In compliance, all American herb companies now test each batch of herbs for E. coli, salmonella, and other potential bio-toxins such as molds and yeasts. GC (Gas Chromatography) methods are used to ensure herb safety by testing for the presence of over 200 potentially harmful substances such as pesticides, herbicides, and fungicides.
High levels of mercury, lead and other heavy metals have been found in some herbs and herbal products manufactured in China by Chinese-based companies. In particular, some of the pre-formed herb pills have been tested and found to contain excessive heavy metals. It is suspected that the large containers used to cook and concentrate herbal liquid for the making of pills have lead solder seams which allow lead to leech into the product. American herb manufacturers ensure this does not occur by using only seamless stainless steel equipment when producing herbal products.
It should be noted that lead is an organic substance occurring in soil, lakes, rivers and oceans and that no soil is lead-free. It is naturally present at an average of about 10 ppm (parts per million), and in general, is usually less than 50 ppm.
Because lead is in the air, water and soil, it enters our bodies by breathing, drinking water, eating plant based foods and food from animals that eat plants. Excessive lead contamination in the environment is an increasing problem, introduced into the water supply by lead pipes and into the air from automobile exhaust and the burning of coal. It contaminates food through the lead solder in cans, and from air pollutants combining with rain that falls on crops and enters the worldwide water system.
The legal limit for lead in pharmaceutical and herbal products has been set at 10 ppm and for mercury at 3 ppm, though most dried Chinese herb material measures well below these levels. American herb companies run sensitive tests measuring these subparts per million of heavy metals in order to assure that no herbs with excessive lead or mercury concentration go on to be sold to the public.
Unfortunately, some herbal patent (pre-formed pill) products manufactured in China by Chinese companies have been found to contain extraneous ingredients not listed on the label. The lack of labeling laws and regulations in China have lead to the formulation of herb products containing pharmaceutical drugs and other unknown additives. This is one reason we strongly advise against buying herb products manufactured in mainland China by Chinese companies. This poor labeling practice does not occur with products manufactured by American owned herb companies and they are tested regularly upon entry to the U.S.
It is extremely important that herbs be subject to careful and accurate identification. Though few, there have been some serious problems associated with the ingestion of toxic plants that were identified incorrectly, mistaken for another, completely harmless herb. For this reason, all American herb companies now require a botanist to be on staff to oversee a three stage process of 1) macroscopic inspection to identify the correct plant, 2) microscopic examination to ascertain species authenticity, and 3) TLC (Thin Layer Chromatography) to analyze the chemical “fingerprint” unique to each species. Every batch of herbs is tested, identified and documented, in order to ensure consumer safety.
Though not an issue of safety, the use of plant and animal medicines from endangered species is an important ethical one. The overwhelming majority of herbalists in the West are strongly committed to the ban on using these substances. Not only is it illegal, but it is also our responsibility to preserve both human health and the health of our natural ecosystems. The demand for natural medicines is great and can tax dwindling species groups. It is our commitment, and that of many, to stay informed and avoid using both endangered plants and animals as well as those that are approaching critically low numbers.
Dedication to High Standards
As a profession, Oriental medicine is strongly committed to the health of our patients and that of the planet. To this end, we recommend that consumers use only herbs and herb products manufactured and imported by American companies, or reputable European or Australian companies. Some of these may have manufacturing plants based in Taiwan or other countries outside the U.S., but their products will be held to the stringent U.S. regulations described above, and are subject to testing and documentation upon entering the U.S. By purchasing herbs only from companies that are well regulated and operating according to FDA and GMP (Good Manufacturing Practice) standards, we are confident in the quality and safety of Chinese herbs we prescribe.