Safety and Regulation

Who’s Watching the Herbal Store?

“Observe that the things which are considered to be right today are those which were considered impossible yesterday. The things which are thought wrong today are those which will be esteemed right tomorrow.”

– Hudhaifa –

According to the Cherokee Indians, all plants belong to one of three classifications:

A. Foods– to be eaten freely
B. Medicines–to be used in times of ill health
C. Poisons–to be avoided at all times

Perhaps we should teach this lesson to our children–thousands of poisonings could be avoided.

Does anyone regulate the safety of the herbal industry?

Reports in the media have spread the idea that the herbal medicine industry is completely unregulated. In fact, the Food and Drug Administration (FDA) regulates it very closely. The FDA reviews an herbal product’s labels, manufacturing standards, and contents. It collects reports of adverse effects, issues warnings, and pulls products off the shelves if problems are reported. Regulation has been increasing over time.

In addition, the Natural Products Association (the industry’s largest trade association), has developed a program to examine the herbal products and factory conditions of its member companies and give them the right to display GMP (Good Manufacturing Practices) seals of approval on their products. It is quite comprehensive, and resembles the certification process used to accredit hospitals. The program is expected to bein wide operation by July of 2002.

While it is true that regulation of the herbal medicine industry is not as extensive as it could be, it is also true that herbs have an excellent track record with regard to safety. Just remember that, as with everything else in life, there is no such thing as total safety with herbs. Even water can drown you.

Note to Chrysalis PatientsThis is how we make sure the herbs we use are authentic.

Howeer there are certain very specific herbs you should avoid, as well as herbal medicine forms and sources that do contain dangers. You do not need to be a “professional” to be safe.  Background knowledge and common sense are the most important safeguards you can use. Read labels carefully. ALWAYS check with your doctor before tampering with your prescriptions or changing over to herbal alternatives.

With solid basic facts, you can make sound judgments about who and what to trust in this “marketplace of occult medicine sellers.”

The Guiding Light

The World Health Organization published its “Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines” in 1993. They made a clear statement that the historical use of an herbal substance is valid proof of its safety unless there is scientific evidence of danger. They said, “A guiding principle should be that if the product has been traditionally used without demonstrated harm no specific regulatory action should be undertaken unless new evidence demands a revised risk-benefit assessment.” However, this idea, while valid, does not take into account the problem of heavy metals described below. It just means that plants that have been traditionally used over time are very likely to be safe, but only as long as they are not contaminated.

Natural Poisons Found In Plants

In spite of the safety statistics on commercial herbal preparations, many plants are poisonous. In fact, about 5% of all poisonings each year are caused by the ingestion of plants, over 10,000 incidents per year (Furbee B et al. 1997). Most of these poisonings occur when children ingest household or outdoor plants (Krenzelok et al. 1997). Parents should learn how to protect their children from truly toxic household plants, and children should be trained to never to eat plants unless an adult first teaches them how to identify and use it. Everyone should know how to contact his or her regional poison control control centers.

Under conditions of drought, livestock also consume poisonous plants for their moisture content and sometimes end up dying. Obviously, these sorts of poisonous plants are not put into capsules and sold to unsuspecting consumers at the health food store, but there are some important lessons to learn here.  In a 1989 report, The Data Collection System of the American Association of Poison Control Centers identified the 20 most frequently ingested plants, with numbers of ingestion episodes and information about toxicity. Most of them are either sold for household use or are extremely common in the wild. If you have any of these plants in or near your home, make sure your kids know that they are dangerous. For a complete list of the plants and their effects, contact your local poison control center.

Contaminants and Adulteration

A contaminant is an impurity, an extraneous material associated with an herb which can cause problems. Contaminants exert their effects by interacting with your cells, where they change,in a negative way, the mannerin which the cells function. They can inflame, irritate, or burn cell membranes, causing redness, pain, swelling, and/or itching. These effects are often delayed or remote, meaning that the contaminant enters your body through the gastrointestinal tract, the lungs or the skin, and then goes through several metabolic steps before exerting its negative effect on a target organ such as the liver or kidneys. Some contaminants can also harm unborn children. I know this all sounds very alarming, but it needs to be clearly understood.

The most important determinant of the true toxicity of a substance is dosage. All things in Heaven and on Earth have the potential to be toxic. In toxicology, this is called the dose-response relationship. Scientists determine this relationship by performing tests on animals to identify the LD50, or lethal dose (the amount necessary to kill 50% of the animals). The only way to avoid contaminants in herbs is to depend on quality manufacture. Some common contaminants include: pesticides, fumigants, irradiation, sterilizing gases, viruses, heavy metals, Western drugs, insects, hairs, additives, bacteria and fungal toxins. Obtaining foods and herbs from organic manufacturers should lessen your exposure to these toxins, especially pesticides and heavy metals.

An adulterant is a consciously introduced additive that dilutes, alters or changes the desired character of an herbal product. Adulteration is usually accomplished by adding a less pure form of a given herb into a batch, or even substitution of another species (usually a cheaper one). For instance, ginseng root (Panax ginseng) is expensive, so ginseng leaves are often added to the brew. David Lytle, lab director of Peak Botanical Laboratories reported on this type of adulteration at the 1999 forum “Applying Scientific Methods to Ensure and Market the Integrity of Your Product.” According to Lytle, “Guarana (Paulina cupana) is the seed of a creeping shrub native to the Amazon region and a popular botanical stimulant. A significant number of guarana extracts on the market today are adulterated.” Adulteration is not necessarily a health concern, as the adulterants themselves may not be toxic. However, if a toxic species is substituted, such as the germander/scullcap or stephania/aristolochia mix-ups mentioned above, serious problems can ensue.

In fact, in an HerbalGram editorial in the fall of 1998 Dr. Dennis Awang stated, “The overwhelming majority of adverse events recorded from herbal treatments has involved adulteration with, or substitution of, toxic plant material from relatively innocuous components . . . Careful characterization of botanical material, whether being assessed for activity or implicated in adverse health effects, is an absolute prerequisite to authoritative judgement.”

Please remember, however, that the overall safety record of herbal medicines is generally good, especially when companies meet the GMP standards we mentioned in our discussion of manufacturing. These problems are what quality control standards are designed to prevent.

Heavy Metals

The problem of heavy metal contamination deserves serious attention, because excessive levels of heavy metals are very toxic. Currently there is not enough attention to this important issue so I want to make a special point about it. Since the information available about this problem is incomplete, the media is occastionally making blanket statements that all Chinese and Ayurvedic medicines should be avoided.  Based upon what they are reading, I don’t blame them.  However, this does a great disservice to responsible and well-trained Oriental herbalists and the people who depend upon them for correct information about the correct use of herbs. In our own practice we have occasionally had patients suddenly stop coming to us because of these reports. It is very important to sort out the facts as we know them. Please note that the main problems seem to be withpatent medicines or herbs imported from India or China, and not individual herbs processed by responsible companies in the US and used by professional herbalists in formulas.

How do heavy metals and pesticides contaminate foods and herbs?

Most heavy metals and all pesticides come from industrial sources. These substances can enter the food chain and contaminate soil, air, foods and herbs. Each year, for example, thousands of tons of lead are dumped into the atmosphere. Cadmium and lead can be found in cigarette smoke. Mercury can come from contaminated fish. Aluminum can come from antacids and kitchen utensils. These are all-too-true environmental concerns. According to a recent review, “Epidemiologic studies on pesticides have found associations with long-term effects on health mainly in three fields: cancer (especially hematological cancer), neurotoxic effects (polyneuropathy, neuro-behavioral hazards, Parkinson’s disease), and reproductive disorders (infertility, birth defects, adverse pregnancy outcomes, perinatal mortality)” (Baldi et. al, 1998). One obvious conclusion is that it is better to purchase foods and herbs from organic sources. Also, it is important to know that some people react to minute amounts of these metals that are harmless for most of us, due to genetic susceptibility or impaired detoxifications capacity.

What can you say about reports stating that significant amounts of heavy metals have been found in Chinese herbs?

This is true. It is also a fact that virtually all animal products and herbs contain small amounts of various naturally occurring heavy metals. These include lead, mercury, cadmium, arsenic, nickel and aluminum. These do not pose a health concern unless they exceed safe levels (remember-dosage is everything).  While it is not true that all Chinese and Ayurvedic herbs contain excessive amounts of heavy metals, it is certainly true that many batches have been tested to show concentrations of heavy metals that exceed safe levels, sometimes to an alarming degree.

Most reports of seriously high levels of heavy metals in Chinese herbs, when investigated, are found to be based upon the fact that certain patented Chinese medicine formulas have purified heavy metals added intentionally for medicinal purposes, just as we do here with, for example, calcium and zinc. Chinese and Ayurvedic doctors purify these heavy metals with methods developed in ancient times. The supposedly “toxic” herbs are prescribed and consumed in China without apparent side effects. These methods have not, to my knowledge, been verified by Western science and cannot be depended upon. More Info.

How can anyone believe that mercury and lead can be “purified”?

I don’t think this is a question on which we should speculate. Completely and totally avoid anything containing these metals until scientists have studied this possibility thoroughly. Of course, this means you would have to know this in advance, which is only possible if you follow the following rules.

1. Only purchase herbs manufactured in this country, or from a foreign source that that has been tested in a GMP approved laboratory.

2. Get advice from your physician, licensed acupuncturist or other professional with credible credentials.

3. Look for GMP certification on your labels.

4. Avoid products with labels not printed in English, or in bottles or boxes that are poorly constructed – all signs of poor manufacturing quality.

Here is info on my primary source for the Chinese herbs we use in my home state of Delaware – This facility is a internationally certified GMP manufacturer with an in-house lab that does extensive quality control testingof all products.

Mayway Safety Info

That said, I found one interesting report in the India Materia Medica that may shed some light. The author reported that “In the Ayurvedic Pharmacopoeia . . . mercury is predominantly used in the form of sulphides . . . the sulphide ion is very inert, and it is clear that unless and until the salt is dissociated into its constituent ions, mercury will not be able to exert its influence on the body tissues.” The author also reported on animal experiments done in India which indicated that small amounts of this supposedly inert form of mercury produced a stimulating effect on production of red blood cells, while larger doses produced a reduction (Nadkarni, 1954). This report from a medical college in India is so interesting I will give you the entire abstract:

“Crude aconite is an extremely lethal substance. However, the science of Ayurveda looks upon aconite as a therapeutic entity. Crude aconite is always processed i.e. it undergoes ‘samskaras’ before being utilised in the Ayurvedic formulations. This study was undertaken in mice, to ascertain whether ‘processed’ aconite is less toxic as compared to the crude or unprocessed one. It was seen that crude aconite was significantly toxic to mice (100% mortality at a dose of 2.6 mg/mouse) whereas the fully processed aconite was absolutely non-toxic (no mortality at a dose even 8 times as high as that of crude aconite). Further, all the steps in the processing were essential for complete detoxification” (Thorat and Dahanukar, 1991).

After reading this, one might think that aconite is completely safe when properly purified. However, we need to weigh this against reports coming from China, which say that “In 1990, there were 46 cases due to aconite root related adverse reactions . . .” (Ko, 1999). I think we should avoid imported herbs that have not been tested, but also keep an open mind and wait for more information.

Institute of Traditional Medicine

How should I react to these reports?

To reiterate, currently it seems that heavy metals of high concentration are purposefully added after purification according to Chinese and Ayurvedic belief that their purification processes make these metals safe. Again, these ideas have not been tested in the West and cannot be trusted. Furthermore, in spite of the fact it is illegal to import these medicines into the United States, they are indeed making their way in. No one should use Chinese or Ayurvedic medicine sold over the counter in ethnic stores, because these have often come in without testing, and several published studies show they can easily contain heavy metals. They can be identified by packaging with native languages. Heavy metals may also be the result of pesticide or other contamination during manufacture or growing. I talked to a professional herbalist working for one of the large herbal medicine companies in America, and she told me that her company occasionally had to reject batches of herbs coming from China, and more frequently, batches coming from India, due to excessive levels of heavy metals. Perhaps the most disturbing report to date was the one done by the California Health Department and reported in the journal Alternative Medicine.

Author Dr. Harvey Kaltsas reported that “A large percentage of traditional Chinese patent medicines sold in the United States are prepared under Good Manufacturing Practice (GMP) standards and are thus guaranteed to be free of heavy metals, sugars, dyes and pharmaceuticals. Certainly almost all such TCM patent remedies made in the United States comply with GMP standards of purity. However, many TCM patent remedies made in China are another story” (Kaltsas, 1999). High levels of either heavy metals or prescription pharmaceuticals were found in 47% of the tested samples. My current conclusion is that it is possible tobe exposed to heavy metals if you take herbs that are processed by companies that do not meet GMP standards or imported from foreign clinics.  Therefore, at the current time I would avoid all patent medicines made outside the United States unless manufactured by companies that follow GMP standards. This warning does not apply to individual herbs imported by responsible natural medicine companies, tested, and then used to make formulas inside the United States. The best was to do this is to consult with a professional herbalist who is able to assess the companies from which they purchase their products. .

The American Association of Oriental Medicine