While the pharmaceutical industry has made important progress in recent decades in developing reliable, effective medications, the emphasis on proving efficacy has often overshadowed safety issues. So, despite federal drug regulations, serious safety problems related to pharmaceutical drugs persist. For example, one in five patients seen in a clinic experiences serious side effects, mainly from antibiotics, antidepressants, and anti-inflammatory drugs.(1)
Herbal products, although made from natural substances, are the forerunners of synthetic prescription drugs. Up to 25% of medications are derived directly or indirectly from naturally-occurring chemicals from plants, bacteria and fungi, or marine organisms. Like medications, herbal products have a biological action, which is why, in Europe, many herbal products are regulated as drugs.
Many herbal products are quite safe and fall into the realm of foods. Examples include gentle herbs, like chamomile and mint, and many of the western “tonic” herbs traditionally consumed as teas, such as nettles and green oats. Many of the herbs commonly used in cooking, have specific indications for the treatment of health conditions. For example, dill reduces gaseousness and colic in children, parsley has mild diuretic action (reduces excess fluid in the body), and ginger may reduce nausea.(2)
A few other herbs, termed “heroics”, have a history of adverse effects well-known to traditional herbalists and have been used specifically because of their toxic properties. (3) An example may be the use of bloodroot for treating skin cancers as popularized by Frederick Mohs, M.D.(4) Most commonly used herbal products have both biological action and a low incidence of adverse effects and side effects.
Legislation is pending currently in Congress that would institute an adverse drug reaction tracking mechanism for herbal products similar to that used to monitor prescription drugs. This systematic approach should permit a better risk-benefit assessment of specific herbal products.
How do I choose herbal products of good quality?
Consumers and health professionals are concerned about variable quality control. They need to know that the product contains the components shown on the label in the listed amounts, and nothing else. Well-publicized cases of contamination of herbal products frequently surface in the news. Herbal products may pose a risk from contamination with pesticides, heavy metals (cadmium, mercury), pharmaceuticals, and micro-organisms.(5) In addition, products containing a misidentified, look-alike herb with toxic propertie, have caused many of the serious adverse reactions related to herbal products.(3)
The Food and Drug Administration (FDA) and private organizations are addressing some of the problems associated with herbal products. The FDA published Good Manufacturing Practices (GMP) in 2003.(6) More recent FDA initiatives include a rating system for the evaluation of scientific evidence and a guideline for presenting this evidence to the FDA.(7,8)
Private organizations have taken on the task of certifying manufacturers that are following good manufacturing practices. These organizations are also developing standards for herbal product quality that will prompt manufacturers to test their products for species identification, constituent composition, and contamination by heavy metals, micro-organisms, and extraneous substances.(9) Further, NSF/ANSI (American National Standard for Dietary Supplements) standards require that each unit of herbal product can be traced with a batch number corresponding to the afore-mentioned quality testing.
Currently, four organizations conduct independent analysis of herbal products: ConsumerLab.com, National Nutritional...