Herbal Medicine and the FDA
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The main discussion revolved around a couple of very important issues, namely establishing the safety and efficacy of herbs, how to regulate herbal medicine, and whether herbs need to be classified as drugs. Devra Lee Davis, who is the senior advisor to the assistant secretary of health, emphasized that the government would like to forge ahead with a scientific agenda to establish the credibility of herbal medicine. She pointed out that cancer therapy has not changed much in the last 30 years and that herbal medicine contains great promise for that and other diseases.
Many of the discussions that followed pointed out that herbs are useful for treating many diseases but they are also dangerous if improperly used or if there is no quality control employed in their manufacture.
Current U.S. regulations require the proper documentation of research to show the vailidity of effect and the safety of the product. If one wishes to label an herbal product as being effective to treat a medical condition it would fall into the category of a drug and would have to show valid research. The FDA explained that according to the new Dietary Supplement Bill that passed Congress in 1994, herbs are in the Category of "dietary supplements" and can be marketed freely as long as there is no medicinal claim made on the label. If there is a claim then it is illegal to market the product unless it has been approved as either an Over the Counter or Prescription drug. The FDA urged people to do responsible research and validate their claims. They also expressed the same desire as the herbal medicine industry to find new medicines that are safe and relatively free of side effects.
The main example of herbal medicine that was debated was garlic. Proponents of herbs argued that if garlic is useful to lower cholesterol then it would suddenly become a drug. The FDA countered by saying that was true, but only if the garlic was available in bottles with labels that claimed that it was effective for lowering the cholesterol. In the absence of claims on the label, the FDA indicated that they have no jurisdiction.
There will be a presidential commission to research the subject and hopefully this was the beginning of establishing a meaningful dialogue.
Clearly the key to integrating herbs into the healthcare system of American will be research done using the double blind randomized trials. In the absence of research, health claims will not be able to be made. For Chinese herbs that come in bottles, the label will not be allowed to include indications.
The FDA assured the acupuncture community that they do not regulate medical practitioners and they have no problem with acupuncturists giving herbs to their patients, however, they stated that they would urge caution in using all herbal medicines from China as they feel there is no quality control and some products contain drugs or toxic ingredients that have been shown to be dangerous or even fatal.
For the next two years, Chinese herbs will be classified as "Dietary Supplements" and will be regulated as such.
Acupuncture.com |