Herbs And Cancer (2)

As a result of this Act, most herbal products are now sold in a food category designated "dietary supplements." The legislative intent of DSHEA was to guarantee availability of herbal products, to allow scientific information, that is truthful and appropriately qualified, to be used in conjunction with the sale of these products, as well as to give consumers some information about the products' benefits, and to provide appropriate cautions about their use. The Act also places the burden of proof that an herb product is adulterated or unsafe on the government. The result is, as Kessler (2000) points out, that, for the most part, dietary supplements need not undergo rigorous FDA review for safety or effectiveness before they are marketed.

What Should be Done? Kessler, in his June 8, 2000 editorial, suggests that the debate could move in any one of several directions.

• First, proponents of herbals and their use might argue that other substances that the patients in Belgium used were the probable cause of the kidney disease and cancer and not necessarily the herbal compound. Given the limitations of the Belgium study, this is certainly a plausible argument.

• Second, opponents of herbal products and dietary supplements might use this opportunity to advocate a ban on all herbs and supplements.

• Third, those like Kessler argue that Congress should require that more testing of herbals and dietary supplements be conducted before they are allowed on the market. This would probably entail more company-sponsored premarket testing and more rigorous FDA regulation and oversight.

• Finally, those like Dr. Varro Tyler, a retired dean of the School of Pharmacy at Purdue University and author of many books on herbs and their use, consider premarket company-sponsored testing to be unrealistic. The reasons are simple: such testing costs the companies too much. Rather, Dr. Tyler suggests that the FDA convene an expert committee, perhaps similar to the German E Commission. (Click on our page, A Guide to Popular Herbs, to read more about the German E Commission's work.) He argues that experts already know a great deal about the safety and effectiveness of herbal products. This information should be reviewed and compiled; then, information about unsafe herbal products should be given to both consumers and manufacturers. Dr. Tyler seems to believe that after this information is provided to a company that markets herbals and dietary supplements, it would not market unsafe products because of the potential for legal action.

Who is Right? One thing is certain: The debate over the use and regulation of herbals and supplements is only beginning. The Institute for the Future (Palo Alto, CA, 1999) has predicted that by 2005 "new consumers" -- people who are actively involved in making choices about the health care that they receive (or purchase for others) -- will become a majority. And, as individuals become disenchanted with mainstream medicine and the practice of medicine, the use of herbals and dietary supplements may increase. Individuals may decide that they are able to get better results using herbal products.

Should Congress require more premarket company-sponsored testing? Should we rely on an expert commission to review the existing evidence and tell consumers what is safe and effective? Are there other alternatives? These are important open questions.