The Sept. 5 front-page story "Herbal Remedies Turn Deadly for Patients" illustrated one problem with "supplements," a term defined in the Dietary Supplement Health and Education Act of 1994 to mean virtually any substance found in nature.

Other problems include:

* Dangerous ingredients -- e.g. hepatotoxins in kava, renal toxins in "Chinese medicines."

* Combinations of ingredients -- e.g. ephedra and guarana (ephedrine and caffeine) -- known to be harmful when combined in over-the-counter drugs.

* Constructed drug products sold as supplements -- e.g., senna teas, ephedra or guarana, and kava.

Almost anyone can go into the supplement business. It requires no knowledge of chemistry, herbs, quality control or the actual contents of the materials being sold. Products can be reformulated daily; lists of ingredients can be withheld as "proprietary." "Sell now and ask later" is the theory that apparently rules.

Most of these products are not foods but drugs in disguise. No daily requirement exists for St. John's wort, kava, ephedra, guarana, etc. Most botanicals are complex mixtures of pharma-coactive compounds. The law allows these to be extracted, manipulated and enhanced in "dietary supplements" as long as no health claim is made about the product.

Quality control and ingredient analysis are illusory. Safety testing is not required. The Food and Drug Administration has been effectively removed from regulation.

Botanical "supplement" products are essentially street drugs. People have no idea what they are getting or what risks are associated with these products. The 1994 act is too broad and should be repealed or revised.



National Council Against Health Fraud

Peabody, Mass.


The story on herbal remedies implied that herbs can be dangerous, but the article focused on a company that secretly included pharmaceuticals and hormones, some already banned, in its "herbal" remedies.

Regulation of herbs wouldn't have helped here, and regulation of herbs could be devastating. Gaining Food and Drug Administration approval is expensive, and while a drugmaker can recoup the costs of the approval process for a proprietary substance, no one can expect to recover the expense of obtaining approval for a widely available, unpatentable herb.

We need to beware of unscrupulous vendors who break laws in creating products -- and we need to prosecute them to the full extent of the law. But for public-domain products, knowledge is the best guideline, and the Internet gives us a great tool to get this information disseminated. Let's keep the FDA out of the picture.