Herbal Information

Although Americans have ready access to herbal remedies, few are officially used as medicines. In 1994, to protect consumer access to these remedies from FDA regulatory zeal, Congress adopted legislation classifying them as dietary supplements, provided they only claim to affect the body’s structure and function.

However, if an herbal product claims it can treat or cure an ailment, it is now a drug, and, hence, subjected to the arduous, expensive, FDA drug regulatory process. Because herbs cannot be patented, no financial incentives exist for profit-making companies to seek such a drug designation. Under this regulatory approach, semantics become important. For example, if an herbal product claims to cure UTI’s instead of just promoting urinary tract health, it becomes a drug.