Complemental Information:

The New England Journal of Medicine
Volume 347:2046-2056 December 19, 2002 Number 25

Herbal medicine is an increasingly common form of alternative therapy in the United States. A 1997 survey estimated that 12.1 percent of adults in the United States had used an herbal medicine in the previous 12 months (as compared with 2.5 percent in 1990), resulting in out-of-pocket payments of $5.1 billion.1 Among those who had used herbal medicine, 15.1 percent had seen an alternative-medicine practitioner, with a total of 10.5 million office visits, 19.8 percent of which had been completely or partially covered by insurance. In 2001, $17.8 billion was spent in the United States on dietary supplements, $4.2 billion of it for herbs and other botanical remedies.

Regulation

Most herbal products in the United States are considered dietary supplements and thus are not regulated as medicines and are not required to meet the standards for drugs specified in the Federal Food, Drug, and Cosmetic Act. The only requirement is that these preparations meet the standards set forth in the 1994 Dietary Supplement and Health Education Act (DSHEA). Herbal products may be produced without the assurance of compliance standards for Good Manufacturing Practice (although such standards are being developed), and they are marketed without prior approval of their efficacy and safety by the Food and Drug Administration (FDA).

According to the DSHEA, the manufacturer of an herbal preparation is responsible for the truthfulness of claims made on the label and must have evidence that the claims are supported, yet the DSHEA neither provides a standard for the evidence needed nor requires submission of the evidence to the FDA.

Under the DSHEA, the manufacturer is permitted to claim that the product affects the structure or function of the body, as long as there is no claim of effectiveness for the prevention or treatment of a specific disease, and provided there is a disclaimer informing the user that the FDA has not evaluated the agent. Some of the claims on the labels of herbal products suggest that they can be used to treat disease, and accompanying materials, produced by persons other than the manufacturer, that overtly promote such use may be available where the herbal remedies are sold. According to the DSHEA, the manufacturer is responsible for controlling quality and safety, but if a concern about safety arises, the burden of proof lies not with the manufacturer but with the FDA, which has to prove that the product is unsafe.

In the title: "Recent patterns of medication use in the ambulatory adult population of the United States" in JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION 287: (3) 337-344 JAN 16 2002, conclusions: Herbals/supplements were taken by 14% of the population. Among prescription drug users, 16% also took a herbal/supplement. In any given week, most US adults take at least 1 medication, and many take multiple agents. The substantial overlap between use of prescription medications and herbals/supplements raises concern about unintended interactions. Documentation of usage patterns can provide a basis for improving the safety of medication use.