Herbal products are classified as either dietary supplements or cosmetics — not medicines — and therefore are handled differently than drugs by the Food and Drug Administration (FDA).

In 1994, Congress passed the Dietary Supplements Health and Education Act (DSHEA), which expanded the definition of “dietary supplement” to include herbs and other botanicals (anything except tobacco) along with vitamins and minerals. The law requires that food products, cosmetics, and supplements be free of “adulteration” and prohibits them from being “misbranded.” Manufacturers are also required to use safe ingredients: Anything that was available before 1994 is considered safe, and anything that's been introduced since that time must pass a premarket evaluation by the FDA.

Of course, that's a far cry from the elaborate approval process that wouldbe drugs face, a fact that leaves some people questioning the inherent safety of herbal products. But herbs don't have it any better (or worse) than any other supplement or cosmetic. The government is surprisingly hands-off in its supervision of the popular (and potentially dangerous) products so many of us pop into our mouths or apply to our bodies every day.

Most Americans assume that the products they buy are being closely monitored — and the mere fact that they're being sold in stores (and not in shady alleyways or on suspicious websites) proves that they're both safe and effective. But both prescription and over-the-counter (OTC) drugs cause more than a million recorded poisonings — and more than 500 fatalities — every year. And cosmetics can cause problems, too. According to the Environmental Working Group, nearly 90 percent of the ingredients in personal care products have not been assessed for safety, and many products contain ingredients that that are known toxins, such as mercury and lead.

Herbal products, in contrast, are almost never involved in cases of serious toxicity or other ill effects. In fact, the vast majority of poisoning cases involving an herbal product involve accidental ingestion by a young child.

The regulations state that herbal products intended to supplement the diet and taken by mouth (such as pills, capsules, or liquids) are classified as dietary supplements. Products that are used externally for self-care or grooming are considered cosmetics.

The FDA can evaluate products and inspect manufacturing facilities at its discretion, but the agency can step in and try to stop the sale of a product (or take action against the company that's selling it) only after the product has been shown to be in violation of the law. Imported herbal products must comply with the same regulatory requirements and are subject to search and sampling by the U.S. Customs Service when they arrive in the country.