For much of human existence, herbal remedies and other similar treatments were the only medications available. Today, the Food and Drug Administration, or FDA, is charged with oversight of dietary supplements, a category in which herbal remedies are included. The FDA's role in regulating the dietary supplement industry is much different than the agency's role in approving medications and drugs, however, and anyone considering using herbal remedies should be aware of the risks of taking them.
Herbal Remedy
Under the 1994 Dietary Supplement Health and Education Act, manufacturers can make and market dietary supplements, such as herbal remedies, without having to get such products approved by the Food and Drug Administration. This means that the FDA plays no role in ensuring that herbal remedies are safe prior to their introduction to the marketplace. It is up to the individual manufacturers to ensure the product is safe.
Health Claims
Similarly to not approving the product, the FDA does not have to approve or review health claims that dietary supplement manufacturers make when selling an herbal remedy. The herbal remedy, however, must include a disclaimer whenever it makes a claim that the nutrient it contains affects the function or structure of the human body. The disclaimer must warn consumers that any health claims made have not been evaluated by the FDA and are not intended to "diagnose, treat, cure or prevent any disease," as only FDA-approved drugs can make this claim.
FDA's Safety Role
The FDA's role in dietary supplements is primarily one of investigation and observation, though it can take other actions if it finds that an herbal remedy is unsafe. The FDA can, for example, warn a manufacturer that its product advertising violates the law, and demand that the manufacturer change it or risk having the FDA remove the product from the market. If the FDA finds that a product is unsafe, it can also recall the product.
Caution
As untested and unproven products, it's important for consumers to be very cautious when considering using any herbal remedy or dietary supplement in treating a health condition. Melanie Johns Cupp, Pharm. D., writing for the "American Academy of Family Physicians," reports that herbal remedies pose risks for people using them, especially if they are already taking a prescription medication. These products can contain impurities and have significant differences in ingredient levels between batches. You should always tell your physician that you're taking an herbal remedy, or consult a healthcare expert if you're considering taking one.
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