As you peruse the shelves of your favorite pharmacy or health food store, you will find a group of products that closely resemble drugs but are not drugs. They contain one or a combination of vitamins, minerals, herbs or other botanicals, and amino acids intended to supplement the diet.
Many individuals worldwide report that they are using such dietary supplements (DS) as St. John’s wort, echinacea, or black cohosh, as well as vitamins. The reasons why they use DS in addition to or instead of drugs are varied, but many consider them to be cheaper, more effective (they “restore health naturally, not with artificial chemicals”), and safer (which is not necessarily true).
The Dietary Supplement Health and Education Act (DSHEA), enacted in the United States in 1994, established the ground rules for DS, including how they differ from drugs and how the Food and Drug Administration views them. Drug products can claim to diagnose, cure, treat, or prevent disease. By contrast, the FDA considers DS to be foods that can claim to improve health by reducing the risk of disease. DS can also describe how the product benefits the organs or systems of the body (a “structure/function” claim) but cannot refer to a specific disease. It permits the claim that “calcium builds strong bones” but not that it can “prevent or treat osteoporosis.”
Drugs must be proven to be safe and effective before the FDA grants them approval to be marketed. Manufacturers of DS are not required to submit such evidence or obtain approval to market their products. Unlike drugs, DS are not required to be standardized to avoid batch-to-batch variability and ensure reliability.
SOME WORK, SOME DON'T. Some DS have been found to be safe and effective, while others have not. Many more have never been adequately evaluated. The onus is on the FDA to remove unsafe products—a process that can take years, as was the case with ephedra.
SEE ALSO Herbs (c. 60,000 BCE), Pure Food and Drug Act (1906), Food and Drug Administration (1906), Kefauver-Harris Amendment (1962), Ephedra/Ephedrine (1994), Direct-to-Consumer Ads (1997).
Herbs are integral components of dietary supplements. Here, an herbal health market displays medicinal plant leaves.