Dietary Supplement Health and Education Act

Because herbs cannot be sold and promoted in the United States as drugs, they are regulated as nutritional or dietary substances. Nutritional or dietary substances are terms used by the federal government to identify substances not regulated as drugs by the FDA but that are purported to be effective for use to promote health. Herbs, as well as vitamins and minerals, are classified as dietary or nutritional supplements. Because natural products cannot be patented in the United States, it is not profitable for drug manufacturers to spend the millions of dollars and the 8 to 12 years to study and develop these products as drugs. In 1994, the US government passed the Dietary Supplement Health and Education Act (DSHEA). This act defines substances such as herbs, vitamins, minerals, amino acids, and other natural substances as “dietary supplements.” The act permits general health claims such as “improves memory” or “promotes regularity” as long as the label also has a disclaimer stating that the supplements are not approved by the FDA and are not intended to diagnose, treat, cure, or prevent any disease. The claims must be truthful and not misleading and be supported by scientific evidence. Some have abused the law by making exaggerated claims, but the FDA has the power to enforce the law, which it has done, and these claims have decreased.