The Nutrition Labeling and Education Act (NLEA) was enacted by Congress in 1990 to provide a clear relationship of nutrition to disease. The purpose of the act was to educate consumers. Information required on the label includes nutritional information, in an easy-to-read format, with the amount of ingredient per serving, the percentage of daily values of the ingredients, and the standard serving size. The act also established that disease-related health claims could be used on labeling of nutritional products, provided there is agreement among qualified scientists that the claim is valid.

The Dietary Supplement Health and Education Act (DSHEA), passed in 1994, restricted the FDA’s control over dietary supplements. It defined herbal products as dietary supplements, which are considered foods. Before this, products had to be proven safe by the FDA; those introduced after the act’s passage had to be proven safe by the manufacturer. The manufacturer of a herbal preparation is responsible for the truthfulness of the claims made on a label and must have evidence supporting the claims; however, there is no standard for this evidence or does the manufacturer need to submit it to the FDA. The manufacturer may claim that the product affects the structure or function of the body as long as there is no claim of effectiveness in the prevention or treatment of a specific disease. A disclaimer must be provided stating that the FDA has not evaluated the product. Since health claims are not preapproved, the statement “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease” must be on the label. Information regarding therapeutic claims for herbal products can be disseminated as long as the information is not misleading or product specific, is physically separated from the product, and has no product stickers affixed to it.

In 2000, the FDA allowed “structure and function” statements to be made. For example, cranberry products could say that the product supports urinary health but not that it treats urinary tract infections. It allowed for claims that do not relate to disease but are health maintenance claims (“maintains a healthy circulatory system”), nondisease claims (“helps you relax”), and claims for minor symptoms associated with life stages (“for common symptoms of premenstrual syndrome”). Anything that uses words such as “prevents,” “treats,” “cures,” “mitigates,” or “diagnoses disease” is subject to drug requirements. This act led to enormous growth in the dietary supplement industry, which today grosses over $18 billion annually.