According to the DSHEA, a dietary supplement is a product that
• is intended to supplement the diet;
• contains one or more dietary ingredients (including vitamins, minerals, herbs or other botanicals, amino acids, and other substances) or their constituents;
• is intended to be taken by mouth as a pill, capsule, tablet, or liquid;
• is not represented as a conventional food or as a food replacement;
• is labeled on the container’s front panel as being a dietary supplement;
• includes products such as an approved new drug, certified antibiotic, or licensed biologic that was marketed as a dietary supplement or food before approval, certification, or license (unless waived by the secretary of the Department of Health and Human Services).
The DSHEA presumes that ingredients introduced prior to October 15, 1994, are safe. A new dietary ingredient, on the other hand, is an ingredient not sold in the United States in a dietary supplement prior to that date or one that is part of a dietary supplement introduced on or after October 15, 1994. At least 75 days before marketing a dietary supplement containing a new dietary ingredient, manufacturers must provide the FDA with their basis for deeming the ingredient “reasonably expected to be safe.”
If they meet the criteria above, botanicals may be considered dietary supplements. A botanical is a plant, or part of a plant, that is used for one or more of its specific characteristics, including medicinal properties, flavor, and scent; herbs are a subset of this group, usually the green, leafy portion of the plant. Botanicals are identified by Latin names designating the genus and species of the plant. Many botanicals, however, have numerous common names or are identified only by their genus. For example, the commonly known dietary supplement black cohosh (Cimicifuga racemosa) is also known as baneberry, black snakeroot, bugwort, cohosh bugbane, rich weed, rattle root, solvlys, and squaw root, to name a few. Botanicals can be sold in many forms, including fresh or dried, as liquid or solid extracts, in tablets and capsules, as loose powders, and in tea bags.
The intended use of a consumable product is essentially what determines its classification—and therefore its regulation—as a food, drug, or dietary supplement. Drugs are created to treat, cure, or somehow mitigate a disease or condition. A dietary supplement cannot claim to have these effects; if such a claim is made by the manufacturer of a dietary supplement, the substance must then be regulated as a drug. However, a manufacturer can claim a supplement is “used for” anything at all, even though it may have no effect.