Dietary Supplement

A dietary supplement is a legal category created by Congress in the Dietary Supplement Health and Education Act of 1994 (DSHEA). It covers products intended to be swallowed that contain a "dietary ingredient," such as vitamins, minerals, herbs and botanicals, amino acids, and similar substances. Pills, gummies, powders, and drinks can all qualify, and the label must identify the product as a supplement.

The key fact for consumers is how lightly supplements are regulated compared with drugs. According to the FDA, under DSHEA the agency does not have the authority to approve dietary supplements before they are marketed, and a company generally does not have to give FDA its evidence of safety. The manufacturer is responsible for making sure the product is safe and the label is truthful, and FDA acts mostly after problems appear.

That gap is why supplements are a steady source of lawsuits. Common claims include:

• Products that contain less of an ingredient than the label says, or ingredients not listed at all.
• "Clinically proven" or health claims without real support.
• Contamination with heavy metals or hidden prescription drug ingredients, a recurring problem with sexual enhancement and weight loss products.

Most supplement cases are consumer class actions seeking refunds, so individual payouts tend to be modest. Cases involving hidden drug ingredients can also involve injury claims. See our pages on supplement mislabeling, male enhancement supplements, and prenatal vitamins.