Regulatory Standards

Dietary supplements are regulated by the FDA differently than prescription or over-the-counter drugs. Supplements do not require pre-market approval demonstrating safety and effectiveness the way drugs do. Instead, manufacturers are responsible for ensuring their products are safe before they reach the market, and the FDA generally acts after a product is already for sale if problems are identified.

The Dietary Supplement Health and Education Act (DSHEA) of 1994 established the modern framework for how supplements are categorized and regulated in the U.S. Under DSHEA, supplements are treated as a category of food rather than drugs, which shapes both labeling requirements and the type of claims manufacturers are permitted to make.

The Federal Trade Commission oversees advertising claims, including those made about supplements and wellness products. Advertising is generally expected to be truthful, not misleading, and backed by adequate substantiation. Claims that a product can diagnose, treat, cure or prevent a specific disease are treated with particular scrutiny.

Transparent ingredient disclosure helps consumers understand exactly what they are purchasing. Reputable manufacturers list active and inactive ingredients clearly, disclose sourcing where relevant, and avoid vague "proprietary blend" listings that obscure individual ingredient amounts.

Supplement labels include a "Supplement Facts" panel listing serving size, ingredients and amounts per serving. Understanding how to read this panel — alongside required disclaimers about FDA evaluation — helps consumers make more informed comparisons between products.

Before trying a new supplement or wellness product, it's reasonable to research the manufacturer, look for third-party testing where available, and discuss significant changes with a healthcare provider — particularly if you take medication or manage an existing health condition.