How Supplements Are Regulated

Dietary supplements are zealously regulated by multiple federal agencies in order to ensure products are safe and that product labels are truthful and accurate. Claims that dietary supplements are unregulated completely overlook the extensive regulatory framework that governs the industry, and ignore the industry’s lengthy record of safety and benefit to consumers.
In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA) which established the current framework for dietary supplement regulation. Under DSHEA, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) were given power to regulate virtually every aspect of the dietary supplement industry including manufacturing, labeling, and marketing.
Because dietary supplements are derived from such ingredients as vitamins, minerals, herbs, botanicals, and amino acids, they are regulated as a category of food. This distinction separates dietary supplements from medical drugs and pharmaceuticals which are comprised of unique chemical compounds and require heightened regulatory oversight, including pre-market approval. Under DSHEA, dietary supplement ingredients with a long history of safe use are “grandfathered in” and considered safe by the FDA.
If a dietary supplement manufacturer wants to introduce a new dietary supplement ingredient (NDI), it must provide the FDA with notice and safety information. DSHEA also gave the FDA and FTC additional powers to remove any products from the market that are deemed unsafe or mislabeled.
The regulatory structure set out in DSHEA gives federal agencies ample power to oversee the dietary supplement industry. It is in the best interest of dietary supplement manufacturers, retailers, and consumers that DSHEA is fully enforced. The industry supports the FDA and FTC in keeping bad actors out of the market so that consumers can continue to enjoy access to safe and affordable products as they have for the more than two decades since DSHEA was enacted.