What is the Origin of Supplement Regulation?

The specific regulatory framework for supplements originated with the passage of DSHEA in the U.S. Congress, following a period of intense debate regarding the appropriate oversight of these products. This legislation established that supplements are regulated as a category of food, not as drugs, placing the burden of proving a product is unsafe on the FDA after it enters the market. This historical context explains the differences in quality control compared to pharmaceutical agents.

What is the Mechanism of Supplement Regulation?

Under DSHEA, manufacturers are responsible for ensuring their products are safe and that claims made on the label are truthful and not misleading. They must follow Current Good Manufacturing Practices (cGMPs) to ensure identity, purity, quality, and composition. Unlike drugs, supplements do not require pre-market approval from the FDA, meaning the regulatory mechanism is one of post-market surveillance and enforcement, which can result in significant variability in product potency and purity.

Supplement Regulation

Meaning

Supplement regulation refers to the legal framework and enforcement policies governing the manufacturing, labeling, marketing, and safety of dietary supplements, which include vitamins, minerals, herbs, and other botanical and amino acid products. In the United States, this framework is primarily established by the Dietary Supplement Health and Education Act (DSHEA) of 1994, which treats supplements differently from prescription drugs. Understanding these regulations is essential for consumers and practitioners in the hormonal wellness space to assess product quality and safety.