What Are Good Manufacturing Practices (GMP), and Why Do They Matter?

You may have seen the phrases “GMP” or “cGMP” referenced on a supplement website or printed on a supplement bottle. But whether you’re aware of them or not, GMPs work behind the scenes to help keep consumers of dietary supplements safe.

Good Manufacturing Practices (GMP), or Current Good Manufacturing Practices (cGMP), are requirements enforced by the Food and Drug Administration (FDA) that ensure products are made safely and meet quality standards. For dietary supplements, specific GMPs govern everything from the manufacturing, packaging, labeling, and holding of supplements.¹ 

In 1938, the groundwork for food (and, eventually, supplement) regulation was laid with the Food, Drug & Cosmetics Act. In 1994, the Dietary Supplement Health and Education Act (or DSHEA) was passed, which laid the foundation for the establishment of specific supplement GMPs. Before this, supplements fell under food GMPs. DSHEA helped to ensure distinct processes for supplements were outlined. Specific dietary supplement GMPs were established in 2007—you may see these referenced as 21 CFR 111. While food GMPs do contain some sections applicable to supplements, dietary supplement GMPs are specifically outlined in 21 CFR 111.¹

In essence, GMP regulations help keep products safe. They create systems that reduce the risk of mistakes that could result in dangers to consumers, like product contamination. Dietary supplement facilities are required to establish written procedures and processes to ensure they follow GMPs, which address matters like: 

GMPs are enforced by the FDA. Any facility involved in the production of dietary supplements marketed in the United States must first register with the FDA—even if they technically exist outside the U.S, and all such facilities are subject to FDA audits. This includes facilities that may not directly manufacture products, but still have any role in processing, packing, or holding them. The FDA then enforces Good Manufacturing Practices to ensure products are made safely and meet quality standards. If the FDA finds an issue with a product or facility, they work with the manufacturer to ensure requirements are met or, if needed, remove the product(s) from the market.²

Good Manufacturing Practices are important for consumers of supplements because their requirements ensure the products you purchase are continually produced to meet quality standards in a controlled environment. They help ensure supplements are safe and trustworthy by supporting high standards of purity, strength, identification, and accurately manufactured—giving you confidence in the supplements you choose to take.