Which regulatory agency oversees biotechnology products in the U.S.?

The Food and Drug Administration (FDA) is the primary regulatory agency in the U.S. responsible for overseeing biotechnology products. This includes ensuring that biotechnology products, such as genetically modified organisms (GMOs), pharmaceuticals, and food products derived from biotechnology, are safe for human consumption and the environment. The FDA evaluates the safety and effectiveness of these products before they can be marketed and utilized.

In the context of biotechnology, the FDA plays a crucial role in regulating the claims made by companies about their products, ensuring proper labeling, and monitoring any potential health risks associated with them. The agency conducts thorough evaluations of clinical trials and product applications to make informed decisions about the approval of biotechnology products.

While the Environmental Protection Agency (EPA) also regulates aspects related to biotechnology, particularly concerning environmental impact and safety measures, the FDA's focus on product safety for human use establishes it as the principal agency for biotechnology products. The Department of Agriculture (USDA) is involved primarily in agricultural biotechnology and animal safety, while the National Institutes of Health (NIH) supports biomedical research but does not directly regulate biotechnology products.