Advancing alternative methods to reduce animal testing

Animal studies have been essential to advancing understanding of diseases and development of therapies and are critical to evaluate the potential for toxicity, safety, and, at times, effectiveness, of consumer products (e.g., medical products, foods, tobacco products, and cosmetics). Although animal toxicity studies have proven essential for identifying potential human risks, finding ways to reduce the use of animals and develop effective alternatives is an important effort. Advances in biology, engineering, and artificial intelligence have created new opportunities to improve our ability to assess safety, quality, and effectiveness of many consumer products. However, multiple steps are required to translate these new technologies into regulatory use and maintain the same standards of safety, quality, and effectiveness. We discuss the approach being taken by one major regulatory body, the US Food and Drug Administration (FDA), to advance new methods into regulatory use.