New technologies have the potential to improve our lives, but they can also cause harm. One way to mitigate harm is through regulation that requires innovators to demonstrate the safety of their products before they can be sold, which is the approach taken by the U.S. Food and Drug Administration (FDA). Another strategy relies on the threat of litigation to deter harm. A decades？long debate considers these alternatives. Critics of regulation claim that it chills innovation and market competition by raising entry costs and that litigation is more efficient. Proponents counter that regulation fosters public confidence in products from lesser？known firms, encouraging entry and innovation. Clear evidence testing these claims is important given the $2.8 trillion market size of FDA？regulated products alone.