TheraLife warning letter

Executive Summary

FDA says claims for TheraLife's Wrist, Fatigue, Neck and Back & Leg products classify them as unapproved new drugs and are misleading. The products make drug claims such as, "Treats painful and chronic conditions often experienced by computer keyboard and mouse users," according to FDA. On its Web site, the firm also says it adheres to all FDA regulatory guidelines and provides a link to FDA's 30-day structure/function claims. FDA says the company is not in compliance and is misleading by linking to FDA's site. TheraLife has 15 days to correct the violations, the agency says...