'Because of a glitch in the law, the U.S. Food and Drug Administration (FDA) never safety-tested fluoride for ingestion. Yet, the FDA recently OK'd cavity-preventing claims on fluoridated bottled water labels, giving Americans a false sense of security about the safety and effectiveness of drinking bottled water with fluoride added.
Sodium fluoride was sold before FDA safety and effectiveness testing laws were enacted in 1938 and 1962, respectively. So fluoride was exempt from scrutiny, or "grandfathered in," without any FDA human or animal studies. "The premise was that all pre-1938 drugs were considered safe," according to FDA correspondence.'