One of the conditions which a drug must fulfill if it is not to be considered a new drug, and thus not subject to the pre-market approval requirements of the Federal Food, Drug, and Cosmetic Act. To be generally recognized as effective, the drug must be so considered by ”experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs” and have been “used to a material extent or for a material time.” FDA determines that a drug is GRAE, subject to judicial reversal if its determination is arbitrary or capricious. The Supreme Court has held that for a drug to be generally recognized as effective, its sponsor must supply the FDA with the same kind of evidence consisting of adequate and well-controlled investigations by qualified experts that the law requires in order to secure approval of a new drug application.