Generally recognized as safe and effective (abbreviated as GRASE, GRAS/E, or GRAS/GRAE) is designation for certain old drugs that do not require prior approval from the U.S. Food and Drug Administration in order to enter the United States marketplace because they are generally recognized as safe and effective by medical professionals. It is important to emphasize that "safe and effective" is always conditional on following the directions. For example, aspirin can be lethal when taken in large amounts but is approved to be GRAS/E by FDA for over-the-counter use as directed.