Generally recognized as safe and effective (abbreviated as GRASE, GRAS/E, or GRAS/GRAE) is 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.
The Federal Food, Drug, and Cosmetic Act defines a "new drug", which requires prior approval, as any drug "the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling." FDCA § 201(p)(1).
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.
FDA has acknowledged the possible existence of drugs that could be considered GRAS/E that they have not found to be GRAS/E yet. As FDA stated in its 2006 Guidance on Marketed Unapproved drugs: "A product would not be considered a new drug if it is generally recognized as safe and effective (GRAS/GRAE) and has been used to a material extent and for a material time… As mentioned above, the Agency believes it is not likely that any currently marketed prescription drug product is grandfathered or is otherwise not a new drug. However, the Agency recognizes that it is at least theoretically possible."
Famous quotes containing the words generally, recognized, safe and/or effective:
“American feminists have generally stressed the ways in which men and women should be equal and have therefore tried to put aside differences.... Social feminists [in Europe] ... believe that men and society at large should provide systematic support to women in recognition of their dual role as mothers and workers.”
—Sylvia Ann Hewitt (20th century)
“There are no new truths, but only truths that have not been recognized by those who have perceived them without noticing. A truth is something that everybody can be shown to know and to have known, as people say, all along.”
—Mary McCarthy (1912–1989)
“But, after the war was over, just think what came to pass—
A letter, sir; and the two were safe back in the old Bluegrass.
The lad had got across the border, riding Kentucky Belle;
And Kentuck she was thriving, and fat, and hearty, and well;
He cared for her, and kept her, nor touched her with whip or spur:
Ah! we’ve had many horses, but never a horse like her!”
—Constance Fenimore Woolson (1840–1894)
“An effective human being is a whole that is greater than the sum of its parts.”
—Ida P. Rolf (1896–1979)