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:
“The inhabitants of St. John’s and vicinity are described by an English traveler as “singularly unprepossessing,” and before completing his period he adds, “besides, they are generally very much disaffected to the British crown.” I suspect that that “besides” should have been a “because.””
—Henry David Thoreau (1817–1862)
“What is called politics is comparatively something so superficial and inhuman, that practically I have never fairly recognized that it concerns me at all.”
—Henry David Thoreau (1817–1862)
“Separation anxiety is normal part of development, but individual reactions are partly explained by experience, that is, by how frequently children have been left in the care of others.... A mother who is never apart from her young child may be saying to him or her subliminally: “You are only safe when I’m with you.””
—Cathy Rindner Tempelsman (20th century)
“A nation fights well in proportion to the amount of men and materials it has. And the other equation is that the individual soldier in that army is a more effective soldier the poorer his standard of living has been in the past.”
—Norman Mailer (b. 1923)