Generally Recognized As Safe and Effective

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 effective, safe, recognized and/or generally:

    I know no method to secure the repeal of bad or obnoxious laws so effective as their stringent execution.
    Ulysses S. Grant (1822–1885)

    Although a firm swat could bring a recalcitrant child swiftly into line, the changes were usually external, lasting only as long as the swatter remained in view....Permanent transformation had to be internal....The habits of self discipline, as laborious and frustrating as they were to achieve, offered the only real possibility of keeping children safe from their own excesses as well as the omnipresent dangers of society.
    Mary Kay Blakely (20th century)

    It is very difficult to be wholly joyous or wholly sad on this earth. The comic, when it is human, soon takes upon itself a face of pain; and some of our griefs ... have their source in weaknesses which must be recognized with smiling compassion as the common inheritance of us all.
    Joseph Conrad (1857–1924)

    Shame is a fitter and generally a more effectual punishment for a child than beating.
    Samuel Richardson (1689–1761)