Generally recognized as safe and effective
Encyclopedia
Generally recognized as safe and effective (abbreviated as GRASE, GRAS/E, or GRAS/GRAE) is a legal term used to describe 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.
This term comes from the Federal Food, Drug, and Cosmetic Act
which 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."
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
marketplace because they are generally recognized as safe and effective by medical professionals.
This term comes from the Federal Food, Drug, and Cosmetic Act
Federal Food, Drug, and Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act , is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from...
which 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
Aspirin
Aspirin , also known as acetylsalicylic acid , is a salicylate drug, often used as an analgesic to relieve minor aches and pains, as an antipyretic to reduce fever, and as an anti-inflammatory medication. It was discovered by Arthur Eichengrun, a chemist with the German company Bayer...
can be lethal when taken in large amounts but is approved to be GRAS/E by FDA for over-the-counter
Over-the-counter drug
Over-the-counter drugs are medicines that may be sold directly to a consumer without a prescription from a healthcare professional, as compared to prescription drugs, which may be sold only to consumers possessing a valid prescription...
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."
See also
- U.S. Food and Drug Administration
- Generally recognized as safeGenerally recognized as safeGenerally recognized as safe is an American Food and Drug Administration designation that a chemical or substance added to food is considered safe by experts, and so is exempted from the usual Federal Food, Drug, and Cosmetic Act food additive tolerance requirements.-History:On January 1, 1958,...
- Grandfather clauseGrandfather clauseGrandfather clause is a legal term used to describe a situation in which an old rule continues to apply to some existing situations, while a new rule will apply to all future situations. It is often used as a verb: to grandfather means to grant such an exemption...
- List of drug interactions