Gras
Background
Generally recognized as safe (GRAS) status is a label used by the US Food and Drug Administration (FDA).
If a substance has GRAS status, this means that the substance is considered safe when added to foods in expected amounts. If a manufacturer wants to add a substance to a food, they must apply for approval from the FDA unless that substance is already on the GRAS list. The FDA grants GRAS status after reviewing the evidence for safety.
GRAS status does not indicate whether or not a substance is safe when used in larger amounts than what is generally expected, or when used as a supplement. It also does not indicate whether a substance is safe when applied topically or inhaled.
If a substance has GRAS status, this means that the substance is considered safe when added to foods in expected amounts. If a manufacturer wants to add a substance to a food, they must apply for approval from the FDA unless that substance is already on the GRAS list. The FDA grants GRAS status after reviewing the evidence for safety.
GRAS status does not indicate whether or not a substance is safe when used in larger amounts than what is generally expected, or when used as a supplement. It also does not indicate whether a substance is safe when applied topically or inhaled.
Safety Safety definitions
GRAS status indicates that a substance is generally safe when it is added to foods in expected amounts, typically as a flavoring or for coloring. It does not indicate whether or not a substance is safe when added to foods in larger amounts or when used as a supplement. It also does not indicate whether a substance is safe when applied topically or inhaled. Some people might be allergic to substances that are considered GRAS.
See specific topics for safety information.
See specific topics for safety information.
Effectiveness
Effective Effectiveness definitions
GRAS status is granted to many different food additives that are considered to be safe. The effectiveness of these substances is not considered as part of GRAS status. See specific topics for more information.
Interactions with pharmaceuticals
GRAS status is granted to many different substances. See specific topics for interaction information.
Interactions with herbs & supplements
GRAS status is granted to many different substances. See specific topics for interaction information.
Interactions with foods
GRAS status is granted to many different substances. See specific topics for interaction information.
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This monograph was last reviewed on 16/01/2024 11:00:00 and last updated on 04/05/2015 23:10:14. Monographs are reviewed and/or updated multiple times per month and at least once per year.
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Natural Medicines rates safety based on scientific evidence according to the following scale: Likely Safe, Possibly Safe, Possibly Unsafe, Likely Unsafe, Unsafe, and Insufficient Evidence to Rate. For more information about Natural Medicines’ Safety Rating System, click here.
The Natural Medicines Effectiveness Ratings are assigned for specific indications. A product might be rated "Possibly Effective" for one condition, but be rated "Likely Ineffective" for another condition, depending on the evidence. For more info click here.
