The GRAS system was established in 1958 as an exception to the FDA's regulation of food additives.
This allowed certain substances commonly added to foods without causing problems to be considered Generally Recognized As Safe (GRAS) and excluded from food additive regulation.
The first GRAS list was published in 1959, which included salt, garlic, spices, and so on.
Voluntary GRAS notification was introduced in 1997.
Companies can determine whether a new substance is GRAS themselves or request a safety evaluation from the FDA.
Therefore, many substances are introduced onto the market as GRAS without being evaluated by the FDA (either as GRAS or as a food additive).
This occurred with tara flour, which caused 113 hospitalizations in the USA in 2022.
For more information, see the attached file.