Post-market Determinations that the Use of a Substance is Not GRAS
Under the Federal Food, Drug, and Cosmetic (FD&C) Act, any substance used or intended for use in food must be authorized by FDA for use as a food additive unless the use of that substance is generally recognized as safe (GRAS) by qualified experts or meets a listed exception to the food additive definition in the Act (sections 201(s) and 409 of the FD&C Act; 21 U.S.C. 321(s) and 348). The use or intended use of a food additive that does not conform with an authorizing regulation (or effective food contact notification, if applicable) is an unapproved food additive and is deemed to be unsafe. Food that is or bears or contains a food additive that is unsafe is adulterated (section 402(a)(2)(C) of the FD&C Act; 21 U.S.C. 342(a)(2)(C)).
As part of its on-going compliance activities, FDA identifies foods that contain a substance for which there is no authorization as a food additive and then reviews the regulatory status of this substance. FDA scientists analyze whether there is a basis to conclude that the intended use of the substance is GRAS or meets a listed exception to the food additive definition. When FDA scientists determine that a substance is an unapproved food additive because it is not GRAS for its intended use (and does not meet a listed exception), they may document their findings in a memo.
These memos, as well as links to FDA actions associated with these substances and other communications, are available in the inventory linked below. These memos are specific to whether the use of a substance in food is an unapproved food additive. The use of such a substance may result in other violations of the FD&C Act. These other violations of the FD&C Act may be referenced in the links to activities related to that substance but are not addressed in these memos. This inventory is not a complete list of substances for which the intended use in food is not GRAS and may not include all actions the agency has taken with respect to unapproved food additives or a particular substance. This may not include memos related to ongoing investigations.
The inventory of these determinations provides the following information:
- Name of the substance
- Selection of known synonyms
- Chemical Abstracts Service (CAS) Registry Number®, if applicable
The substance name also serves as a hyperlink to the following additional information:
- Links to memos documenting FDA’s determination that the use or intended use of the substance in food does not meet the statutory criteria for GRAS and is therefore an unapproved food additive
- Links to warning letters, enforcement actions, and other communications related to the substance
Recently Posted Memos
The following is a list of recently posted memos documenting FDA’s determination that the use of a substance in food does not meet the statutory criteria for GRAS. The memo inventory database is linked above.
| CAS Registry Number® | Substance | Memo |
|---|---|---|
| — | Amanita muscaria | Scientific Memorandum: Amanita muscaria (9/9/2024) |
| 63-05-8 | 4-androstenedione | Scientific Memorandum: Androstenedione (3/1/2022) |
| 1420-49-1 | Arimistane | Scientific Memorandum: Arimistane (3/15/2021) |
| — | Betel nut (Areca catechu) | |
| — | Caffeinated alcoholic beverages (CABs) | Scientific Memorandum: CABs (10/28/2010) |
| 13956-29-1 | Cannabidiol (CBD) | |
| 5957-75-5 | Delta-8-tetrahydrocannabinol (THC) | |
| 105-41-9 | 1,3-dimethylamylamine (1,3-DMAA) | Scientific Memorandum: 1,3-DMAA (3/18/2015) |
| — | Ginkgo biloba | Scientific Memorandum: Ginkgo biloba (5/24/2012) |
| — | Kava | Scientific Memorandum: Kava (8/11/2020) |
| — | Live microorganisms intended for use in food for pre-term infants | |
| 73-31-4 | Melatonin | |
| 62936-56-5 | Picamilon | |
| — | Tara flour | Scientific Memorandum: Tara flour (4/10/2024) |
| 72797-41-2 | Tianeptine |