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FDA warns that N-Methyltyramine is a new dietary ingredients subject to notification requirement


May 16, 2024

On March 1st, the Food and Drug Administration (FDA) has updated the directory of ingredients and other substances found in products labeled as dietary supplements, with the inclusion of a new ingredient N-Methyltyramine. The FDA issued a warning letter saying that N-Methyltyramine is considered a new dietary ingredient as there is no information demonstrating that it was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is there information demonstrating that this ingredient has been present in the food supply as an article used for human food in a form in which the food has not been chemically altered. As such, N-Methyltyramine is subject to the notification requirement.

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