On April 3, 2024, according to the U.S. Federal Register, the U.S. Food and Drug Administration (FDA) issued Notice 2024-07095, proposing to develop guidelines for pre-market notification documentation requirements for dietary supplements.

The guidance stipulates that manufacturers or importers of dietary supplements containing new ingredients should provide FDA with documentation including the characteristics of the new ingredient, production process, safety assessment data, etc., before the product is marketed, and provide guidance for relevant companies to prepare documentation.

The notice will be published in the Federal Register on April 4, 2024, and there will be a 60-day comment period.