Rulemaking by Guidance? FDA's Process for NDIN Procedures and Timeframes: While some aspects are welcome, the agency continues to stray from its task of clarifying the applicable statutory and regulatory requirements.

The article focuses on the Food and Drug Administration's (FDA) final guidance on dietary supplements' New Dietary Ingredient Notification Procedures and Timeframes, raising concerns about potential shifts in FDA's interpretation. Topics include the statutory requirements for New Dietary Ingredient notifications, FDA's authority in the notification process, and ongoing challenges and uncertainties surrounding FDA's regulatory approach to dietary supplements.