The FDA requires manufacturers or distributors of dietary ingredients introduced after October 15, 1994, to submit an NDIN at least 75 days prior to marketing the product. This submission must include comprehensive details regarding the ingredient’s identity, manufacturing process, and safety evidence, ensuring that the ingredient can be considered safe for consumer use. This NDI application for dried kratom leaf powder from Johnson Foods was submitted by the company, and responded to by the FDA.
Original Notification:
https://kri.org/wp-content/uploads/2024/10/NDI-1264-Original-Notification.pdf
Response:
https://kri.org/wp-content/uploads/2024/10/NDI-1264-FDA-Response.pdf
