Recent Experience with Botanical Ingredients Submitted to FDA in New Dietary Ingredient Notifications

Prior to marketing, US law mandates submission of a pre-market safety notification for dietary supplement products which contain new dietary ingredients, those without prior history of use in food. While dietary ingredients include several categories such as vitamins and minerals, most new dietary ingredient notifications address ingredients derived from botanical source material. FDA has 75-days to review these notifications before the product(s) containing the ingredients can be marketed. FDA regulations require inclusion of information such as the history of use or other evidence of safety establishing that the ingredient, when used under the conditions of use recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe. After 90 days, FDA sends the response letter and the notification (except for trade secret and other confidential information) to be posted on the public docket. Recent experience with NDI notifications will be discussed, particularly with respect to those containing ingredients derived from botanicals.