Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues
The Food and Drug Administration (FDA) released the “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues" prior to its publication in the Federal Register on July 5th 2011.
This guidance address following issues:
It also makes recommendations to industry for preparing better NDI notifications that the agency will be able to review more efficiently, which should result in quicker response times.
- To assist industry in deciding when a premarket safety notification for a dietary supplement containing a new dietary ingredient (NDI) is necessary and in preparing premarket safety notifications (also referred to as "NDI notifications").
- Addresses in question and answer format what qualifies as a NDI,
- When a NDI notification is necessary,
- Procedures for submitting a NDI notification,
- Types of data and information that FDA recommends manufacturers and distributors consider when they evaluate the safety of a dietary supplement containing a NDI, and
- What should be included in a NDI notification.
- Questions and answers about parts of the dietary supplement definition that can affect whether a particular substance may be marketed as a dietary ingredient in a dietary supplement.
The agency recommends that the data and information that are submitted should include:
- a full description of the identity and composition of the NDI and the dietary supplement in which it will be marketed,
- a discussion of the basis for the notifier's conclusion that the substance is a NDI,
- a description of the conditions of use recommended or suggested in the labeling of the dietary supplement, or, if no conditions of use are recommended or suggested in the labeling, the ordinary conditions of use of the supplement, and
- an explanation of how the history of use or other evidence of safety in the notification justifies the notifier's conclusion that the dietary supplement containing the NDI will reasonably be expected to be safe.
For more information on this guidance you can go to the following link:http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm257563.htm or contact mdi firstname.lastname@example.org REF: New Draft Guidance for NDI.