FDA Draft Guidance for Industry New Dietary Ingredient Notifications and Related Issues
标准简介
Draft Guidance for Industry New Dietary Ingredient Notifications and Related Issues[附网盘链接]是于过去发布的FDA标准，适用于US。标准截图
![Draft Guidance for Industry New Dietary Ingredient Notifications and Related Issues[附网盘链接]](/img/202109141037260go8x.jpg)
标准文档说明
标准文档类型为Draft Guidance for Industry New Dietary Ingredient Notifications and Related Issues[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Draft-Not for Implementation Dietary Supplements: New Dietary Ingredient Notifications and Related 1
Issues: Guidance for Industry This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance. I. Introduction Under section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350b(a)(2)), the manufacturer or distributor of a new dietary ingredient (NDI) that has not been present in the food supply as an article used for food, or a dietary supplement containing such an NDI, must submit a premarket safety notification to FDA at least 75 days before introducing the product into interstate commerce. This guidance is intended to help manufacturers and distributors of dietary ingredients and dietary supplements (“you”) decide whether to submit a premarket safety notification to FDA (“we” or “us”) for a product that is or contains an NDI. These premarket safety notifications are commonly referred to as NDI notifications. The guidance is also intended to help you to prepare NDI notifications that we will be able to review more efficiently and respond to more quickly. The guidance answers frequently asked questions about NDI notifications and related issues. The major topics it addresses are: • What qualifies as an NDI; • When an NDI notification is required; • What are the procedures for submitting an NDI notification; 1
This guidance has been prepared by the Office of Dietary Supplement Programs in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.
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