2025 年 6 月 11 日，美国食品药品管理局 (FDA) 发布了两段教学视频和一份补充情况说明书，旨在加深膳食补充剂行业对FDA新膳食成分申报 (NDIN) 审查流程的认识和理解。这些教学材料目的是帮助膳食补充剂制造商和分销商正确准备并向 FDA 提交完整的 NDIN。
根据《联邦食品、药品和化妆品法》第 413 条规定，生产商和经销商若希望销售某些新膳食成分，必须通过 NDIN 流程向 FDA 提交上市前安全申报。该流程是 FDA 在膳食补充剂新膳食成分上市前评估其安全性和特性的唯一机会。提交结构清晰、具有科学依据的NDIN，有助于FDA高效、及时地完成审查。
第一个视频名为“NDIN 流程的重要方面”，其配套情况说明书概述了 FDA 在 NDIN 提交流程中发现的几个常见问题，这些问题可能会导致不必要的延误或 FDA 的否定回应。第二个视频名为“FDA与申报方之间的通信”，解释了制造商在向 FDA 提交 NDIN 后需要注意的事项，包括 FDA 与申报方之间在 NDIN 流程中应进行的通信。
这些材料旨在帮助简化申报流程，使制造商和分销商能够向 FDA 提交更完整的 NDIN，并促进 FDA 的科学审评。如有任何关于FDA NDIN 流程的问题，请通过电子邮件 NDITeam@fda.hhs.gov 与膳食补充剂项目办公室联系。
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原文件附后：
FDA Releases Educational Materials on the New Dietary Ingredient Notification Process for Dietary Supplements
June 11, 2025
Today, the U.S. Food and Drug Administration (FDA) has released two educational videos and a supplemental fact sheet to broaden the dietary supplement industry’s awareness and understanding of the agency’s New Dietary Ingredient Notification (NDIN) review process. These educational materials are intended to help manufacturers and distributors of dietary supplements correctly prepare and submit complete NDINs to the FDA.
Section 413 of the Federal Food, Drug, and Cosmetic Act requires that manufacturers and distributors who wish to market certain new dietary ingredients submit a premarket safety notification to the FDA through the NDIN process. This process represents the agency’s only opportunity to evaluate the safety and identity of a new dietary ingredient in dietary supplements before it becomes available to consumers. Having a well-organized and scientifically supported NDIN facilitates an efficient and timely FDA review.
The first video, titled “Important Aspects of the NDIN Process,” and the fact sheet outline several common issues the FDA has observed in the NDIN submission process that could result in unnecessary delays or a negative response from the agency. The second video, titled “Correspondence Between FDA and the Notifier” explains what manufacturers can expect after an NDIN has been submitted to the agency, including the correspondence expected between the FDA and the notifier during the NDIN process.
These materials are intended to help simplify the process for manufacturers and distributors, resulting in more complete NDINs submitted to the FDA and facilitating the agency’s scientific review. For additional questions regarding the agency’s NDIN process, please contact the Office of Dietary Supplement Programs by email at NDITeam@fda.hhs.gov.
Additional Information:
· How to Submit Notifications for a New Dietary Ingredient
· New Dietary Ingredients in Dietary Supplements - Background for Industry
信息来源：美国FDA驻华办公室
