FDA发布新膳食成分通报最终指南：明确膳食补充剂新成分申报应提交的身份与安全资料
美国食品药品监督管理局（FDA）宣布发布最终指南《新膳食成分通报及相关问题：新膳食成分的身份与安全信息》，该指南于 10 月 20 日通过《联邦公报》通知对外公布。指南汇总了企业在提交新膳食成分通报（NDIN）时最常遇到的问题，并就通报中应包含的身份信息与安全信息给出 FDA 的建议。
按美国《膳食补充剂健康与教育法》（DSHEA）的框架，含有「新膳食成分」的膳食补充剂在上市前，生产商或经销商须向 FDA 提交通报，说明该成分的身份以及支持其安全性的依据；FDA 并不像对药品那样对膳食补充剂作上市前批准。此次最终指南针对的正是这一通报环节，说明企业应如何描述成分的身份特征、生产工艺与规格，以及应提交何种安全性资料。
FDA 表示，这份指南解答了行业长期以来就通报要求提出的常见问题，目的是让企业在准备申报材料时更有可预期性。膳食补充剂在美国市场规模庞大、产品数量众多，新成分通报是这一事前监管环节的核心文件。
该指南属于 FDA 针对膳食补充剂领域的一系列监管文件之一。按 FDA 的惯例，最终指南代表该机构当前对相关问题的看法，企业可自愿采用指南建议的方法，或使用能满足适用法律要求的替代方法。
FDA Issues Final Guidance on New Dietary Ingredient Notifications: Clarifying the Identity and Safety Information Supplement Filings Should Include
The U.S. Food and Drug Administration (FDA) has announced the availability of a final guidance, "New Dietary Ingredient (NDI) Notifications and Related Issues: Identity and Safety Information About the NDI," in a Federal Register notice dated October 20, 2026. The guidance addresses frequently asked questions about NDI notifications and sets out the agency's recommendations on the identity and safety information that should be included in a notification.
Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), a manufacturer or distributor must notify the FDA before marketing a dietary supplement containing a new dietary ingredient, identifying the ingredient and providing the basis for concluding it is reasonably expected to be safe; unlike drugs, dietary supplements are not approved by the FDA before marketing. The final guidance focuses on that notification step, covering how firms should describe an ingredient's identity, manufacturing and specifications, and what safety information should accompany the filing.
The FDA said the guidance is intended to give industry a clearer, more predictable framework for preparing notifications, in a market with tens of thousands of supplement products where the NDI notification is the central premarket filing.
As with other FDA guidance documents, the final guidance represents the agency's current thinking on the topic. Firms may use the approach described in the guidance or an alternative approach, provided the alternative satisfies the requirements of the applicable statutes and regulations.
发布：GSM·美国（发布链接）
图片来源：各类维生素与膳食补充剂片剂（资料图）。照片：Raysonho 摄，CC0，经维基共享资源。 / File photo: assorted vitamin and dietary supplement tablets. Photo by Raysonho, CC0, via Wikimedia Commons.
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