FDA Implementing Nationalized Entry Review Program - Important Changes Effective August 4, 2025 (FDA 实施国家入境审查计划 - 重要变更将于 2025 年 8 月 4 日生效)

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Dear Filers, Brokers, and Importers,   

The Food and Drug Administration's Office of Inspections and Investigations (OII) Office of Import Operations (OIO) is implementing important changes to our import entry review process that will impact the way you engage with FDA import operations.   

Effective, August 4, 2025, OIO will implement the Nationalized Entry Review (NER) program to address the increasing volume of imported FDA-regulated commodities driven by e-commerce growth, expanded trade volume, and supply chain complexities.   

What's Changing   

The NER program revolutionizes FDA's import operations by implementing a standardized, efficient, and technology-driven approach to entry reviews across all ports of entry. We are transitioning from our current geographic location model to a national-based review system that will:   

• Conduct entry admissibility reviews on a national basis versus the current port-by-port entry review approach 
• Utilize staff across multiple time zones for expanded coverage 
• Explore automation opportunities to streamline processes 
• Optimize resource allocation to focus on higher-risk products   

What is NOT Changing   

•  Review Processes and Standards: Our established entry review procedures, quality standards, and regulatory requirements remain unchanged  
•  Review Criteria: The methods and standards we use to evaluate entries will continue as before  
•  Public Health Protection: Our commitment to identifying and addressing risks in imported products remains our top priority 
• All other processes and requirements remain the same. As this is an internal operational enhancement, the NER program modernization requires only one change for industry: Modifying how you contact FDA regarding status of shipments under entry review that have not already gone to the Field for assigned work using the NERInquiry@fda.hhs.gov email address.  Contact Information (Effective August 4, 2025) 

CRITICAL:  New communication protocols have been established effective August 4, 2025,  

Entry Status Inquiries 

1. Initial review status (pending review, documents requested, etc.): NERInquiry@fda.hhs.gov
2. Field review status (pending exam/sampling, detained, refused, etc.): Contact the appropriate division at FDA Import Offices and Ports of Entry

General Import Questions 

1. General import operation questions: imports@fda.hhs.gov or 301-796-0356 
2. Prior notice for food products: notice@fda.hhs.gov or 866-521-2297
3. ITACS issues: ITACSSupport@fda.hhs.gov
4. NER program questions: NERInquiry@fda.hhs.gov
5. For all other inquiries, see Contact the FDA Program

Email Guidelines for NER Inquiries 

When contacting NERInquiry@fda.hhs.gov: 

• Use this mailbox only for checking status of entries under initial review or providing entry documents.
• Email only one FDA mailbox at a time (sending out to multiple boxes may delay your response)  
• Use proper subject line formatting:

Subject Line Format Example 

1. Entry number (one entry number per email)
2. Space
3. Commodity type: 
4. Animal Foods, Animal Drugs, Animal Devices, Biologics, Cosmetics, Dietary Supplements, Food Related Products, Human Drugs, Human Foods, Infant Formula, Medical Devices, Medicated Feed, Rad Health Products, Tobacco, Multiple
5. Space
6. Port code

Examples of properly formatted subject lines: 

• 000-1234567-8 Food 2704
• 987-7654321-0 Multiple 4601

Remember 

• Check ITACS for real-time entry status before contacting the NER Team.
• Always provide accurate information.
• Use ITACS whenever possible for faster processing.

Thank you for your cooperation as we implement this enhanced program to better protect public health. 

FDA NER Team

Office of Inspections and Investigations

Office of Import Operations

NERInquiry@fda.hhs.gov 

For detailed procedures regarding urgent shipments and additional contact protocols, please refer to the FDA National Entry Review (NER) Trade Communications Guide [Separate document].

An unofficial translation of this announcement is provided below.

#翻译参考#

尊敬的报关员、报关行和进口商：

美国食品药品管理局 (FDA) 检查与调查办公室 (OII) 进口运营办公室 (OIO) 正在对进口入境审查流程进行重大变更，这将影响您与 FDA 进口业务的互动方式。

自 2025 年 8 月 4 日起，OIO 将实施国家入境审查 (NER) 计划，以应对受电子商务增长、贸易量扩大和供应链复杂性推动的 FDA 监管进口商品数量的增长。

变更内容

 NER 计划通过在所有入境口岸实施标准化、高效且技术驱动的报关审查方法，彻底改变了 FDA 的进口业务。我们正在从目前的地理位置模式过渡到全国范围的审查系统，该系统将：

• 在全国范围内进行入境许可审查，而非目前的逐港入境审查方式
• 利用跨时区的员工扩大覆盖范围
• 探索自动化机会以简化流程
• 优化资源配置，专注于高风险产品

不变之处

• 审查流程和标准：我们既定的入境审查程序、质量标准和监管要求保持不变
• 审查标准：我们用于评估入境产品的方法和标准将与以往相同
• 保护公众健康：我们始终致力于识别和解决进口产品的风险，这仍然是我们的首要任务
• 所有其他流程和要求保持不变。由于这是一项内部运营改进，NER 项目的现代化只需要对行业进行一项更改：调整您通过 NERInquiry@fda.hhs.gov 电子邮件地址联系 FDA 的方式，了解尚未送往现场进行指定工作的入境审查货物状态的方式。联系信息（自2025年8月4日起生效）

重要提示：新的沟通协议已于2025年8月4日起生效。

 入境状态查询

1. 初步审查状态（待审查、所需文件等）：NERInquiry@fda.hhs.gov
2. 现场审查状态（待检查/抽样、扣留、拒绝等）：联系FDA进口办公室和入境口岸。

一般进口问题

1. 一般进口操作问题：imports@fda.hhs.gov 或 301-796-0356
2. 食品产品预先通知：notice@fda.hhs.gov 或 866-521-2297
3. ITACS 问题：ITACSSupport@fda.hhs.gov
4. NER 计划问题：NERInquiry@fda.hhs.gov
5. 所有其他如有疑问，请参阅 Contact the FDA Program

NER 咨询电子邮件指南

联系 NERInquiry@fda.hhs.gov 时：

• 此邮箱仅用于查询初步审查中的入境状态或提供入境文件。
• 一次只向一个FDA邮箱发送电子邮件（发送到多个邮箱可能会延迟您的回复）
• 使用正确的主题格式：

主题格式示例

1. 条目编号（每封电子邮件一个条目编号）
2. 空格
3. 商品类型：
4. 动物食品、动物药品、动物器械、生物制品、化妆品、膳食补充剂、食品相关产品、人类药品、人类食品、婴儿配方奶粉、医疗器械、药用饲料、辐射保健产品、烟草、多种
5. 空格
6. 港口代码

正确格式的主题示例： 

• 000-1234567-8 食品 2704
• 987-7654321-0 多种 4601

切记

• 在联系NER团队之前，请查看ITACS以获取实时条目状态。
• 始终提供准确的信息。
• 尽可能使用ITACS以加快处理速度。

感谢您在我们实施这项增强计划期间给予的合作，以更好地保护公众健康。

FDA 国家入境审查 (NER) 团队

检查和调查办公室

进口运营办公室

NERInquiry@fda.hhs.gov

 有关紧急装运的详细流程和其他联系方式，请参阅 FDA 国家入境审查 (NER) 贸易沟通指南 [另附文件]。

Sincerely,

Sarah McMullen

Country Director

FDA China Office

Office of Global Operations