2026年 7 月 20 日，美国食品药品管理局（FDA）提醒相关企业，仅应在法律法规要求的情况下办理食品企业设施注册（FFR），并妥善保护食品企业设施注册（FFR）信息，防止其被不当使用。
一、FDA已注意到与食品企业设施注册要求及 FFR 信息潜在滥用有关的一系列问题，包括：
1.越来越多的企业在实际上无需注册的情况下，仍向FDA 办理食品企业设施注册。
2.第三方企业或所谓的“注册代理（registrars）”要求企业提供FFR 编号、PIN 码、FIS-FURLS 用户名和/或 FIS-FURLS 密码，以核实注册状态。
3.TikTok Shop及其他第三方销售平台要求食品企业在产品上架过程中提供 FDA 食品企业设施注册副本或所谓的注册证书。
二、上述情况可能给企业和FDA 带来以下问题：
1.安全风险：如果企业本身无需取得FFR 编号，却进行了注册，并将相关信息分享给第三方平台，就会增加不法分子利用这些注册信息实施欺诈的风险。当企业向这些机构提供 FFR 编号和 PIN 码（或用户名和密码）后，这些机构可能会将企业的 FFR 与其自己的 FIS-FURLS 账户关联。一旦完成关联，对方即可查看、修改，甚至注销企业的 FFR。要核实您的 FFR 状态，请始终通过 FDA 官方网站进行查询。
2.监管混淆：对于依法豁免或本无需注册的企业设施，如果进行了注册，可能会导致接受不必要的检查，或引发企业履行合规义务方面的混淆。
3.占用FDA 监管资源：不必要的注册会分散 FDA 的监管资源，使其无法集中监管那些依法必须注册、尤其是存在较高食品安全风险的设施。
三、如果您的企业已在FDA 完成注册，务必采取措施保护企业的 FFR 信息。以下是一些建议：
1.切勿向任何人共享您的FIS-FURLS 用户名和密码。 任何 FIS-FURLS 账户均属于创建该账户的个人，不应与他人共享。如需其他人员协助管理注册或其他提交事项，账户持有人可根据需要为相关人员创建子账户。
2.请记住，FDA并不要求您向第三方提供 FFR 编号。FFR 信息并非公开信息。不过，对于进口食品，企业可能需要将FFR编号提供给负责向FDA提交进口食品预先通报（Prior Notice）的下游商业实体（参见《联邦法规汇编》第 21 篇第 1 部分 I子部分）。需要注意的是，FEI（FDA企业 设施识别号）是另一种独立且唯一的公开标识符，可通过FEI搜索门户网站.进行查询。
3.如果您已经错误地向他人披露了FFR 编号和/或 PIN 码，请考虑注销现有 FFR，并重新为您的设施办理注册。
请切记，并非所有食品企业都必须向FDA 注册。首先应确认贵公司是否属于必须注册的企业设施，这是实现合规的第一步。根据规定，凡从事食品制造/加工、包装或储存的食品企业设施，除依法豁免外，均应进行注册（21 CFR 1.225；21 CFR 1.226）。私人住宅不属于食品企业设施（21 CFR 1.227）。如需判断您的企业是否适用豁免，可参阅FDA行业指南：食品企业设施注册相关问答（第七版） Section II.B（第二部分 B 节）。
有关链接：
1.食品企业设施注册 相关信息
fda.gov/food/registration-food-facilities-and-other-submissions/online-registration-food-facilities?utm_medium=email&utm_source=govdelivery
2.食品企业设施注册要求（21 CFR Part 1, Subpart H）
https://unblock.federalregister.gov/
3.关于注册豁免的信息：21 CFR 1.226和FDA行业指南：食品企业设施注册相关问答（第七版）第二部分 B 节
https://unblock.federalregister.gov/
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-food-facility-registration-seventh-edition?utm_medium=email&utm_source=govdelivery
4.如您怀疑自己的注册号遭到滥用或存在欺诈性使用，请向 FDA 报告.。
https://www.fda.gov/safety/report-problem-fda?utm_medium=email&utm_source=govdelivery
FDA网站原文：
FDA Advises Human and Animal Food Facilities to Protect their Food Facility Registration Information
View on the FDA Website
July 20, 2026, the FDA is reminding businesses that it is important they register their food facilities with the FDA only when required and to protect theirFood Facility Registration (FFR) information from potential misuse.
The FDA has become aware of a number of issues regarding when registration is required and potential misuse of FFR, including:
·An uptick in businesses registering their facilities with the FDA when they are not required to.
·Third-party businesses or "registrars" requesting FFR number, PIN, FIS-FURLS username, and/or FIS-FURLS password to verify registration status.
·The TikTok Shop and other third-party seller platforms asking food companies to provide a copy of their FDA Food Facility Registration, or a certificate, as part of their product-listing process.
The above issues can create problems for both these businesses and for the FDA, including:
·Security Risks: Having an FFR number when you don't need one, and then sharing it with third-party platforms, creates opportunities for bad actors to misuse your registration information for fraudulent purposes. When you provide your FFR number and PIN (or username and password), these entities can link your FFR to their own FIS-FURLS accounts. Once linked, they can view, change, or even cancel your FFR. To check your FFR status always use the official FDA websitehere.
·Regulatory Confusion: Registering when exempt or otherwise not required to may subject your facility to unnecessary inspections or create confusion about your compliance obligations.
·Straining FDA Resources: Unnecessary registrations divert FDA resources away from monitoring facilities that are required to register, including those that pose increased food safety risks.
If you are registered with the FDA, it is critical to safeguard your business’ FFR information. Below are some steps you can take to keep your business’ information safe:
·Never share your FIS-FURLS username and password for any FDA registration system. Each FIS-FURLS account is designated for the individual who created it and should not be shared. If additional personnel are desired to help manage registrations or other submissions, an account holder may create subaccounts for those personnel as necessary.
·Remember that the FDA does not require you to share your FFR number with third parties. FFR information is not public. However, for imports, a facility may need to provide its FFR number to the downstream commercial entity submitting prior notice to FDA for an imported food (see 21 CFR part 1, subpart I). Note that the FEI (FDA Establishment Identification) number is a separate, unique public identifier that can be looked up via FEI Search Portal.
·Consider cancelling your FFR and re-registering your facility if you've already shared your number and/or PIN in error.
Remember not all food businesses are required to register with the FDA. Understanding whether your company must register is the first step in compliance. Food facilities that manufacture/process, pack, or hold food must register unless exempt (21 CFR 1.225; 21 CFR 1.226). Private residences are not considered facilities (21 CFR 1.227). See Section II.B of the FDA Guidance for Industry: Questions and Answers Regarding Food Facility Registration for assistance in determining if an exemption applies.
Additional Information
·Information on Food facility registration
·Food Facility Registration Requirements: 21 CFR Part 1, Subpart H
·Information on exemptions: 21 CFR 1.226 and Section II.B of the Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition)
·If you suspect misuse or fraudulent use of your registration number, report it to the FDA.
·END·
▌文章来源：中国出入境检验检疫协会
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