DEPARTMENT OF HEALTH AND HUMAN SERVICES
Many importers are starting to receive messages like the below in regards to the new Food and Drug Administration Re-registration. Information in the below email has been changed to protect identities, but will serve as a resource for our clients.
Example Letter from FDA includes:
- Receipt of this message is because one of your overseas suppliers has listed you as their registered US Agent for purposes of FDA
- If you have already had conversations with your overseas supplier(s) in regards to this (and agreed to be their US Agent), double check the information they entered and advise them if anything in inaccurate
- Note that this comes with potential financial burdens and responsibilities so we therefore recommend some form of agreement be in place between you and your foreign supplier(s)
- Also remember that as the US Agent, should there be a reason for financial burdens, they may not be for the product you import from said overseas supplier(s) i.e., they probably export to parties other than yourselves
- If you have already had conversations with your overseas supplier(s) in regards to this (and denied their request to be their US Agent), follow this link https://www.access.fda.gov/ and advise FDA you have not agreed to these responsibilities. You should also notify your overseas supplier(s) about your decision
DEPARTMENT OF HEALTH AND HUMAN SERVICES
The U.S. Food and Drug Administration (FDA) is hereby notifying you that FDA received a food facility registration listing you as the U.S. Agent for the foreign food facility identified below. The registration was submitted to FDA as required by section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d] and FDA’s food facility registration regulation at Title 21, Code of Federal Regulations (CFR) Part 1, Subpart H. Under section 415 of the FD&C Act and 21 CFR Part 1, Subpart H, a foreign food facility engaged in manufacturing/processing, packing, or holding of food for consumption in the United States must be registered with FDA and such registration must include, among other things, the name and contact information of the U.S. Agent for the facility.
|Food Facility Name:||Overseas Supplier|
|Food Facility Address:||1234 Exporter Way, Manufacturer, 1234 CHINA|
|Name of U.S. Agent:||John Smith|
|Title of U.S. Agent:||Importer 1|
|Street Address Line 1:||1234 Importer Way|
|Street Address Line 2:|
If you are the U.S. Agent for the foreign food facility listed above and the above information is correct, no action is necessary.
If you are the U.S. Agent for the foreign food facility listed above, but your contact information is incorrect, the owner, operator, or agent in charge of the facility must update this information within 60 calendar days of any change to the previously submitted contact information using Form FDA 3537. The owner, operator, or agent in charge may authorize an individual to update a facility’s registration. The authorized individual may be, but is not required to be, the U.S. agent for the facility. When using Form FDA 3537, the owner, operator, or agent in charge, or the individual authorized by one of them, must check the items being updated in Section 1 of the form. If the facility has an existing electronic account (established when the facility is registered electronically) that is linked to this registration, the registration may be updated electronically via https://www.access.fda.gov/.
Alternatively, the owner, operator, or agent in charge of the facility, or an individual authorized by one of them, may submit an update by mail or fax to:
U.S. Food and Drug Administration
5100 Paint Branch Parkway, HFS-681
College Park, MD 20993
If you are not the U.S. Agent for this facility, please click on the following link to notify us that you have not agreed to serve as the facility’s U.S. Agent: https://www.access.fda.gov/.
Once we receive your notification, we will inform the facility that you notified us that you have not agreed to serve as the U.S. Agent for the facility and request that the facility amend its registration to designate as its U.S. Agent a person who has affirmatively agreed to serve as the facility’s U.S. Agent.
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a foreign facility, FDA will assess and collect fees for reinspection-related costs from the U.S. agent for the facility.
You may contact the FDA Industry Systems Help Desk via telephone at 1-800-216-7331 or 301-575-0156 if you have any questions about this process.
FDA Unified Registration and Listing and Prior Notice System Helpdesk.