FDA

Question: Does the FDA allow for a self-disclosure, similar to the way CBP does?  Can anyone point me to the FDA regs where it is detailed if in fact it is allowed? Answer 1: You want to be careful here and talk to you company’s legal counsel about this.  You did not indicate if this […]

Question: We are looking to import novelty sunglasses and glasses that are part of costumes.  They will not offer any type of protection from the sun. Are we able to disclaim FDA on these items?  If so, do we have to place a warning label on the packaging?  I saw the following in some publications […]

Question: For imported adult products (massagers) that contain lubricant, is FDA required?  If so, does it depend on the size of the lubricant pack/bottle that is sold with the product? Answer 1: FDA would definitely be required regardless of lubricant for the massager item. The question about the lubricant is whether its inclusion triggers an […]

Question: Question about FDA data governance between trade compliance and regulatory. In your company (or experience with other companies), does your regulatory group define and provide Affirmation of Compliance codes and related FDA data to the trade compliance group or is your trade compliance group expected to tell regulatory what data elements are required (to […]

Question: TRUE OR FALSE: A factory does not have to register with the FDA if it produces only a ‘component’ for the finished good and the importer does not have to report the component as an FDA item. The added issue is if the component is cleared as the finished good, which definitely is regulated […]

QUESTION: Is it possible to update FDA information that has been accepted and not in reject status within the US Customs Entry without cancelling/deleting the entry and resubmitting another entry? The scenario is information is entered for the entry, the shipment crosses the border.  Once the shipment is in the US, the shipment is verified.  […]

QUESTION: Is FDA required for imports of stainless steel water bottles, HTS code 7323.93.0080?  This is a new commodity for us, and I was previously advised that anything that holds food or drink is subject to FDA.  If so, can anyone share the FDA product code? ========== Answers: Here is the link to the FDA […]

QUESTION: Does anyone in the membership have a training they can share for FDA requirements for Customs? I’m looking to put together a training in the next week to cover import requirements for Customs when they are flagged for FDA. =========== Answer: FDA can hold a shipment for many reasons. Usually, they are checking for invoice […]

QUESTION: We operate in MX under Maquiladora License (IMMEX). I have FDA subject products made in MX – Catheters for Intravascular, Diagnostic. The catheters were sold to a customer in India and are not being returned to the customer under RGA (Return Goods Authorization). The Shipper/Exporter in India does not have an FDA registration. Can […]

QUESTION: One of our employees in Mexico is shipping his laptop computer to our facility in the United States.  The HTS,  8471.30.0100, is flagging as FD1.  Can the FDA be disclaimed or do we need to submit form 2877 and determine a product code? Where can this information be found? ========== Answers: Flag Meaning Examples […]

QUESTION: Our company imports medical devices. Since we import all, we are the IOR. I do not understand whether we are also considered the initial importer under FDA. We occasionally repackage items to send to domestic customers. We are FDA registered for various devices as specification developer or complaint file established. Are we considered to […]

QUESTION: What is the best practice when submitting the Affirmation of Compliance code? Is having the AofC code for each commodity onto the commercial invoice sufficient for the import clearance review? =========== Answer: No, that is the wrong place to submit the data.  To be fair, you can them on your docs if you like, […]