Question: It appears on October 10, 2003, FDA issued an interim final rule to implement amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), which requires domestic and foreign facilities that manufacture, process, pack, or hold food […]
Question: What is the best way to import items that are being used for the sole purpose of testing? What information should we provide FDA at time of import? ************** Answers: A foreign-trade zone provides enormous flexibility, especially if you will destroy or re-export the material. **************** Depending on the country of export I would […]
Question: I would like to ask the membership how they handle imports that are marked as “import for export” and are subject to FDA. We traditionally have long clearance times on this type of import. Is there any type of paperwork we could provide ahead of time or at time of clearance? Or, are […]
Question: I would like to ask members who in your company keeps and files the FDA notices for hold , detention and exams regarding imports. Is this Customs compliance area or Regulatory Affairs Dept. who is responsible of keeping the records. ========== Answers: Customs compliance ========== We at Global Trade Compliance keep these notices as […]
Question: Are US produced goods returning to the US subject to FDA regulations (FDA accession number)? ANSWER: Yes… however there are some exceptions that are available. Personal goods Repair and export samples etc %%%%%%%%%%% Yes, absolutely. You need to make a declaration to FDA with US goods returned. FDA will be interested in why the […]
Question: I would like to see if anyone in the group can share, without any specifics, recent experiences or issues with FDA and importing cosmetics? For anyone importing cosmetics, are they experiencing an increase in FDA exams? Problems with meeting FDA labeling requirements? ———————————————————— ANSWERS: We are not experiencing an increase in FDA exams or […]
Question: My company generally does not import food products, but we have a senior leader wanting to ship a gift pack of tea to another senior leader in the US. If our sister company ships it to the US, and my company serves as IOR in the US, do we have to be concerned about […]
Question: Does anyone in the group have an educational document they could share that they have used to help explain FDA regulations covering importation of cosmetics? ========== Answers: I don’t have a document but I know you need the actual manufacturer name and address, a list of ingredients and a FDA product code. The product […]
Question: When bonded goods are entered into an FTZ for storage and are subject to OGA (FDA) is a declaration with FDA required? When the goods exit the FTZ but will not be entering into the commerce of the US (let’s say they are being shipped onto a cruise ship) and a VSTE is being […]
Question: I would like to ask the membership for those who have knowledge and or participating in an FTZ in which the imports are applicable to FDA. From my understanding, under an FTZ, one entry is completed per week. What happens if and/or when FDA places a hold on a particular item? Does the entry […]
Question: Can anyone advise of their current best practice under this scenario? Customers are requesting the FDA registration number for overseas food/drug manufacturing facilities. We believe that this information should be kept confidential inasmuch as there is no “public” list available from the FDA on the facility registration numbers. As we are the importer of […]
Question: My company is importing alcohol hand sanitizer under code 3824.90.9290 based on several binding rulings on CROSS. We are attempting to make entry for our first shipment. The HTS is flagging prior notice. I’ve provided the NDC and foreign facility identifier number for the manufacturer. FDA is requesting an 11 digit number for the […]
