Questions and answers about FDA

  • FDA Import of Non-Regulated Medical Devices

    Question: Hello Members: My supply chain wishes to import Non-Regulated Medical Devices for the purpose of consolidating these Non-Regulated goods with other goods and than export so as to save on transportation cost.  I don’t think I can claim TIB (9813) for the import does not qualify.   I can’t use FDA Import For Export (IFE) […]

  • Manifest Hold Agriculture & FDA Memphis

    Question: Dear Members: Does anyone know what triggers a “Manifest Hold Agriculture”?  Broker could not explain why and submitted entry docs to CBP. Also, I am seeing a good amount of FDA Holds in the Memphis area when importing under headings 3002, 3822 and 9027. At a previous company we import headings 3002, 3822 and […]

  • Pharma Good Distribution Practices

    Question: Hello ICPA members.  My company is downsizing and consolidating roles.  My trade compliance function will be brought under supply chain and logistics.  It will be expanded to handle some OGA regulatory matters that are more supply chain than regulatory filings etc.  The role will involve leading the Good Distribution Practice efforts at our mfg […]


    Question: Hello ICPA Community. I’m preparing to take on a role focusing on FDA Import for Exports.  Can you please recommend some resources that will help me become acquainted with the nuances of IFE?  I’m currently reading as  much as I can on the FDA site, but I’m looking for some of your tribal knowledge. […]

  • FDA Export Certs

    Question: Hello Membership!   We are brainstorming ideas to improve our export process and documentation requirements.  Do all countries require a certificate of resale from the US to import?  Is there a centralized resource available which identifies which states will issue a certificate of free sale for export and the validity of the certificate?  How do […]

  • FDA Refusal

    Question: Two weeks we had a shipment that was held by FDA.  We presented the goods to FDA and they seized the article in question.  Now, this week we received notice of FDA action stating the entry of the good from 2 weeks ago, was refused and we need to present it for destruction.   We […]

  • FDA Holds

    Question: Dear Members:  I joined a new company and have been noticing that at times there are FDA holds or awaiting disposition for our perishable shipments (medical device).  I have noticed that a product number was held for say 2 weeks.  When I checked the same product number on previous entries, that same product number […]

  • Supplements

    Question: Company is looking to import various supplements for general health, skin care. What FDA requirements are there for these? Any other requirements. Think “natural” supplements for digestive health, etc.. Answer 1: FDA regulates both finished dietary supplement products and dietary ingredients. Good wbpages to visit are: https://www.fda.gov/food/dietary-supplements https://www.fda.gov/food/information-consumers-using-dietary-supplements/questions-and-answers-dietary-supplements https://www.fda.gov/consumers/consumer-updates/fda-101-dietary-supplements What is FDA’s role in […]

  • Chemical and biological compounds

    Question: Can you please let me know if FDA is required for chemical and biological compounds for research? These materials are for very early research and development. At that point these are toxins. These organic compounds or biological materials are for research that are not part of a clinical trial and that have not been […]

  • Relationship between ACE and ITACS

    Question: For FDA regulated imports, what is the relationship between ACE and ITACS.  Do you use them in conjunction with each other to better manage compliance for FDA regulated product?  Is ITACS supplementary/complimentary to ACE or do these both need to be managed? Answer 1: ACE is used to transmit the entry data to FDA […]

  • AM7 PGA Flag

    Question: Can anyone provide me with guidance as to how the “AM7 – USDA/Agriculture Marketing Service data related to organics may be required” would apply to things like furniture, bathroom towels/bath mats, and rugs?  I’m having a hard time understanding whether I should claim or disclaim this flag. Answer 1: It sounds like your classifications […]

  • AQ1 Flag

    Question: We are about to import diagnostic reagents (3822).  These reagents get flagged for FD1 which is no disclaimed and proceed with entities role & AOC information.  However, when I get flagged AQ1 and I have a Statement (Guideline 1121) saying products do not require an import permit.  Because of statement can I disclaim AQ1? […]