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Law Educator, Esq.
Law Educator, Esq., Attorney
Category: Business Law
Satisfied Customers: 111647
Experience:  All corporate law, including non-profits and charitable fraternal organizations.
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I have an air shipment stuck in Atlanta airport by FDA

Customer Question

i have an air shipment stuck in Atlanta airport by FDA visual inspection. Product is dietary supplement, all natural herbal extract and the country of origin is South Korea. This is my first shipment and was advise by custom's broker first shipment takes longer to clear Customs and FDA. Shipment arrived in Atlanta June 20. 23 days now. Everytime my customs broker calls FDA in Atlanta all we hear is sorry we are backed up and will get to your shipment tomorrow for sure. I understand FDA is a government agency but this is not fair holding my shipment without any explanation indefinitely. What is my right and what can i do instead of waiting for FDA forever. to make bad things worse they charge me $80 daily storage fee, which has been accrued at $1,600 now. Looking for someone who is experienced with FDA import process
Submitted: 4 months ago.
Category: Business Law
Expert:  Law Educator, Esq. replied 4 months ago.
Thank you for your question. I look forward to working with you to provide you the information you are seeking for educational purposes only.
This is something that happens frequently when the importer does not seek FDA approval ahead of hipping in the product. I am afraid that legally there is nothing that you can do in speeding up the FDA and I actually just had one where the customer was waiting 45 days for approval and despite calls and letters to them, the FDA refused to speed up the process. The only way to have reduced this cost would have been to apply for FDA approval before bringing it into the US.
Customer: replied 4 months ago.
do you know how to get the FDA approval ahead? I have more shipments with new SKU coming in about 2 months. I want to do my homework ahead. FDA just inspected my pallet last Friday, 7/15. They took a sample and told my freight forwarder they would do a sample analysis. Please tell me what kind of analysis they are going to do? Are they going to review supplement panel to be sure the panel on the product complies or are they going to actual product ingredient analysis?
Expert:  Law Educator, Esq. replied 4 months ago.
Thank you for your reply.
You must submit the compound information to the FDA and get them to issue an approval letter to you.
The FDA is going to do a chemical test on the sample to determine what it is to make sure that it is what you claim it to be.
Customer: replied 4 months ago.
what kind of compound information do FDA need? is there a certain FDA form I need to use? I have COA ( certificate of analysis ). How long will chemical analysis take?
Expert:  Law Educator, Esq. replied 4 months ago.
Thank you for your reply.
They will compare the COA to their own analysis of the chemicals. Typically it does not take them more than 10-14 days, it depends on how busy their lab is at the time it comes in.
Customer: replied 4 months ago.
I figured they would do so. now for future product pre-approval you said I need to submit compound information for FDA to issue an approval letter. could you be more specific what type of information do I need to submit pls?
Expert:  Law Educator, Esq. replied 4 months ago.
Thank you for your reply.
If the shipment you are bringing in is an approved substance you apply for approval of that substance to FDA and most times they will issue an approval letter to Customs for when the product arrives. The FDA does not test every shipment into the US and if they have a certified test and Certification before arrival in the US the process is a bit faster.
Customer: replied 4 months ago.
how can I apply for approval? what documents do I need to submit? is this process document review only or do I need to submit samples as well?
Expert:  Law Educator, Esq. replied 4 months ago.
Thank you for your reply.
You will have to send a request for approval with proof of your testing of the item, you should not have to send samples unless they request it from you.
Customer: replied 4 months ago.
Where do I need to send a request for approval? Do you have FDA approval Department contact information?
Expert:  Law Educator, Esq. replied 4 months ago.
Thank you for your reply.
You would send a request to the FDA at the port of entry where you will be bringing in the product (http://www.fda.gov/ForIndustry/ImportProgram/ucm319216.htm) and supply them the information and the dates that the product should arrive. They will then determine whether they will send someone out to take a sample of the shipment or whether they will release it when it arrives.