FDA Import/Export License

[lucky2008]

I'm in need of a FDA Import/Export License.

Can anyone recommend a good lawyer that can help me with the paperwork? 
 

[blackcab]

What do you need the license for? Is this for a one off import that has been stopped by customs, or do you intend importing or exporting on a commercial basis?

 

The FDA do not issue import or export licenses as such. The FDA grants registration to the company that applies, and it approves products on a one by one basis.

 

The registration requirements differ depending on whether you wish to register food or drink, medicines, cosmetics, etc. and whether you will be manufacturing the product yourself or not.

 

It would help if you would be able to clarify the product category (such as either food, alcohol, medicines, medical devices, etc.) and whether you manufacture the product yourself.

[lucky2008]

1 hour ago, blackcab said:

What do you need the license for? Is this for a one off import that has been stopped by customs, or do you intend importing or exporting on a commercial basis?

 

The FDA do not issue import or export licenses as such. The FDA grants registration to the company that applies, and it approves products on a one by one basis.

 

The registration requirements differ depending on whether you wish to register food or drink, medicines, cosmetics, etc. and whether you will be manufacturing the product yourself or not.

 

It would help if you would be able to clarify the product category (such as either food, alcohol, medicines, medical devices, etc.) and whether you manufacture the product yourself.

Nothing has been stopped.  This is only for planning purposes. 

We will be importing dry herbs and spices repacking and selling them on a commercial basis.  

We will not be exporting at this time. 
 

[blackcab]

So first steps, before you engage a lawyer or other specialist consultant is that you will need to decide your business structure. In this situation, most people opt for a limited company.

 

This is because you will need to apply for paperless customs approval, and normally you will be VAT registered.

 

Also, in terms of the FDA, the license and product approvals will be issued in a specific name. That is normally done in a company name as the company will endure whereas individuals do not. FDA registrations in individual names can get very messy to be honest.

 

Remember that to import, the FDA license will need to match the name of the importer.

 

Next steps are that you will need a physical premises that will need to be food safe, as you will be handling food items for repackaging. You will also need a satisfactory storage area for raw and finished products.

 

You will need your premises before you apply for each product approval.

 

Moving on, each product, in each size, needs FDA approval, which requires a separate submission, analysis, etc.

 

So dried sage 50 gram needs a separate submission and approval to dried sage 100 gram.

 

Also, the packaging for each product, in each size, needs approval as part of each product approval.

 

I'm aware that none of this directly answers the question in your OP, however I'm letting you know these details as it's a lot cheaper than a lawyer running through the same details.

 

So, first steps would be company formation, VAT registration (if required), obtain appropriate premises, apply for FDA license, undergo inspection, obtain license.

 

Once this has been done, you then need to make an FDA submission for each item/size and gain approval to produce and package each item/size.

 

Once you have completed this you will have a product number that can be placed on the packaging for each item.

 

Next you need to register for paperless customs.

 

At this point you can correctly import, repackage, and sell on your approved items.

 

It's an expensive do.

[lucky2008]

Thank you so much this really helps.
 

I do have some follow up questions if you don't mind? 

1. My Thai wife will be the sole proprietor of the business. Will this structure be sufficient? 
2. Can the physical premises be in a residential home, rented condo, or temperature controlled storage facility? 
4. What are the costs in relation to FDA product submission and licensing?