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Does a company importing dietary supplements need to be FDA registered?

regisration dietary supplement regulatory fda

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#1 jbell4711

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Posted 26 June 2020 - 01:01 AM

Hi,

 

My company is importing dietary supplements ready for retail from overseas. I know our co-packer, ingredient vendors, co-mans, warehouse etc all need to be FDA registered, but does our company in the USA need to be registered with the FDA as well? Even though we are not directly handling the product?



#2 SQFconsultant

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Posted 26 June 2020 - 01:11 AM

I had a supplement company as a client and they were required to register.

 

If your supplements are classified as consumable/food and even if the only thing you do is HOLD the product prior to onward shipping you are required to register.

 

FDA/FSMA details here:

https://www.fda.gov/...her-submissions


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#3 jbell4711

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Posted 27 June 2020 - 02:31 AM

Hi thank you. But we will have another warehouse hold our product not us. The warehouse/3PL will be registered. I spoke with a consultant at Registrar Corp and they said as an importer not holding or handling you are not required to register. Does this clarify at all? Do you still think we need to register?







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