21CFR in USA


I know that food/drink businesses in the USA have to comply with 21 CRF regulations if they keep electronic records but is that also true of food/drink businesses exporting to the USA?


Hello Emma,

For compliance with the FDA, UKTI can provide information but not advice on how to do so –we typically suggest you work with a private company like Registrar Corp (www.registrarcorp.com), which provides assistance with US FDA regulations for Food and Drink, Medical Devices, and Cosmetics.

Best of luck,


Hello Lauren,
Something else to think about is the terms of shipment. It is important to establish who is the importer of record for your product as that will help with a division of responsibilities. The importer will certainly need to comply with US legislation.

Kind regards,

Export Action Plan