Are You Ready for FDA’s Establishment Registration and Product Listing?
The deadline is fast approaching - by December 31st all businesses in the United States that manufacture, prepare or sell tobacco products need to register with the FDA. Since vaping products are now considered tobacco products, every vaping business needs to do the same thing.
Two things need to be registered with the FDA - establishment and product listing. The easiest way to do this is by utilizing FDA’s electronic listing or FURLS, which can be accessed here. FURLS is used to register an establishment and submit a product listing. All other documents, such as health documents and ingredient reports, are submitted through the CTP Portal. If you’re not inclined to used the electronic submission process, you can fill out the FDA Form 3741 and mail it to the CTP Document Control Center.
Currently, this regulation does not require non-domestic companies or importers to go through the same process. However, every business, including small vape shops, that mixes, labels, assembles, or bottles products on the US soil, needs to complete the registration by December 31st, otherwise they’re risking severe fines that will definitely put them out of business.
Original post by Azim Chowdhury and Owen Chaput