What you need to know: FDA Establishment Registration and Product Listing Compliance Deadline

What you need to know: FDA Establishment Registration and Product Listing Compliance Deadline

The FDA’s Registration and Listing compliance deadline is coming up on October 12 2017 (extended from the original deadline of September 30 2017).

If you are a manufacturer that only sells e-liquid made with TFN synthetic nicotine, you may be subject to an FDA ‘case-by-case’ review of your products, but you may not need to register your domestic establishment and submit product listings for these TFN products, unless you are also a manufacturer selling e-liquids that contain tobacco-derived components. If so, you will have to list your establishment, and provide your list of tobacco-derived products and their labels, as manufactured at that establishment location.

So what do you do if retailers are asking for your FDA FEI number?

As with other tobacco products, retailers and distributors are not required to keep a list of FEI manufacturer numbers, they are also not required to police manufacturers registrations, and therefore retailers do not have to pull any products off the retail shelf on October 13 2017 if they don’t have a manufacturers FEI.

Have a look at this video from VTA to understand what the deadline means for retailers. The association has also created a handy Retailer Guidance document that you can share with your retail customers concerned about TFN e-liquids not having an FEI number.

This information does not constitute legal advice, but is provided as information. All manufacturers should review their filing requirements with their own legal counsel.

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