• Deanna Clark-Esposito

How Can I Find Out if My Vendors Have Applied for a PMTA?



This is a great question and an important one too. The PreMarket Tobacco Application, otherwise known as the “PMTA,” which now has a current deadline of September 9, 2020, must be submitted in order for many of the products a vape shop sells to remain lawfully sold. If you're a store owner and don’t know if your supplier has been working on its application, it’s time to ask them the question.

Governed by the US Food and Drug Administration (FDA), the vapor products (e-liquids, vape pens, etc.) which had been in the US market as of August 8, 2016 were only allowed to remain being sold because enforcement by the authorities over their unlawful sale had not been implemented – rather, it was put on hold. This is because no vapor product may currently be sold without FDA authorization. They simply have been allowed by the FDA to be sold because of the enforcement being put on hold.

The current expiration date for this “hold” is now September 9, 2020, which means you don’t want to have too much inventory of products that will be unauthorized for sale after this date due to the manufacturer not having submitted a PMTA.

So what can you do? Start asking your vendors if a PMTA has been done by the manufacturer on the products. Use the template below as a guide for drafting your own.

Keep track of who is responding and who has responded affirmatively in that they plan to make the submission. You DO NOT want to continue buying from the suppliers who are either (1) non-responsive or (2) not doing a PMTA because with those products no longer being considered lawful for sale after September 9th, you as the retailer are now in a position to get into trouble with the FDA or your local Consumer Product Safety authority (think, monetary fines) should you continue to sell them as you try to get rid of the inventory.

My thoughts? Start reaching out to your vendors today. Use the template below as a guide for drafting your own email to them and if you run in to any issues, you can always reach out to us.

TEMPLATE EMAIL TO YOUR SUPPLIER OF VAPOR PRODUCTS

Subject Line: Please Confirm your PMTA Submission

Dear ______,

We recognize that many of our vendors intend to submit a PreMarket Tobacco Application (PMTA) with the US Food and Drug Administration (FDA) which is due on September 9, 2020.

As this deadline is around the corner, we are requesting someone in management from your company confirm with us that you are in the process of preparing the PMTA and intend to submit it on or before September 9, 2020.

Please either:

1. Reply directly with your answer, if you are part of the management at your company

2. Forward this to someone in management and ask them to reply to us directly, or

3. Confirm you’ve spoken with them, provide us with their first and last name, and provide us with your answer.

Stay safe and thanks in advance for your reply. Your prompt response would be appreciated.

Sincerely,

Your Name


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