The FDA has officially put out new guidance for the PMTA also known as Premarket Tobacco Product Applications. The official statement the FDA issued with the announcement of these new guidelines was “The FDA is committed to providing a solid, science-based regulatory foundation to ensure that ENDS products authorized for marketing are appropriate for the protection of public health.”

Furthermore they state, “The final guidance issued today provides companies seeking to market e-cigarette and ENDS products with recommendations to consider as they prepare a premarket tobacco product application to authorized e-cigarettes currently on the market and we encourage companies to use this valuable document now as a guide to submit applications.”

To begin to understand this new guidance, it must be compared to the previous draft guidance. North Guide Solutions will be issuing a series of blogs to compare, contrast and digest the information provided in the guidance.  

One of the key takeaways in differences between the old guidance and the new guidance is the inclusion of youth usage, protecting those who have never used tobacco products and the promotion that those who currently use vapor products will eventually quit.

The FDA stated that,”The FDA has been and will continue to take all necessary actions to protect children as part of our Youth Tobacco Prevention Plan, including maintaining our focus on enforcement actions and policies aimed at ensuring e-cigarettes aren’t being marketed to, sold to or used by kids.”

So what exactly does this mean for the industry? It means the FDA has officially included in the guidance a hard position against child marketing on top of looking at health concerns alone. They also updated the chemical constituents to be tested for proposed new tobacco products.

Lastly the FDA is looking at the impact of these products on people behavior- including but not limited to cessation rates and youth engagement with these products. While manufacturers strive to meet these requirements it can be sure that this will change the face of e-cigarette marketing and usage. If you are a manufacturer who is looking for a more user friendly guide to the PMTA, stay tuned to our blogs. Always remember Stay competitive, stay compliant.


FDA News Release: