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FDA Finalizes Guidance For Premarket Tobacco Product Applications

June 13, 2019

On June 11th, the FDA issued a press release announcing that it has finalized the guidance needed by vape product manufacturers to file the required Premarket Tobacco Product Applications, applications required for vape businesses to be able to continue to manufacture and sell their products.


As we've covered before, these applications are so expensive and onerous that they will almost certainly decimate the vaping industry, putting the vast majority of vape companies out of business. The only players remaining will be those that have pockets deep enough to afford the hundreds of thousands to millions of dollars required to navigate the application pathway--primarily, as many have pointed out, those companies owned by Big Tobacco.

“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 help the FDA evaluate the public health benefits and harms of a product. There are no authorized e-cigarettes currently on the market and we encourage companies to use this valuable document now as a guide to submit applications. At the same time, the public can be assured 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," said Acting FDA Commissioner Ned Sharpless, M.D.

O.K., but what does this all mean? Unfortunately, there is still a great deal of uncertainty as to what is likely to happen next. The lack of guidance had previously made it impossible for vape businesses to submit applications (assuming they could afford to do so). Now that the guidance has been published, it seems to be signaling that the FDA is going to be moving the application process forward. However, the big question mark has to do with the timeline.

As we covered in a previous post, the FDA had originally required vape manufacturers to submit applications by August of 2017. However, in part due to the lack of guidance from the FDA, the FDA pushed back this deadline to August of 2021. The vape industry breathed a collective sigh of relief. That is until a coalition of public health entities led by the American Society of Pediatrics sued the FDA over the delay. About a month ago, Judge Paul Grimm of the District Court of Maryland sided with the plaintiffs and gave the FDA 30 days to issue guidance for moving forward with the application process.

District Court Ruling

The FDA has the option to appeal that ruling but we have yet to learn if they intend to exercise that option. If they don't appeal, and issuing the guidelines could be a signal that they don't intend to, then the 2021 deadline could be in jeopardy. If that deadline gets moved up, expect to see a lot of vape companies going under.

There's certainly still a lot of legal wrangling on the horizon before we have a definitive picture of what's coming next. We'll keep you posted as things develop.

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