Shortly after the vaping industry lost its first legal challenge against the FDA’s deeming regulations in the Nicopure lawsuit, the FDA’s Commissioner, Dr. Scott Gottlieb shocks the industry today by announcing a new regulatory plan is to come and furthermore shares it’s extending the PMTA (Premarket Tobacco Product Application) for ENDS (Electronic Nicotine Delivery Systems) to August 8th, 2022.
Both business owners and consumers of the vaping industry are doing backflips in excitement over today’s speech by Dr. Gottlieb, where the FDA announces a comprehensive regulatory plan to shift trajectory of tobacco-related disease, death, as well as saying this plan “extends timelines to submit tobacco product review applications for newly regulated tobacco products that were on the market as of August 8th, 2016.”
In the speech, there were several points that were highlighted by Clive Bates, such as product standards, process clarity, reduced nicotine cigarettes, flavors, medicinal nicotine, and redeployed resources. For instance, when speaking of product standards Gottlieb said the “FDA intends to develop product standards for e-cigarettes to protect against known public health risks”, while Clive Bates shares that “standards provide certainty and transparency, and if sensibly defined, should lower the costs of participating in the market and provide meaningful benefits to consumers.”
Note: I highly encourage you to read over the article published by Clive Bates titled Huge FDA announcement on future tobacco and nicotine strategy, as it shares several highlights and goes more in-depth with the announcement.
The desire to have to rethink and introduce a comprehensive approach to nicotine is exactly right, necessary and urgent. The positive messages from Dr. Gottlieb about harm reduction and his discussion nicotine, addiction, and harm from the delivery system show that he gets it. These statements are really important and show that FDA leadership is getting to grips with the concept of exploiting differential risks in tobacco products for public health gain. And unlike the past, the warm words are backed by at least some deeds. — Clive Bates
This morning I was bombarded by several people attached to the industry in some way or another, vapers, vendors, and trade show owners expressing their excitement for the news announced today by the FDA’s Commissioner, Dr. Gottlieb. Our friend Todd from VaporAuthority.com expressed his excitement to me earlier this morning saying “I’m doing backflips over here, they are postponing the submittal deadline to 2022!! I’m so happy, this is huge!” — My close friend and boss at the Ecig Advertising Group, Steve Mac, immediately contacted me urging me to jump on the Gottlieb press release and shared this is “Huge news for our industry!”
Though this is great news for the vaping industry and no doubt a huge win for vapers, business owners, and advocates, it only means that it’s a win for now and doesn’t conclude our dealings with the FDA or our fight to keep the vapor products industry alive and well. There’s much more work that must be done, however it does buy us time, and right now that’s exactly what we need. So for now my friends, breathe a sigh of relief, enjoy this wonderful day, and continue to do anything in your power to advance this life saving alternative.