Yesterday, in a devastating blow to public health, President Biden’s FDA bowed to radical anti-science political activists late yesterday and refused to grant PMTA authorizations to any life-saving reduced risk tobacco alternative vaping product. As a result, it is now illegal to sell any vaping product in the United States.
While the FDA has already rejected many applications hundreds of companies remain in limbo as the FDA refuses to finalize their applications, despite a September 9 deadline. It is now illegal to sell any vaping product without FDA authorization.
These outrageous now regulations were imposed even though these products are proven to be 95% safer than combustible tobacco, 3-7 times more effective than other nicotine replacement therapies, and, according to Georgetown University Medical Center, having the potential to save up to 6.6 million American lives. For this reason, they are endorsed by over 50 of the world’s leading medical organizations. And it is now illegal to sell any of them.
While the FDA has stated it will use its discretion in enforcing the law while outstanding applications are pending, so far, it has rejected every application it has ruled upon. Moreover, in its rulings, it has demanded that individual vape manufacturers would have needed to supply a “randomized controlled trial or longitudinal cohort study,” costing hundreds of thousands of dollars, for every product, variety, or strength or e-liquid a manufacturer develops. Even the smallest of vape stores sell hundreds of different products. In order to have any chance of approval, they would have to spend over a hundred million dollars – something impossible.
As a result, it is now almost certain that thousands of independent vape shops will shut down. Millions of former smokers who rely on vaping devices will gradually return to smoking, with deadly consequences.
Smoking kills seven million Americans annually – twice as many as have been killed thus far by the Covid-29 Pandemic. For the FDA to rule that tens of millions of smokers will be unable to quit their deadly habit through a scientifically proven reduced risk alternative will leave a long-term death toll far higher than Covid ever would.