As the doomsday clock continues to count down to the Vapocalypse due to decimate Planet Vape on May 11th of this year, another desperate hope for a reprieve has been dashed.
As we wrote on our blog back on May 21st of 2019, there was a slight problem with the FDA's so-called Deeming Rule, which "deemed" e-cigarettes to be subject to oversight by the FDA in the same way that combustible cigarettes are regulated under the Tobacco Control Act. The problem was that the rule was signed off on by one Leslie Kux, a low level FDA employee who had no Constitutional authority to do so.
According to the authors of a piece in The Hill we quoted, due to bureaucratic laziness or simple stupidity, a full 98% of the FDA's regulations enacted since 2001 are unconstitutional because they were signed by individuals who lacked the authorization to regulate. This snafu amounts to 1,860 separate rules and regulations made by the FDA during the period between 2001 through early 2018 all of which are, apparently, unconstitutional.
A few scrappy small vape businesses stepped up and tried to use this procedural gaff to challenge the FDA's Deeming Rule. It was a brave and novel approach.
Unfortunately, Judge Christopher Cooper handed down his ruling on Tuesday, dashing any hopes that this innovative approach would bear fruit.
As we noted in our original article on this story, on his second to last day as FDA Commissioner, Scott "Epidemic" Gottlieb attempted to retroactively ratify the Deeming Rule by adding his signature alongside that of Leslie Kux. This 11th hour attempt to shore up the FDA's vulnerability to being challenged on Constitutional grounds succeeded.
Judge Cooper ruled that previous court rulings have “consistently held that a rulemaking ‘that would otherwise be unlawful due to procedural or technical defects . . . can be cured through a subsequent lawful ratification of that action’.” Gottlieb's signature cured the technical defect with the stroke of his pen and the lawsuit is officially dead.
We're now less than three months away from May 11th, the deadline for vape companies to submit Premarket Tobacco Product Applications to the FDA. These applications are so expensive and burdensome that many view them as a transparent attempt to hand the industry to Big Tobacco by shutting out all but the largest players who can afford to stay in the game.
Sadly, with the closing down of the Leslie Kux loophole, the outlook for a last minute stay of execution for the small business vaping industry looks bleak.