...And It's Gone! FDA Revokes Final PMTA Guidance - Kai's Virgin Vapor, A Private Vape Club

...And It's Gone! FDA Revokes Final PMTA Guidance

February 16, 2021

Just what vaping needs, more chaos and uncertainty!

In a move aimed at kneecapping anything put in motion by the Trump administration, the Biden administration issued a regulatory freeze on all pending regulations that were introduced in the final part of Trump's term. As it so happens, that includes the long awaited final guidance on the PMTA from the FDA.

Premarket Tobacco Product Applications (PMTA's) were due on September 9th of last year. Any vape manufacturer who didn't submit a PMTA by that date is now selling illegally in the United States. However, despite the deadline already having passed, the FDA has yet to issue official and final rules for the PMTA process.

After years of waiting, the final rules were announced January 19th, 2021, and published in the Federal Register only to be snatched back almost immediately.

White House Chief of Staff Ronald Klain sent out a memo instructing all agency and executive department heads to “propose or issue no rule in any manner – including by sending a rule to the Office of the Federal Register [OFR] – until a department or agency head appointed or designated by the president after noon on January 20, 2021, reviews and approves the rule.”

What does this mean?

No one knows. The Biden admin could choose to review the rule and approve it as is, they could make changes to the rule, or they could scrap it entirely and do something completely different.

However, given Biden's past statements about vaping, I wouldn't hold my breath for any good news. When questioned about his stance on vaping at a rally last year, Biden called for "serious scientific data as to whether or not it has the kind of long-term damage on the lungs and it causes death before we allow it to be sold."

"I don't care what it does to a small business person who's selling this stuff," Biden said. "If it turns out that it is that (causing lung damage) I would eliminate it."

Biden is apparently unaware of the numerous studies that have already been done on electronic cigarettes, which have been used by millions of vapers in the United States for nearly 14 years. He also seems unaware of the promise of vaping as a harm reduction strategy for adult cigarette smokers, and blind to the hypocrisy of not caring about killing off small businesses while allowing Big Tobacco, whose product is known to cause lung damage and death, to continue with business as usual.

In any case, we'll all just have to wait and see what happens.

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