In July, a US District Court judge, Paul Grimm, produced a remedy order that requires the FDA to enforce the premarket tobacco application (PMTA) requirement starting in May of 2020. This effectively moves up this particular compliance deadline by more than a year. While a small handful of companies might be in a position to attempt compliance with this new deadline, the rest of the vapor industry is not.
Strict enforcement of this deadline will force most US manufacturers to shut down. Even though the FDA will retain enforcement discretion with regard to certain compliance deadlines on a case-by-case basis, it is not clear how (or even if) the agency will apply it. In other words, there is no guarantee that companies will be allowed to keep their products on the market.
At the same time, several bills are active in Congress that would undermine FDA’s authority over new tobacco products. These bills propose to raise taxes, ban flavors, limit online sales, and one bill even goes as far as requiring vapor products to be approved for market only as medical drugs/devices.
CASAA is asking our members to take action by sending a message to your federal lawmakers urging them to reject this legislation and prevent a massive underground market from taking the place of our current legal, regulated marketplace. We will start delivering your messages on September 18th to coincide with a lobby day organized by the Vapor Technology Association.
Take Action - Make a Call! (Click here, then on the phone icon to see phone scripts.)
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More details ...
Strict enforcement of this deadline will force most US manufacturers to shut down. Even though the FDA will retain enforcement discretion with regard to certain compliance deadlines on a case-by-case basis, it is not clear how (or even if) the agency will apply it. In other words, there is no guarantee that companies will be allowed to keep their products on the market.
At the same time, several bills are active in Congress that would undermine FDA’s authority over new tobacco products. These bills propose to raise taxes, ban flavors, limit online sales, and one bill even goes as far as requiring vapor products to be approved for market only as medical drugs/devices.
CASAA is asking our members to take action by sending a message to your federal lawmakers urging them to reject this legislation and prevent a massive underground market from taking the place of our current legal, regulated marketplace. We will start delivering your messages on September 18th to coincide with a lobby day organized by the Vapor Technology Association.
Take Action - Make a Call! (Click here, then on the phone icon to see phone scripts.)
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More details ...
