Deeming Regulations have been released!!!!
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Below is an email I got from CASSA. Scroll down far enough and you'll find a link to writing to the Pres and your zip code will identify your senators and rep and compose emails for them too.
While all eyes are on the White House this week, we are reminding members that several bills in Congress could do more harm to consumers and be enacted faster than FDA can take enforcement action against the vapor industry.
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.
Take Action - Send a Message!
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 one week from now to coincide with a lobby day organized by the Vapor Technology Association.
Take Action - Send a Message!
---
The long version:
By way of background, In July, Judge Paul Grimm, US District Court District of Maryland, ruled that the FDA has until May 2020 to enforce the premarket tobacco application (PMTA) requirement for new tobacco and vapor products.
The initial compliance deadline for PMTA was August 8, 2018. But in July 2017, the FDA delayed the PMTA deadline to 2022--for non-combustible products--citing a need to give vapor manufacturers more time to prepare and submit meaningful applications that would be more likely to be accepted by the agency.
Within a year, the FDA changed course after reviewing national survey data showing a sharp uptick in youth use of vapor products. The updated guidance would require applications to market vapor products in flavors other than tobacco to be submitted and accepted by the FDA by August of 2021. Although never finalized, the draft guidance would have also limited sales of flavored vapor products to adult-only specialty vapor/tobacco stores.
In 2018, the American Academy of Pediatricians (AAP) sued the FDA with the goal of reinstating the original August 8, 2018 PMTA compliance deadline. Following an exchange of proposed remedy briefs by both parties, Judge Grimm ruled that FDA’s suggestion of no less than ten months from the date of the court’s decision would be necessary for companies to finalize and submit acceptable applications. Judge Grimm granted FDA’s request.
The ten-month deadline is one of four points detailed in Judge Grimm’s remedy order. The remaining provisions of the order are as follows:
It may be hard to believe, but FDA specifically asked the court to preserve the agency’s enforcement discretion citing negative consequences of a mass exodus from the vapor market and an extreme and sudden decrease in access to safer alternatives to smoking. The FDA expressed strong concern that such an event would cause thousands of people who vape to return to smoking.
Preserving FDA’s enforcement discretion is not a free pass for the vapor industry and consumers should be very concerned about what this remedy order means for our access to vapor shops, vapor products, and other resources. The FDA and Congress are still facing tremendous pressure from anti-nicotine activists to ban flavors, enact taxes on vapor products, ban online sales, and raise the purchase age to 21. Additionally, we are monitoring a budding movement by local governments in California to take matters into their own hands by requiring that a vapor company has a marketing order from the FDA in order to sell their product in their city.
Take Action - Send a Message!
Thank you,
CASAA Legislative Team
Click here to unsubscribe from this mailing list.
While all eyes are on the White House this week, we are reminding members that several bills in Congress could do more harm to consumers and be enacted faster than FDA can take enforcement action against the vapor industry.
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.
Take Action - Send a Message!
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 one week from now to coincide with a lobby day organized by the Vapor Technology Association.
Take Action - Send a Message!
---
The long version:
By way of background, In July, Judge Paul Grimm, US District Court District of Maryland, ruled that the FDA has until May 2020 to enforce the premarket tobacco application (PMTA) requirement for new tobacco and vapor products.
The initial compliance deadline for PMTA was August 8, 2018. But in July 2017, the FDA delayed the PMTA deadline to 2022--for non-combustible products--citing a need to give vapor manufacturers more time to prepare and submit meaningful applications that would be more likely to be accepted by the agency.
Within a year, the FDA changed course after reviewing national survey data showing a sharp uptick in youth use of vapor products. The updated guidance would require applications to market vapor products in flavors other than tobacco to be submitted and accepted by the FDA by August of 2021. Although never finalized, the draft guidance would have also limited sales of flavored vapor products to adult-only specialty vapor/tobacco stores.
In 2018, the American Academy of Pediatricians (AAP) sued the FDA with the goal of reinstating the original August 8, 2018 PMTA compliance deadline. Following an exchange of proposed remedy briefs by both parties, Judge Grimm ruled that FDA’s suggestion of no less than ten months from the date of the court’s decision would be necessary for companies to finalize and submit acceptable applications. Judge Grimm granted FDA’s request.
The ten-month deadline is one of four points detailed in Judge Grimm’s remedy order. The remaining provisions of the order are as follows:
- New products for which applications have not been filed within this period shall be subject to FDA enforcement actions, in the FDA’s discretion;
- New products for which applications have been timely filed may remain on the market without being subject to FDA enforcement actions for a period not to exceed one year from the date of application while FDA considers the application;
- The FDA shall have the ability to exempt New Products from filing requirements for good cause on a case-by-case basis.
It may be hard to believe, but FDA specifically asked the court to preserve the agency’s enforcement discretion citing negative consequences of a mass exodus from the vapor market and an extreme and sudden decrease in access to safer alternatives to smoking. The FDA expressed strong concern that such an event would cause thousands of people who vape to return to smoking.
Preserving FDA’s enforcement discretion is not a free pass for the vapor industry and consumers should be very concerned about what this remedy order means for our access to vapor shops, vapor products, and other resources. The FDA and Congress are still facing tremendous pressure from anti-nicotine activists to ban flavors, enact taxes on vapor products, ban online sales, and raise the purchase age to 21. Additionally, we are monitoring a budding movement by local governments in California to take matters into their own hands by requiring that a vapor company has a marketing order from the FDA in order to sell their product in their city.
Take Action - Send a Message!
Thank you,
CASAA Legislative Team
Click here to unsubscribe from this mailing list.
Ok. How about some links to those videos. I'll check them out.
Thank you for what you do for all of us... You’re information is invaluable. You may not have felt that way at midnight, but we’re thankful for you!
Intentional, organized chaos. A common practice of many CEOs. Pisses people off but it also wakes them up.
Thanks, Kristin. I can't even imagine how inundated you all must be ATM. Thanks for all your hard work. It's just that there are so many new members here who don't even know you exist... They ask for guidance; many want to help, do something, make their voices heard. It would be nice to have a place to send them to for all the latest calls to action etc.
I got another email today, I'm not sure if it's OK to share it with others here on the forum? You see, when I click on it, I see my info--I hope that when someone else opens it, they can't see it, is that correct? Could someone here please click and confirm that my name, address and email are not visible?
Vaping Prohibition is On the Table in Congress!
Thanks!
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I dont see it.
I often wondered about that. Polonius:
[Aside] Though this be madness, yet there is method in't.
Trump and Hamlet.
Likewise, this is a response that I have given to a couple of friends who presume to know a lot about a lot.
Well, one thing is for certain. It's not the ghost town around here that it was just a few weeks ago. I've never seen so many notifications, posts, and so much activity here. Speaking of conspiracy theories, does anyone think Oliver hacked @RealDonaldTrump's twitter account to boost membership?
Sure is busy. Kind of cool to see so many old timers who haven't been around lately.
Fear is a powerful motivator.
Vaping has been elevated to the Oval Office. Wow. May be there are things we can do so it turns out to be a good thing. Any ideas?
He's too busy hangin' out on Martha's Vineyard before it disappears with/like Miami.
"Disposable income", indeed.
I'm not assimilated yet either. And I'm not that close....Atty, are you on Twitter/Facebook? If so, can you tweet this to POTUS?
I'm not but I'm this close to joining both just to let the Prez know how I really feel.
The Wall Street Journal editorial page chimed in on the vaping crisis on Friday the 13th appropriately enough.
They mused how the same politicians and suburban parents can support the legalization of a certain substance, a very large issue in schools, and at the same time go into orbit over vaping. They also threw in the fact that alcohol, also a larger problem in schools, seems to skate by without a call to ban Pinot Noir.
It is behind a paywall, and I am of course paraphrasing since I don't want to violate their copywrite. Nonetheless these do show up on google after a while.
Having said that, after 10 plus years of reading their editorials, rarely does anything change as a result.
They mused how the same politicians and suburban parents can support the legalization of a certain substance, a very large issue in schools, and at the same time go into orbit over vaping. They also threw in the fact that alcohol, also a larger problem in schools, seems to skate by without a call to ban Pinot Noir.
It is behind a paywall, and I am of course paraphrasing since I don't want to violate their copywrite. Nonetheless these do show up on google after a while.
Having said that, after 10 plus years of reading their editorials, rarely does anything change as a result.
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