Deeming Regulations have been released!!!!

[Eskie]

Don't they realize if they require a skull and crossbones printed across every box of e cig stuff people will all think they're just buying the latest Apocalypse rda?

 

[Alexander Mundy]

Unless the FDA appeals this Judge's decision, things could go south for us really quick.

Judge orders FDA to speed up review of e-cigarettes


.

Well if there is a silver lining whatsoever there it's: "The FDA and most health experts agree that e-cigarettes are likely less harmful than traditional cigarettes because they don’t produce the cancer-causing byproducts of burning tobacco." Which would have been heresy just a few years ago.

 

[Rossum]

@Rossum
For your convenience, here is the decision with a link to download the opinion. The pdf is far easier to read.
Am. Acad. of Pediatrics v. U.S. Food & Drug Admin, 330 F. Supp. 3d 657 | Casetext

I'm confused. That case was decided on Sep 5, 2018 by Indira Talwani, United States District Judge.

It does not seem to be the same case referred to by this article, originally posted by @WorksForMe, or referenced by this link at Justia.com, posted by @zoiDman

 

[zoiDman]

I'm confused. That case was decided on Sep 5, 2018 by Indira Talwani, United States District Judge.

It does not seem to be the same case referred to by this article, originally posted by @WorksForMe, or referenced by this link at Justia.com, posted by @zoiDman

You are Correct. There are Two, Independent, American Academy of Pediatrics (AAP) Lawsuits. And by some Strange Alignment of the Planets, each received a Ruling/Order within in the last 60 Days.

That is why I posted that Mention of the "Graphic Warnings" earlier. Because that was one that CMD-Ky referenced.

Anti-Tobacco Groups Sue FDA to Force Graphic Warning Labels
Judge Directs FDA to Move Fast on Graphic Cigarette Warnings
Court Directs FDA to Issue Final Graphic Cigarette Warning Rule by March 2020

 

[WorksForMe]

District Court ruling against FDA: Communication from Tony Abboud Executive Director, Vapor Technology Association

Federal District Court Rules Against FDA; Vacates FDA’s 2017 Guidance Extending PMTA Deadlines

May 16, 2019

As you may have heard, yesterday the U.S. District Court for the District of Maryland issued a 54-page decision in American Academy of Physicians, et al. v. FDA, et al., Case No. 18-CV-00883, that may have a future impact on FDA’s compliance policy for deemed “new tobacco products” that were on the market on the August 8, 2016 effective date of the deeming rule. As explained below, however, there remain a number of procedural steps that must first occur (including potential appeals of the decision) before we will have a clear understanding of the actual impacts of this decision on industry. The case could result in significant changes to FDA’s compliance policy and deadlines for filing premarket submissions for deemed “new tobacco products” that were on the U.S. market on August 8, 2016. However, at this time, we do not view this development as having any immediate impact on industry’s ability to continue marketing such products. We will continue to update you on any important developments.

Background

On May 10, 2016, FDA issued a final rule deeming all products that meet the statutory definition of a tobacco product, except accessories of newly deemed tobacco products, to be subject to FDA’s tobacco product authority (Deeming Rule). In conjunction with the Deeming Rule, FDA announced a compliance policy for newly deemed products (e.g., cigars, pipe tobacco, e-cigarettes) that qualify as “new tobacco products” (i.e., products not commercially marketed in the United States as of February 15, 2007, or modified in any physical respect since) but that were on the U.S. market on the August 8, 2016, effective date of the Deeming Rule (Deemed Products).

The initial policy allowed the continued marketing of Deemed Products until staggered deadlines for filing premarket review submissions for them (and for up to one year thereafter during FDA’s review of such submissions) as follows:

Substantial equivalence (SE) exemption requests were due 12 months after the effective date (8/8/2017);
SE reports were due 18 months after the effective date (2/8/2018); and
Premarket tobacco applications (PMTAs) were due 24 months after the effective date (8/8/2018).


In May 2017, FDA published a guidance document entitled “Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule” under which the Agency announced that it would extend by three months all future compliance dates for requirements under the Deeming Rule, including those for premarket submissions for Deemed Products. In July 2017, FDA announced a new comprehensive plan for tobacco and nicotine regulation intended, in part, to “ensure that the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act” and “[t]o make certain that the FDA is striking an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes.” In order to reach these goals, FDA further extended the compliance dates for the filing of premarket submissions for Deemed Products to August 8, 2021, for combustible products and to August 8, 2022, for noncombustible products (August 2017 Compliance Policy). FDA also modified the compliance policy by permitting the continued marketing of a Deemed Product after the applicable deadline throughout FDA’s review of a timely filed submission.

In March 2018, a number of health groups, including the American Academy of Pediatrics and Campaign for Tobacco-Free Kids, as well as a handful of pediatricians, challenged FDA’s August 2017 Compliance Policy on the basis that it: (1) conflicts with the Tobacco Control Act, exceeds FDA’s statutory authority, and violates the Constitution’s Take Care clause because premarket review of new tobacco products is required under the statute; (2) was promulgated without notice and comment in violation of the Administrative Procedure Act (APA); and (3) was not the product of reasoned decision-making and is therefore arbitrary and capricious in violation of the APA.

On March 26, 2019, the District Court issued a Letter Order denying the parties’ motions without prejudice in light of FDA’s issuance of the March 2019 Draft Guidance proposing to revise the Compliance Policy. The court stated that because “the Draft Guidance, if finalized, will supplant the 2017 Guidance—the focus of Plaintiffs’ claims in this lawsuit—and perhaps necessitate an amendment to Plaintiffs’ Complaint, it is premature and would be neither efficient nor a wise allocation of resources to consider Plaintiffs’ Motion for Summary Judgment at this time, when the very guidance that Plaintiffs’ challenge is subject to possible imminent revision.” However, after the plaintiffs filed a Motion for Reconsideration, the court changed course and decided the case on the merits.

The Court’s May 15 Decision

On May 15, 2019, the District Court in American Academy of Pediatrics et al. v. FDA issued an order finding in favor of the plaintiffs and vacating the August 2017 Guidance. The court ordered: (1) plaintiffs to submit additional briefing regarding a remedy in fifteen pages or less within fourteen days; (2) defendants to respond in fifteen pages or less within fourteen days of the plaintiffs’ submission; and (3) plaintiffs to reply in ten pages or less within five business thereafter. With respect to the “remedy,” the court acknowledged that the application deadlines set in the Deeming Rule and the May 2017 Guidance have passed and states that “[a]ny Guidance providing for a compliance period will, of course, have to adhere to the notice and comment requirements of the APA [Administrative Procedure Act].” The court concludes: “. . . n adopting new Guidance, [FDA] can propose that the deadlines can be set sufficiently soon beyond the end of the notice and comment period to afford relief to Plaintiffs and to attempt to combat the epidemic-level use of new tobacco products like e-cigarettes, especially by teenagers.”

Potential Impact of the May 15 Decision

It appears that the court misunderstood the underlying facts and both misunderstood and misapplied the applicable law. Based on our initial review, we believe there exists a reasonable likelihood of reversal should FDA appeal the decision. Importantly, because this decision goes to the heart of FDA’s authority to exercise enforcement discretion with respect to premarket review and other legal requirements—a tool FDA commonly uses in implementing the Federal Food, Drug, and Cosmetic Act across all categories of products within the agency’s jurisdiction, including drugs and medical devices—we anticipate that FDA will appeal this decision. Even if FDA does not appeal this decision, however, the court’s reference to the need to adhere to the notice and comment requirements of the APA in implementing the court’s order indicates that industry may still not need to file premarket submissions for Deemed Products for many months if not years. We will continue to monitor this case and update you on any significant developments.

Please let us know if you have any questions.

Tony Abboud Executive Director

 

[englishmick]

This isn't exactly Deeming, but I just watched Mitch McConnell talking about the bill he is introducing in the Senate proposing a national age limit of 21 for tobacco products. Haven't seen the details. But from the speeches I heard one of the main motivations behind it is the epidemic of vaping among teens. The talking heads were looking at the epidemic and the shocking lack of regulations around vaping was mentioned, so Deeming could be pulled in. They even had an expert Doctor on the show explaining the dangers of teen vaping, mainly the effect of nicotine on brain development and the recent surge in smoking rates caused by nicotine addiction arising from vaping.

Doesn't look good for us.

 

[dreamvaper]

They even had an expert Doctor on the show explaining the dangers of teen vaping, mainly the effect of nicotine on brain development

And as usual they forgot to mention that if not vaping most of these teens wd be smoking regulars instead. How about comparing the possible harm from both sources? And btw, a lot of teens are vaping 0nic juices.

Are they really ......ed or they are doing what they were paid for? In any case

Doesn't look good for us.

 

[Eskie]

It's fine by me if a raise in age to 21 is enough to calm things down for a few years to allow for a proper, orderly, and reasonable method for further regulation to be enacted. Because the fact is, regulations on the sale of hardware and juice will happen. It won't magically go away. But I'd consider it a win if those rules are fair and economically feasible for manufacturers of modest means to satisfy.

In a way, for someone like McConell who is quite anti-regulation to get something like that passed will be helpful in quashing arguments that nothing is being done to address the problem, while still not crushing the industry by poorly thought out and written legislation.

 

[DaveP]

Same for me. I have no problem with a restriction to age 21 to buy ecig products or tobacco.

 

[englishmick]

It's fine by me if a raise in age to 21 is enough to calm things down for a few years to allow for a proper, orderly, and reasonable method for further regulation to be enacted. Because the fact is, regulations on the sale of hardware and juice will happen. It won't magically go away. But I'd consider it a win if those rules are fair and economically feasible for manufacturers of modest means to satisfy.

In a way, for someone like McConell who is quite anti-regulation to get something like that passed will be helpful in quashing arguments that nothing is being done to address the problem, while still not crushing the industry by poorly thought out and written legislation.

I think Mitch wears anti-regulation the same way he wears a red tie. He will use it as long as it helps his actual goal which is staying in power. Like the rest of them. He's just a bit more ruthless and unprincipled than most, which is why he's the boss. He has a Dem co-sponsor. As good an operator as he is he probably counted the votes, tied up the loose ends, and obtained corporate buy-in long before he made the announcement.

Thing that worries me most about this bill is what mechanism they will use to enforce the age limit. It could involve on-line sales bans, bringing forward the requirement for approvals, increasing taxes. He's smart enough to have figured out the black market angle so maybe regulating nic sales. Generally tackling the problem from the supply side by making it harder to obtain vaping gear and limiting the available options.

On the other hand it could just be a show vote aimed at the 2020 audience. Guess we'll find out.

 

[mikepetro]

I may be wrong, but wasn't there a previous attempt to make vape a drug, and we (vapers of the time) actually fought that off, arguing that it shouldn't be a "drug"? If (a big "if") my memory serves me, that's how it came that vape got labeled as a tobacco product.

I'm not 100% on that, and I think it happened somewhere in the 2010-2012 (ish) range, but I think we (vapers as a whole) may have had a hand in the bullet that now resides in our collective foot. It's not something that's often discussed here, but for some reason I'm thinking it played out along similar lines (of my thought).
........

It wasnt "we vapers", but rather the companies that imported the ecigs. I.e. it was money that drove those lawsuits.

"We vapers" have not made a very effective voice. Disappointing really. Lack of motivation and organization by the vaping masses. Albeit, the vaping majority probably dont even realize that our right to vape as we please is even threatened. What % of vapers are on forums like this?

We need the Juuls, Blus, Smoks, IJoys, JoyeTechs, UWells, Eleafs, Kangertechs, Sigelies, Wisemecs, etc etc of the world to throw some serious money at this, and at organizing vapers. The companies making millions off of selling vape products should step up, and in a meaningful way!

Sure, we have Casaa, and the AVA, but these groups just dont have the resources that are needed to fight the behemoth that is trying to shut us down. It needs a well funded and serious Lobby effort behind it, one that can effectively exert political pressure, which is usually done by throwing serious money around.

 

[Eskie]

Well, Juul sure has the money to go after this, combined with access to all the lobbyists and BT politicians already owned. I hate to put the burden on one company, especially when their product is a closed pod system, but you can't ignore their presence and their recent activities in discussions and policies on this very issue. I expect Nicopure is doing the same, but still not on the scale Juul is now capable of doing.

 

[mikepetro]

Well, Juul sure has the money to go after this, combined with access to all the lobbyists and BT politicians already owned. I hate to put the burden on one company, especially when their product is a closed pod system, but you can't ignore their presence and their recent activities in discussions and policies on this very issue. I expect Nicopure is doing the same, but still not on the scale Juul is now capable of doing.

Alas, if it is one company, then any positive legislation achieved will be slanted favoring that company. A consortium is what is really needed.

 

[DaveP]

This is what we started with back in 2009.

WOW! World’s Top Tobacco Companies LOST $100 BILLION To Vaping

Big Tobacco Does Not Understand Vaping

This Is What Big Tobacco Thinks A Vaping Product Should Look Like…

 

[rosesense]

I did not know that Cosmic Fog and Vapor Shark were owned by BT. I knew about VaporBeast so I quit shopping with them.

 

[Rossum]

I did not know that Cosmic Fog and Vapor Shark were owned by BT. I knew about VaporBeast so I quit shopping with them.

I would not call Standard Diversified, Inc "BT", despite the fact that they have some tobacco-related holdings.

 

[dreamvaper]

Big Tobacco Does Not Understand Vaping

Oh, they do, most of them also understand that the future is with vaping and/or HNB not with regulars.
I'm a bit amazed how much is spent on marketing and promotion of Iqos all around the world. And it works for them, I see a lot of users lately.
Juul at the moment is acting like they are innocent angels all pro legal vaping, no kids allowed and other kinds of honorable blahblah. But the market share they have right now is just amazing, esp. in US.

 

[rosesense]

I would not call Standard Diversified, Inc "BT", despite the fact that they have some tobacco-related holdings.

Perhaps not but I will not knowingly buy anything from anyone associated with BT in any way. Just my personal beliefs, not knocking others who see it differently.

 

[5cardstud]

From the above-linked article:

I find this statement misleading. Congress has never made a law requiring the FDA to treat vape products as tobacco products. Instead, a previous administration's FDA "gained" that authority by "deeming" vape products to be "tobacco products". In other words they gave themselves this authority, despite not being under any legal obligation to do so. Heck, the current administration's FDA could (if it were so inclined) simply rescind/revoke the entire Deeming. It would be perfectly legal to do so, although I'm sure doing that would create quite a furor in some circles.

However from a purely pragmatic perspective, we should all acknowledge that the industry has been on borrowed time since at least August 8th of 2018, the original PMTA deadline. If you're reading this and you haven't already figured out how you're going to survive the vape industry getting decimated, well, there's no better time to do that than right now.

Follow the money. Right now the tobacco industry is paying senators more money than the vaping industry.

 

[Rossum]

Juul at the moment is acting like they are innocent angels all pro legal vaping, no kids allowed and other kinds of honorable blahblah. But the market share they have right now is just amazing, esp. in US.

I suspect it's because it's effective and in a form-factor that appeals to people who don't want a clunky mod.

I was at my bank a couple of weeks ago, doing some administrative stuff with a floor manager. She was fairly young, no more than 30. I spotted a Juul on her desk and asked her how she liked it. She was all embarrassed that I noticed it put it in a drawer, "Some people are offended by it". So I pulled the l'il pinch out of my shirt pocket and said, "Not me!" and I asked her if she smoked. "Not anymore!" "Good, I smoked for 36 years and wish vaping had been around when I was your age."