FDA Federal Judge Orders FDA to Begin Reviewing All E-Cigarettes in the U.S. Market

[sofarsogood]

May be this is not such a good development. Apparently the judge is telling the FDA to stop dragging their feet on regulation. The last I heard the FDA agrees they haven't given enough guidance for the vape industry to comply with the pre market approvals. An abrupt cutoff of vape products would be disruptive to put it mildly. The story says the FDA has 2 weeks to respond to court requests. Then I suppose there would be more time to impliment,, etc. May be the FDA will appeal. That would add some months to the process.

Federal Judge Orders FDA to Begin Reviewing All E-Cigarettes in the U.S. Market

 

[Fredman1]

Maybe the FDA should join ECF. Most of the reviews are already here for them...

 

[sofarsogood]

Maybe the FDA should join ECF. Most of the reviews are already here for them...

Government brinksmanship on ecigs for all these years has been pretty impressive. Instead of pulling all the ecigs off the market why not take all the cigarettes off the market. That would save more lives.

 

[Rossum]

Government brinksmanship on ecigs for all these years has been pretty impressive. Instead of pulling all the ecigs off the market why not take all the cigarettes off the market. That would save more lives.

Because that would create a black market and crime wave the likes of which hasn't been seen since the Volstead Act was the law of the land?

 

[Philabos]

And every state would face instantaneous bankruptcy without tobacco taxes.
They were supposedly use them for smoking cessation, but 98% plus goes to fill other budget "needs".

 

[Rossum]

And every state would face instantaneous bankruptcy without tobacco taxes.
They were supposedly use them for smoking cessation, but 98% plus goes to fill other budget "needs".

While I am certain the revenue would be missed and some belt-tightening would certainly be necessary, I do not think states are so dependent on tobacco taxes (and MSA funds) that "instantaneous bankruptcy" would be inevitable.

 

[sofarsogood]

Because that would create a black market and crime wave the likes of which hasn't been seen since the Volstead Act was the law of the land?

When I first started vaping and noticed the government hostility my thought was leave vaping alone and ban the sale of rolled cigarettes. Only allow loose tobacco and papers. It's hard to picture a robust black market because there is so little money to be made compared to the traditional illegal items that are black marketed.

Now the iQos is for sale and won't be going away regardless of what happens to vaping. The problem with taxing that product is it already costs about the same as cigarettes. If the cost goes too high it won't sell. Even vaping is hard to tax more than token amounts. They must know that abruptly closing thousands of vape shops will do far far more harm to public health than what some kids are doing to themselves.

We'll have to see if the FDA appeals this ruling or if they have other tricks up their sleeve that they can use, assuming they want to resist.

 

[sofarsogood]

While I am certain the revenue would be missed and some belt-tightening would certainly be necessary, I do not think states are so dependent on tobacco taxes (and MSA funds) that "instantaneous bankruptcy" would be inevitable.

I agree with you for most states operational funding. But it's not the states that are protesting vaping, it's the organizations the states give money to who believe their funding will be cut if cigarette taxes decline. Those have been the complainers all along.

 

[Bill Godshall]

Here's another news article.
Federal judge orders FDA to begin review of e-cigarettes

The opinion and court order by Obama appointed US Judge Paul Grimm are below, and appear to
written by attorneys representing the Big Pharma funded plaintiffs (CTFK, ACS, AHA, ALA, AAP)
that also lobbied for the 2009 TCA, FDA's unlawful 2009 e-cig import ban, and FDA's Deeming Rule ban.
https://www.courthousenews.com/wp-content/uploads/2019/05/e-cig-opinion.pdf
https://www.courthousenews.com/wp-content/uploads/2019/05/e-cig-complaint.pdf

Reminds me of Grimm's awful Fairy Tales that gave me nightmares as a child.

Lots of pages expressing concern for the damages being suffered by the prohibitionist plaintiffs, but no concern was expressed for the 10 Million vapers in the US (millions of whom will be forced to either go back to smoking cigarettes and/or buy black market vapor products unless Grimm's order is appealed by FDA) or the 35 Million cigarette smokers in the US (who won't have legal access to vapor products, but will still be able to buy exponentially more harmful cigarettes at 230,000 retail stores).

Grimm failed to acknowledge (and may not have even realized) that the Deeming Rule's vapor product sales
ban protected/s cigarettes (by banning sales of all vapor products), that FDA's 2016 draft guidance at
Premarket Tobacco Product Applications (PMTA) for ENDS
for submitting a PMTA was extremely vague, would cost $100+ Million to submit, and would create a multi-billion $$$$$ monopoly/cartel for the FDA's first/several PMTA jackpot winners (that is almost certain to be one or several Big Tobacco companies).

Judge Grimm also failed to acknowledge that Big Pharma (J&J, GSK & Pfizer smoking cessation aids) will benefit from FDA's vapor sales ban (which is why their financial shills sued FDA), failed to understand the definition of "epidemic" (just as Gottlieb did/does), and failed to analyze CDC surveillance data on teen vaping (which found that much/most of the of the recent increase in teen vaping was/is due to marijuana vaping).

I suspect FDA will appeal Grimm's ruling and order because acting FDA Commissioner Norm Sharpless,
DHHS Secretary Alex Azar, and President Trump won't want to blamed for protecting cigarettes (by implementing the Deeming Rule's ban on the sale of all vapor products (which is also why Gottlieb delayed the Deeming Rule's original vapor industry execution date from 8/8/2018 to 8/8/2022).

Two years ago, FDA promised to make it more "efficient, transparent, and predictable" for vapor companies to submit PMTAs, but has done nothing since, which helps explain why nobody has submitted a PMTA for a vapor product yet (including Altria Mark Ten, BAT/Reynolds Vuse, Imperial/Fontem blu, JTI Logic or JUUL).
FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death

I suspect FDA may now back off Gottlieb's proposal to ban cigarette sales (via limiting nicotine levels) because
FDA's key talking point about that similarly disastrous proposal was that it would prompt millions of
smokers to switch to lower risk vapor or smokeless tobacco products (which I've repeatedly pointed out could never occur if FDA simultaneously bans the sale of all or virtually all vapor products).

Since 2011, I've been pointing out the disastrous ramifications (for public health and market competition)
of FDA's Deeming Rule, and am still waiting for any of the thousands of vapor prohibitionists (or anyone at FDA) who advocated the FDA's Deeming Rule to explain why FDA should protect cigarette markets from
legal competition by far less hazardous alternatives, or why FDA should reward the world's largest
cigarette company/ies (or anyone else) with a multi billion $$$$$$$$$ monopoly or cartel for the exclusive legal right to market vapor products in the US (while >99.9% of all other very similar vapor products are banned).

 

[Bill Godshall]

The bottom line is that FDA cannot politically begin to enforce its Deeming Rule (that banned the sale of ALL vapor products on 8/8/2018, according to Judge Grimm's ruling) unless and until FDA approves at least one or several PMTAs for vapor products.

If FDA follows Judge Grimm's order, the agency would have to begin enforcing a 100% vapor product sales ban throughout the US.

 

[Izan]

The bottom line is that FDA cannot politically begin to enforce its Deeming Rule... unless and until FDA approves at least one or several PMTAs for vapor products.

Mr. Godshall,
Do we know if Juul has begun the PMTA process, yet?

Thank you.
Izan

 

[Rossum]

Mr. Godshall,
Do we know if Juul has begun the PMTA process, yet?

I would bet you half the nic base in my freezer (a fairly substantial amount!) that Juul has a PMTA "ready to file". I'm sure they will keep revising it until just before the hard deadline (whenever that actually comes). However, I don't think there's any benefit to filing substantially before they absolutely have to.

 

[Rossum]

If FDA follows Judge Grimm's order, the agency would have to begin enforcing a 100% vapor product sales ban throughout the US.

That's not the way I read the Deeming. Let's assume that Judge Grimm's ruling stands and there's a hard PMTA deadline sometime this year still. Once that deadline has passed, the FDA should begin enforcing against any product for which a PMTA has not been filed, but not against any product for which a PMTA has been submitted, because the Deeming explicitly grants an additional period of one year for such products to remain on the market while the FDA reviews the PMTAs. So approval isn't required for some products to remain on the market, just submissions.

 

[Rossum]

FWIW, here's the bottom line paragraph from Judge Grimm's ruling:

Given that the application deadlines set in the Deeming Rule and the May 2017 Guidance have passed, Plaintiffs will submit additional briefing regarding a remedy (which should be specific, rather than generalized), in fifteen pages or less, within fourteen days of the date of this Memorandum Opinion. Defendants will have fourteen days to respond, in fifteen pages or less, and Plaintiffs will have five business days to reply, in ten pages or less. Any Guidance providing for a compliance period will, of course, have to adhere to the notice and comment requirements of the APA. Even so, manufacturers long have been on notice that they will have to file premarket approval applications, substantial equivalence reports, and exemption requests, and if they have chosen to delay their preparations to do so, then any hardship occasioned by their now having to comply is of their own making. And, in adopting new Guidance, the APA 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 ecigarettes, especially by teenagers.

A separate order will issue.

 

[puffon]

"Two years ago, FDA promised to make it more "efficient, transparent, and predictable" for vapor companies to submit PMTAs, but has done nothing since, which helps explain why nobody has submitted a PMTA for a vapor product yet (including Altria Mark Ten, BAT/Reynolds Vuse, Imperial/Fontem blu, JTI Logic or JUUL)."
FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death

Seems it would be hard to submit a PMTA if the FDA hasn't spelled out what's required.

 

[Rossum]

Seems it would be hard to submit a PMTA if the FDA hasn't spelled out what's required.

I think only two PMTAs have ever been approved; one for some Swedish Match snus, and more recently one for IQOS.

If I were the head of the FDA, I'd comply with the court order. "Folks, submit your vapor product PMTAs now". And then I'd rubber stamp every one of them:

 

[sofarsogood]

I think only two PMTAs have ever been approved; one for some Swedish Match snus, and more recently one for IQOS.

If I were the head of the FDA, I'd comply with the court order. "Folks, submit your vapor product PMTAs now". And then I'd rubber stamp every one of them:

The FDA had discretion whether to deem or not. Do they have the discretion to change the rules to make the lawsuit moot?

 

[Rossum]

The FDA had discretion whether to deem or not. Do they have the discretion to change the rules to make the lawsuit moot?

That's a good question. I've raised it before, but it wasn't in this thread. The dang media articles all imply that the FDA is in violation of the TCA. But I ask: How can that be when the TCA doesn't mention vapor products at all?

The FDA gave itself the power to regulate vapor products via the Deeming regulation. In principle, it could rescind that regulation by using the same process that created it to begin with.

 

[Bill Godshall]

Mr. Godshall,
Do we know if Juul has begun the PMTA process, yet?

While JUUL has conducted some of the hundreds of studies and toxicology data
needed for a PMTA (even with the help of many Altria scientists and regulatory
affairs staff), JUUL won't be able to submit a PMTA (that FDA would officially review)
before the 90 day deadline that vapor prohibitionists AAP, CTFK, ACS, AHA, ALA, etc.
have urged Judge Grimm to impose.

BAT/Reynolds is further along with their PMTAs for various Vuse products
(which Reynolds introduced in 2014 and has conducted lots of studies on),
but I'd be shocked if they could submit PMTAs for Vuse before the end of 2019.

Please note that the PMTA submitted to FDA by PMI/Altria for IQOS
(which FDA recently approved) was more than 2 million pages, and PMI
began conducting its studies on IQOS (for its PMTA) nearly a decade ago.

Back to the AAP v FDA lawsuit, JUUL, NJOY, and the E-Vapor Industry
have submitted letters of intent to Judge Grimm to Petition to Intervene
in the lawsuit.

We need to inform/convince Judge Grimm that if FDA aggressively imposes
the Deeming Rule's ban on the sale all nicotine vapor products in the US:
- cigarette sales will begin to increase as some vapers switch back to smoking,
- a multi billion dollar black market for vapor products will be created, and
- Judge Grimm will be blamed for forcing FDA to ban vapor sales.

 

[WorksForMe]

"Two years ago, FDA promised to make it more "efficient, transparent, and predictable" for vapor companies to submit PMTAs, but has done nothing since, which helps explain why nobody has submitted a PMTA for a vapor product yet (including Altria Mark Ten, BAT/Reynolds Vuse, Imperial/Fontem blu, JTI Logic or JUUL)."
FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death

Seems it would be hard to submit a PMTA if the FDA hasn't spelled out what's required.

I'm not sure if this is good news or bad, but it's got to help.

FDA finalizes guidance for premarket tobacco product applications for electronic nicotine delivery systems as part of commitment to continuing a strong oversight of e-cigarettes


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