“Public Health England’s Martin Dockrell hailed a new study by “The Fantastic Four” of tobacco and nicotine research. The team looked at claims surrounding a so-called teen epidemic of vaping in the United States. They analysed the National Youth Tobacco Survey to see if it could reveal the true picture of who is vaping and what this means. “Our analysis of data from the NYTS confirms the headline reports of a large increase in past-30-day use of e-cigarettes from 2017 to 2019. However, there was a strong association between lifetime history of use of tobacco products and use of e-cigarettes: in 2019, high school students who had smoked more than 100 cigarettes in their lifetime were some 18 times more likely to have used e-cigarettes in the past 30 days than students who had only ever used e-cigarettes and never other tobacco products. In 2018, use of e-cigarettes on 20 or more days in the past month was seen in only 1.0% of those who were otherwise tobacco naive and in 2019 the figure was only 2.1%.””

ARTICLE LINK:

Fab Four Find Flaws

MY GUY!!!

Here’s the latest from Brent Stafford at Regulator Watch:

It’s only been one day since the U.S. Food and Drug Administration’s anti-vaping regulation went into effect and already the FDA has informed some stakeholders that their Premarket Tobacco Applications have been received and accepted for review by the regulator.
Is there truly a glimmer of hope for the survival of the U.S. vaping industry or do vapers have a dark future to face?

If there’s anyone who might know the answers, it’s Dimitris Agrafiotis a.k.a. the VapinGreek. He’s a globally known vaping advocate and executive director of the Tennessee Smoke Free Association. If you’re looking for frank talk and piercing analysis, we’ve got it in this episode of RegWatch.

Live Streamed: September 10, 2020

Sr. Producer: Cindy Schmidt
Exec. Producer: Brent Stafford

This episode is supported by: DEMAND VAPE

Make RegWatch happen, go to: support.regulatorwatch.com

“Officials had already taken steps to curtail vaping in New Jersey, passing a law banning the sale of flavored vaping products. Some lawmakers said they hoped the rule would keep vapes out of the hands of children (those under 21 were ineligible to purchase the products already). Vaping advocates say the approach had the opposite of its intended effect. Shop owners said a ban would turn people to unregulated products that might prove more harmful. The Yale study backs them up. The authors argue that well-developed and regulated markets likely drove out the riskier products, and that legislation banning such items could subject vapers to more risks.” “I was sort of wanting to promote non-smoking and the health benefits of quitting smoking,” Adam Mitrani said. “The government has forced me to sell smoking products.”

ARTICLE LINK:

A ban on flavored vapes devastated N.J. shops. New study shows it might make vaping riskier

“Plaintiffs have appealed to the Eighth and Ninth Circuits, challenging flavored tobacco bans in Los Angeles County, California, and the City of Edina, Minnesota. The cases could have implications for similar laws in other States and localities. Has Congress preempted local authority to ban the sale of flavored tobacco products? Two different U.S. Courts of Appeals will have the opportunity to answer the question in R.J. Reynolds Tobacco Co., et al. v. City of Edina, et al., No. 20-2852 (8th Cir.), and R.J. Reynolds Tobacco Co., et al. v. Los Angeles County, et al., No. 20-55930 (9th Cir.). The plaintiffs are appealing adverse decisions in each case.”

ARTICLE LINK:

Two U.S. Courts of Appeals to Consider Federal Preemption of Local Flavor Bans

“Wednesday’s long-delayed deadline for e-cigarette companies to seek permission from the Food and Drug Administration to keep selling their products is launching a new era of uncertainty for the industry and a slog for regulators facing applications that can exceed 100,000 pages. The FDA has a year, under a court order, to assess the companies’ data and decide which devices or flavors can be legally sold. In the meantime, the agency says it will start deciding whether applications are complete and warrant a further review. Applicants whose submissions are accepted can keep selling their existing products for a year.”

NOTE 1: Theoretically [and possibly Legally], if FDA decides to accept application (including ‘incomplete submissions) and processes it quickly with a FAILED or DECLINED [perhaps based on it being ‘Incomplete’ so that they wouldn’t actually need to even read it to process it], it would eliminate the rest of the ‘year’ period remaining for them to stay on the shelves

NOTE 2: Dimitris Agrafiotis and Mark Anton have short commentaries supporting the e-liquid vapor product industry in the video

ARTICLE LINK:

FDA to review huge applications from vaping companies

PMTA DEADLINE ARRIVES:
VAPOR INDUSTRY RESPONDS
September 9, 2020

This is a BIG DAY for the vapor technology industry. The day that so many said could not come has arrived. And, just like with every other deadline imposed by the FDA, the vapor industry has stepped up to the task.

Once thought impossible, already reports are coming in of many manufacturers filing their Pre-Market Tobacco Applications (PMTAs) covering what is sure to be thousands of products. Congratulations to all those companies who dug in, did the hard work, gathered the science and submitted their PMTAs by the deadline. Yes, companies had to make some tough decisions along the way, but that was always expected as we headed into the final phase of the Deeming Regulation.

Last week, the FDA confirmed it will take each applicant’s individual circumstances into account during the review process. To be sure, FDA already has been quickly replying to early applicants and issuing initial acceptance letters accepting applications for a variety of products.

While this may feel like a finish line, it is really only the beginning of an ongoing process with FDA as CTP reviews each application submitted and engages with further questions of the applicants.

VTA will continue our existing dialogue with FDA to strongly advocate for our members participating in the process.  To that end, the process rolls out as follows:

Phase 1:  Administrative Review.  FDA initially reviews the application to make sure that basic requirements are in the application, it is in English, it includes required contact information and that it contains product identifying information. If these basic elements are included, a company should receive a letter from FDA accepting their application for further action. If not, FDA will send a “refuse to accept” letter.

Phase 2:  Filing.  FDA engages in a preliminary scientific review to make sure that everything required by the statute is included, such as health risk data, HPHC studies, descriptions of components, ingredients, additives, and principles of operation, description of facility controls, manufacturing, etc.  If FDA finds these elements, a company will receive a letter accepting the application for filing.  If not, FDA will send a “refuse to file” letter.

Phase 3:  Substantive Review:  This is FDA’s full-blown evaluation of all the science and data presented in each application.  FDA will take recommendations from TPSAC and will engage with the applicant with questions.  This process could take up to 12 months and during this time FDA may send the applicant a deficiency letter, giving them 90 days to provide missing or deficient information.  If FDA has made a scientific decision to issue a marketing order, FDA will send an environmental information request letter before it can issue a final marketing order. Otherwise, FDA will send a “no marketing order” letter.

Phase 4:  Post Marketing Reporting.  As part of its approval process, FDA may require that the sale and distribution of your product is restricted (i.e., to protect kids).  Or FDA may require the applicant to establish and maintain certain records and make certain reports available to FDA.  Post market reports will vary based on submission and may include a requirement that the applicant engages in serious or unexpected adverse experience reporting or any manufacturing deviations.

VTA’s full, in-depth analysis summarizing the important developments for those impacted by the PMTA deadline, particularly as it relates to FDA’s enforcement now that the PMTA deadline has been reached, can be found here.

“Flavored vaping products are now banned in Chicago. City Council voted overwhelmingly in support of the ban Wednesday, 46-4, with supporters — including Mayor Lori Lightfoot — saying it will help save lives and keep young people from becoming addicted to tobacco. The new rules prohibit sales of liquid nicotine products that create the taste or aroma of menthol, mint, wintergreen, chocolate, vanilla, candy or dessert. And Ald. Matt O’Shea (49th), a supporter of the ban, said those who vape are more likely to face serious illness from coronavirus. Only a few alderman spoke up against the ban, saying they fear it will lead to people simply going to the suburbs to buy flavored vaping products — and Chicago needs tax dollars from such sales as it faces a $1.2 billion budget shortfall next year.”

ARTICLE LINK:

Chicago City Council passes ban on flavored vaping products

The DP Show! Phil & Dimi go to Washington! The “Save The Vape” Rally Recap
S01E12

In this video we recap the UVA Save The Vape Rally in Washington DC.
You’ll get to hear the speeches made by Dimitris and Phil.
We’ll talk about the PMTA deadline.
Then we have some fun and go for a motorcycle ride.

As always we take your calls and questions.

VAPE WHEEL PRIZE DONATORS:
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THE VIDEO:

THE PODCAST:
COMING SOON!

“which is superfluous given this is already mandated by federal law”

Hmmm… who has been screaming that for a while now?  😉

• THANK YOU Ron DeSantis for doing the right thing and not being a Cuomo!
• THANK YOU Ron DeSantis for making sense!
• THANK YOU Ron DeSantis for understanding that adults also enjoy flavors and for understanding small businesses and lives depended on this decision!
• THANK YOU to Nick Orlando and the rest of the FSFA for your tireless efforts with this.
• THANK YOU to everyone else who was involved with this result.

Looks like I made the right decision moving out of NY for more reasons than one!
On a sadder note… There goes my black market business plan and we’re probably going to lose the deposit on the submarine.

PLEASE!!!  Tweet Ron DeSantis (@GovRonDeSantis) and thank him for this!

“A team of five researchers at the University of Salford have conducted research concluding that vaping is “an effective nicotine replacement therapy”. Although they feel further research is required, the success rate of 60% outstrips anything seen with conventional quit smoking methods. Salford’s quintet sought to build on PHE’s declaration of vaping’s relative safety by seeing if it demonstrably worked as a smoking quit tool, and so they embarked on a study involving 1022 subjects. They found that “for every five people entering the scheme, three stayed on the programme and reduced their cigarette smoking and one cut out cigarettes altogether” – a success rate of 60% for the scheme and a 20% successful quit rate.”

ARTICLE LINK:

Vaping Works