Category: Recent News

“If a company does not submit a PMTA by the end of today, it must remove its products from the market. If the product was “verifiably” on the market prior to Aug. 8, 2016 (the FDA’s cutoff for new products) and submitted a PMTA application before Sept. 9, the product can stay on the market for up to a year or until the FDA approves or denies the PMTA. For any PMTA submitted after today’s deadline, a product may not be marketed until the FDA grants a marketing order, according to the FDA. Because the cost of complying with the regulations is staggeringly high, experts expect that many manufacturers will fail to clear the hurdle, and the e-cigarette market will be left largely to the tobacco giants. Although the FDA estimates a single PMTA costs anywhere from $117,000 to $466,000, those figures are considered low by the industry. As of Aug. 31, the FDA had received applications for around 2,000 deemed products, of which around 40 percent have been resolved, according to Mitch Zeller, director of the agency’s Center for Tobacco Products.”

NOTE: By “resolved” he means accepted for consideration, not “Approved” for market

ARTICLE LINK:

The Final Countdown: PMTA Submissions Due Today

“A report, published by the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT), has looked at potential toxicological risks from electronic nicotine (and non-nicotine) delivery systems. “The report correctly highlights that, as a comparative risk, vaping is less harmful than smoking tobacco cigarettes.” This supports the current UK consensus and the position taken by The Royal College of Physicians in its report ‘Nicotine without the Smoke’.”

ARTICLE LINK:

expert reaction to Committee on Toxicity report on ecigs

“Gov. Ron DeSantis vetoed a bill Tuesday that would have raised the legal age to buy tobacco products to 21 and banned flavored nicotine products commonly used in vape cartridges. DeSantis vetoed the vape and tobacco bill (SB 810), arguing it was, in part, redundant and also detrimental to smoking cessation efforts. “While originally conceived as a bill to rate the legal age to buy tobacco to 21, (which is superfluous given this is already mandated by federal law) … SB 810 effectively bans tobacco-free vaping flavors used by hundreds of thousands of Floridians as a reduced-risk alternative to cigarettes, which are more dangerous,” DeSantis wrote in his veto transmission letter.”

ARTICLE LINK:

Gov. DeSantis vetoes flavored vaping ban

Gov. Ron DeSantis [Twitter] 

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“We are writing to you because of our concern about a recent paper published in the Journal of Adolescent Health which we feel was based on flawed data, leading to questionable conclusions, which now appears to be influencing policy decisions. The paper in question is the one published recently by Gaiha and colleagues (2020) which reported on a cross-sectional online convenience sample to examine correlations between self-reported vaping and smoking behavior and self-reported COVID-19 symptoms, testing, and positive COVID-19 test results. Facts do matter, which is why we write to you urging you to retract this flawed and misleading paper. The data are fraught with serious problems that render the analyses presented by the authors and conclusions reached as not reliable. The concern about COVID-19 is real. However, we worry when policymakers rely upon faulty data to justify policy initiatives. This has already happened in the case of the Gaiha et al paper which was cited as the basis for proposals (Krishnamoorthi, 2020; Shaheen et al, 2020) to ban the sale of nicotine vaping products until the COVID-19 pandemic is resolved.”

ARTICLE LINK:

Bad Data and Bad Conclusions Will Lead to Bad Policy – Implausible Claims that Vaping Increases COVID-19 Risk for Youth and Young Adults

“The Australian Tobacco Harm Reduction Association (ATHRA) is pleading with vapers to submit short video clips that could be used as part of a campaign to fight the unjust ban on nicotine base import. They are also after friends and families of vapers and shop owners who all stand to suffer from the prohibition. “As you know,” says ATHRA, “the Australian Government intends to impose a fine of $220,000 for anyone importing nicotine e-liquid from 1 January 2020. This is a disaster for Australia’s 520,000 vapers. Many will relapse to smoking and others will turn to the black market. Lives will be lost unnecessarily.””

ARTICLE LINK:

Video Stars Wanted

“Reynolds announced its final submission of a group of Premarket Tobacco Product Applications (PMTAs) to the Food and Drug Administration (FDA) through R.J. Reynolds Vapor Company (RJRV), seeking orders authorizing the marketing of Vuse Alto electronic nicotine delivery systems (ENDS) under Section 910(c)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act. The group of applications concludes a multi-year application process launched in advance of FDA’s Sept. 9 deadline for PMTAs. Reynolds first submitted a PMTA application in October of 2019 for Vuse Solo, and submitted additional applications for its Vuse Ciro and Vuse Vibe vapor products in April of 2020. Applications for VELO lozenge and pouch products submitted in August of this year. The VELO product PMTAs have been accepted by the FDA after their August filing, while the Vuse products are currently in substantive scientific review by the FDA. Thirteen Vuse Alto ENDS products are included in the Vuse Alto PMTAs, comprised of an ENDS component (the Vuse Alto Power Unit) and 12 closed e-liquid cartridges. Vuse Alto Cartridges are available in four flavors, each in three nicotine levels.”

ARTICLE LINK:

Reynolds Completes PMTA Submissions With Vuse Alto E-Cigarette Applications

Phil,

I just wanted to take a moment of your time to say thank you for the Innokin Sceptre deluxe kit that you sent me last week, it is really a great AIO.

After over seven years vaping it amazes me on how far things have come and where it might be allowed to go if the anti’s don’t get their way.

I appreciate all the work that you and Dimitri do for our community and working to help people get away from cigarettes and finding a safer alternative. Thank you for fighting for all of us.

Sincerely,

Tony

“The United Vapers Alliance (UVA) organised a mass demonstration in Washington this Saturday to push home the message that vaping saves lives, the administration is set to kill the bulk of the independent business sector, and remind politicians that vapers vote – a key message for Donald Trump as he continues to sit behind in the polls. The UVA says it “educates the public and politicians regarding the benefits of harm reduction via vapour products, and strongly conveys that changes must be made, within the FDA, to provide an economically feasible pathway to market. Currently, the FDA pathway to market is not obtainable for small and medium size manufacturers. The only entities that can afford the FDA pathway to market is Big Tobacco, while more than 11,000 family owned vapor businesses will shut their doors. Left unchallenged, 99% of the vapor products, will exit the market in September 2020.””

ARTICLE LINK:

Washington Vape Demo

“Aldermen are set to consider a ban on the sale of most flavored liquid nicotine products in Chicago on Friday, after an effort to prohibit the sale of all flavored tobacco products failed to advance in July. The measure set for a vote by the City Council’s Committee on Health and Human Relations would ban the sale of all flavored nicotine products — except those that taste and smell like tobacco, according to the proposal. The ban applies to products that feature liquid nicotine that has “tastes or aromas of menthol, mint, wintergreen, chocolate, vanilla, honey, cocoa, any candy, any dessert, any alcoholic beverage, any fruit, any herb, or any spice,” according to the proposal. The initial proposal from Ald. Matt O’Shea (19th Ward) would have banned all flavored tobacco products, however, business groups pushed back on the ban, saying it could hurt small businesses struggling to stay afloat. The scaled-back ban would not apply to flavored cigarettes, cigars or chewing tobacco, according to the proposal, after objections from groups like the Illinois Retail Merchants Association. Instead, the ban takes aim at those who vape flavored tobacco.”

ARTICLE LINK:

Aldermen to Weigh Scaled-Back Ban on Flavored Tobacco Products