Author: pbusardo
THE SMOKER’S SHOW EPISODE # 31 – MORE JUNK SCIENCE
On Tonight’s Show We Discuss:
- More junk science and Dr. Farsalinos’ Response (A link to his full response is provided below)
- The Back To Basics Seminar @ GoodGuyVapes.
- The Innokin Gala & The VaperGate Pug
As always we answer your questions and take your calls!
The Smoker’s Show is a vape show not for vapers, but for smokers.
A show to get information about vaping, to debunk vaping myths, to discuss vaping terminology & technology, and to look, review, & provide starter kits for the transitioning smoker.
We urge all vapers to invite those they know who still smoke to watch the show!
#SMOKERSWANTED
Thank you all for your support and let’s convert more smokers together!
THANK YOU TO AND PLEASE SUPPORT OUR SPONSORS!!
COUPON CODES FOR YOU…
- For 10% off Innokin/Platform Products at MyVaporStore use coupon code: MTL10
- For 15% off your Lunar Rover order use coupon code: smokersshow
THE VIDEO:
*NOTE: Any use of these videos in part or in their entirety without Phil Busardo’s and Dimitris Agrafiotis’s expressed written consent is strictly prohibited.
Information found in this show:
- Dr. Farsalinos’ response to the Journal of the American College of Cardiology Study and CNN Report can be found HERE.
- Seeing the effects of Tobacco Smoke and Ecig Vapor on Heart Cells video can be found HERE.
See everything Smoker’s Show Related HERE!
What’s really behind teen vape use?
By Dimitris Agrafiotis…
FDA Efforts to ban flavors fails to address biggest issue— JUUL
We all agree, we want to prevent teens from accessing or using vape products. But the Food and Drug Administration’s focus on limiting flavors are misguided and counterproductive to improving public health— and ultimately won’t solve the problem of youth vaping.
The FDA has suggested new regulations to limit the sale of flavored vape products, effectively removing a majority of vape products from the marketplace and eliminating a powerful alternative that is helping adult Tennesseans to stop smoking cigarettes.
Vape flavors have been available as far back as 2009, yet they are blamed for the recent increase in youth use in the last three years.
Keeping vape products out of the hands of youth is critical, which is why the 100+ members of the Tennessee Smoke Free Association absolutely support FDA actions to increase enforcement against bad actors selling or marketing illegally to minors.
We believe the FDA should focus policy efforts on a broader approach taking into account all of the potential causes contributing to youth initiation including social media, retailer enforcement of existing age-restrictions, straw purchases, etc.
TSFA applauds the recent FDA enforcement efforts to root out bad actors and crack down on those companies using packaging marketing or advertising gimmicks that imitate kid-appealing foods or that are otherwise unnecessarily appealing to minors. The agency can and should do more to prevent companies from marketing or selling to youth, focusing on bad practices and the point-of sale.
Specifically, the agency should consider the dominating trend of youth vaping, an attraction to high nicotine salt concentrations in pod-systems, like JUUL.
Introduced in 2015, JUUL announced it had the unique ability to deliver nicotine in a similar fashion to traditional combustible cigarettes through nicotine salts. JUUL pods give a stronger hit of nicotine and are less customizable than other vapor products.
Today, JUUL makes up over 75% of the US Market. It is no accident that when JUUL exploded, teen vape use increased.
According to some reports, teens are sixteen times more likely to use JUUL than 25-34 year olds. Another recent report said that a majority of the brand’s Twitter followers last year were teens.
The company has said it is taking these concerns seriously, erasing their social media accounts and implementing strict age-verification processes on their website.
It’s important that we all recognize that JUUL is not the entire vape industry.
Vaping started because adult smokers wanted an alternative to the traditional quit methods. From our association of independent vape shops across Tennessee, we hear stories about how lifelong smokers finally found relief by switching to vaping— and for many, having the ability to customize flavors can make the difference.
There are much more effective ways to protect youth from accessing vape products without eliminating a key lifeline helping hundreds of thousands of adult smokers stop smoking.
Eliminating vape flavors may sound like a quick fix, but in the end, we know it will not stick.
THE SMOKER’S SHOW – TONIGHT AT 9PM EST!
The Smoker’s Show returns tonight at 9PM EST.
We’re going to be talking about more junk science!
A couple product tours of the Innokin Gala and the VaperGate Pug!
Starter kit giveaways!
Taking your calls and questions!
Click the banner below at 9PM EST tonight to be taken directly to the show!
#smokerswanted
LATEST FROM REGULATOR WATCH – Unconstitutional | Judge Tosses Key Provisions of Quebec’s Anti-Vaping Law
Here’s the latest from Brent Stafford at Regulator Watch:
It’s a huge win for the vaping industry.
A Superior Court judge invalidates key provisions of Quebec’s Tobacco Control Act, which promulgated harsh new regulations and fines, seemingly intended to eviscerate the vaping industry.The ruling comes after a three-year legal challenge spearheaded by the Canadian Vaping Association, which argued the vaping restrictions infringe on the “right to security of the person” and “freedom of expression” under both the Canadian and Quebec charters of rights and freedoms.
In this episode of RegWatch hear about the ground-breaking ruling directly from Audrey Boctor the lawyer who led the fight and learn exclusive details about the court trial, expert witnesses and what happens next. Also, Daniel Marien president of the 35-store La Vape Shop retail chain joins the show to discuss the draconian rules and hear his reaction to the ruling.
Only on RegWatch by RegulatorWatch.com.
Produced by: Brent Stafford
Released: May 22, 2019
From Susan
Hey Phil! It’s me – Susan. It has been awhile since we spoke. I believe the last time was on Facebook. Anyway, I just had to write to you about the Zlide tank. When I first saw it online, I knew that I just HAD to have one. I didn’t think anything could pull me away from the Zenith, but oh my goodness! This tank could not be any more perfect!!
When it came in the mail, I just sat and looked at it for nearly an hour. It was too gorgeous to even use 🤗! My husband was looking at me as if I had grown a second head, then
he finally asked me if I was going to fill it up, and I just mumbled like an idiot. I couldn’t take my eyes off it.I had ordered the gunmetal with the red drip tip. They were all so pretty, but I had never owned anything in gunmetal before, and with that red drip tip – oh my❣
You and Dimitri are truly doing a wonderful job with these tanks. I’ve always been a mtl kind of girl, and you have hit it out of the ballpark with the Zlide. I’ve loved all of your tanks, but this one is just special, somehow.
I won’t keep you. I can’t even imagine how busy you must be nowadays. I just had to write to you about my new, gorgeous Zlide tank. I am truly in love with it😍, and couldn’t be any more happier if I tried!
I only have one small problem…. after I started vaping with the Zlide with a rapture-like look on my face, my husband said, “You’re gonna give me the Zenith now, right?” 😮🤣
Keep up the great work! The vaping world is most definitely better off with you and Dimitri in it.
Talk to you soon, my friend! 💞
Susan.
LOL Susan! I think you need to get hubby a NEW tank, not a hand-me-down! 🙂 Thanks for taking the time to write this and we’re so happy you like it!!
VTA Update: Federal District Court Rules Against FDA
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: “. . . [I]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
THE VANDYVAPE JACKAROO KIT
A PBusardo Review – The VandyVape Jackaroo Kit
In this video, the VandyVape Jackaroo gets the “Full Busardo” treatment. Another rugged shock, dust, and waterproof device for your vaping pleasure.
The Links:
VandyVape
Element Vape
MyVPro
VapeWild
Thank you to and please support the premier TYJ Sponsor… LUNAR ROVER!
Use coupon code “pbusardo” for 15% off your order at Lunar Rover!
The Video:
*NOTE: Any use of these videos in part or in their entirety without Phil Busardo’s expressed written consent is strictly prohibited.
The Photos:
THE JOYETECH EXCEED GRIP REVIEW + ALL CONTEST WINNERS & A NEW ONE!
A PBusardo Review – The Joyetech Exceed Grip + Contest Winners!
In this video we take a quick look at the Joyetech Exceed Grip. We also find out who won the last two “Not A” Contests and kick off a new one!
The links (no affiliate links ever used):
Joyetech
Exceed Grip @ Heaven Gifts
Innokin
SvoëMesto
KHW Mods
Thank you to and please support the premier TYJ Sponsor… LUNAR ROVER!
Use coupon code “pbusardo” for 15% off your order at Lunar Rover!
The Video:
*NOTE: Any use of these videos in part or in their entirety without Phil Busardo’s expressed written consent is strictly prohibited.
The Photos:
THE NEW FLAVOURART NORTH AMERICA FACILITY TOUR
A PBusardo Video – The FlavourArt North America Facility Tour!
Although this video appeared in the last Smoker’s Show, here is the stand-alone video.
Join us for a tour of the new FlavourArt North American Facility!
Thank you to Shaun, Richard, and everyone at FlavourArt for inviting us on this tour and allowing us to bring it to everyone!
Wishing you the best of luck with the new facility!
The Links:
https://flavourart.com/en/
Thank you to and please support the premier TYJ Sponsor… LUNAR ROVER!
Use coupon code “pbusardo” for 15% off your order at Lunar Rover!
The Video:
*NOTE: Any use of these videos in part or in their entirety without Phil Busardo’s expressed written consent is strictly prohibited.
THE SMOKER’S SHOW – EPISODE # 30 – FLAVOURART NORTH AMERICA TOUR & MAKE THE SWITCH INITIATIVE
On Tonight’s Show We Discuss:
- The Juul
- Nicotine strengths or lack thereof in vape shops.
- The new FlavourArt North America Facility
- Phil Cruise 😉
We are also joined by Wayne Walker of diyordievaping.com and Richard Hong, Vice President of FlavourArt North America to discuss the Make The Switch Initiative and Competition!
As always we answer your questions and take your calls!
The Smoker’s Show is a vape show not for vapers, but for smokers.
A show to get information about vaping, to debunk vaping myths, to discuss vaping terminology & technology, and to look, review, & provide starter kits for the transitioning smoker.
We urge all vapers to invite those they know who still smoke to watch the show!
#SMOKERSWANTED
Thank you all for your support and let’s convert more smokers together!
THANK YOU TO AND PLEASE SUPPORT OUR SPONSORS!!
COUPON CODES FOR YOU…
- For 10% off Innokin/Platform Products at MyVaporStore use coupon code: MTL10
- For 15% off your Lunar Rover order use coupon code: smokersshow
THE VIDEO:
*NOTE: Any use of these videos in part or in their entirety without Phil Busardo’s and Dimitris Agrafiotis’s expressed written consent is strictly prohibited.
See everything Smoker’s Show Related HERE!
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