Author: pbusardo

PMTAs cost anywhere between $117,000 and $466,000—entirely unaffordable for your average mom-and-pop shop. What’s worse is that manufacturers with different flavored products have to submit these expensive PMTAs multiple times, one for each variant. But according to the FDA, store owners should not fret—at least each application is not “millions of dollars [as] described by some others.” Requiring vape shops to shell out six figures to get approval to sell a product is unreasonable and borderline punitive.

Read the entire article HERE.

Last month, 15 past presidents of the venerable Society for Research on Nicotine and Tobacco (SRNT), the top tobacco research society in the world, co-authored a courageous, groundbreaking article that argues that the media, legislators, and the general public have developed a negative view of e-cigarettes (vaping products) because of the heavy emphasis public health organizations have placed on protecting youth from vaping while ignoring the potentially substantial benefits of e-cigarettes in helping tens of millions of addicted adults quit smoking. The authors lay out thoughtful policy recommendations on how to balance concerns about the risks with the potential benefits.

See the entire article HERE.

Here’s the latest from Brent Stafford at Regulator Watch

In this episode a passionate and pissed off PBusardo joins Brent Stafford, Dimitris Agrafiotis and Amanda Wheeler to discuss the latest FDA death sentence to smokers and vapers alike.

Join RegWatch for a special live episode to unpack the reckless behaviour of the U.S. Food and Drug Administration in its decision to delay authorizations of nicotine vaping products for controversial companies such as Juul. While issuing Marketing Denial Orders for millions of products manufactured and sold by thousands of small businesses operating in the U.S. market.

*Guests: Amanda Wheeler, Exec. Dir., Arizona Smoke Free Business Alliance & President, Rocky Mountain Smoke Free Alliance / Dimitris Agrafiotis, Exec. Dir. Tennessee Smoke Free Association / Phil Busardo, Vape Evangelist
Only on RegWatch by RegulatorWatch.com

Streamed Live: September 10, 2021
Produced by Brent Stafford

This episode is supported by DEMAND VAPE

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

Matthew Myers, president of the Campaign for Tobacco Free Kids, which sued the FDA to create the Sept. 9 deadline, applauded that progress but insisted it was not enough.

“While FDA has said it has ruled on 93% of the applications, it hasn’t ruled on the products that have driven the youth e-cigarette epidemic. Every day those products remain on the market, our kids remain in jeopardy,” said Myers. “It is very frustrating that this problem has been allowed to fester for more than a decade. There needs to be a resolution and a resolution quickly.”

Myers added that if the FDA does not decide on the major applications soon, his group will “have no choice but to go back to the court to have the court enforce its order requiring FDA to begin to remove any product not authorized.”

Myers declined to say when the group would go back to court but added that “this can’t be a delay of months, it has to be resolved promptly or else we have to ask a court to intervene.”

Read the entire article HERE.

To me, it looks like we are going to know nothing new, outside of the horrible news we already know, today. To quote a friend, “they are worms”.

Bottom line, NOTHING has been approved, but them cigarettes are still out there though!

They have banned millions of private sector, small business products while delaying the decision on the larger, Big Tobacco owned Juul. Let’s think about that for a second.

Let’s add more job loss, more business loss, more stress, and more death to an already struggling society. But hey, the kids are safe because Mom and Dad can’t control them.

Perhaps the title of this press announcement should have been, “FDA Makes Significant Progress in destroying lives, jobs, and killing people.”

Press announcement from the FDA:

As of today, the agency has taken action on applications for over 6 million ENDS products, including refusing to file (RTF) one company’s applications for approximately 4.5 million products because required contents were missing as well as issuing 132 MDOs for more than 946,000 flavored ENDS products, including flavors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal.

We continue to work expeditiously on the remaining applications that were submitted by the court’s Sept. 9, 2020, deadline, many of which are in the final stages of review. For premarket tobacco product applications, our responsibility is to assess whether applicants meet the applicable statutory standard for marketing their new products. As we have said before, the burden is on the applicant to provide evidence to demonstrate that permitting the marketing of their product meets the applicable statutory standard. Our continued review also includes a smaller number of pending applications that are being reviewed under the “substantial equivalence” standard, for cigars, pipes and hookah tobacco and for which we’ve granted marketing orders covering over 350 products.

All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and subject to enforcement action at the FDA’s discretion. The FDA is committed to completing the review of the remaining products as quickly as possible to provide regulatory certainty and will continue to keep the public informed of our progress. In the meantime, products for which no application is pending, including, for example, those with a Marketing Denial Order and those for which no application was submitted, are among our highest enforcement priorities. If such products are not removed from the market, the agency intends to follow its usual enforcement practices in these circumstances and will issue a warning letter before initiating enforcement action (such as civil money penalties, seizure, or injunction) and afford the recipient an opportunity to respond. Since January 2021, we have issued a total of 170 warning letters to firms that collectively have listed more than 17 million ENDS with the FDA and that had not submitted premarket applications for these products. Among those warning letters, and in an effort to take action on products with a likelihood of youth use or initiation, the FDA issued a warning letter in July to a single company that did not submit an application and has more than 15 million products listed with the FDA.

Read the full article HERE.

Our friend Amanda Wheeler appears in this article:

Is the delay just for Juul? I guess we’ll find out later today. I’ll post more as I see it.

The Food and Drug Administration will reportedly seek more time before deciding whether Juul can continue to sell its e-cigarettes in the United States, The Wall Street Journal reported Thursday.

A court mandate created a timeline for the agency to review vaping products, following years of pressure from politicians and public health groups to regulate the segment as strictly as other tobacco products.

The FDA did not immediately respond to CNBC’s request for comment.

See the entire article HERE.

I saw a post by Jay and wanted to help, not to mention that I thought this was a really good idea.
Hopefully this can stick around for a while and expand!

Go to the FIVE PAWNS website for more information!

The Legacy Collection by Five Pawns

The Rebirth of USA-Made iconic Flavors

We’ve partnered and curated a stable of iconic USA-made e-liquid brands and their most popular flavor profiles, which are handcrafted in small batches in our state-of-the-art facility. The Legacy Collection represents some of the original pioneers in tobacco harm reduction, and we are excited to bring these award-winning, highly sought-after flavors back to the market.

All wholesale orders in and paid by 9.9 will receive special pricing!

Good luck with the new collection Jay and the rest of the Five Pawns Team!

Fake and misleading news! This is from an NPR article:

Inhaling the vaporized oil introduces harmful chemicals into the lungs, including vitamin E acetate. Dozens of people have died in recent years from vaping complications in the U.S., and thousands more have been hospitalized.

We all know this was from illegal, tainted THC carts, yet presented as if it was a common issue in all vapes. Why are the FACTS not mentioned, just the FEAR.

Also, when I say “We all know”, that is an issue because WE DO KNOW, but the general public does not know due to articles such as this.

The above paragraph followed this one…

Though vaping allows users to avoid some of the harmful carcinogens caused by smoking traditional cigarettes, studies have found that e-cigarettes are still harmful.

So they went from talking about apples in the first paragraph (harm reduction from cigarettes by switching to nicotine and non-nicotine vaping) to oranges in the very next paragraph (illegal, tainted THC cartridges) unnecessarily confusing the general public with their fear mongering narrative.

Not to mention, they have to throw that “e-cigarettes are still harmful” dig in there. Ok… How harmful when compared to a cigarette? How about telling us that?

Not having the ability to combat their narrative is just one of the reasons we sit and wait to see what this day will bring.

So frustrating.

Here’s the article:

A Major Decision From The FDA Today Could Dramatically Reshape The Vaping Industry

Here’s the latest from Brent Stafford at Regulator Watch

It is a remarkable development in the contentious debate over nicotine vaping. A group of influential tobacco control experts authored a paper, published in The American Journal of Public Health, calling on the broader health community, policymakers, and the media to re-evaluate and reform their positions on vaping in favor of vaping as a tool for harm reduction
Joining us today on RegWatch is Dr. Robin J Mermelstein, Distinguished Prof. of Psychology and IHRP Director at the University of Illinois-Chicago, and Chair of FDA’s Tobacco Products Scientific Advisory Committee. Dr. Mermelstein is one of 15 past presidents of the prestigious Society for Research on Nicotine and Tobacco that coauthored the paper.
Why does this renowned group of anti-tobacco scientists advocate for greater adult access to nicotine vaping products? Find out.

Only on RegWatch by RegulatorWatch.com

Released: Sept 2, 2021
Produced by Brent Stafford

This episode is supported by DEMAND VAPE

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

At least there is SOMEONE in mainstream media that is making sense. Thanks Greg!