Category: Vaping News

In the letter, dated Sept. 14, the trade associations argued that if the price of tobacco products spikes, buyers would move to the tobacco black market where sellers don’t abide by standard regulations and often prey on young people.

“When the price of a product rises too much too fast, illicit purveyors will seize the opportunity to exploit and take advantage of current users and entice new users without discriminating based on age,” the letter read. “This undermines the responsible measures our retailers have taken and creates a problem for society as a whole.”

Read the entire article HERE.

The department said it pulled back the proposal on Wednesday because it’s working on an alternative legislative solution to address youth vaping, one that so far appears to be significantly scaled back from the department’s full ban.

Read the entire article HERE.

According to the latest results from the National Youth Tobacco Survey (NYTS), 11 percent of high school students qualified as “current” electronic cigarette users this year, meaning they reported vaping in the previous month. That’s down from nearly 20 percent in 2020 and nearly 28 percent in 2019—a 60 percent drop over two years. The Centers for Disease Control and Prevention (CDC), which conducts the survey, and the Food and Drug Administration (FDA), which regulates “electronic nicotine delivery systems,” both welcomed this evidence that the “epidemic” of underage vaping is abating.

See the entire article HERE.

This segment of What’s Ahead sharply admonishes the Food and Drug Administration’s cruel and wrongheaded crusade against e-cigarettes.

The agency refuses to green-light even a single application, putting the vaping industry in legal limbo. It should follow the science, as other countries are doing.

Real world experience and studies have demonstrated that nicotine vaping is 95% safer than traditional cigarettes. It’s by far the most effective way to stop smoking—better than nicotine patches, gums and other antismoking aids. That’s why British health authorities strongly recommend vaping to reduce cigarette smoking. In fact, the country’s national health service hosts vaping shops in its hospitals. And France doesn’t tax e-cigarettes, in sharp contrast to the levies it imposes on traditional tobacco products.

Contrary to myth, vaping isn’t a gateway to teenage smoking, which has actually been declining.

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.

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.

In a new paper, the most influential tobacco control experts in the country have come together to endorse the harm reduction benefits of vaping for adult smokers, calling for the rehabilitation of its public image and emphasizing its ability to save lives as a safer alternative to combustible cigarettes. The publication represents the most organized and explicit call-out by such scholars to date.

The article, published August 19 in The American Journal of Public Health, was led by Kenneth Warner, a professor emeritus of health management and policy at the University of Michigan and a distinguished tobacco control expert. It addresses everything from the confusion of nicotine’s effect on the developing brain to how we should balance the concerns about the risks and potential benefits of vaping. It should serve as a much-needed corrective to the swirl of misinformation that surrounds vaping.

LINK TO FULL ARTICLE
LINK TO ENDORSEMENT ARTICLE – Balancing Consideration of the Risks and Benefits of E-Cigarettes

Endorsement Article can also be found below…