On March 4th, 2020, Public Health England (PHE) released its sixth independent report titled: Vaping In England: 2020 Evidence Update Summary, to summarise evidence on e-cigarettes to inform policies and regulations. The report starts off stating: “This report presents updates on the prevalence of vaping among young people and adults and reviews the literature on vaping among people with mental health conditions and pregnant women. A comprehensive e-cigarette safety review will be the focus of a future report.”

This report states that it’s collected it’s data from 6 nationally representative surveys to examine the prevalence and characteristics of vaping in England. They have also screened the international academic literature for studies published between November 2018 – October 2019 that report on vaping prevalence. Other data was collected by NHS Digital from stop smoking services, the MHRA’s Yellow Card Scheme, peer-reviewed publications, and 2 systematic reviews of the published academic literature in regards to vaping among people with mental health conditions and vaping in pregnancy.

Some takeaways from this 2020 report include:

• Current vaping pervasiveness among adult former smokers continued to increase in 2019 from 12% to 13% while adult smoking rates simultaneously continue to plummet.
• Adult smoking rates in England are continuing to decline sharply over the past 10 years to historic lows in 2019 of around 15%.
• Most adults utilize vaping items to help them quit smoking cigarettes.
• Vaping remains most popular among both current and former cigarette smokers with less than 1% of never smokers being active, daily vapers.
• Between 2018 and 2019, about 37% of current daily smokers admit to never having even tried vapor products as a smoking cessation aid.
• Regular vapers report that the banning of flavored vapor products would only discourage them from trying vaping as a safer alternative to smoking, thus potentially driving them back into the arms of Big Tobacco.
• Flavored vaping bans could also push current former-smokers-turned-vapers towards illicit or black market products.
• Less than 1% of young people who are never smokers are current vapers.
• There is an absence of evidence in England on the frequency and consequences of vaping during pregnancy and on the potential impacts of vaping on maternal health.
• “Perceptions of harm from vaping among smokers are increasingly out of line with the evidence. The proportion who thought vaping was less harmful than cigarettes declined from 45% in 2014 to 34% in 2019. These misperceptions are particularly common among smokers who do not vape.”
• “Similar to previous years, data from stop smoking services in England suggests that when a vaping product is used in a quit attempt, either alone or with licensed medication, success rates are comparable to, if not higher than, licensed medication alone.”

The report continues on to say “The data presented here suggests that vaping has not undermined the declines in adult smoking. Increasingly incorrect perceptions among the public about the harms of vaping could prevent some smokers from using vaping products to quit smoking. A ban on flavored liquids could have adverse effects and unintended consequences for smokers using vaping products to quit. It should only be considered with caution.”

The UK Vaping Industry Association (UKVIA) was in strong support PHE’s latest report. In a press release on March 4th, 2020 on the UKVIA’s website John Dunne, Director of the UKVIA, said “This provides further and concrete evidence that vaping has a crucial role to play in changing the lives of smokers around the country and it dispels the myths that youth vaping is currently a major issue. However, it also tells us that the gross misinformation that has been spread about the safety of vaping has had an effect on consumers’ perceptions of e-cigarettes which could greatly influence their decision to switch from smoking which carries significantly more health risk.” Needless to say, the American Vapor Industry couldn’t agree more.

To quote Clive Bates in an interview with Regulator Watch, “That is why they (our government) retaliated with a barrage of disinformation and regulatory overkill that they hope will suppress this (the vaping industry). Effectively they are prohibitionists. They are trying to use regulation, taxation, and disinformation to kill these products off.” This sums up exactly what’s been happening to the vaping industry over the past year.

Starting in August, a new ‘mysterious lung illness’ swept the nation that had many becoming ill and even leading to some deaths. The media ran with headlines like; “Vaping illness outbreak surpasses 1,000 cases, 18 deaths with no sign of slowing, CDC says” and “Death toll rises from mysterious lung illnesses linked to vaping, prompting CDC to sound alarm on e-cigarettes“. With help from the FDA and the CDC, lead to the perfect storm of mass hysteria and misinformation spread across the country leading vaping as the media’s new target in their onslaught of fear-mongering. Anytime you heard vaping, it was immediately associated with this ‘mysterious illness that was killing innocent people’. One couldn’t step outside and vape without someone telling them how vaping was going to kill them. This lasted for weeks before reports finally started coming out that illicit THC cartridges were the cause of this outbreak of illnesses. It took even longer before the FDA and CDC would share that this was the culprit as well.

Needless to say, this situation was completely mishandled and blown out of proportion. But the damage was done, leaving many vape shop owners feeling the effects as they soon saw a decline in business. Then on September 3rd, 2019, Democratic Governor Gretchen Whitmer became the first to announce a statewide flavor ban by signing an executive order in Michigan. This quickly became a dangerous precedent as many other state governors decided to follow her lead and set their own flavor bans; states like New York, California, Washington State, and Utah just to name a few. It’s still happening, New Jersey’s Governor just signed a bill that will take effect April 20th, 2020.  This will and has caused many vape shops within these states to close either temporarily or permanently. Without the selection of flavors, vape shops were left with only tobacco and in some cases menthol flavors for sale. Many vape shops can attest that a majority of their profits come from candy/dessert/fruit-flavored eliquids. Some of these state’s flavor bans did not take effect or were even stopped by a judge thankfully. Regardless, some states didn’t get this saving grace and even those that did already seen the negative impact on their sales.

Between the numerous amounts of bogus; ‘medical studies’, the ‘youth vaping epidemic’ and the mishandling of the EVALI outbreak, the vaping industry has taken quite the beating. In the general public’s eyes, vaping is deadly and has been wrongly assumed by some to be more dangerous than smoking. It’s extremely disappointing for anyone who advocates for vaping, to see just how quick the public opinion has changed. Many of the stories that have been circulating have cherry-picked data that highlights ‘risks’ associated with vaping to scare and intimidate the public, rather than providing an unbiased and educated overview. Not only has this been fueled by the media, but even the anti-vaping organizations have played a huge part in pushing these cherry-picked reports and information. Just recently the Truth Initiative’s most recent campaign even asks kids to destroy their Juuls to quit vaping. The campaign shows a lot of younger people ‘creatively’ destroying their Juul devices in ways that could cause the lithium battery to explode. This type of campaign is not only suggesting dangerous actions, but it presents it in a ‘fun and cool’ manner trying desperately to appeal to a younger demographic. There is no excuse for spreading misinformation – not only is it causing harm to our industry, but it can also put many in harm’s way. That is why it’s so important to keep educating about vaping.

Then the FDA released its new guidance on January 2nd, 2020 titled – Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization. This 53-page document goes into detail over the ban on all flavored cartridge-based ENDS products; excluding tobacco and menthol flavors, how they plan to enforce the PMTA deadline on May 12th, 2020 and covered points regarding cigars. The key takeaways are as follows:

• The agency will prioritize the enforcement of pre-filled flavored cartridge/pod based ENDS, other than tobacco and menthol flavors. On February 1st, all retailers/manufacturers must remove and stop production of any cartridge/pod based ENDS product immediately, no matter where it is sold. Open tank systems (i.e. Box Mods, Tanks, etc) will not be affected.
• The FDA does realize that in order to utilize their resources effectively, they have to prioritize how they enforce these policies. After May 12, 2020, FDA intends to prioritize enforcement regarding the lack of marketing authorization (those who haven’t filed their PMTA) specifically against:
  • All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access.
  • Any ENDS product that is targeted to minors or whose marketing is likely to promote the use of ENDS by minors.
  • Any product still offered for sale after 5/12/2020 without a PMTA submission.
• The guidance also reviews the PMTAs and their enforcement priorities when it comes to premarket applications. After May 12th, 2020, any product on the market without a premarket application will be considered illegal and can face penalties. The FDA reserves the right to refuse any application for any reason, resulting in permanent expulsion from the market. Those who do get their applications accepted will have a 12-month extension for their products to remain on the market.

With this guidance, it seems like the FDA may not have plans to help streamline the process for small businesses. There’s no telling what exactly will happen as the deadline inches closer and closer.  Through everything; youth vaping epidemic, EVALI, bogus medical studies, raising the minimum age to 21 and over, and our government’s ever-changing regulations, our industry has been fighting to keep this amazing technology available to adult smokers looking for an alternative to smoking combustible cigarettes. We strongly believe in what we do and will continue with a fiery passion to keep these products on the market. With the help of numerous advocacy groups, we couldn’t have made it this far. If you haven’t joined an advocacy group or are looking for ways to become more involved in the fight, please consider donating to your local advocacy group like PSFA. As more updates come out on the new FDA regulations, we’ll be sure to post them on our social media accounts and on our website. If you have any questions or concerns, feel free to contact us at wearepsfa@gmail.com.

Every quarter we’ll post our newsletter with information regarding PSFA. Check back each quarter for our most recent newsletter!

Every quarter we’ll post our newsletter with information regarding PSFA. Check back each quarter for our most recent newsletter!

REGISTRATION NOW OPEN for VTA’s 4th Annual Vape & the FDA 4 Conference in Washington D.C., September 16-18.

VAPE & THE FDA 4
Defending Your Right to Vape

This is a critical time for our industry’s future and it is time to draw the line for vapor!
VTA is putting together another impressive program and Day on Capitol Hill. The issues being addressed this year are so important that they are expanding the conference to a 3-day event.

SEPTEMBER 16-17, 2019 – VAPE & THE FDA 4 CONFERENCE
SEPTEMBER 18, 2019 – DAY ON CAPITOL HILL

Last year’s 3rd Annual Vape & the FDA 3 Conference was a great success, attended by nearly 200 industry professionals representing 120 companies from 25 states and 3 countries.

On Day 1 and 2, top-notch speakers will provide practical information on how our industry and your company can and will survive and thrive. On Day 3, VTA’s team will organize another professional Hill Day as we take more than 100 small business owners to Capitol Hill to make the case for our industry.

Last year, VTA’s team orchestrated 100 meetings on Capitol Hill and we are looking to better that showing with all of you again this year! All you have to do is register and VTA will get your meetings set up, provide the relevant talking points and materials, and escort your group to Capitol Hill!

Shortly VTA will be publishing a detailed agenda shortly but here are some of the numerous timely topics that will be covered:

• Defending Flavors
• PMTA Deadlines & Requirements
• PMTA Strategies
• HPHC Testing Strategies
• FDA Litigation Updates
• Ending Improper Marketing
• Social Media & Advocacy
• Good Manufacturing Practices
• FDA Inspections
• State Vapor Round-Up
• State and Local Vapor Fights
• New State-Level Strategies for 2020

You need to be part of this event! Please forward this invitation to anyone you think may be interested in attending! Thank you and please contact VTA if you have any questions.

CLICK HERE to register.

Every quarter we’ll post our newsletter with information regarding PSFA. Check back each quarter for our most recent newsletter!

Below we have collected links to help manufacturers and retailers. We’ve included links from the FDA’s website that will direct you to specific topics. If you have any questions or comments regarding anything please feel free to contact us directly at wearepsfa@gmail.com.

MANUFACTURING – Goes over the different requirements needed from the FDA for vape manufacturers.

LABELING & WARNING REQUIREMENTS – Goes over the what is required on eliquid labels, and rules regarding the Nicotine Warning Statement

ADVERTISING & PROMOTIONAL REQUIREMENTS – Discusses what eliquid manufacturers and retailers can and can not do. For example – Sponsoring Events, Use of Brand Name, Free Sample Restrictions, and the requirements of the Nicotine Warning Statement on advertisements/promotions.

PREMARKET TOBACCO PRODUCT APPLICATIONS  – This document explains which products this guidance applies too, when a PMTA is required, General Procedures for review of Electronic Nicotine Delivery Systems (ENDS), What information the FD&C requires you submit, and what information the FDA recommends you submit.

SCIENTIFIC POLICY MEMORANDA – Memoranda to assist reviewers with the evaluation of tobacco product applications. This information adds detail about key areas of regulatory science.

CUMULATIVE NUMBER OF PMTAS RECEIVED SINCE PROGRAM INCEPTION – Reviews the numbers of PMTA’s received, approved or denied, etc.

HPHC COMPLIANCE – Reviews how companies can comply with the requirement to report on the quantities of harmful and potentially harmful constituents (HPHCs) in tobacco products.

Over the past several months, the FDA has been gunning for the vaping industry. Then to top it all off, we recently seen the Surgeon General get involved by jumping on the ‘epidemic’ bandwagon. Between the FDA, the Surgeon General and other Health Organizations the vaping industry has been getting a lot of attention – be it both good and bad.

THE GOOD:

We’ll start with the good news. The commissioner of the FDA, Scott Gottlieb M.D., praised the work of vape shops for their work with age verification during an interview with USA Today. Last year, the FDA had setup uncover operations to see if stores were selling to minors. Their data showed that convenience stores were not following proper procedures, resulting in over 1300 infractions being sent out to these stores. This made shop owners proud, knowing that together we were finally getting some recognition for our efforts.

According to New England Journal of Medicine’s Study, published on January 30th, vaping is twice as effective to help smokers quit compared to the traditional nicotine replacement therapies (such as gum, lozenges or the patch). The study found that among the 886 randomized participants 18% of the e-cigarette participants were smoke-free after a year, while only 9.9% of the nicotine-replacement group were smoke-free. The study’s conclusion states “E-cigarettes were more effective for smoking cessation than nicotine-replacement therapy when both products were accompanied by behavioral support.” Obviously, both the anti-vaping and the pro-vaping groups had a lot to say about this study. In an article from the Washington Post, they shared two opinions from both sides. One editorial, by Boston University researchers, said that e-cigarettes should only be used when FDA approved treatments do not work. While David Abrams, professor of social and behavioral sciences at New York University (who is a strong supporter of e-cigarettes) said that the British study provides “very strong evidence’ e-cigarettes” can help you quit, as good or better than nicotine-replacement therapy” over the long term. “Anybody who smokes should be switching to e-cigarettes now.” This study, along with the Royal College of Physician’s report from April 2016 has definitely made leaps for the vaping industry. It’s been great to see the positive news coming out proving what we have all been fighting and believing in over the past several years!

Besides Gottlieb’s praise, we’ve noticed there are other groups rallying behind the industry. On February 4th, the American’s for Tax Reform led a coalition (of free market, limited government and conservative organizations) that sent a letter to President Trump saying “We urge you to immediately halt the Food and Drug Administration’s aggressive regulatory assault on businesses who sell and consumers who rely on less harmful alternatives to cigarettes in the United States.” Their letter was upfront and honest but written very respectively and filled with a good collection of facts about the industry. They asked for the president to take a closer look into what’s been going on in the FDA. “We do not write you today urging your administration to ignore the concerns about the use of e-cigarettes by teens. We do, however, urge your administration to subject the FDA’s response and actions to much closer scrutiny and examine it within the context of your broader deregulatory and pro-jobs agenda.” Their final statement in their letter really gets to the heart of the problem, “We ask you to direct the FDA to pump the brakes on its new regulatory efforts against an innovative industry that is helping American smokers quit.”

Then on February 17th, the American Council on Science and Health called out the CDC for their mislabeling vaping as a ‘tobacco’ product and the spreading of misinformation on how vaping could lead to traditional smoking. According to the ACSH’s mission statement: “We do not represent any industry. We were created to be the science alternative to “news” that is often little more than hype based on exaggerated findings. We help policymakers see past scaremongers and activist groups.” They continue to say “We fight back against activists who have attacked the credibility of the overwhelming consensus of academic and private sector scientists who dispute their claims, undermining the integrity of the scientific enterprise.” This means a lot for the industry, having a group like this to speak up for us. They believe vaping may not be completely safe, and that this product should stay out of the hands of teenagers, but continue on to say that “the exaggerated hype and fear surrounding e-cigarettes runs the very real risk of undermining a valuable public health tool.” They even go as far as to make this statement: “This is very important to understand: E-cigarettes and other vaping devices do not contain tobacco. Period. They are not tobacco products, even though the government apparently considers them to be tobacco products.”

They believe that the CDC is trying to claim that vaping is a gateway to traditional smoking, but the CDC’s own data shows that this is just not true. The graph on the right shows that while vaping is on the rise, smoking rates have declined. If the CDC’s statement was true then this wouldn’t be the case, their data would show the opposite.

These are positive leaps in the right direction for the vaping industry. Although between the PMTA’s and other various hoops, we’ll need to jump through, our fight is definitely not over yet. That is extremely apparent when you see some of the negative press that has come out over the past few weeks.

THE BAD:

There have been various papers/studies released, some in favor of vaping and others that are just downright bogus. Between making claims of how vaping can cause popcorn lung or heart attacks…these studies just keep popping up. Spreading the misinformation and falsified facts that our government wants you to believe. These bogus studies have been becoming viral overnight, helping to feed the general public’s fear over vaping. It’s extremely frustrating that these scientists are continuing the efforts to spread these so-called ‘facts’ as truth, but thankfully we have a few good people out there working hard to disprove/debunk these ridiculous studies. On February 1st, a scientific paper was published on nature.com, trying to again persuade those unfamiliar that if you use eliquid that contains diacetyl, you are at risk of developing ‘popcorn lung’. The industry has all but eliminated this compound in their eliquids, and in the UK they have banned it from eliquids altogether. The other fact to consider is that cigarettes contain hundreds of more times that amount of this chemical even in eliquids that did contain it. For this study to come out now, just seems like a stretch. But thankfully it was debunked by numerous people according to vapes.com. Besides the ‘popcorn lung’ hoax popping up again, there was another study that showed vaping can cause heart attacks. Thankfully, this was also debunked but it’s another report that went viral causing more confusion and fear to be spread about vaping. This incredible amount of lying is what could be the end of the industry and that’s what makes these types of events frustrating. We work hard to provide as much information as we can, and we are going to be constantly met with opposition regardless if it is or true or not. The Pennsylvania Department Of Health tweeted “E-cigarettes, e-cigs, e-hookahs, mods, vape pens or vapes—whatever you call them, they are NOT safer than other tobacco products. Learn how you can help protect your child’s health by talking about the dangers of vaping”. Many will believe what these top-notch health organizations will put out, and many of those who do believe these lies think our information is biased and not backed up by science. It’s hard to accept that this is what the fight can really come down too, but it’s extremely important that we continue to work on educating our nation about vaping.

This video also sheds some light on how anti-vaping groups has been working or at least coordinating together to benefit one another. Watch the video to hear, in her own words, what is really going on. In this episode of RegWatch Michelle Minton, Sr. Fellow from the Competitive Enterprise Institute and author of the exhaustive report “Fear Profiteers: How E-Cigarette Panic Benefits Health Activists,” pulls back the curtain to expose the motives and tactics behind the public health crusade against vaping. (Courtesy of Regulator Watch’s Youtube Channel)

After hearing all that, it can’t get any worse, right? Well sadly no. Many cities, towns, and boroughs have been taking the law into their own hands. They have either passed their own regulations for flavor bans, T21 policies or creating their own ‘sin’ tax on vaping. Lindsey Stroud wrote a very compelling piece about why the T21 policy just doesn’t work (if you have the chance we strongly recommend reading it). Raising the minimum age to purchase tobacco to 21 won’t prevent youth use, as much our lawmakers would like to believe it would, and it only punishes adults and the state’s revenues. Some states have tried to pass a wholesale tax or flavor bans on vaping products, like Vermont was facing a 92% wholesale tax and more recently New Mexico has proposed a flavor ban. States will continue to try to pass these bills, but we must stay vigilant and work hard to stop them. Virginia, for example, was facing the same 40% wholesale tax we have in PA, but thanks to VSFA and VTA, the bill was stopped. This applies to flavor bans, T21 policies, tax bills etc. It’s extremely important to join your state and national advocacy organizations if you haven’t already. Be a part of this fight and stand up for your business, your employees and your customers! Standing together, creating that united front, is the only way we can fight against false claims, coordinated attacks, and aggressive regulations.

The vaping industry has taken a beating over the past few years. There is no denying that. It’s been a struggle for many business owners to handle flavor registrations, ingredient listings and let’s not forget some state’s wholesale taxes just to name a few. Today, the U.S. Surgeon General Jerome Adams, released a rare national advisory about the dangers of e-cigarettes.

He posted this statement today on the U.S. Surgeon General twitter account ‘Today, I am officially declaring e-cigarette use among youth an epidemic in the United States.” He goes on to pledge to use his bullypulpit to protect our children from a lifetime of nicotine addiction & associated health risks by immediately addressing the epidemic of youth e-cigarette use. In an article by Business Insider they continue the hysteria by saying, “Because of their runaway popularity, e-cigs could create a new generation of Americans hooked on nicotine, one of the worlds most addictive substances and the key ingredient in e-cigs like the Juul, these experts warn. Their concern comes in part from a host of studies suggesting that teens who vape are significantly more likely to go on to smoke regular cigarettes than teens who never vape.” It’s also important to acknowledge that nicotine salts (which is found in the Juul pods) help make this specific product more addictive. Nicotine salts have a higher nicotine ratio than that of their regular eliquid counterparts. One Juul pod contains roughly 23mg to 40mg of nicotine per pod (depending on the strength purchased). To put that into perspective, many manufacturers don’t make eliquids that go above 24mg, and many everyday users don’t use this high of an eliquid.

To recap, the majority of the industry (like our members for example) has been working diligently to combat youth access for as long as they have been open. Many shops do not allow anyone to enter who is under-the-age and card anyone who may look suspicious. They take their jobs and their responsibilities seriously.  These companies work hard to keep their doors open even amongst the other issues our industry has to face. The main point is that we agree that this is important to keep in mind, but we also don’t feel as if this is an ‘epidemic’ type of problem. This seems to be more brand-related than ‘vaping’ related.  It’s not fair that we get wrapped up into these assumptions that were created solely by these companies not making the right decisions. Throughout the FDA’s continued statements and the U.S. Surgeon General’s advisory statement, the brand Juul and blu were mentioned directly. According to the article by the Business Insider, they mention that Juul alone has captured nearly 80% of the market share in the United States. That leaves roughly 20% of shops as we mentioned earlier being roping into the problems of what these big corporations have caused. The FDA has acknowledged that a majority of the sales to minors happens at convenience stores and gas stations so they are at least starting to work in the right direction. But sadly, it’s still going to take some time before we can separate ourselves from these companies in the eyes of the general public.

Companies like Juul and others have been working to create better measures to prevent youth access. Juul Labs, who is the manufacturer of the Juul pod system, has temporarily halted sales of their flavored pods in 90,000 retail stores. They are even going as far as shutting down their social media accounts according to CBS News. This is part of Juul’s plan to continue working on strengthening their age restriction policies. This was in response to the FDA’s statement on September 12, 2018, requesting that ‘5 of the biggest e-cigarette manufacturers to put forward a plan to immediately and substantially reverse these trends [of youth vaping] or face a potential decision by the FDA to reconsider extending the compliance dates for submission of premarket applications.’ Who knows how this will work out for these companies. Will the limitation of flavors really stop kids from getting their hands on products like the Juul?

In a video released on November 17th, 2918 by regulatorwatch.com, Dr. Michael Siegel M.D. had this to say about the FDA’s terminology of ‘epidemic’ in regards to teen vaping. “I don’t think that health authorities describing this degree of a threat for a product[vaporizers] that when compared to another product[cigarettes] that’s on the market poses a much much great threat. Often there is hysteria about various health risks. But this is a really strange one because of the contrast between the harms that tobacco cigarettes are causing and the harms that e-cigarettes are causing. And just to be very clear on the science, we know that cigarettes are causing more than 400,000 deaths each year. To the best of our knowledge, there are no deaths that ever been associated with vaping.” He even goes on the mention how many health groups have misled the public about the dangers of vaping. For instance, many people are afraid of getting ‘popcorn lung’ but not one case has been reported. He goes on to discuss that there are many statements that health groups like thetruth.com etc. use to mislead the public about vaping. It’s grossly inappropriate that these groups can do this. Not only does this cast a shadow on new innovative technology for adult smokers, but it also deters many from ever giving vaping a try.

Overall, with the U.S. Surgeon General’s warning being released today, and the fact that there is no clear distinction between companies like Juul and vape shops, this can potentially deter more adult smokers from ever giving vaping a try. This gives vaping a bad reputation that is just going to be hard to shake. We must continue to educate, inform and fight for our rights as vapers and continue to move through this together.