On March 12, the U.S. FDA issued warning letters to 13 firms who manufacture and sell unauthorized e-liquids. The regulatory agency advised the companies that selling products lacking a premarket authorization is illegal, and therefore cannot be sold or distributed in the U.S.
Credit: Isaiah Rustad
The firms did not submit a premarket tobacco product application (PMTA) by the Sept. 9, 2020 deadline, according to a press release from the FDA. The firms receiving warning letters are VapinUSA-WI, LLC d/b/a VapinUSA, Vapor Springs, LLC, Vapor Cigs, LLC, Vegas Vapor Emporium, LLC, Vape 911, The Philosopher’s Stone, LLC, The Clean Vape, Tooters Vape Shop, Cloudchasor LLC, Boardwalk Elixir, LLC, Dieselbycg-Hometown Vape Lounge, Blue Lab Vapors LLC, and Revolution Vapor LLC.
“While each warning letter issued today cites specific products as examples, collectively these companies have listed a combined total of more than 75,000 products with the FDA,” the statement reads.
Following an initial set of such warning letters announced earlier this year, FDA has continued to issue additional warning letters for products that failed to submit a PMTA.
Per a court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016—including e-liquids—were required to be submitted to FDA by Sept. 9, 2020. For companies that submitted applications by that deadline, FDA generally intends to continue to defer enforcement for up to one year pending FDA review, unless there is a negative action taken by FDA on the application.
The U.K. Vaping Industry Association (UKVIA) has unveiled a landmark package of recommendations to government, aimed at maximizing the public health benefits of vaping and bolstering ambitions for a “Smokefree 2030.” The document, A Blueprint for Better Regulation, urges government to use its post-Brexit independence to become a world leader in harm reduction.
The U.K.’s Tobacco and Related Products Regulations (TRPR) are currently being reviewed, with a crucial consultation due to close on March 19. The resulting decisions made by government are set to shape public health and smoking cessation policy for years to come.
Former Health Minister Norman Lamb, also a former chair of Parliament’s science and technology committee, praised the recommendations.
The TRPR review offers a great opportunity to improve public health across the U.K. by tackling misinformation about vaping.
“I welcome the launch of the UKVIA’s Blueprint document responding to the government’s consultation—the TRPR review offers a great opportunity to improve public health across the U.K. by tackling misinformation about vaping.
“It also presents an opportunity for the industry to build on the evidence-based approach, which the government has consistently taken on vaping products, and to support smokers who want to switch to a less harmful product.”
“The current public consultation on TRPR and SPoT is an ideal opportunity to highlight how less harmful products have improved public health,” said former Labour MP Kevin Barron, who is also a former chair of Parliament’s health and social care select committee.
“The current lowest recorded smoking rates have been achieved by numerous avenues including switching from tobacco to less harmful products. The opportunity to bring in legislation to further encourage the move to products that can satisfy an addiction using products 95 percent less harmful than burning tobacco should not be missed.”
The opportunity to bring in legislation to further encourage the move to products that can satisfy an addiction using products 95 percent less harmful than burning tobacco should not be missed.
Developed by the sector’s leading businesses, the recommendations aim to help adult smokers quit, while increasing vaping’s economic contribution and even addressing environmental concerns. The UKVIA Blueprint, among other things, calls for:
The use of government-approved, expert health claims on products, to encourage smokers to switch
Greater opportunities to engage with smokers, as current restrictions also deter those who may otherwise make the switch
The extension of certain regulations to cover additional vaping products, such as non-nicotine e-liquids, thereby supporting a highly responsible industry
Product size changes that reduce prevalence of single-use plastic
John Dunne
“The recommendations published today are the result of intense collaboration among vaping’s leading experts and entrepreneurs,” said John Dunne, director general of the UKVIA. “This is truly a landmark moment in the history of our industry, which has grown to be a genuine market disrupter, and a route out of smoking for people all over the world. With the adoption of these recommendations, the U.K. could take its place as a progressive, global leader on public health.
“The government has claimed that post-Brexit regulatory independence will mean a new, and better, way of doing things. Now is the time for this pledge to become a reality. By embracing this evidence-based approach, we can empower consumers, revitalize businesses and put the ‘Smokefree 2030’ ambition within our grasp.”
A new film being launched by a Yorkshire cancer charity wants to turn around the growing mistrust surrounding vaping and e-cigarettes. The group says that the misinformation is inhibiting efforts to save lives.
The 30-minute documentary “Vaping Demystified” was commissioned by Yorkshire Cancer Research (YCR) and launched on No Smoking Day (March 10). The film features interviews with several tobacco harm reduction experts in the hopes of fixing the falsehoods surrounding vapor products.
The film confronts the impact of negative media coverage when the general public give their opinions on e-cigs. Many think that it is as bad as or worse than smoking, which is completely false, according to numerous studies. The film makes clear that many people are not aware of the ground-breaking scientific studies involving vaping.
Martin Dockrell, tobacco control lead for Public Health England (PHE), for example, discusses a PHE study that found vaping to 95 percent safer than smoking combustible cigarettes, according to a story in the Yorkshire Post. “We have been following the evidence about vaping as it has been evolving, and what has become increasingly clear is that vaping is far less harmful than smoking and perhaps twice as effective as licensed medicines at helping smokers to quit,” he said in the film.
The film details additional studies that show an increasing mistrust of vaping, with the proportion of those who think it is less harmful than cigarettes falling from 45 percent in 2014 to 34 percent in 2019. In 2019, the e-cigarette or vaping product use-associated lung injury (EVALI) cases hit the headlines globally. EVALI was found to have been caused by black market THC vapes that contained vitamin E acetate, and had nothing to do with e-cigarettes like many media reports had claimed.
Stuart Griffiths, director of research at YCR, said by the time the true cause had been found, the media cycle had moved on. “We didn’t see any of these vaping injuries that the US saw,” he said. “It got a lot of coverage – but the end of the story never really came out, that it was a consumer product that had been tampered with.”
White Cloud Electronic Cigarettes, a stalwart in the vaping industry, will end all online sales for U.S. customers on March 26 at 4pm. In a post on its Facebook page, the vapor company stated that it will continue to fill international orders (the vape mail ban is for U.S. customers) and will post a list of retail stores that will still carry White Cloud products.
“This was not a decision we wanted to make, especially after putting so much effort into submitting our PMTAs to the FDA and ensuring our products never reached the hands of minors. But, after spending the last couple of months searching for a solution to the vape mail ban, we’ve reached the end of all possible options and there is simply nothing we can do to continue shipping domestically,” the post states. “We will be fulfilling all U.S. orders until March 26, and inventory is running out rather quickly, so we urge you to place an order as soon as possible to ensure you’ll have a chance to stock up on your favorite White Cloud products for the last time.”
The company asks that vapor industry advocates send a message to Congress, as well as support the Consumer Advocates for Smoke-free Alternatives Association (CASAA), an advocacy group to raise awareness and protect consumers right to access reduced harm alternatives. CASAA has organized a campaign to fight the U.S. mail ban.
“CASAA has been made aware that some lawmakers are refusing to acknowledge the validity of organized consumer campaigns, and are insisting their constituents contact them directly via their website,” a recent CASAA statement says. “Therefore, CASAA is recommending that you also copy and paste your comments from our form below to the contact form on your lawmaker’s website. You can find their website by using our Legislator Lookup tool.”
Amid the economic devastation caused by Covid-19, one industry has actually thrived: the cigarette business. Some people are smoking to relieve the emotional and economic stress of lockdowns. But many others returned to smoking when the lower-risk options they relied on, such as nicotine vapor products, became too expensive or hard to find when compared with the combustible tobacco available at every gas station and corner store.
Now, Congress wants to eliminate the ability for adults to receive e-cigarettes by mail, a measure that will reduce access to these life-saving options even after the lockdowns end, Minton writes in National Review.
Buried within the omnibus spending bill passed at the end of last year was the “Preventing Online Sales of E-Cigarettes to Children Act.” The Act, colloquially called the “vape mail ban,” prohibits the U.S. Postal Service (USPS) from delivering nicotine or cannabis vaping products.
One might think that e-cigarette makers could simply switch to private carriers, such as FedEx or UPS. But these private carriers don’t deliver to all addresses, particularly in rural areas. Private carriers actually rely on USPS to make “last mile” deliveries. Even if private carriers did deliver everywhere in the U.S., most — including FedEx, UPS, and DHL — have yielded to the anti-vaping mob, voluntarily ending e-cigarette deliveries.
For any carrier hoping to fill the gap, the new law also imposes strict requirements on records-keeping, tax collection, and reporting. These requirements will significantly raise the cost of e-cigarette deliveries, which will be passed on to consumers. And that added expense, even if relatively small, will be enough to discourage many adults — particularly those in lower-income brackets — from continuing to use e-cigarettes.
Supporters of the law seem to think that if they force adults to quit vaping, they will simply quit using nicotine altogether. They’re dead wrong.
Study after study has shown that policies that make e-cigarettes more expensive can reduce e-cigarette use. But they also increase smoking. The same is true for convenience: The harder it is for smokers to access e-cigarettes, the less willing and able they’ll be to choose e-cigarettes over combustible cigarettes, which are available almost everywhere.
Perhaps some think that more adult smoking is a small price to pay to protect children. More adults smoking is, in their mind, a small price to pay to stop the small percentage of minors willing to break the law to get their hands on e-cigarettes.
MIchelle Minton / Credit: Competitive Enterprise Institute
As the name of the law implies, the purpose of the Preventing Online Sales of E-cigarettes to Children Act is to stop those under 21 years old from illegally purchasing nicotine products online. But if that were really the goal, there are less-extreme approaches, such as requiring an ID check on delivery, a service offered by all major delivery services (and USPS) and that has proved sufficient for alcohol deliveries.
But that’s not the purpose of the law. The real goal is to hurt the legal vaping industry, which the vape mail ban will almost certainly do. It will also be a boon to the illegal vaping market, as well as the traditional cigarette business. What it won’t do is stop youth from buying e-cigarettes. Ironically, it may only make it easier, as less respectable businesses step up to fill the gap in the market that the law is creating.
Most of us would prefer to buy the things we want from licensed, reputable businesses, especially given the dangers associated with illicit goods. But, if regulation prohibits those things or makes them too expensive, it rapidly opens the door for illegal markets. The more unmet demand there is, the larger the illegal market. For example, New York City’s high cigarette taxes led to a vibrant underground market for cheap cigarettes.
The bootleg cigarette business became so widespread, in fact, that by 2013 more than 60 percent of all cigarettes sold in the state were illegal. The continued prohibition on recreational cannabis in some states and high taxes in states where it is legal also explain the continued existence of an illicit THC market, which in 2019 caused thousands of people to be hospitalized and several deaths due to contaminated products.
The illegal market for nicotine vapor is small at the moment, because there remains a relatively vibrant, legal market for adults. But it will grow if lawmakers continue their irrational push to make e-cigarettes as expensive and hard-to-get as possible. And the larger it grows, the easier it will be for youth to buy these products online. That is because, in addition to ignoring shipping laws and skirting taxes, dealers on Snapchat and Facebook aren’t likely to verify the age of their customers.
So, by banning vape mail, Congress is not only kicking legal vapor businesses when they are down, forcing adults back to smoking tobacco, and forfeiting much-needed tax revenue; it is also making youth vaping more likely and more dangerous by encouraging an illicit vapor market and forcing consumers into it.
Michelle Minton is a senior fellow specializing in consumer policy for the Competitive Enterprise Institute, a free-market public policy organization based in Washington, D.C. The author’s opinion may not be the same as Vapor Voice staff.
West Virginia Governor Jim Justice committed to phasing out the states income tax in his 2021 State of the State Address. His proposal, submitted days ago to the state legislature for review, includes a hike in the states e-cigarette tax from 7.5 cents per millimeter of e-liquid to 75 cents per milliliter.
Credit: Pasja1000
Under the proposal, a 100 milliliter bottle would carry a tax of $75, a 1000 percent increase. The bill also increases the tax on combustible cigarettes by 80 cents per pack, bringing the total to $2 per 20 cigarettes.
At 75 cents per ml, a standard 30ml bottle of e-liquid would carry a $22.50 tax, which is 12.5 percent higher than the proposed tax burden on a full carton of cigarettes (200 cigarettes) if taxed at $2 per pack.
In a story for Filtermag.com, many West Virginia vapers, vape shop owners, and tobacco harm reduction advocates—is that many will return to smoking or resort to a dangerous black market to save money.
“We won’t be able to stay in business,” said Cheryl Lockhart, the owner of Hazy Hollow Vapors in South Charleston, West Virginia. “Nobody is going to pay for that.” The tax on the bottle would be more than the cost of the bottle itself, and most of what Lockhart sells—she ballparked up to 90 percent—are 100 milliliter bottles of e-juice. “I don’t see any path around it,” she told Filter. “It’s just one more thing.”
Another concern is that West Virginia vapers may turn to neighboring states such as Kentucky and Ohio to make e-liquid purchases and denying the state any tax dollars from vapor products. This is what happened when Massachusetts increased its vapor tax.
“No other state has a one-size-fits all volume tax higher than 10 cents per milliliter, yet Governor Justice and his team concluded that 75 cents per milliliter is rational,” said Gregory Conley, the president of the American Vaping Association. “While they may see this tax hike as a ‘small’ part of their overall plan, this is going to anger a whole lot of voters and cause them to believe their elected officials would prefer they keep smoking cigarettes.”
Lawmakers in Ceredigion county, Wales want vaping and e-cigarettes to be treated the same as combustible cigarettes and be banned in public areas like schools, playgrounds and hospital grounds, according to reports.
Credit: Krystian Graba
New legislation came into force from March 1 banning smoking from school grounds, hospitals and play areas, with Welsh Government leaving the decision on vaping up to local authorities, according to Nation CYMRU. Ceredigion county councilors recommended that the same new rules banning smoking be the same for those using alternatives such as vapes and e-cigarettes but added that the same level of enforcement would not be possible.
Chairman of the healthier communities overview and scrutiny committee said on Monday, March 8 that seeing people vaping in playgrounds, combined with the different flavors available, could be “drawing children in.” He added he was a “little disappointed” the current legislation did not go further in allowing enforcement of vaping restrictions.
Cllr Bryan Davies supported this and said that vaping should be treated the same as smoking. Questions were raised about how the legislation covered council land leased by community councils and how enforcement would be resourced.
The council will be the enforcement body for premises while the police will enforce the ban on smoking in cars with children. The committee approved the report, adding that consideration be given to including vaping on any signage indicating where smoking is banned.
It is recommended that “steps are taken to ensure all Local Authority smoke-free settings comply with the new legal requirements.” It also noted the additional enforcement requirements on public protection services and “further recommends necessary changes to the Constitution to reflect the implementation of the Smoke-free Premises and Vehicles (Wales) Regulations 2020.”
In an effort to secure its commercial customers, Securience, LLC is merging with VapinDirect, an online vaping wholesaler. The parent to the DuraSmoke, Forge, AmericaneLiquidStore, and VapeMoar brands will officially become a part of VapinDirect beginning March 31, 2021, according to an email to its customers.
Credit: VapinDirect
Last month, Securience announced it would be shuttering its business. In a letter to its partners, the company stated that the recent amendment of the Prevent All Cigarette Trafficking (PACT) Act to include vaping products, which prohibits the shipping of vapor products through the U.S. Postal Service (USPS), was the catalyst for the decision to close the company’s doors.
“A top priority of ours has always been to ensure guidelines and legal rules are held to the utmost standards. PACT Act raises these standards, and we want to ensure all our customers that they will be maintained,” the email stated. “This merger will allow us to continue to distribute products business to business
Based in Green Bay, Wisconssin, VapinDirect will add Securience’s manufacturing capabilities in Wauwatosa. VapinDirect will also be adding another 14,0000 products to Securience’s existing catalog.
“VapinDirect is larger and thus more financially stable, having about [five times] our employment level, and thus better able to manage growth and change in the industry,” the email states. “Our existing employees will be added to their team and will continue to use the same ISO-certified processes and equipment in the same Wauwatosa location.”
The email states that the company will be contacting its wholesale customers over the coming weeks to introduce VapinDirect. The company will also be clarifying its procedures regarding shipping. “There are many other challenges within the industry concerning PACT and this merger is one of the many ways we will continue to find a way,” the email states.
The litigants in two lawsuits challenging the constitutionality of the the U.S. Food and Drug Administration’s (FDA) Deeming Rule for vapor products have asked the Supreme Court of the United States (SCOTUS) to take up the cases.
The cases are Big Time Vapes, Inc., et al. v. FDA, and Moose Jooce, et al. v. FDA.
Attorneys for the plaintiffs in the Moose Jooce case filed a petition for writ of certiorari, a request to have the U.S. Supreme Court consider the case. On February 26, 2021, the Moose Jooce challengers filed their petition asking the Supreme Court to take up questions related to their challenge to the Deeming Rule under the “Appointments Clause” in Article II, § 2 of the Constitution.
The plaintiffs claim that FDA acted improperly because the person that issued the deeming regulations was not qualified to do so per the Appointments Clause. In this case, the rule was issued by Leslie Kux, the associate commissioner for policy, and not the commissioner himself, according to an attorney for Troutman Pepper.
FDA has argued that the commissioner—in both 2016 and 2019—ratified the regulations. Both the U.S. District Court for the District of Columbia and the U.S. Court of Appeals for the District of Columbia have ruled against plaintiffs in the Moose Jooce case. The district court and court of appeals held that these circumstances did not render the Deeming Rule invalid. The plaintiffs are represented by the Pacific Legal Foundation.
In the Big Time Vapes case, the challengers petitioned the Supreme Court for a writ of certiorari on December 18, 2020. The case involves the claim that the statute purportedly authorizing the Deeming Rule is an unconstitutional delegation of Congress’ legislative power.
The challengers in the Big Time suit initiated their case in the U.S. District Court for the Southern District of Mississippi. The court granted the FDA’s motion to dismiss and denied the challengers’ motion for preliminary injunction and the Fifth Circuit affirmed the decision.
There is no guarantee that the Supreme Court will take up these cases. According to the Administrative Office of the U.S. Courts, the court accepts 100-150 of the more than 7,000 requests it receives each year.
The FDA will have the opportunity to respond to the challengers’ petitions before the Supreme Court acts on them. Review “is not a matter of right, but of judicial discretion,” and the petitions “will be granted only for compelling reasons.”
Currently, vapor businesses are still subject to the Deeming Rule.
VPR Brands has filed lawsuits against three more vapor companies for violating its “auto draw” patent. The company filed a lawsuit against three previous companies in February. The company owns intellectual property rights for one of the original patents filed for electronic cigarette technology.
Credit: VPR
The patent dates back to 2009 and includes independent claims covering vaping products containing an electric airflow sensor, including a sensor comprised of a diaphragm microphone. The sensor turns the battery on and off, and covers auto-draw, button less e-cigarettes, cigalikes, pod devices and vaporizers using an airflow sensor.
“Just this week we have filed three additional lawsuits which brings the total to six with many more expected and likely as almost every company in the vape space has at least one product which uses the Patented “auto draw” technology.” said Kevin Frija, CEO of VPR Brands. “We will be aggressively pursuing every company infringing on our patent no matter how small or how large they maybe.”
VPR Brands along with SRIPLAW has started to identify and notify over 50 of the leading companies. These companies were prioritized, based on sales volume and popularity. Most recently VPR Brands LP and its legal team, headed by Joel B Rothman of SRIPLAW, have filed litigation against Mong LLC, B&G Trading LLC, and Lightfire Holding LLC. The three previous suits were filed against Jupiter Research, Cool Clouds Distribution and XL Vape.
“We want to make sure VPR Brands Patent which is valid until 2030 is enforced and our Intellectual property rights are protected,” said Frija. “We intend to send a clear message to the industry that we mean business and of course, as they say, “business is business” it’s nothing personal, in the end its just business.”
