Author: Staff Writer

U.S. FDA Could Enforce Synthetic Nicotine on July 13

The U.S. Food and Drug Administration tomorrow is expected to officially close the loophole that allows synthetic nicotine to be sold. July 13 is the deadline for the regulatory agency to complete its approval process on synthetic nicotine products.
It is unlikely the FDA will have been able to have reviewed premarket tobacco product applications (PMTAs) that were submitted by the May 14 deadline. The agency has not yet completed reviews for many other electronic nicotine-delivery system (ENDS) products using tobacco-derived nicotine that submitted PMTAs by the Sept. 9, 2020 due date.
Attorneys in the vaping industry say Congress set unrealistic deadlines for manufacturers to submit PMTAs and for the FDA to review them. The law, which took effect April 14, gave companies until May 14 to submit a PMTA, and all existing products that haven’t garnered authorization must come off the market by July 13.
The FDA said last week that it’s still reviewing the “large number of applications” it received for synthetic nicotine products, but declined to share the total number submitted, according to media reports.
Synthetic nicotine products on the market after July 13 “without an FDA marketing granted order” would be considered in violation of federal law and “may be subject to FDA enforcement,” the agency stated.
It is expected that FDA will issue at least some marketing denial orders for companies that submitted a PMTA but didn’t include required data, such as an environmental impact assessment.
In March, the U.S. Senate approved a $1.5 trillion legislation by a 68-31 bipartisan margin that included language that changed the definition of a tobacco product to include synthetic nicotine.
The rule became law 30 days after the bill’s passage date. Congress further granted synthetic nicotine products a transition period in which such products would be allowed to stay on the market until July 13, 2022, provided that they submit the required PMTA by the May 14 deadline—unless the FDA had already denied a non-synthetic version of the same product (meaning those manufacturers were subject to enforcement 30 days after the passage of the bill).
The language of the Tobacco Control Act changed to define a tobacco product as “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption.”
Matthew Myers, president of the Campaign for Tobacco-Free Kids, said that the FDA needs to act on Congress’ rules for synthetic products.
“It would be outrageous if the FDA failed to enforce the law after Congress acted with urgency to address a growing threat to the health of our nation’s kids: E-cigarette manufacturers’ use of synthetic nicotine to evade FDA regulation and keep selling flavored products that attract and addict kids,” he said. “In recent years, a growing number of e-cigarette makers have switched to using synthetic nicotine – nicotine that is made in a lab, rather than derived from tobacco – after the FDA acted against their flavored products made with tobacco-derived nicotine.”
July 12, 2022
U.S. FDA Updates Safety Reporting Portal for Tobacco
The U.S. Food and Drug Administration has made several updates to the desktop Safety Reporting Portal (SRP) tobacco questionnaire to improve the clarity, internal consistency and utility of the information being collected, according to the regulatory agency. The move will enhance the agency’s Center for Tobacco Products’ (CTP) public health surveillance for new and existing safety signals.
Some of the updates include:
Questions have been edited for inclusiveness and clarity that FDA is interested in health and product problems arising both from direct use of (by users) or exposure to (in nonusers) tobacco products
Questions about a tobacco product’s manufacturer are now designed with a search/select response list that provides submitters who know the manufacturer’s name with the full contact information for many of the manufacturers
The optional health questions now include questions about use of alcohol and other substances of abuse, and ask more details about diagnostic testing, treatment settings, and final health outcomes
Additionally, when manufacturers register an account in the SRP, they are asked to specify the type of manufacturer.
“FDA encourages anyone who has had a reaction to, or was hurt by, a tobacco product – or knows someone who experienced such effects – to visit the SRP and provide as much information as possible,” according to an FDA statement. “Reports from consumers/concerned citizens and healthcare professionals may be submitted anonymously, but including contact information allows FDA the option to find out more about the adverse experience. FDA reviews all tobacco-related SRP reports to identify new or concerning trends.”
July 11, 2022
Judge Blocks Washington, Oregon Flavored Vape Ban

A voter-approved ban on flavored tobacco in Washington County, Oregon, has yet to go into effect after a judge issued an injunction, saying the county wasn’t prepared to enforce it anyway.
County health officials say that’s not exactly the case. But they concede they’ll have to allow sales of the flavored products to continue for now.
It’s just the latest in a series of setbacks for the county’s first-in-the-state ban on flavored tobacco products, according to Oregon Live.
The original ban was put into place by the Washington County Commission in November of 2021 and enforcement was set to begin in January of this year.
But opponents of the ban, spearheaded by Plaid Pantry CEO Jonathan Polonsky, gathered enough signatures to put it on the ballot and let voters decide in May.
Opponents realized the ballot language would cause confusion for many voters over what a “yes” vote really meant, however, so they stopped campaigning on behalf of their own measure.
Proponents of the ban, meanwhile, spent more than $1 million to defend it, and, in the end, Washington County voters overwhelmingly opted to keep the ban.
In February, before that vote, several Washington County businesses filed a lawsuit challenging the ordinance. Serenity Vapors, King’s Hookah Lounge and Torched Illusions, represented by attorney Tony Aiello, contended in their suit that they are legal businesses and would be unfairly harmed by the county’s ordinance.
Last week, Washington County Circuit Court Judge Andrew Erwin agreed to pause the ban, which had yet to be enforced. According to Erwin, the county’s arguments for keeping the ban in place while the law was challenged weren’t “compelling,” because he said the county’s lawyer said it had zero plans to enforce it “in the foreseeable future.”
On the other hand, Erwin reasoned, the businesses would “imminently and irreparably harmed” by following the law.
In his injunction, Erwin wrote: “Defendant argues that the public’s interest in Ordinance 878 overwhelmingly trumps plaintiffs’ interests. But defendant concedes they have no plans to further the public’s interest as they do not anticipate enforcing the ordinance in the foreseeable future.”
Supporters of the ban find this logic a bit circular — the ban only went into effect on June 13 and the apparatus for enforcement is not yet in place.
“Enforcement was to start along with the state inspections for the tobacco retail licensing law,” Mary Sawyer, a county health spokesperson explained. “Businesses are inspected annually by the state to make sure they have a license and are following new state law, and then if inspectors find that businesses in Washington County are selling flavored products, they would let us know.”
After the county is notified, it would start by educating the business about the flavored products law and only write a ticket if the business then failed to comply.
“None of this happened yet,” Sawyer said, “as the state was just starting their inspections this summer and they haven’t referred any businesses to us yet.”
The county has already filed a motion to dismiss the complaint. But as of now, flavored tobacco and vape products are available in Washington County.
Jordan Schwartz is the owner of Serenity Vapors, one of the plaintiffs in the case, which has three Washington County locations. Schwartz contends that his company has helped thousands of people quit smoking.
Now, he said, customers are coming in telling him, “I guess I am going to go back to cigarettes. That’s what they’re forcing us to do.”
According to Schwartz, Serenity Vapors sells mainly vape liquid or “vape juice.”
“North of 80 percent of our business comes from some type of flavored product,” he said.
July 11, 2022
Retailers: Potential Juul Ban will Boost Other Brands

Even in the slow summer months in a college town, Aj’s Liquor in Ames, Iowa, sells roughly 160 Juul pods a week to customers between the ages of 21 to 24.
But convenience store shelves could be stripped of Juul products, depending on a decision by the U.S. Food and Drug Administration about the products’ safety, according to a story in the Iowa Capital Dispatch.
Will Montgomery, sales representative for Aj’s Liquor, said customers are already transitioning to alternative brands for nicotine products as the FDA considers a marketing denial order against Juul. Even if the ban is successful, Montgomery said he doesn’t expect electronic nicotine delivery systems to decrease in sales.
“People are still going to need nicotine,” Montgomery said.
Taylor Boland, director of communications for Kum & Go, said all Kum & Go stores ceased sales of all Juul products on June 23 but resumed sales following the federal court’s block.
“Kum & Go remains committed to selling age-restricted products responsibly and complying with local, state and federal laws, orders, and mandates,” Boland said in an email response to Iowa Capital Dispatch.
Montgomery said the majority of customers who buy Juuls aren’t using them to stop smoking. If they were, they’d buy lower-nicotine products, he said.
Payton Hartz started vaping because of how convenient the products were. After Juul limited their flavors, Hartz transitioned to an alternative disposable vape brand.
The potential ban has “opened the door for other companies to push to the front,” Hartz said. “I feel like the throw-away vapes hadn’t existed until the Juul really came around. I feel like with the laws, all it has really done is push more companies to be even with Juul.”
July 11, 2022
Philip Morris Opens Flagship IQOS Store in South Africa

Credit: Arkadiusz Fajer
Philip Morris South Africa (PMSA) announced the opening of its new flagship boutique IQOS store in Canal Walk, Cape Town, South Africa, five years after the smoke-free brand was introduced to the local market.
“Our significant continued investment into stores like the Canal Walk site, reinforces our commitment to achieving a smoke-free South Africa, with a product that is a much better choice for adults than continued smoking,” said Branislav Bibic, managing director of PMSA. “It’s a commitment like this that is in line with PMI’s full-scale global effort to offer adult smokers better alternatives that can ultimately replace cigarettes.”
The company has openly committed to a move away from the cigarette business and continues to expand its IQOS portfolio of electronic tobacco devices designed to heat rather than burn tobacco, and the brand’s retail footprint, according to Biz Community.
IQOS heats specially-created tobacco sticks, called Heets, at a controlled temperature, avoiding combustion and “producing an aerosol that emits on average 95 percent lower levels of harmful chemicals than an ordinary cigarette”, according to the company.
While the device provides a nicotine fix and tobacco-taste satisfaction for smokers, Iqos does not produce smoke, ash or a cigarette smell.
Since 2008, the Marlboro and Chesterfield maker has invested over $9 billion in scientific research, product- and commercial development, and in production capacity to drive the continuous innovation of smoke-free products.
July 6, 2022
State AGs Ask Congress to Fight THC That Attracts Youth

Credit: S. Price
By Agustin Rodriguez, Chris Carlson & Christina Sava
This article was first published on the Troutman Pepper blog, Regulatory Oversight
On June 23, the Virginia and Nevada attorneys general sent a letter on behalf of a bipartisan coalition of 23 state attorneys general, expressing concern about edible products containing tetrahydrocannabinol (THC) sold in packaging to look like popular snacks and sweets.
Before Halloween 2021, a number of these same attorneys general warned parents about many of the same “copycat” products, with New York Attorney General Letisha James declaring: “[T]hese unregulated and deceptive cannabis products will only confuse and harm New Yorkers, which is why they have no place in our state.”
Background
A patchwork of regulatory approaches to cannabis and THC has been adopted and enacted across the United States. Further, the advent of Delta-8 THC products, following the legalization of hemp production under the 2018 Farm Bill, has resulted in additional regulatory differences between states. The June 23 letter acknowledges these differences, while also sharing a core concern for youth health: “The undersigned Attorneys General do not all agree on the best regulatory scheme for cannabis and THC generally, but we all agree on one thing: copycat THC edibles pose a grave risk to the health, safety, and welfare of our children.”
The group cites specific examples of youth unknowingly ingesting such edibles and having to seek medical attention, while also noting that “[i]n the first half of 2021, the American Association of Poison Control Centers reported poison control centers received over 2,622 calls for services related to young children ingesting cannabis products.”
What Are These Products?
The letter indicates that the products are sold through e-commerce platforms — websites advertising Cannaburst and Stoner Patch Dummies, which are not hard to find.
It is not entirely clear whether the attorneys general refer specifically to hemp-derived THC products, such as Delta-8, Delta-10, and even Delta-9 THC products sold outside of regulated dispensaries in most states but legally protected under federal law (read about that here), or whether they refer to federally-illegal marijuana products sold in contravention of state law. Nor is it clear from visiting one of the websites selling these products whether they contain hemp-derived or marijuana-derived THC.
The attorneys general admit that one would not find these products in a regulated dispensary, as most states already prohibit packaging that mimics popular snacks or potentially attractive to children. They also noted that these products often contain far more THC than typically allowed to be sold in state-regulated cannabis products.
What Actions Do AGs Want the Federal Government To Take?
The appropriate solution to this issue remains to be seen. The coalition wrote the letter to U.S. House and Senate leadership because it believes that Congress can remedy the situation by “immediately enact[ing] legislation authorizing trademark holders of well-known and trusted consumer packaged goods to hold accountable those malicious actors who are using those marks to market illicit copycat THC edibles to children,” or at least “think creatively for potential solutions to this growing public safety issue.” The trademark legislation fix likely refers to a gap in existing law identified by the Consumer Brands Association (CBA) as aiding the proliferation of such copycat products. According to a letter sent by CBA to Congress earlier this year, the SHOP SAFE Act, which aims to combat the sale of unsafe counterfeit products by incentivizing e-commerce platforms to engage in best practices for screening and vetting sellers and products, should be amended to hold the e-commerce platform contributorily liable in a civil action against an infringer that uses a famous, and not just counterfeit, mark. The definition of “counterfeit,” they argue, is not broad enough to capture these activities.
It’s important to note that if the products are indeed made with hemp-derived THC, then they are technically legal under federal law, hence the focus on trademark violations as an enforcement pathway.
What Options Do States Have?
The state AGs’ approach aligns with recent AG letters, stressing the importance of establishing a “cooperative federal-state partnership” that strikes the right balance to avoid “both under and overregulation.”
In the tobacco context, some states have passed and enforced online sales bans of electronic nicotine delivery systems (ENDS). They could similarly pass bans of online sales of such copycat products or products that violate their hemp-product standards where they exist. In addition, the state AGs could undertake enforcement actions on the grounds that these sales constitute unfair and deceptive sales practices. It remains to be seen, however, whether the actors behind these websites can be successfully identified and held accountable.
All attorneys with Troutman Pepper, Agustin Rodriguez is a seasoned business counselor to regulated consumer products companies, Chris Carlson represents clients in regulatory, civil and criminal investigations and litigation, and Christina Sava brings years of experience representing clients in highly-regulated industries, such as tobacco and cannabis.
July 1, 2022
Smoore Recognized in Shenzhen for Industrial Design

Photo: Smoore
Smoore has been recognized by the Shenzhen Municipality Industrial Design Development Support Program for its innovation and design capabilities.
The municipality singled out the vaping technology’s specialist for its “innovative design and achievement transformation of closed-pod electronic atomizer based on leadless ceramic heating technology.”
The industrial design team of Feelm, Smoore’s flagship atomization brand, has designed a number of solutions that combine consumer experience with advanced smart manufacturing.
Between 2020 and 2022, Feelm’s industrial design team won eight prestige International design awards, including the Red Dot Award, the iF Design Award, the German National Design Award and the MUSE Design Award.
In 2022, won a Red Dot Product Design Awards for four products, including a lipstick-inspired vaporizer with a twistable nozzle that prevents dust from collecting on the mouthpiece, and an eco-friendly disposable e-cigarette composed of recyclable and reusable aluminum foil.
“Feelm design is devoted to helping clients in improving the user experience from the perspective of a vaping tech brand,” said Totom Lu, head of Feelm Industrial design team, in a statement. “I think the future direction of design of closed-pod vaping solution should lean on three dimensions: product experience, emotional experience—to identify problems before users notice them—and sustainable experience, to focus on product sustainability.”
July 1, 2022
ZoVoo Launches New Products During Global Event

During a recent product launch broadcast live worldwide on June 29, ZoVoo released four new products, its Gene Tree special edition ceramic core technology, and ZoVoo shared information on its peak performance in the electronic atomization field.
The first disposable product in the DRAG family, the new DRAGBAR R6000 is ZoVoo’s pod-style disposable. It has a classic leather texture design and its new airflow adjustment function, according to a press release.
ZoVoo also launched its lightest and thinnest ceramic core disposable product, the DRAGBAR Z700 GT, which “adopts the latest upgraded ceramic core technology, and reconstructs a new thin and light experience,” according to a release.
The new core is the latest nano-microcrystalline ceramic core independently developed by ZoVoo, GENE TREE Special Edition is the first “powder free” ceramic core with proprietary patented technology in the industry, according to the release.
Also launched, DRAGBAR F8000, with max 8000 puffs, adopts the infinite airflow adjustment system, and matches with high-performance of a mesh coil. Also, the new VINCIBAR F2500 adopts Kevlar texture, integrates light and shadow aesthetics, elegant and comfortable. With max 2500 puffs, 15 flavors and mesh coil design.
June 30, 2022
EU Lawmakers Propose Flavor Ban for Heated Tobacco
Credit: DMF87
The European Commission on June 29 proposed a ban on the sale of flavored heated tobacco products.
Contrary to other media reports, the proposal does not include e-cigarettes or vaping products that use an e-liquid that contains a liquid nicotine. The ban only applies to heated tobacco products, such as Glo or IQOS.
The move is part of Europe’s “beating cancer plan,” which envisions less than 5 percent of the EU population using tobacco by 2040.
“With nine out of 10 lung cancers caused by tobacco, we want to make smoking as unattractive as possible to protect the health of our citizens and save lives,” said EU health commissioner Stella Kyriakides.
According to EU figures, cancer is the second-leading cause of death in the bloc of 450 million residents. There are about 1.3 million cancer deaths and 3.5 million new cases per year in the EU.
Kyriakides said that regulators need to “keep pace” with new developments to “address the endless flow of new products entering the market.”
A recent report showed a 10 percent increase in sales volumes of flavored heated tobacco products in more than five EU countries between 2018 and 2020. Overall in the EU, these products exceeded 2.5 percent of total tobacco product sales in 2020.
The Council and the Parliament will debate the Commission’s proposal before it enters into force 20 days after the publication in the Official Journal. EU countries will have eight months to transpose the directive into national law, and a further three months before the provisions will apply.
June 29, 2022
Reynolds’ Vuse Continues Market Gains Over Juul

The R.J. Reynolds Vapor Co. and its Vuse brand e-cigarette continues to gradually grow its U.S. market-share lead over Juul.
Vuse’s market share rose from 35.1 percent to 35.5 percent, compared with Juul declining from 33.1 percent to 32.9 percent, according to the latest Nielsen analysis of convenience-store data that covers the four-week period ending June 18.
It is the first Nielsen report since the U.S. Food and Drug Administration announced Thursday that Juul Labs would be required to remove all of its e-cigarette products from U.S. shelves. The U.S. Court of Appeals for the D.C. Circuit on Friday granted Juul Labs an emergency administrative stay of enforcement.
For the latest report, NJoy dropped from 3 percent to 2.9 percent, while Fontem Ventures’ blu eCigs slipped from 1.9 percent to 1.7 percent.
The decision to remove the No. 2-selling electronic cigarette in the country will likely to lead to a dominant market share for Vuse products. However, for the past 52 weeks, Juul remains ahead 35.1 percent to 31.2 percent, according to the Winston-Salem Journal.
“Having received the emergency temporary stay, we are now seeking the ability to continuously offer our products to adult smokers throughout our appeal with the court and science- and evidence-based engagement with our regulator,” Joe Murillo, Juul Labs’ chief regulatory officer, said Tuesday. “We remain confident in our science and evidence and believe that we will be able to demonstrate that our products do in fact meet the statutory standard of being ‘appropriate for the protection of the public health.’ “
Nielsen largely covers larger chain stores and doesn’t track local vape shop sales. For the smaller chains, the group extrapolates trends, which is why trend changes don’t appear immediately in Nielsen, such as the rise of disposable products.
Nielsen determined that Vuse recaptured the top market share in the April 23 report. That was the first time Vuse held the top market share in the Nielsen report since November 2017.
Juul’s four-week dollar sales in the latest report have dropped from a 50.2 percent increase in the Aug. 10, 2019, report to a 12.2 percent decline in the latest report.
By comparison, Reynolds’ Vuse was up 40.5 percent in the latest report, while NJoy was down 14.1 percent and blu eCigs down 27.9 percent. Goldman Sachs analyst Bonnie Herzog has said that NJoy “refutes Nielsen’s data and methodology.”
Another factor is that e-cigarette sales overall have slumped since February 2020, when the FDA implemented its latest round of heightened regulations on the products.
June 29, 2022