Tag: e-cigarettes

Abboud: Congress Intended for FDA to Use Discretion

Credit: Sagittarius Pro
By Tony Abboud
Under the new law governing synthetic nicotine products signed on March 15, 2022, Congress imposed a short 60-day deadline for companies to file premarket tobacco product applications (PMTAs) and declared that if such applications were not approved within 120 days (the Act) they would be “in violation of” the Federal Food Drug & Cosmetic Act’s (FDCA) PMTA requirement.
Since no authorizations have been granted as of today, the question is will FDA use its enforcement discretion to continue reviewing PMTAs, or will it precipitously declare that all synthetic nicotine products must be removed from the market after July 13, 2022?
There is no question that the FDA should use its enforcement discretion. In a series of direct engagements with FDA since the Act’s passage, the Vapor Technology Association (VTA) has provided a complete set of scientific and policy justifications for synthetic nicotine products, and specific recommendations on how FDA should use its enforcement discretion – just as it has in the past – to allow synthetic nicotine products to remain on the market during the PMTA review process.
However, some have suggested that Congress mandated all products be removed from the market this week if they are not approved by FDA. But a close review of the Act reveals that the opposite is true: Congress did not require synthetic nicotine products with pending PMTAs to be removed from the market after July 13.
In interpreting laws, a court will first look to the plain language of the Act and, only if there is an ambiguity, will it look to Congressional intent to resolve such a question. Here, both support the FDA’s continued use of enforcement discretion for pending PMTAs.
The Plain Language Supports Enforcement Discretion
There are four relevant sections of the Act. First, under Section (d)(2)(A), Congress expressly stated that “as a condition to market” all manufacturers wishing to continue selling their products must file a PMTA no later than May 14, 2022.
Tony Abboud
Second, under Section (d)(2)(B), Congress expressly stated that companies which filed PMTAs “may continue to market” their products during what the Act calls a “transition period.”
Third, under Section (d)(2)(C), Congress expressly required that if a company did not file a PMTA for its synthetic products by May 14, 2022, that company is “not eligible for continued marketing.” In each of these sections, Congress expressly uses some variation of the term “market” to articulate its direction on what may (not) be marketed and when.
However, in the operative Section (d)(3), which addresses what happens after July 13, 2022, Congress makes no statement regarding marketing at all. Instead, it states that products with pending PMTAs not yet approved would be “in violation of…section 910” of the FDCA (21 USC 387g).
When presented with this question, a court likely would rule that because Congress did not expressly state that pending applicants are “not eligible for continued marketing” or that they “may not market” after July 13, as it clearly said in the immediately preceding sections, Congress did not require the removal of products with pending PMTAs.
This places synthetic nicotine products with pending PMTAs in precisely the same position as all other products with pending PMTAs which, for years, FDA has made clear are “illegal” (i.e., in violation of section 910) but are allowed to remain on the market at FDA’s enforcement discretion.
Congressional Intent Supports Enforcement Discretion
Even if a court finds that Section (d)(3) is ambiguous, there is nothing in Congressional intent that would lead to the conclusion that Congress intended for products with pending PMTAs to be removed from the market.
First, Congress could have banned synthetic nicotine products, if that is what it intended, but it did not do so. To the contrary, Congress expressly authorized manufacturers to bring new products to market after the Act’s passage. Thus, it would be folly to suggest that Congress intended all synthetic nicotine products be removed from the market without PMTA review.
Second, Congressional intent is generally divined by on the record statements made in committee hearings and in floor debate (not from press releases or media statements). But there is little to nothing which a court could rely on [with] this question because the provision was quietly slipped into the Ukraine-omnibus spending bill with no relevant hearing or floor debate.
Third, Congress was fully aware that FDA could not review PMTAs within 180 days (as required under the FDCA). In fact, the FDA told a court it will not be finished reviewing tobacco derived PMTAs until June of 2023. Thus, no one could suggest that there ever was any reasonable expectation or intent that the FDA would rule on synthetic nicotine PMTAs in 60 days.
Hence, the only reasonable conclusion that can be drawn from the plain language and Congressional intent is that Congress did not require removal of products with pending PMTAs but, rather, expected the FDA to continue to use its discretion in enforcing its PMTA regulation after July 13.
Congress did, however, expressly state that products for which no PMTA was timely filed have no continuing ability to market, authorizing the FDA to take immediate action. VTA has repeatedly communicated to the FDA the need for it to aggressively remove all tobacco products from the market for which no PMTA has been filed and to publish a list of all products covered by a synthetic nicotine PMTA so that retailers know which products can be sold.
A Careful and Complete Evaluation of Synthetic Nicotine PMTAs is Required
We live in a world that remains captive to [combustible] cigarettes. Congress won’t ban them and Congress has prevented the FDA from doing so. While electronic nicotine-delivery system (ENDS) products offer a technological solution to delivering nicotine in a substantially less harmful way, synthetic nicotine now represents the first technological innovation in nicotine itself.
Synthetic nicotine uniquely offers consumers the cleanest and purest form of nicotine with numerous benefits, i.e., the absence of heavy metals, nitrosamines, and pesticides. Synthetic nicotine uniquely offers consumers the opportunity to break free from the last remaining vestige of the tobacco plant.
Synthetic nicotine uniquely offers the FDA unprecedented product constituent clarity, replicability, and traceability down to the batch level. Not only does synthetic nicotine offer companies the opportunity to change the dynamics regarding total reliance on tobacco-derived nicotine for all tobacco and pharmaceutical nicotine products, but it also provides companies the ability to address their ESG [sustainability] goals and take a significant step to ameliorate the adverse environmental impacts of tobacco.
Our message to the FDA has been constructive and clear: it is critical to the adult smoker that FDA takes aggressive steps to create an orderly and regulated marketplace with a diversity of desirable nicotine alternatives.
Given recent history with tobacco derived PMTAs, the best way for FDA to realize that objective now is to avoid the blanket denial mistakes of the past which have mired the agency in protracted litigation. Such litigation will only delay the time until we achieve an orderly and regulated marketplace.
Instead, we have asked the FDA to work companies which timely filed synthetic nicotine PMTAs – the good actors – through the PMTA scientific process and provide them the requisite time and guidance to fulfill FDA’s requirements.
At the same time, we have asked the FDA to aggressively enforce against the non-compliant companies that have refused participate in the PMTA process – the bad actors – by interdicting such products at the border and removing such products from the market Congress has clearly required.
In the end, it is incumbent on the new FDA leadership to use its power to create an orderly marketplace by embracing scientific innovations, stimulating additional financial investment, accelerating authorizations of pending tobacco-derived PMTAs, and ensuring that synthetic nicotine products which now contain the cleanest and purest form of nicotine that science has created are available to adult smokers.
Tony Abboud serves as president for Strategic Government Solutions, Inc., and executive director of the Vapor Technology Association (VTA).
July 12, 2022
Study on Vape’s Adverse Effects on Teeth Debunked

Credit: Kraken Images
A claim in the British Dental Journal that found vaping to cause tooth damage was made by two food science lecturers at the Cardiff Metropolitan University School of Sport and Health Science. That study has now been shown to be rife with errors.
A letter has since been published in the British Dental Journal by Newcastle University vaping and dentistry experts Richard Holliday, Elaine McColl, Anthony Weke and Zella Sayeed debunking the claims out of Cardiff.
The four wrote they “were disappointed to see several basic errors and misrepresentations” and went onto correct five major errors in the “erosive potential of vaping” paper.
Newcastle’s experts say the study authors cite a World Health Organization poster and incorrectly claim that nicotine causes a “high risk of oral and whole-body health complications.”
In reality, nicotine has been used in the form of NRT for over 30 years, including in pregnant women, and is regarded as extremely safe, even for long-term use, according to Scoop.
Also significantly, the authors wrongly claim that e-cigarettes are associated with cancer. The supporting reference does not make this claim and instead states “no long-term evidence related to oral and systemic health effects exist.”
The Newcastle experts then “point UK dental professionals to the well-considered public health guidance which basically concludes that, for the best chances of quitting smoking, one should use support and pharmacotherapy and that e-cigarettes can be part of that package.”
Nancy Loucas, executive coordinator of the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA), said the food science lecturers’ biggest mistake was “one made by so many – that is talking up the WHO’s anti-vaping stance” as the official public health position.
“Tellingly, all UK public bodies, including the NHS, ignore the WHO’s advice. They support vaping, knowing it does not erode teeth nor lead to gum disease,” said Loucas. “Once again science and human evidence have trumped another untenable ideological lie about vaping.”
July 12, 2022
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
‘Current’ Underage Vaping Jumps 3 Percent in U.K.

Photo: Oleg
Current vaping among U.K. children aged 11-17 was up from 4 percent in 2020 to 7 percent in 2022, according to the annual YouGov youth survey for Action on Smoking and Health (ASH) carried out in March and published on July 7. The proportion of children who admit ever having tried vaping has also risen from 14 percent in 2020 to 16 percent in 2022.
Disposable e-cigarettes are now the most used product among current vapers, up more than seven-fold from 7 percent in 2020 and 8 percent in 2021, to 52 percent in 2022. Elf Bar and Geek Bar are overwhelmingly the most popular, with only 30 percent of current users having tried any other brands.
Over the past year there has been growing concern about the increasing popularity of disposable vapes with young people, but this is the first time national figures have been available to show the scale of the change. ASH said the increase in vaping shown by the survey is a cause for concern, and needs close monitoring. However, 92 percent of under 18s who’ve never smoked, have also never vaped, the organization pointed out—and only 2 percent have vaped more frequently than once or twice.
“Just to give it a try” is still the most common reason given by never smokers for using an e-cigarette (65 percent). For young smokers the most common reason for using an e-cigarette was “because I like the flavors” (21 percent) followed by “I enjoy the experience” (18 percent) then “just to give it a try” (15 percent), but they also said, “because I’m trying to quit smoking” (11 percent) or “I use them instead of smoking” (9 percent). Fruit flavors remain the most popular (57 percent).
Vaping behavior is strongly age related, with 10 percent of 11-15 year olds ever having tried vaping, compared to 29 percent of 16 and 17 year olds (the figures for those currently vaping are 4 percent and 14 percent respectively). And while underage vaping has risen, underage smoking is lower than it was in 2020 (14 percent in 2022 compared to 16 percent in 2020).
For the first time this year the survey asked about awareness of promotion of e-cigarettes. Over half (56 percent) of 11-17 year olds reported being aware of e-cigarette promotion, most frequently in shops, or online, with awareness highest amongst those who’d ever vaped (72 percent). Tik Tok was the most frequently cited source of online promotion (45 percent) followed by Instagram (31 percent).
In response to the survey results, the U.K. Vaping Industry Association (UKVIA) called for a range of get-tough measures to crack down on unscrupulous retailers who sell vapes to young people.
“The UKVIA understands the need for the right balance between supporting adult smokers to quit without encouraging take up amongst under-18s and ‘never-smokers,’” said UKVIA’s Director General John Dunne in a statement.
In a letter to the Department for Health and Social Care, the UKVIA proposed a set of recommendations to come down hard on those who sell vapes to minors while maintaining vaping’s critical role for helping smokers to quit, including fines of £10,000 ($11,897) and a national retail licensing scheme.
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
Brazil Maintains Ban on E-Cigarette Sales, Imports

Photo: Brenda Blossom
Brazil’s national health surveillance agency, Anvisa, decided on July 6 to maintain its ban on the import, advertising and sale of electronic cigarettes in Brazil, according to News Bulletin 24/7. The restriction began in 2009, but marketing continues illegally in the country, so Anvisa also called for increased inspections and educational campaigns to curb the illicit trade in e-cigarettes.
The decision was taken unanimously during a meeting of the body’s collegiate board. According to Anvisa Director Cristiane Rose Jourdan, scientific studies show that the use of electronic smoking devices increases the risk of smoking in young people, the potential for dependence and the likelihood of lung, cardiovascular and neurological health problems.
The Brazilian Medical Association (AMB) applauded Anvisa’s position. ”This is a wise decision, as there is increasing scientific evidence that the use of electronic smoking devices, the DEFs, is not harmless, does not support smoking cessation or is a form of harm reduction, but a product that causes dependence and can cause several diseases, especially cardiovascular, respiratory and cancer,” said Ricardo Meirelles, coordinator of the Commission to Combat Tobacco at AMB.
A survey carried out in the first quarter of 2022 by the Vital Strategies organization and the Federal University of Pelotas, revealed that 19.7 percent of Brazilians aged between 18 and 24 have tried electronic cigarettes.
BAT Brasil (formerly Souza Cruz) said it will assess the regulatory impact analysis of Anvisa’s decision when it is published.
“Dozens of countries have already understood the importance of risk reduction as part of their tobacco control policies and, given this reality, have advanced in the regulation of these devices,” the company said in a statement, citing the examples of United States, the European Union and the United Kingdom, among others.
Japan Tobacco International regretted Anvisa’s decision. “The use of electronic devices in the country is current and supplied exclusively by illicit trade. Legalized companies do not sell the product and the growth in consumption that affects the population comes from the illegal acquisition of devices,” the company said.
July 8, 2022
FDA Showered with Opposition to Vaping Flavor Bans

Image: nosyrevy
The U.S. Food and Drug Administration has received more than 110,000 comments on the proposed rule that would end the sale of menthol cigarettes and nearly 60,000 comments on the proposed rule that would prohibit characterizing flavors in cigars.
Many wrote to oppose the ban, including business owners who said it would force them to cut jobs.
“If implemented, this proposal could hurt retailers and wholesalers in the U.S. and directly impact my bottom line,” wrote a tobacco retailer in Florida. “This ban targets a significant portion of my revenue; menthol cigarettes alone make up 36 percent of all cigarette sales in the United States. Additionally, adult customers who purchase menthol cigarettes also purchase gas, food and other items that my store depends on.”
Thousands of letters submitted online came from menthol cigarette smokers who perceived the proposed restrictions as an unfair attack on personal liberty.
“This regulation far beyond overreaches the authority that the government should have over the American people,” wrote one respondent. “We have age restrictions for a reason, and once you reach that age you should be able to make the choice to use any legal product that you wish.”
Others supported the proposal, saying removing menthol and other flavors would improve health and help rectify racial injustices.
“The ban on menthol in cigarettes is a necessary step toward health equity and health promotion,” wrote Kaelor Gordon. “This substance unjustly and unfortunately places the burden of tobacco use and death on Black individuals and communities of color at higher and disproportionate rates, so to ban menthol would be in tune with the anti-racist and health equitable culture we are strongly cultivating today.”
The FDA recently extended the comment period from July 5 to Aug. 2, 2022.
July 8, 2022
Geekvape Shares Expertise in Fluid Dynamics

Photo: trodler1
Geekvape shared its expertise in computational fluid dynamics (CDF) at the 14th International Conference on Computer Modeling and Simulation, hosted June 24-26 by the Chongqing University of Posts and Telecommunications.
Geekvape has used CFD to structurally optimize ceramic atomizers. In designing electrically heated atomizers, the heat and mass transfer phenomenon is essential for maximizing the product’s performance. The company’s engineering team developed patented product designs with higher heat efficiency and better atomization performance.
“This invitation is a great honor for Geekvape to communicate with many international experts and scholars in related research fields, to discuss the latest technological progress and share our most recent findings,” said Jiadong Zang, who represents Geekvape’s advanced technology and application research institute, in a statement.
“This has profound implications for the future development of the global e-cigarette industry, as well as for the improvement of scientific and technological innovation to facilitate the industry’s high-quality development.”
July 7, 2022