Broughton Nicotine Services has published a summary of the U.S. Food and Drug Administration’s rule for the premarket review of new tobacco products.
Released on Jan. 19, the FDA’s final rule makes amendments and recommendations to the previous rule and helps ensure that PMTAs contain sufficient information for the agency to determine whether a marketing granted order should be issued for a new tobacco product.
The purpose of the rule is to improve the efficiency of the submission and review of PMTAs as well as providing applicants with a better understanding of the information a PMTA must contain.
Amongst other topics, the rule addresses:
The submitting of detailed information regarding the physical aspects of the new tobacco product and full reports of information regarding investigations that may show the health risks of the new tobacco product.
Whether the product presents the same or different risks compared to other tobacco products. The FDA requires the submission of these health risk investigations to ensure it understands the full scope of what is known about the potential health risks of a new tobacco product.
Electronic submission of the PMTA.
Post-market reporting requirements for applicants that receive marketing granted orders.
Retention of records requirements for PMTAs
Procedures by which the FDA reviews a PMTA
Broughton Nicotine Services summarized the 516-page recommendations and requirements report into a digestible guide, which is available for download here.
The Indiana state legislature has begun to debate raising taxes on vaping products … again. The annual introduction centers on a proposed tax rate of $1.56 on a two-pod pack, the equal nicotine content to a pack of combustible cigarettes.
Credit: Davis Mark
Indiana’s traditional cigarette tax of just under a dollar a pack is the 13th lowest in the nation. Legislators are considering a bill to double it, and tax e-cigarettes for the first time, according to an article on wibc.com. Marion County health director Virginia Caine says it’s critical to include e-liquids in the bill.
She says vaping among teenagers has doubled in the last two years, wiping out any progress the state has made in reducing teenage smoking. Recent U.S. CDC reports say that teen smoking rates declined in 2020. Mason Odle, owner of Just Vapors in Fishers, says he fully supports raising the cigarette tax, but argues e-liquids shouldn’t be included.
He contends e-cigarettes are a more popular and effective means of quitting smoking than FDA-approved products like nicotine gum or patches. That brought a fierce pushback from health officials, who point out the FDA has specifically banned vape manufacturers from marketing their product as a stop-smoking aid until they produce more evidence that it works. And Caine says there are serious concerns about lung damage from vaping.
Former Libertarian candidate for governor Don Rainwater argues increasing cigarette taxes would punish store owners at a time when they’re already reeling from the coronavirus pandemic. But the main objection from House Public Health Committee members centered on the lack of a specific plan for the proceeds from the tax. A vote has been put off till next week to add language earmarking the money for health programs.
Governor Holcomb and House and Senate leaders have all said a cigarette tax hike isn’t on their agenda, without flatly ruling out the possibility. The House approved an increase in 2016 and 2017, and a vape tax in 2019. All three times, the proposals died in the Senate.
According to the U.K. Vape Industry Association (UKVIA), leaked EU plans for a “Tobacco Free Generation” would increase controls on e-cigarettes, despite their proven value in smoking cessation efforts.
This latest EU plan could include the following proposals:
Extend taxation to “novel tobacco products,” including e-cigarettes
Extend the coverage of smoking bans, both indoor and outdoor, to vaping
A full ban on flavored products
The enforcement on plain packaging for vaping products
John Dunne
“We at the UKVIA are seriously concerned by reports that the European Commission is considering such regressive action, which will likely reduce the positive impact that vaping has on people’s lives,” said John Dunne, director general of the UKVIA.
“While we completely support efforts to combat the scourge of cancer in our society, the creation of artificial barriers to harm-reduction products is clearly counterproductive. Adult smokers must be empowered to make positive change, rather than being discouraged.
“Cancer Research UK, along with the Royal College of GPs, have confirmed vaping’s significant harm-reduction compared to cigarettes, as well as its efficacy in smoking cessation. The EU’s plans are out of step with this latest evidence.
“It is vital that the U.K. now take advantage of the legislative and regulatory independence afforded by Brexit, to safeguard this country’s proportionate, evidence-based approach to vaping.”
The document was leaked ahead of the announcement today of the EU’s “Beating Cancer Plan,” which among other things calls for reducing tobacco use to less than 5 percent of the EU population by 2040.
The City of Chicago has filed a lawsuit against Equte LLC, parent to Vapes.com, for “marketing and selling flavored vaping products.” The company allegedly marketed its products to youth, alongside selling flavored products. Four months ago, the Chicago City Council banned the sale of flavored vaping products favored by teens, but exempting flavored tobacco products, including menthol cigarettes.
Credit Emily Ralph
The latest in a string of city lawsuits against the e-cigarette industry follows an investigation by the Department of Business Affairs and Consumer Protection. It identified the two companies as having violated the flavored tobacco ban, according to the Chicago Sun Times.
“E-cigarettes are unhealthy and addictive, and businesses deliberately target young people in the hope they’ll develop lifelong customers,” Mayor Lori Lightfoot was quoted as saying in a news release. “The City of Chicago’s message to vaping companies is clear: If you break the law, we will go after you, especially if you try to sell to our youth.”
O’Shea originally championed a much stronger, citywide ban on all flavored tobacco products. He was forced to settle for less — a ban on “flavored liquid nicotine products” — after running into a buzz-saw of opposition from gas stations, convenience and tobacco stores. They accused O’Shea of kicking them when they’re down, with their businesses hurting during the pandemic.
O’Shea could not be reached for comment. The press release quoted him as saying that this lawsuit “not only takes these companies to task, but sends a clear message to anyone who thinks they can push vaping products onto our kids and get away with it.”
A recent survey from South Korea found that 8 in 10 South Korean e-cigarette users said they had secretly smoked stealthily in non-smoking areas. At 83.5 percent, the vast majority of e-cigarette users said they had vaped illegally, dwarfing the 16.5 percent who said they did not participate in such activity.
Credit Sungho Song
Under the National Health Promotion Act, those who use e-cigarettes in non-smoking areas can be fined, just like for smoking conventional tobacco cigarettes.Heat-not-burn products were not mentioned in the study and would face similar fines, according to a story by The Korea Bizwire.
A research team from the Asan Medical Center conducted a survey of 7,000 men and women between 20 and 69 years of age. Of the total, the number of people who had used e-cigarettes in the previous month stood at 394. Among vapers, 44.6 percent between 20 and 34 years old, while men accounted for 74.1 percent of the total.
Most participants said the smoked at home indoors, which accounted for the largest share at 46.9 percent, followed by private cars at 36.9 percent and outdoor non-smoking areas at 28.3 percent. Men and women accounted for 44 percent and 55.6 percent of the violators, respectively, indicating that more than half of female vapers users are vaping secretly at homes.
In its initial public stock offering, Supreme, a maker of fast-moving consumer goods such as vaping brand 88Vape, announced the pricing for its initial public offering in London, joining a rush to market early in the new year.
Credit: 88Vape
Supreme is listing on AIM and expects to start trading today.
Supreme said it has placed 5.0 million shares at 134 pence each to raise GBP67.5 million. Of this, GBP60.0 million is for selling shareholders, and GBP7.5 million from new shares for the company, which it said will be used to pay off debt, according to Alliance News. The selling shareholders include Sandy Chadha, the founder and chief executive officer, who will retain a 56.8 percent stake, leaving a 43 percent free float.
Supreme will have a GBP156.1 million market capitalisation at its IPO price. Supreme’s IPO is part of a flurry of new listing activity in London early in the 2021. These have been headlined by large-size floats by bootmaker Dr Martens and card seller Moonpig. Also planning IPOs are miner Cornish Metals Inc, investment fund Cordiant Digital Infrastructure Ltd, and life sciences company 4basebio UK Societas.
Not yet confirmed for London, but potentially biggest by far, is food delivery firm Deliveroo, which is expected to have a market cap of more than $7 billion. Deliveroo also is considering a New York listing, according to media reports.
Supreme supplies products across five target categories: batteries, lighting, vaping, sports nutrition & wellness, and branded household consumer goods. In addition to brands it owns, such as 88Vape, Supreme licenses major battery brands Duracell, Energizer and Eveready. Its customers include Fraser Group PLC’s Sports Direct, motor supplies chain Halfords Group PLC, and grocers Asda and Iceland.
Supreme recording adjusted earnings before interest, tax, depreciation and amortisation of GBP16.2 million on revenue of GBP92.3 million in the financial year that ended March 31 last year. In the six months to September 30 last year, Ebitda was GBP8.4 million on revenue of GBP56.3 million.
The company said it plans to pay dividends at a rate of 50 percent of net profit. “I am deeply proud of the business we have developed and believe our flotation on AIM will provide Supreme with the tools with which to capitalise on a number of exciting growth opportunities,” said CEO Chadha. “We have created a profitable business of significant scale, underpinned by a platform which provides a seamless route to market for a number of leading brands and product categories.”
The owner of the Kool cigarette brand sued the maker of Bloom cannabis e-cigarettes in Los Angeles federal court for allegedly infringing the brand’s trademark, according to Bloomberglaw.com.
Credit: Bloom
Bloom’s logo uses interlocking “O” letters that confusingly resemble ITG Brands LLC’s famous Kool logo, according to ITG’s complaint. The suit was filed last week in the U.S. District Court for the Central District of California.
ITG says Capna Intellectual, which owns the Bloom brand, has applied for federal trademarks covering Bloom for e-cigarettes and oral vaporizers. ITG says it sent Capna a cease-and-desist letter in December.
The complaint says the Bloom marks are intended to trade off of Kool’s well-known branding.
The U.S. Food and Drug Administration should encourage harm reduction products and help smokers give up cigarettes, according to Markus Lindblad, head of external affairs at the Haypp Group, the parent company of NicoKick, which describes itself as the world’s largest American e-commerce company in the smokeless industry.
In a letter to Acting Food and Drug Administration (FDA) Commissioner Janet Woodcock, Lindblad encouraged her to prioritize the goal she helped set at the FDA in previous years to enable greater use of healthier harm reduction products and help smokers quit combustible products.
“Our mission at NicoKick is to drive real change in the industry and encourage alternative nicotine enjoyment for adults seeking products other than inhalants,” Linblad wrote.
“We recognize that your focus is understandably on addressing the coronavirus pandemic, but we hope as you lead the Food and Drug Administration that you continue to prioritize tobacco harm reduction products that will produce better health outcomes for millions of American smokers. We can all agree any effort to transition from traditional tobacco products to those that reduce harm to the consumer should be supported and would be an important win for public health.”
SwissX Labs, a U.S.-based CBD company, has brought a lawsuit claiming that Juul Labs infringed on one of its patents. Filed in the U.S. District Court of Delaware, the suit alleges that Juulpods copy the use of a patented combined e-liquid and vaporization chamber (cartomizer) owned by SwissX.
Credit: Insurance Journal
Owned by billionaire Alki David, SwissX states in the suit that Juul Labs has known about U.S. Patent No. 9,351,522 (522 patent) since at least March 2018. The U.S. Patent and Trademark Office (USPTO) issued the patent in 2016 to inventor Robert Safari, who assigned it SwissX.
After its issue on May 31, 2016, the 522 patent was was active until June 1, 2020. On June 2, 2020, “the enforceability of the 522 patent temporarily lapsed, due to an inadvertent failure to pay the maintenance fee,” according to the filing. On Dec. 21, 2020, SwissX filed a petition to reinstate the 522 patent at the USPTO. The Petition was granted, and SwissX paid the outstanding fee.
“Thus, on December 21, 2020, the [522 patent] was restored to full force and effect … SwissX is entitled to damages adequate to compensate it for all acts of infringement that occurred, or which may occur, at any point while the [522 patent] was or is in force,” the suit states.
Juul Labs has not publicly responded to the lawsuit. A judge recently dismissed an investor lawsuit against Juul Labs. However, the company still faces lawsuits from several states and school districts around the U.S.
Vapers say taste matters. According to a survey conducted by Frost & Sullivan, among 3,000 Chinese vapor consumers, taste was a key factor in choosing an e-cigarette. The top three indexes in flavor were the overall sensation of taste (66 percent), aroma (61 percent) and the amount of vapor (50 percent).
In late-December, FEELM, a heating technology brand, introduced the industry’s first Taste Evaluation Model. The model allows FEELM researchers the ability to describe the taste of atomization scientifically. Composed of four dimensions, flavor, strength, note and vapor, and 51 specific indexes, the model establishes a system to evaluate the human senses of mouth, tongue, nose and throat.
FEELM Taste Evaluation Model
Frank Han, CEO of FEELM, said the company’s devotion to continuously improving the taste of e-cigarettes originated from a client’s concern. “How’s the taste of California strawberries at 6am? What’s the difference between it and that of refrigerated ones?” he said the client asked. “Could FEELM ceramic coils bring back the taste of California strawberry at 6am with flavored e-liquid?”
Inspired by the client, FEELM team members conducted numerous studies with the goal of developing a scientific system to properly evaluate and provide the perfect flavor. “As you can imagine, analyzing and delivering such an abstract concept as taste will [take] anyone tons of effort,” Han said.
In order to help with challenging endeavor, FEELM’s parent company, Smoore Technology, set up several research institutes both in China and other locations around the world (Smoore does not produce any e-liquid). More than 700 Smoore technical experts that have received more than 2,000 international patents began building a world-leading atomization platform, according to the release. Now, over 75 percent of those researchers are focused on understanding and improving taste through atomization. Smoore also established relationships with other research institutions such as Tongji University, Tsinghua University and Princeton University.
FEELM CEO Frank Han
“This institute will focus on the background study and harm reduction from new perspectives such as bio-medicine and artificial intelligence,” the release states. “To further study the science behind atomization, FEELM has also established a professional taste evaluation team, and built a Taste Evaluation Lab complied with the national standard and could hold seven tasters at a time.”
The process for evaluating a flavor is precise. Before picking up a vaping device, each taster washes and sanitize their hands and then chews a slice of lemon or yellow peach to clean the palate. Testers than drink boiled water to freshen up the mouth and smell coffee beans, according to a FEELM representative.
Reporter in FEELM Taste Lab
“It is not until the light and the exhaust fan in the booth are turned on that the taster begins tasting. While tasting, a recorded form with all detailed criteria is prepared for scoring and taking notes,” the representative said. “Afterwards, the same vaping device will be handed over to chromatography, electron microscope as well as reliability labs to analyze its e-liquid ingredients, coil and safety … a diagnostic report will be produced based on both human and machine criteria. FEELM is then able to figure out the deficiencies in the vaping experience and work out precise solutions.”
FEELM research lab
The FEELM Taste Scientific Institute is made up of more than 10 labs, including Cell Lab, Taste Evaluation Lab, Element Analysis Lab, Chromatography Lab, and Electron Microscope Lab. The company says its labs can produce 50 physical tests, more than 200 chemical tests, six microbiological test items, three genetic toxicology tests, three categories of clinical abuse tests, as well as three categories of human factor testing.
“Besides scientific research, great taste cannot be separated from production. Smoore has established a rigorous production safety standard, which is even stricter than the TPD in the EU and AFNOR in France,” the representative said. The production protocols are also more stringent than what is required by the premarket tobacco product application (PMTA) process for the U.S. Food and Drug Administration (FDA), covering 50 individual tests.”
FEELM also developed the first fully automated pod production line in the vapor industry. Its production capacity is 6,000 pieces per hour, boosting efficiency five times over manual production. Automated production guarantees the stability and consistency of quality.
“Taste is a meaningful word,” said Han. “Great taste relies on the scientific system of fundamental research, the persistent improvement of product development and manufacturing, strict quality control, and a devoted focus towards science and ingenuity.”
