Author: Staff Writer

FDA in Philippines Wants Control of Vaping Devices

Credit: Carsten Reisinger
Regulation of e-cigarettes, vaping devices and other heated tobacco products (HTPs) must remain with the Food and Drug Administration (FDA) and not be transferred to the Department of Trade and Industry (DTI) in the Philippines because these products concern public health, according to the FDA.
The FDA made its position clear in a statement it released in support of the Department of Health (DOH)’s request for a presidential veto of the Vape Bill (Senate Bill No. 2239 and House Bill No. 9007), which transfers regulatory jurisdiction of the products to the DTI, according to PhilStar Global.
“It is the DOH, through the FDA, which bears the constitutional mandate to protect every Filipino’s right to health, through establishing effective regulatory systems,” the FDA statement read.
Contrary to the proposed measure, the FDA said vape products and HTPs must be considered as health products instead of consumer products.
“This is especially as such products are being marketed by the industry as an alternative to conventional cigarettes, with some even claiming or implying that these products as being safer or less harmful,” the FDA said.
July 24, 2022
BAT Launches Glo Hyper X2 Heated Tobacco Device

Photo: BAT
BAT unveiled its Glo Hyper X2 tobacco heating device in Tokyo on July 21.
Building on the technology of Glo Hyper+, which launched in 2020, the Hyper X2 incorporates advanced induction heating technology encased in a smaller, lighter weight device. A separate boost function for faster heating, battery status LED indicator, a protective iris-shaped shutter and bold new colors complete the new hyper X2 offer, according to BAT.
Hyper X2 works with existing consumables from the Glo Hyper series.
“The launch of Glo Hyper X2—our newest, state-of-the-art heated tobacco product—marks another key milestone in our transformation as we build the brands of our future,” said Kingsley Wheaton, chief marketing officer at BAT, in a statement. “Since launching our first Glo product in Japan in 2016, we have built Glo into a billion-dollar global brand through our deep consumer insights, science and innovation.
“Our multi-category portfolio offers the industry’s widest choice of scientifically substantiated, less risky and enjoyable products for adult smokers who are looking to switch. This is a further big step in accelerating our transformation into a consumer products business that defines itself by the consumer needs that we meet, rather than the products we sell.”
“In addition, final results from our landmark one-year clinical study of Glo have provided important new data that adds to evidence supporting Glo as a reduced-risk product. In the study, people switching completely to Glo achieved significant and sustained improvements across many exposure and potential harm measures compared to those who continued to smoke, with many indicators similar to quitting.”
Glo hyper X2 will be available in Glo stores across Japan and on the Glo and Velo official online store from July 25, 2022, and in convenience stores in Japan from August 2022.
Glo products are available in 25 countries. The global rollout of Glo Hyper X2 will take place over the coming months.
July 24, 2022
Study: Major Drop in Vaping by Under-20s During 2020

Credit: Feng Yu
Use of e-cigarettes vaping devices dropped during the first year of the Covid-19 pandemic, according to a new study.
Researchers from Johns Hopkins University in Baltimore, Maryland, found that usage of vaping products dropped seven percent overall from 2018 to 2020 – including a 17 percent drop among people aged 18 to 20.
Researchers published their findings Friday on the JAMA Network Open after gathering data from the U.S. Centers for Disease Control (CDC) and Prevention’s Behavioral Risk Factor Surveillance System for the study, according to media reports.
The survey included a total of 994,307 respondents. In 2017, the CDC reported 4.4 percent of U.S. adults reported use of an e-cigarette. The figure climbed 25 percent to 5.5 percent in 2018.
‘This increase, primarily observed in younger age groups, was associated with the concurrent rise in the availability of flavored products and high nicotine–concentration pod mod devices (modular vaping devices with refillable or replaceable nicotine cartridges, or pods, such as JUUL brand devices),’ the researcher’s wrote in the study.
Data from 2019 was not gathered. In 2020, overall usage of e-cigarettes fell to 5.1 percent, a seven percent drop from two years earlier. The most dramatic shift was seen among people aged 18 to 20 years old – the youngest group included in the study.
July 23, 2022
Court: No Confusion in ‘Raw’ Cannabis Trademark Case

The District Court of Arizona Tuesday issued an order in a trademark dispute between BKK Tobacco & Foods and Central Coast Agriculture Incorporated (CCA), a cannabis products manufacturer.
The mixed ruling granted the defendant cannabis company’s summary judgment motions, but voided their trademark applications for lack of demonstrated intent to use in commerce, according to lawstreetmedia.com.
Further, the complaint states that in late 2013, Central Coast Agricultural Incorporated (CCA) began distributing cannabis concentrate products branded as “RawCo2,” “Raw Hashish,” “RawSin” and “Raw Gold.” The order also states that in 2016, CCA began selling cannabis concentrates under the unified brand “Raw Garden.”
On September 18, 2019, BKK initiated the present lawsuit alleging trademark infringement, false designation of origin, false advertising, unfair competition, cybersquatting and a petition to void several trademark applications by CCA due to a lack of a bona fide intent to use. On May 4, 2021, the court granted CCA’s motion to dismiss the false advertising claim but declined to dismiss the petition to void the trademark applications.
CCA moved for summary judgment on BBK’s infringement, false designation of origin, cybersquatting and unfair competition claims and raised a number of affirmative defenses including laches, waiver, estoppel, acquiescence, statute of limitations and unclean hands. Additionally, BKK filed cross-motions for summary judgment for all of CCA’s affirmative defenses and counterclaims and BKKS petition to void CCA’s trademark applications.
The court ruled that there is no likelihood of confusion between BKK’s Raw trademark and CCA’s applications for Raw Garden and thus granted CCA’s summary judgment motion, lawstreetmedia.com writes.
Further, the court stated that because no likelihood of confusion exists, the court declined to address CCA’s laches and unclean hands defenses.
However, the court granted BKK’s motion for summary judgment to void CCA’s trademark applications because CCA failed to provide evidence showing that it intended to use the Raw Garden trademark in connection to non-hemp-related products as identified in the trademark application, according to lawstreetmedia.com.
Due to the court’s ruling in the various motions for summary judgment, it closed the case stating that all claims and counterclaims asserted by the parties have been resolved or rendered moot by its order.
July 23, 2022
U.S. Senate Introduces Marijuana Legalization Bill
Leaders in the U.S. Thursday Senate introduced sweeping legislation that would end federal prohibitions on marijuana more than 50 years after Congress made the drug illegal.
Senate Majority Leader Chuck Schumer’s Cannabis Administration and Opportunity Act (CAOA) would decriminalize weed on the federal level and allow states to set their own marijuana laws without fear of punishment from Washington, according to media reports.
Just over a year after first unveiling a draft version of the cannabis reform legislation, Senate Majority Leader Chuck Schumer, Senate Finance Committee Chairman Ron Wyden and Sen. Cory Booker formally filed the CAOA. The legislation is expected to shape the conversation around cannabis legalization going forward and portions of it are likely to find their way into other bills that could pass before the end of the year, according to Marijuana Moment.
The legislation includes both Democratic and Republican priorities: It expunges federal cannabis-related records and creates funding for law enforcement departments to fight illegal cannabis cultivation. It also establishes grant programs for small business owners entering the industry who are from communities disproportionately hurt by past drug laws, requires the Department of Transportation to research and develop a nationwide standard for marijuana-impaired driving, and restricts the marketing of cannabis to minors.
While marijuana legalization has spread rapidly across the U.S. over the past decade, Capitol Hill has not transitioned as quickly. Nineteen states now allow anyone at least 21 years old to possess and use the drug, and 37 states have established medical marijuana programs. National polls have consistently shown that roughly two-thirds of Americans back marijuana legalization, and support is even higher among younger voters.
The U.S. House of Representatives has twice passed its own sweeping marijuana legalization package, known as the Marijuana Opportunity, Reinvestment and Expungement Act. That legislation does not include much of the regulatory structure that’s part of the Senate bill, and also has a different tax rate.
And even if a bill were somehow to pass, it is unclear if President Joe Biden would sign it. He has repeatedly said he does not support federal weed legalization.
July 22, 2022
Numerous Public Comments on EU Tobacco Changes

Credit: Savvapanf Photo
An overwhelming majority of EU citizens who responded to a European Commission initiative say they support tobacco harm reduction products.
The Commission’s “Call for Evidence” on the legislative framework for tobacco control received an unprecedented level of feedback, with consumers of alternatives to tobacco products – vaping, heated tobacco and oral nicotine pouches – making their voices heard in huge numbers, according to EU Political Report.
More than 24,000 EU citizens responded to the call, launched by the Commission as part of its ongoing evaluation of what future EU tobacco laws will look like through revision of the Tobacco Products Directive.
The massive interest in the issue may surprise some and may put the European Commission on the back foot as has been seen by some as having previously failed to support ‘tobacco harm reduction’.
The 4-week public consultation, from May 20 May to June 17, had one of the biggest ever responses to a consultation. On average, calls of this length receive around 354 submissions. In recent years, only the “call for evidence” for a digital euro for Europe received a similar scale of a response, but still fell short of the 20,000 submission mark despite taking place over a longer period of time (10 weeks).
Of the 24.000 submissions, more than 90 percent came from individual EU citizens, suggesting the extent to which this issue is a priority for the European public at large. Many submissions came from citizens in Germany, Italy and Romania.
It showed that the biggest issue for citizens across all member states is the regulation of reduced-risk products such as e-cigarettes. On this, it has been argued that the Commission it out of sync with public opinion.
The Commission has favored the introduction of new restrictions on reduced risk products, including flavor bans and sale restrictions but some in the industry hope the public response could now force it to reconsider these plans.
In June, the Commission announced plans to prohibit the sale of flavored heated tobacco products in the EU. The proposal came, it said, in response to the “significant increase” in the volumes of heated tobacco products sold across the EU.
A Commission report showed a 10 percent pick up in the sales volumes of heated tobacco products in more than five Member States and overall in the EU, heated tobacco products exceeded 2.5 % of total sales of tobacco products.
An overwhelming majority of submissions supported tobacco harm reduction products, including vaping and nicotine pouches, as “critical tools” that have helped smokers to quit. Respondents were nearly unanimous in opposing any plans to restrict access to such products for adults over the age of 18.
July 22, 2022
Juul Quarterly Revenues Drop 23%, Sources Say

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Juul Labs Inc. had its first quarter revenues plummet 23% from the prior year, according to people with knowledge of the matter, according Bloomberg.
The company received $259 million of revenue for the quarter ended March 31, said the sources, who say they saw the company’s results as it seeks financing alternatives.
“As we continue to operate in the market and go through the FDA’s review process, we are in the early stages of exploring a variety of options including various potential financing alternatives to protect our business and to address the impact of the FDA’s now stayed order so we can continue offering our products to adult consumers who have or are looking to transition away from traditional cigarettes,” a spokesperson for Juul said in a statement when asked for comment by Bloomberg.
Juul Labs had a loss of $28 million in the period, compared with earnings of $29 million for the same period a year earlier, based on unadjusted results before interest, taxes, depreciation and amortization.
In June, the FDA banned Juul products on US shelves, citing a lack of evidence demonstrating the overall safety of the company’s products, and noting Juul’s “disproportionate role in the rise in youth vaping.” Then the company won an emergency court order temporarily blocking the decision, and the agency separately stayed its order, allowing the company to keep selling products.
As of the first quarter, Juul had $323 million of cash on hand, down from $428 million at the same point last year, according to people who asked not to be identified because results are confidential for closely held Juul, according to Bloomberg.
Its debt totaled approximately $2.15 billion, including a $394 million term loan due in August 2023 and around $1.7 billion of 7 percent notes due 2025 that “payment-in-kind securities,” allowing the company to delay interest payments.
July 22, 2022
JWEI Submits PMTA to U.S. FDA for New Vape Device
China-based JWEI has announced today that they have successfully submitted a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration for a device created with “new innovative technology” that focuses on safety, harm reduction and is designed to curb underage use.
“JWEI has been a leader in this industry from the start and this milestone again reiterates our commitment to the industry and public health: ensuring our adult customers continued access to less harmful alternatives to traditional tobacco products, while setting a new standard preventing underage youth access.” said VP of JWEI Group Jason Yao.
JWEI is the parent to the brands Joytech, Eleaf, Wismec and Joyevita. The company did not offer additional information on the specific device submitted for the PMTA.
JWEI developed a set of principles to guide through every step of its new product development, led by safety and effectiveness studies in early 2019. “The design philosophy is the foundation and guide rails for designing, manufacturing, verifying, validating, and continuously improving innovative, responsible, reliable, and high-quality products,” the release states.
The limited product debut in the UK has received overwhelming recognition from users and commercial partners after a few months’ actual use, according to JWEI
“As one of the world-leading device manufacturers and innovators of e-cigarette and vaping products, JWEI has over 3,600 granted patents and multiple internationally recognized manufacturing and quality certifications (GMP, HACCP, ISO9001, ISO13485, EHS, and ERP),” according to a press release.
July 21, 2022
Vaporesso Gets Chinese Special Production License

Vaporesso, a wholly-owned subsidiary of Smoore, has obtained a production licence from China’s State Tobacco Monopoly Administration (STMA), the country’s top regulator of tobacco products.
The license gives Vaporesso products lawful status in the country, Hong Kong-listed Smoore said in a statement on Wednesday. The license will be valid through July 2023, according to the South China Morning Post.
Smoore, the largest e-cigarette manufacturer in the world, is among the first group of companies to comply with China’s tightened rules for the e-cigarette industry, which recently became regulated as a traditional tobacco product.
In March, STMA published final guidelines for the industry, which require that manufactures comply with certain technical standards, including permitted ingredients and additives.
Licensed manufacturers must also trade with downstream wholesalers on a transaction platform overseen by STMA, according to the rules.
Licensed manufacturers must also trade with downstream wholesalers on a transaction platform overseen by STMA, according to the rules.
Less than 50 e-cigarette related companies, including retailers and manufacturers, have met the new restrictions and received licences from the authority so far, STMA’s website shows.
There are an estimated 1,500 companies involved in the vaping industry, according to calculations by the Electronic Cigarette Professional Committee of China Electronics Chamber of Commerce (ECCC) last year.
However, more licenses are expected to be issued in coming months as regulators work through a backlog of applications, according to news reports.

July 21, 2022
Reports of Possible $5 Billion Offer Coming for NJOY
E-cigarette maker NJOY Holdings Inc has hired bankers for a possible sale of the company, the Wall Street Journal reported on Tuesday, citing people familiar with the matter.
The report added the privately held NJOY is likely to be valued at up to $5 billion, according to the sources who cautioned the process was still at an early stage and there was no guarantee a deal would materialize.
If NJOY does not receive a high enough valuation, the company could raise money and stay private, potentially paving the way for a future initial public offering, the Wall Street Journal said.
The e-cigarette maker is simultaneously exploring a new fundraising round and aims to raise between $300 million and $500 million, the report added.
NJOY has two devices that have received marketing approval from the U.S. Food and Drug Administration, including its Ace device and Daily disposables.
Late June, Bernstein analyst Callum Elliott wrote in a note that Altria could try to buy privately owned NJOY, which “has already succeeded with its PMTA process applications.”
Rival Juul Labs Inc said on Friday it was in the early stages of exploring several options, including financing alternatives, as the company deals with lawsuits and a probable ban on sales of its e-cigarettes by U.S. health regulators.
NJOY and Mudrick Capital Management, a majority owner of the company, did not immediately respond to a Reuters request for comment.
July 20, 2022