Category: News This Week

Juul Labs to Pay $462 Million to Six US States

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Juul Labs has agreed to pay $462 million to settle claims by six U.S. states, including New York and California, that it unlawfully marketed its products to minors.
With the deal, Juul has now settled with 45 states for more than $1 billion. The company did not admit wrongdoing in the settlement, which also included Colorado, Illinois, Massachusetts and New Mexico as well as the District of Columbia.
Juul announced on Dec. 6 it has secured an investment to cover the cost of the settlement. The company has been in talks with two early investors to fund a bailout that would cover legal liabilities.
The states had accused Juul of falsely marketing its e-cigarettes as less addictive than cigarettes and targeted minors with glamorous advertising campaigns, according to Reuters.
“Juul’s lies led to a nationwide public health crisis and put addictive products in the hands of minors who thought they were doing something harmless,” New York Attorney General Letitia James said at a news conference.
The company said that use of its products by people under age 18 had fallen by 95 percent since the fall of 2019, when it changed its marketing practices as part of a “company-wide reset.”
In September, Juul Labs agreed to pay nearly $440 million to settle a two-year investigation by 33 U.S. states into the marketing of its vaping products.
Juul’s e-cigarettes were briefly banned in the U.S. in late June after the Food and Drug Administration concluded that the company had failed to show that the sale of its products would be appropriate for public health. But following an appeal, the health regulator put the ban on hold and agreed to an additional review of Juul’s marketing application.
In October, Juul published the details of its MDO appeal. In late September, Juul shareholder Altria Group exercised the option to be released from its noncompete deal with the e-cigarette maker.
Last month, Altria Group exchanged its entire investment in Juul Labs for a nonexclusive, irrevocable global license to certain of Juul’s heated-tobacco intellectual property.
April 13, 2023
Smoking Down Among Danish Youth

Image: Tobacco Reporter archive
Cigarette consumption among Danish youth has declined, but the use of nicotine products has increased, reports The Local Denmark.
Snus, nicotine pouches and vaping devices have become more popular with youth in Denmark, with 35.1 percent of 15-year-olds to 29-year-olds using these products daily or regularly, up from 26.3 percent in 2020.
Cigarette use fell to 19 percent from 20.1 percent while smoke-free nicotine product use increased to 12.9 percent from 9.1 percent, according to a study by Denmark’s National Institute of Public Health and the University of Southern Denmark on behalf of the Danish Health Authority.
“We also found that it is especially newer products, such as vaping devices and smoke-free nicotine products, that seem to be especially popular among very young people,” said Nanna Jarlstrup, one of the report’s researchers. “That is naturally concerning.”
“We are also unfortunately seeing use of some of the illegal products increasing. That is, for example, the new disposable vapes, Puff Bars,” Jarlstrup said.
“It’s not legal to sell them in Denmark, but we can see young people have access to them because they use them,” she said.
The number of people aged 15 to 17 who smoke has increased despite fewer people aged 18 to 24 smoking cigarettes daily or occasionally compared to 2020.
Denmark has banned smoking during school and further education hours and removed cigarettes from displays in stores as well as increased the price of a pack of cigarettes to help decrease smoking.
April 13, 2023
Imperial On Track to Meet Full-Year Guidance

Image: Tobacco Reporter archive
Imperial Brands is on track to deliver full-year results in line with expectations and the company’s guidance of low-single-digit constant currency net revenue growth. Over the next three years, the company continues to expect operating profit growth to accelerate to a mid-single-digit CAGR at constant currency.
The company has seen a robust tobacco pricing and stable aggregate market share across its top 5 combustible markets against a strong comparator.
Product launches across vapor, heated tobacco and modern oral have driven next-generation product net revenue growth.
First-half group adjusted operating profit is expected to be at a similar level to last year on a constant currency basis. Tobacco and next-generation product (NGP) adjusted operating profit has been impacted by the planned increase in NGP investment, the impact of the company’s exit from Russia and the continued unwind of Covid-19. Growth in distribution adjusted operating profit has helped to mitigate these headwinds.
Imperial is on track to meet full-year expectations and its guidance of growing revenue and operating profit. The company completed £523 million ($654.82 million) of the fiscal year 2023 £1 billion share buyback as part of an ongoing program of capital returns.
The interim results for the six months ended March 31, 2023, will be announced on May 16, 2023.
April 13, 2023
Malawi Tobacco Auction Floors Open

Photo: Taco Tuinstra
President Lazarus Chakwera is set to preside over the official opening of Malawi’s tobacco marketing season at Lilongwe Auction Floors today. He will announce the minimum prices for the leaf as well, reports Nyasa Times.
The opening of the tobacco market brings hope for foreign currency availability. Malawi has been struggling with a shortage of foreign currency this year, in part due to comparatively low tobacco export volumes in 2022.
The Tobacco Commission stated that about 20,000 bales have been presented to market, and 2,600 are expected to be sold on opening day.
Production is expected to increase from 85 million kg last year to 126 million kg this year.
Auction floors at Chinkhoma, Limbe and Mzuzu are set to open on April 13, April 17 and May 2, respectively.
April 12, 2023
Serbia Introduces Fines for Underage Vape Sales

Image: Miljan Živković | Adobe Stock
Merchants caught selling e-cigarettes or other tobacco products to minors in Serbia risk a fine of RSD50,000 ($469), following a recent amendment to the Law on Consumer Protection, reports EurActive.
The revision fills a void in an area that was previously unregulated. According to Serbia’s Internal and Foreign Trade Ministry, the law did not define e-cigarettes or ban their underage sales.
The ministry believes electronic nicotine-delivery systems present a significant health problem, encouraging nicotine addiction and exposing users to carcinogenic substances. They also increase the likelihood that individuals will start using other tobacco products, such as cigarettes, according to the ministry.
“The conclusion of all conducted research is that by consuming an electronic cigarette, with or without nicotine filling, not only water vapor is sent into the air but also a number of chemicals. The harmful effects of these products reflect on the health of individuals and intensively spread to all components of the environment,” it stated.
The changed law prohibits the sale, service and gifting of electronic cigarettes with or without nicotine as well as other products intended for smoking, snorting, sucking, chewing or inhaling vapor to persons under 18. It also bans persons under 18 from selling such products.
April 12, 2023
New Resources to Help Amend PMTAs

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The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has created two new resources to help applicants prepare and submit amendments to their premarket tobacco product applications (PMTAs): Fact Sheet—Amendment Tips: Completing Form FDA 4057a and Video—Using the CTP Portal.
The fact sheet provides quick tips for completing Form FDA 4057a—Premarket Tobacco Product Application Amendment and General Correspondence Submission. In most circumstances, the CTP can only accept PMTA amendments for review that include Form FDA 4057a. In general, when submitting amendments for a PMTA, the FDA will review the required Form FDA 4057a first. If required content is missing from the form, the FDA may not continue reviewing the amendment.
The video provides an overview of the CTP Portal and how to use it, including how to find application submission tracking numbers online.
Recently, CTP Director Brian King outlined several new actions to enhance the center’s efficiency, effectiveness and transparency. These activities include enhanced communication on scientific issues and practices. By providing these new resources, the CTP is aiming to better support applicants navigating the PMTA process.
April 12, 2023
Zovoo Dragbar Z700 GT Wins Red Dot Award

Image: BusinessWire
Zovoo has won a 2023 Red Dot Award for its Dragbar Z700 GT, which was recognized for its innovative design and exceptional functionality, according to BusinessWire.
The Red Dot Award is organized by the Design Zentrum Nordrhein Westfalen in Germany, recognizing outstanding products in various categories such as Industrial Design, Communication Design and Product Design.
April 12, 2023
Broughton Joins UKVIA

Photo: Courtesy of the Broughton Group
Broughton has joined the U.K. Vaping Industry Association (UKVIA) as the 2023 vaping awareness month, VApril, kicks off. Nveed Chaudhary, chief scientific and regulatory officer at Broughton, attended a meeting of industry experts at the Houses of Parliament to encourage more regulatory rigor in applying U.K. vape regulation to protect consumers, according to a press release. The event provided a platform for key stakeholders to discuss the current state of the vaping industry and explore ways to improve public health outcomes.
“Recent compliance issues with some manufacturers could impact consumer trust in vapes in the U.K.,” said John Dunne, UKVIA director. “Quality control and analytical testing experts Broughton joining UKVIA at this time illustrates the importance of product quality and safety to ensuring the continued transition of smokers away from cigarettes.
“At UKVIA, we believe vapes have a key role to play in helping reduce death and disease caused by smoking. Ensuring vape safety is of the utmost importance to us and our members, and as a group, we’re advocating for stronger action against noncompliant vapes. This should include faster removal of noncompliant products, complete testing of products and greater penalties for manufacturers and retailers who break the rules.”
Broughton has also introduced a new U.K. and European Union Vape Compliance Package to help address concerns about vape regulatory compliance. The service will focus on labeling, packaging, nicotine strength, fill volume and banned ingredients.
Manufacturers, distributors and retailers who use the compliance package will receive a Certificate of Analysis that verifies their products’ compliance with current U.K. or EU regulations.
April 12, 2023
CTP Held Public Hearing on Manufacturing Rules
Image: Tobacco Reporter archive
On April 12, 2023, the Food and Drug Administration’s Center for Tobacco Products (CTP) held an online public hearing regarding its recently released proposed rule on “Requirements for Tobacco Product Manufacturing Practice.” This public hearing was scheduled when the CTP issued the proposed rule on March 10.
The hearing began with introductory comments by CTP Director Brian King. In addition to welcoming the participants and audience to the hearing, King noted that the CTP has been designing this proposed rule since 2011. Following King was Matthew Brenner, CTP senior regulatory counsel. Brenner summarized the proposed rule and highlighted the definitions of a “finished tobacco product” and a “bulk tobacco product” with regard to the rule. Emil Wang, senior advisor for manufacturing and regulatory policy at the CTP’s Office of Compliance, concluded the introductory session by detailing the timeline of the proposed rule. The proposed rule’s 180-day public comment period is between March 10 and Sept. 6, 2023. The effective date for the regulation would be two years after the final rule is published in the Federal Register. For small manufacturers (those manufacturers with fewer than 350 employees), the effective date for the regulation would be six years after the final rule is published in the Federal Register.
The public comment session featured the following scheduled participants (in order):
James O’Reilly—professor of public health policy at the University of Cincinnati. O’Reilly called the proposed rule “comprehensive” and noted that the CTP needs to add another $100 million in additional staff to properly enforce this rule. O’Reilly also called on the CTP to coordinate with other federal agencies, such as the Environmental Protection Agency, to handle foreign chemical imports that relate to this rule.
Drew Newman—JC Newman. The premium cigar maker representative highlighted four items: flexibility is required as each tobacco product differs from one another; recordkeeping is lengthy and costly; qualifying suppliers such as tobacco leaf growers will be difficult; and batch coding for final products will prove very difficult for the premium cigar industry.
Hiuyu Shi—e-cigarette manufacturer from Shenzhen, China. Shi noted that foreign components will be very difficult to regulate and monitor. One example was the difference in water quality between nations.
Laura Searcy—National Association of Pediatric Nurse Practitioners. Searcy supports the proposed rule.
Gabby Kaife—Boutique Cigar Association. Kaife is against the proposed rule.
Jason Hodge—former smoker and current vaper. Hodge is against the proposed rule.
Joshua Habursky—deputy executive director of the Cigar Association. Habursky is against the proposed rule.
Meredith Berkman—Parents Against Vaping. Berkman supports the proposed rule.
Maham Akbar—The Truth Initiative. Akbar supports the proposed rule.
Connor Fuchs—Campaign for Tobacco-Free Kids. Fuchs supports the proposed rule and notes that the timeline is too long and should be shortened.
Mark Anton—e-cigarette/vapor product manufacturer. Anton believes that sections of the proposed rule conflict with previous statements by the CTP. Also, he believes that the burden has been shifted from the regulator to the manufacturer.
Patrick Murphy—vice president of scientific and regulatory affairs at Reynolds American Inc. (RAI). Murphy calls for further refinement and guidance to the proposed rule. He calls for more clarity in several sections and better processes that are product dependent. RAI will forward its notes in a written comment.
Michelle Paige—tobacco chemist. Paige discussed storage conditions and stability issues regarding electronic nicotine-delivery system liquids. Further product standards are needed in this area.
Sammy Hamdouche—Lucy, manufacturer of oral nicotine products. Hamdouche called the regulation onerous for small manufacturers such as his company. Further labor for his company and their suppliers could eliminate parts or potentially all of their business. Costs could be 10-fold for these processes for his company. Predetermined acceptance criteria could be one solution. The CTP has wide latitude to make this rule more flexible, but Hamdouche is not optimistic.
Ron Tully—tobacco industry consultant. Tully believes that the proposed rule should recognize manufacturers of different products and sizes. Small manufacturers could face financial disaster with this rule.
Pamela Ling—professor at the University of California at San Francisco. Ling supports the proposed rule. She also calls to strengthen the section of the rule regarding storage procedures and shelf life.
Pamela Granger—anti-tobacco activist. Granger supports the proposed rule.
The public comment session featured the following unscheduled participants (in order):
Jason Hodge concluded his earlier
Delores Orlando—Florida Smoke-Free Organization, nicotine product manufacturer. Orlando is against the proposed rule.
On May 18, 2023, the CTP’s Tobacco Product Scientific Advisory Committee will meet the discuss the proposed rule on “Requirements for Tobacco Product Manufacturing Practice.”
April 12, 2023
Public Hearing for Manufacturing Rules

Credit: Monticello
The U.S. Food and Drug Administration will hold a public hearing tomorrow, April 12, concerning its proposed guidelines for vaping product manufacturers. When finalizing its rules, the agency weighs the public’s perspective and the perspectives of stakeholders like the vapor manufacturing companies that produce the products.
The FDA will also bring together its Tobacco Products Scientific Advisory Committee on May 18 to get the opinions of those independent experts. The proposed rules would apply to all FDA-regulated bulk and finished tobacco products, including cigarettes, cigars, chewing tobacco and e-cigarettes.
The hearing is an opportunity for the public to verbally comment on the agency’s proposed rule “Requirements for Tobacco Product Manufacturing Practice.” The FDA is proposing new requirements for vaping and other tobacco product manufacturers regarding the manufacture, design, packing and storage of their products.
Registration also includes a “listen-only” option for those who want to attend the session but do not want to request to speak.
When announcing the hearing, the FDA said speaking spots were limited, and the agency could not guarantee that it would be able to accommodate all requests. The agency asked groups and organizations to select a single spokesperson to help the agency hear as many different perspectives as possible.
Registration to provide oral comments closed on March 31, 2023. The oral session will be recorded, and a transcript will be added to the docket of the proposed rule.
April 11, 2023