Author: Staff Writer

CTP Ends Public Hearing on Manufacturing Rules
Courtesy: US FDA
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 additional participants who missed their original slotted time (in order):
Jason Hodge concluded his earlier diatribe
Delores Orlando—Florida Smoke-Free Association and vape shop owner. Orlando is against portions of 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
Juul Labs to Pay $462 Million to Six US States

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Juul Labs Inc 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, the states announced on Wednesday.
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 FDA 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 non-exclusive, irrevocable global license to certain of Juul’s heated tobacco intellectual property.
April 12, 2023
Serbia to Fine Retailers Selling Vapes to Youth

Credit: Bits and Splits
Sellers of e-cigarettes and other tobacco products will be fined around €430 ($469) for selling to minors, according to a recent amendment to the Law on Consumer Protection.
In Serbia, minors can purchase e-cigarettes and other products such as vapes in local markets, kiosks, and even in coffee shops, though sellers will now be fined for selling them, according to EurActive.
“In the legislative system of the Republic of Serbia, this issue is not regulated. There is no definition of electronic cigarettes and other products with or without nicotine, as well as a ban on selling them to minors. This is precisely why the urgent need for regulatory action, which is being implemented now, is emphasized,” Serbia’s Internal and Foreign Trade Ministry stated.
The relevant ministry announced that it is starting to work on amendments to the Law on Consumer Protection in this part because it believes that this is the solution to a major national problem.
“The main goal is to ban the sale of electronic cigarettes and other products to minors, as a particularly sensitive category. In this way, sanctions will also be enabled in the case of the sale, service and gifting of these products,” the Ministry stated.
With the new decision, a merchant will be fined 50,000 dinars (around €430) if they sell to a minor, the Ministry said.
The popularity of e-cigarettes and other electronic nicotine delivery systems among non-smoking youth and adults represents a significant public health problem, as they encourage nicotine addiction and expose 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 added.
The change in the law will prohibit 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 is also prohibited for persons under 18 to sell them.
April 12, 2023
Texas House Bill Would Ban Vaping at Colleges

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A bill introduced in the Texas House of Representatives would ban the use of all tobacco and vaping products at colleges and universities in the state of Texas by Aug. 1, 2024.
Rep. Suleman Lalani has introduced H.B. 3124, requiring “each institution of higher education shall adopt a policy prohibiting the use” of tobacco products and e-cigarettes by Aug. 1, 2024, according to Charlie Minato of Halfwheel.
The bill received a public hearing Monday in the Texas House’s Higher Education Committee. It currently does not appear to have any additional sponsors.
The five largest universities in the state all have some sort of tobacco-free policy on campus though some—Texas A&M and UT Arlington—are stricter than others like the University of Houston.
April 12, 2023
Numerous Vape Shops Close After Taiwan Vape Ban

Credit: Yao Photograph
Since the vaping ban was enacted in Taiwan on March 22, 15 out of 44 vape shops in Kaohsiung City have closed, according to the city’s Department of Health.
Among the city’s 44 stores, 10 have completely shut down their businesses while 15 have closed their doors, according to media reports. The rest of the stores have switched to selling other products, as the store owners said that the fines are too high to risk, according to Taiwan News.
In addition to intensive inspections of physical stores, the health department is monitoring online sales and social media advertisements. So far, one violator who made e-cigarette advertisements will be interviewed and fined.
The amended regulations to Taiwan’s Tobacco Hazards Prevention Act ban e-cigarettes entirely, raise the smoking age to 20 and increase penalties for violators.
According to the new regulations, manufacturing or importing e-cigarettes is punishable by a fine of up to NT$50 million ($1.65 million). Advertising agencies, media, and advertisers are subject to a maximum fine of NT$2 million if they are caught advertising unsanctioned tobacco products.
Selling or displaying unsanctioned tobacco products is punishable by a maximum fine of NT$1 million. The fine for supplying novel tobacco products and their paraphernalia is NT$10,000 to NT$250,000, and vaping is punishable by a fine between NT$2,000 and NT$10,000.
April 12, 2023
UK to Offer 1 Million Smokers Free Vapes to Quit

Credit: Brian Jackson
Up to 1 million smokers will be encouraged to swap their cigarettes for vapes, according to the British government. Pregnant women will be offered financial incentives to switch, reports Reuters.
“Up to two out of three lifelong smokers will die from smoking. Cigarettes are the only product on sale which will kill you if used correctly,” Health Minister Neil O’Brien will say in a speech later on Tuesday, the government said.
“We will offer a million smokers new help to quit. We will be funding a new national ‘swap to stop’ scheme—the first of its kind in the world.”
One million smokers will be given a free vaping starter kit to encourage them to give up tobacco products.
Pregnant women will also be offered up to £400 to stop smoking as part of a package of measures in England unveiled by the government on Tuesday.
A consultation will be launched on compelling cigarette manufacturers to put advice on quitting inside packs.
April 11, 2023
Public Hearing for Manufacturing Rules Tomorrow

Credit: Xtock
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 perspective 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
Juul Labs Settles With West Virginia for $7.9 Million

Credit: Carol
West Virginia has reached a settlement agreement with e-cigarette manufacturer Juul Labs Inc. based on its advertising and marketing practices, according to state Attorney General Patrick Morrisey.
Juul Labs has agreed to a $7.9 million settlement, based on accusations the company violated West Virginia’s Consumer Credit and Protection Act, according to media reports.
The company was accused of “engaging in unfair or deceptive acts or practices in the manufacturing, designing, selling, marketing, promoting and distributing of e-cigarettes” in the state, especially promotions targeting underage users, according to Morrisey.
“This settlement puts companies like Juul in check to not copy big tobacco’s playbook and gear marketing strategies toward underage people,” he said. “In Juul’s case, we have alleged it has deceived consumers about its nicotine strength, misrepresented the nicotine equivalency of its products to traditional cigarettes and understated the risks of addiction that occur with such powerful levels of nicotine.”
The settlement represents “yet another step in Juul Labs’ ongoing commitment to resolve issues from the company’s past,” according to a statement from Austin Finan, vice president of corporate communications at Juul Labs.
“The terms of the agreement, like prior settlements, provide financial resources to further combat underage use and develop cessation programs and they reflect our current business practices, which were implemented as part of our company-wide reset in the fall of 2019,” Finan said. “With West Virginia having the highest cigarette-smoking rate in the U.S., we hope that some funds will go directly to interventions to reduce the use of combustible cigarettes and improve public health in the state.”
Juul has now settled with “40 states and territories, providing hundreds of millions of dollars to the participating states,” according to Finan.
April 10, 2023
Russia’s Vape Market Growing With Boost From China

A vape shop in Vladikavkaz, Russia in 2019. (Credit: irinabal18)
The withdrawal of European and American tobacco manufacturers and the gradual reduction of foreign e-cigarette brands doing business in Russia due to its war with Ukraine has allowed for the growth of Chinese e-cigarettes in Russia.
As Russia’s tobacco industry relies heavily on the support and investment of foreign brands, the withdrawal of international tobacco companies will cause a large shortage in the Russian tobacco market, which will lead to a sharp increase in the price of tobacco products sold in Russia, according to iGeekPhone.
By the end of 2021, there were more than 5,000 stores selling e-cigarettes in Russia, including more than 1,100 in the Moscow region.
According to real estate platform DNA REALTY, the number of tobacco shops in Russia grew by at least 20 percent in 2022, with the bulk of their profits coming from e-cigarette sales.
BAT announced it will withdraw from the Russian and Belarusian tobacco markets in 2023. Philip Morris International (PMI) and its subsidiary Fimo International, are also considering retaining their business in Russia because Russia is the seventh-largest tobacco market for PMI.
Japan Tobacco suspended investments in Russia and Imperial Brands transferred its Russian operations to a successor in Russia.
“E-cigarettes have great potential as alternatives to the tobacco market in Russia, where e-cigarette consumers account for 6.8 percent of the total number of smokers,” the article states. “After the United States and Europe, Russia is the world’s third-largest importer of electronic nicotine delivery systems (ENDS).
“China accounts for 90 percent of the global market. In 2021, China’s exports to Russia reached 82.5 billion rubles. This year it could increase by 35 percent to 111 billion rubles.”
April 10, 2023
UK to Launch Youth Vaping ‘Enforcement Squads’

Credit: DIY13
The UK is set to launch “illicit vapes enforcement squads” as part of a crackdown on the illegal sale of e-cigarettes to youth under the age of 18.
Led by Trading Standards, the squads will work across the country and share knowledge across regional networks and local authorities.
The government says its priority is to prevent people from smoking, and supporting them to quit. It has admitted vaping is a preferable alternative for adults, reports Sky News.
However, it recognizes it has an issue with illegal sales to children and illicit vapes being introduced into the market.
Neil O’Brien, the health minister who will unveil the new plans said the new illicit vapes enforcement squad will work across the country and clamp down on those businesses that sell vapes to children.
“Our call for evidence will also allow us to get a firm understanding of the steps we can take to reduce the number of children accessing and using vapes,” he said.
April 10, 2023