Category: News This Week

FDA Issues Two Final Rules for Applications

Photo: Araki Illustrations
The U.S. Food and Drug Administration has issued two final rules for the premarket review of new tobacco products. These foundational rules provide additional information on the requirements for the content, format and review of premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports—two of the most commonly used pathways through which a manufacturer can seek marketing authorization for a new tobacco product from the FDA.
According to the agency, the finalization of these rules helps ensure that all future submissions contain the basic information needed to determine whether the new tobacco products meet the relevant premarket requirements to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act.
“These final rules are important components of the FDA’s comprehensive approach to tobacco product regulation, which includes premarket application review, science-based use of the product standard authority and prioritized compliance and enforcement actions,” said acting FDA Commissioner Janet Woodcock in a statement. “The FDA is committed to protecting Americans from tobacco-related disease and death by ensuring that new tobacco products undergo appropriate regulatory review to determine if they meet the public health standards set by law. If new tobacco products do not meet the standards for these pathways, they cannot be marketed or sold in the United States.”
“Conducting review of new tobacco products before they can be legally marketed is a critical responsibility of the FDA,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “These final rules will provide greater clarity and efficiency in review of new tobacco products by describing information that any company must provide if they seek to market a new tobacco product in this country.”
On Jan. 19, 2021, the PMTA and SE final rules were displayed in the Federal Register but did not publish. On Jan. 20, 2021, a memo from the White House Chief of Staff ordered the withdrawal of any rules that did not publish in the Federal Register by noon on that day. Therefore, these final rules were withdrawn at that time. The rules displaying today reflect clarifying changes made from the previous versions but no significant substantive changes. Both final rules will publish on Oct. 5 and are effective Nov. 4. Beginning on the effective date, applications submitted through these pathways must meet the requirements described in these final rules.
October 4, 2021
Estades Re-Elected as Cigar Association Chair
Javier Estades (Photo: Tabacalera USA)
Javier Estades, president and CEO of Tabacalera USA, has been reelected as chairman of the Cigar Association of America (CAA) for a three-year term. Estades previously served as chairman from 2016 to 2020.
“Javier Estades has always just been one of those people who gets it,” said CAA President Craig Williamson in a statement. “When he stepped down as chairman, I said that we would miss his leadership, affable demeanor and steady hand, and now I am thrilled to welcome Javier back as our chairman once again.
“Challenges remain ahead for our industry, but with Javier’s leadership and our continued commitment to speaking as one voice for the cigar and pipe tobacco industry, I know we will navigate the days, months and years ahead successfully.”
“It was an honor to serve as chairman of CAA, and I am excited to once again join my partners in industry to lead this century-old association,” said Estades. “We continue to face a perfect storm of regulatory intervention, increasing tax burdens and evolving industry trends. We will have to join together to preserve our industry for future generations.”
October 4, 2021
First Lawsuits Filed Over Marketing Denials

Turning Point Brands has challenged the Food and Drug Administration’s orders that denied some of the company’s products access to the U.S. market. The company first filed a petition for review with the U.S. Court of Appeals for the Sixth Circuit. TPB then filed an emergency motion to stay the FDA’s order to remove TPB’s products from the market.
TPB is asking the court to review the FDA order “on the grounds that it is arbitrary and capricious, an abuse of discretion, contrary to the Federal Food, Drug and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act of 2009, and otherwise not in accordance with law.” The company requests the court “vacate or modify” the FDA order and asks that TPB be allowed to “continue to market the products subject to the challenged order.”
TPB accuses the FDA of moving the goalposts for data needed to receive a marketing order based on what the agency “learned” from the “review [of] PMTAs for flavored ENDS so far,” according to the stay. TPB noted that the “North Star of administrative law” is that agencies cannot induce regulated parties to rely on “agency representations about regulatory requirements,” then penalize them using the previously unannounced criteria after the fact.
“But that is precisely what FDA did here,” the stay motion states. “[The] FDA reasoned that TPB failed to conduct ‘a randomized controlled trial and/or longitudinal cohort study’ or other studies performed ‘over time’ to show that TPB’s specific flavored products help adult users stop smoking more than tobacco-flavored products do. Yet FDA previously deemed these studies unnecessary.”
Bidi Vapor and at least one other company have reportedly filed similar suits.
October 4, 2021
‘Tobacco firms breached Belgian competition law’

Photo: Schlierner
Belgium has charged four cigarette manufacturers with breaching competition law by exchanging information of future prices to wholesalers, reports Reuters.
The Belgian Competition Authority (BCA) identified the firms as subsidiaries of Philip Morris International, Imperial Brands, Japan Tobacco and British American Tobacco, which together account for 90 percent of cigarette consumption in Belgium.
“The competition prosecutor alleges the existence of anti-competitive practices that lasted for several years and consisted in repeated exchanges of information on their future prices through wholesalers,” the BCA wrote in a statement.
It said that, through the wholesalers, they received information on the future prices of competitors.
A formal inquiry started in May 2017, followed by raids a month later as part of the investigation.
October 4, 2021
Australia to Crack Down on Nicotine Imports

Photo: amazing studio
Effective today, Australian Border Force Agents will have the power to intercept vaping products sent from overseas, reports Filter. Vapers who import nicotine illegally into Australia risk fines of up to AUD222,000 ($161,070).
Australia regulates nicotine for vaping as a medicine. An Australian smoker looking to switch to vaping must visit a doctor and get a prescription. The pharmacy then has to stock the desired vaping product or be able to deliver it. To get around the prescription requirement, many vapers have been importing their products from overseas.
The new rules are meant to end that practice.
Therapeutic Goods Administration (TGA) head John Skerritt said the ban was to prevent people from taking up nicotine vaping.
“There are a lot of tobacconists and convenience stores, and even things like sex shops, who are selling these products illegally at the moment,” Skerritt told ABC Australia.
“Especially young children; we’ve had many reports of schools, in fact, some even year 7 students, kids who are 11, 12, 13 using high levels of nicotine vapes.
“The trend is on the up in Australia.”
Australia’s prescription model has attracted heavy criticism from tobacco harm reduction proponents, given that combustible cigarettes—which are far more harmful than vapor products—remain readily available as consumer products. The policy will keep smokers smoking, drive vapers back to cigarettes or encourage consumers to purchase illicit products, according to critics.
“The people who will be most affected will be the people who are currently smoking and who decide they want to switch to vaping,” said Alex Wodak, director of the Australian Tobacco Harm Reduction Association.
“Some people who are currently vaping will undoubtedly go back to combustible cigarettes.”
About 2.5 million Australians still smoke, with around 21,000 smoking-related deaths every year. There could be up to 600,000 vapers in Australia, according to some estimates.
October 1, 2021
PMI Closes Business Transformation Credit

Photo: alswart
Philip Morris International has entered into an agreement for its first financing instrument following the issuance of its August 2021 Business Transformation-Linked Financing Framework. The new revolving credit facility provides for borrowings up to an aggregate principal amount of $2.5 billion and expires on Sept. 29, 2026, unless extended as per the terms of the credit agreement.
“We are pleased with the broad engagement and support of lenders for our first business transformation-linked financing instrument,” said Emmanuel Babeau, chief financial officer at PMI. “This credit facility further reinforces our industry-leading transformation and our commitment to accelerate the end of smoking and to use our strong capabilities to develop products that go beyond nicotine and have a net positive impact on society.”
Consistent with the company’s framework, the facility includes business transformation-linked pricing adjustments based on progress on two of PMI’s most ambitious and strategic business transformation metrics: PMI’s smoke-free/total net revenue percentage and the number of markets where PMI’s smoke-free products are available for sale. The adjustments may result in the reduction or increase in both the interest rate and commitment fee under the credit agreement if PMI achieves, or fails to achieve, certain specified targets.

This credit facility further reinforces our industry-leading transformation and our commitment to accelerate the end of smoking.
Emmanuel Babeau, chief financial officer, PMI
“Investors, lenders and other stakeholders can play an important role in driving change by encouraging and supporting companies that are committed to transform and improve their impact on society,” said Jennifer Motles, chief sustainability officer, in a statement. “We look forward to continued engagement with our stakeholders in order to further accelerate our smoke-free transformation and set an example for other companies, both inside and outside our industry.”
The facility replaces PMI’s existing $3.5 billion revolving credit facility, which was set to expire on Oct. 1, 2022, and was terminated effective Sept. 29, 2021.
October 1, 2021
‘Flavored Vapes Remain Popular Among Youth’

Photo: flydragon
A study released today by the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention (CDC) estimated that more than 2 million U.S. middle and high school students reported currently using e-cigarettes in 2021, with more than 8 in 10 of those youth using flavored e-cigarettes.
The report, published in the Morbidity and Mortality Weekly Report, was based on data from the 2021 National Youth Tobacco Survey (NYTS), a cross-sectional, self-administered survey of U.S. middle (grades 6–8) and high (grades 9–12) school students. The study assessed current (used on one or more of the past 30 days) e-cigarette use; frequency of use; and use by device type, flavors and usual brand.
Administered Jan. 18–May 21, 2021, this NYTS was the first to be fully conducted during the Covid-19 pandemic. Data were collected using an online survey to allow eligible students to participate in the classroom, at home or in some other place to account for various school settings during this time. Prior to the pandemic, the survey was conducted in-person inside the school classroom. Because of the changes in the way the survey was conducted this year, results of the 2021 NYTS cannot be compared to findings from previous surveys.
“These data highlight the fact that flavored e-cigarettes are still extremely popular with kids. And we are equally disturbed by the quarter of high school students who use e-cigarettes and say they vape every single day,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “The FDA continues to take action against those who sell or target e-cigarettes and e-liquids to kids, as seen just this year by the denial of more than one million premarket applications for flavored electronic nicotine-delivery system products. It is critical that these products come off the market and out of the hands of our nation’s youth.”
September 30, 2021
BMJ Completes New Headquarters

Photo: BMJ
BMJ has completed construction of its new headquarters.
Located at the BMJ complex near Jakarta, the building has been positioned to optimize the footprint of the specialty paper and packaging materials supplier. Equipped with the latest security technologies, the facility features comfortable rooms to accommodate visitors.
The building has been designed to minimize its environmental impact. Through the use of extensive greenery and a pool, BMJ has reduced its dependence on artificial climate control methods—a considerable advantage in a hot and humid country like Indonesia. A weaving structure surrounding the building’s facade and roof limits heat gain. Designed by computer and handcrafted by rattan master weavers, the structure offers shade during the day and architecturally pleasing shapes at night.
In designing its new headquarters, BMJ has emphasized utility, effectiveness and efficiency. For example, roster walls promote airflow while exposed ceilings facilitate maintenance. Consistent with BMJ’s philosophy of collaboration, the new facility features open workspaces with minimal partitions.
BMJ says its new headquarters, which were developed during the pandemic, reflect the company’s resilience and innovative spirit. “We believe our new headquarters symbolize every ‘eureka!’ moment we had in the past and will become inspirations for our ‘eureka!’ moments in the future,” the company wrote in a statement, referring to its “Eureka Everyday!” corporate slogan.
September 30, 2021
U.S. IQOS Imports Halted

Photo: theaphotography
The International Trade Commission (ITC) has upheld an initial determination from May 2021 that Philip Morris International’s IQOS device infringes on two patents owned by BAT subsidiary Reynolds American Inc. (RAI).
The agency has instituted an import ban and a cease-and-desist order preventing IQOS consumables and devices from being sold in the U.S. in 60 days. PMI’s U.S. partner, Altria Group, plans to continue to sell IQOS through the 60-day period in its existing markets.
BAT welcomed the ruling. “Infringement of our intellectual property undermines our ability to invest and innovate and thereby reduce the health impact of our business,” the company wrote in a statement. “We will therefore defend our IP robustly across the globe.”
The patents relate to an electronically powered device with a heater to generate an aerosol and expire in October 2026 and November 2031. BAT has filed similar cases globally, including in Germany, the U.K., Japan and Italy.
Morgan Stanley said the ruling would have limited financial impact on PMI and Altria, as IQOS in the U.S. is not a meaningful contributor to the companies’ earnings. The outcome of similar cases brought by BAT against PMI internationally, however, could have a greater impact. But so far, PMI has been successful defending cases in the U.K. and Greece.
The investment bank also noted that the IQOS ban applies to imported product, suggesting it may be overcome by shifting production to the U.S.
The ITC decision will now be reviewed by the U.S. Trade Representative. If the decision is not vetoed within 60 days (only a handful have ever been vetoed), it can be appealed to the U.S. Court of Appeals, but the import ban would still be in effect throughout an appeals process.
September 30, 2021
Juul2 Launched in the United Kingdom

Photo: steheap
Juul Labs has unveiled its Juul2 device in the U.K.
The device features a more consistent vapor experience, a longer battery life and anti-counterfeit technology.
Launching initially on the Juul.co.uk website on Sept. 30, the Juul2 system has been updated from previous versions with new technology and features based on feedback from smokers.
Among other features, the Juul2 features a more consistent vapor experience, a longer battery life and a smart light system communicating e-liquid level and battery life.
The Juul2 also comes with newly designed tobacco and menthol Juul2 pods (18 mg/mL nicotine strength) and technology to prevent unauthorized use. The device will not work when it detects counterfeit pods.
“We are pleased to launch the next-generation Juul2 in the U.K.,” Juul Labs’ EMEA vice president, Dan Thomson, said in a statement. “A key part of our mission is to transition adult smokers away from cigarettes, the leading cause of preventable death in the world, killing some 90,000 Britons annually.
“We believe the best method to switch adult smokers from combustible cigarettes to a potentially less harmful noncombustible alternative is to provide a product that closely resembles the consistency and experience of smoking. With Juul2, we believe we are taking another step in that direction as we aim to transition even more adult smokers.”
A retail rollout is planned for early 2022, and all U.K. retailers stocking Juul products will continue to uphold the company’s Challenge 25 age verification policy, which includes continued mystery shopping audits.
September 30, 2021