Category: Featured

OSC Letter Describes FDA’s ‘Public Failure’

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The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) had relaxed its standards of review for certain tobacco products and stifled attempts by its scientists to raise concerns, according to an investigation conducted by the U.S. Office of Special Counsel (OSC). The OSC sent a letter to President Joe Biden and Congress outlining the findings.
The investigation began after a leading CTP toxicologist-turned-whistleblower disclosed to the OSC that a 2019 memorandum issued to the CTP’s scientists revised the process for evaluating potentially harmful ingredients in substantial equivalence applications used for certain tobacco products. According to the whistleblower, the memo directed scientists to stop using objective, quantitative data to evaluate applications and to instead use an approach that was more akin to “eyeballing it,” resulting in unclear review standards and less reliable decisions, according to the CTP.
The whistleblower also alleged that flaws in the CTP’s internal scientific dispute resolution process effectively prevented the whistleblower and several other concerned scientists from raising these issues within the agency. “This internal dispute process is intended to safeguard the integrity of CTP’s scientific evaluations, including consideration of certain tobacco products to ensure those authorized for market meet the applicable health and safety standards,” the CTP stated.
The OSC referred the whistleblower’s allegations for investigation. In response, the FDA convened an independent panel of scientific experts to evaluate allegations concerning the allegedly flawed tobacco application review process. The panel largely agreed with the whistleblower’s concerns, finding that the process lacked “quantifiable standards or criteria.” The expert panel made six recommendations, including a new process for resolving scientific discrepancies, which the agency largely adopted.
In response, the whistleblower acknowledged the CTP’s progress in giving scientists discretion to consider quantitative data in reviewing potentially harmful chemical compounds in substantial equivalence applications for new tobacco products. The CTP also revamped its scientific dispute procedures and created a mandatory training program for all CTP staff involved in scientific decision-making. While supportive of these steps, the whistleblower stated that FDA scientists will still need courage to challenge a system that “discourages dissenting voices.”
“The public depends on the FDA to vigorously implement and enforce our nation’s health and safety laws, especially when new tobacco products are being brought to market,” said Special Counsel Henry J. Kerner. “I am deeply troubled that FDA’s own scientific dispute process failed our whistleblower and fellow concerned scientists, and as a result failed the public. I commend the whistleblower for persevering in the face of these unnecessary obstacles. I also thank the FDA for taking the allegations seriously by convening an independent expert panel and for taking positive steps to repair its review process.”
December 21, 2022
Belgium Bans Smoking at Train Stations

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Belgium has banned smoking and vaping at train stations, both indoor and outdoor, effective Jan. 1, 2023, according to The Brussels Times.
The ban will apply to all 550 stations in Belgium, and those caught in violation will be fined. Ashtrays will be removed from platforms, and prohibition signs at visible places will indicate the ban.
“Our children have the right to grow up in good health, including without exposure to tobacco. As children see fewer and fewer people smoking, the absence of tobacco is becoming the new norm for them,” said Marc Michils, Generation Smoke-Free spokesperson. “Generation Smoke-Free welcomes this measure that brings us closer to the first generation without tobacco.”
“There are 14,000 victims of tobacco every year in Belgium—that should spur us into action,” said Federal Mobility Minister Georges Gilkinet. The ban will “ensure healthier air on the platforms and, above all, reduce the pressure for young people who have quit or want to quit smoking.”
December 20, 2022
Universal Releases 2022 Sustainability Report

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Universal Corporation released its 2022 Sustainability Report.
“Sustainability continues to be an essential part of how we conduct business at Universal. We are committed to disclosing our operational activities as well as our sustainability performance in a consistent and transparent manner,” said George C. Freeman III, Universal’s chairman, president and CEO, in a statement. “We have updated our materiality assessment and are excited about the new information and disclosures within our 2022 Sustainability Report. We are also proud to announce an improvement in our CDP Climate Change and Forestry scores and will continue to build on our disclosures into the future.”
Universal’s 2022 Sustainability Report focuses on the company’s material sustainability topics as well as its environmental, social and supply chain goals. Data disclosed in this report reflects activities from April 1, 2021, to March 31, 2022.
December 20, 2022
Austria to Expand Smoking Ban

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The Austrian government plans to expand the country’s smoking ban to include “additional outdoor public places” in 2023, according to The Local.
The new amendment to the Tobacco and Nonsmoker Protection Act would add public places, such as “children’s playgrounds and recreational areas for children and young people,” to the list of banned smoking areas. The amendment would also regulate nicotine pouches, which have become increasingly popular among young people.
A ban on indoor smoking, including in bars and restaurants, was implemented in 2019.
The new amendment will be reviewed at the beginning of 2023.
December 19, 2022
Governor to Veto ‘No Flavor Bans’ Bill

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Ohio Governor Mike DeWine appears primed to veto a bill just passed by the state legislature that would prohibit cities like Columbus from regulating vaping and other tobacco products.
DeWine told ABC 6 On Your Side he supports the Columbus ordinance passed Monday banning the sale of flavored vaping and other tobacco products.
“Making a decision not to have flavored cigarettes is a logical decision that will save many, many lives and will save taxpayers a lot of money,” DeWine said. “Smoking costs the citizens of Ohio hundreds and hundreds of millions of dollars every single year.”
The day after the Columbus tobacco ban passed, Republicans who control the legislature added a proposal to an unrelated bill mandating that only the state can regulate tobacco products in Ohio. The bill would wipe out attempts by local governments, such as that in Columbus, to rein in the use of tobacco products.
December 19, 2022
Altria Abandons Expiring Cronos Warrant

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Altria Group has notified Cronos Group of its irrevocable abandonment of its warrant to purchase additional common shares of Cronos and all rights that it may have held in the warrant or any common shares underlying the warrant for no consideration, according to an Altria press release.
In March 2019, Altria acquired, through its subsidiaries, a 45 percent ownership interest in Cronos and the warrant. The warrant was exercisable until March 8, 2023, at an exercise price of CAD19 ($13.93) per common share. Prior to abandonment of the warrant, Altria, through its subsidiaries, owned 156,573,537 common shares of Cronos (representing approximately 41 percent of the Cronos common shares issued and outstanding) and, by fully exercising the warrant, could increase its ownership by 84,243,223 Cronos common shares to 240,816,760 Cronos common shares (representing approximately 52 percent of the Cronos common shares that would be issued and outstanding following full exercise of the warrant).
The closing share price of Cronos common shares on Dec. 15, 2022, was CAD3.81, and the Cronos common shares have not traded above CAD6 over the past 12 months. Given the Cronos trading levels and the March 2023 expiry of the warrant, Altria elected to abandon the warrant on Dec. 16, 2022. As a result of the warrant abandonment, Altria expects to claim a capital loss of $483 million on its U.S. federal consolidated income tax return for 2022. Altria continues to own 156,573,537 common shares of Cronos.
Altria, through its subsidiaries, holds the Cronos common shares for investment purposes. Altria will continue to evaluate Cronos’ business and prospects and all other factors it deems relevant in determining whether it or its affiliates will acquire additional common shares of Cronos or dispose of common shares of Cronos in the open market, in privately negotiated transactions (which may be with Cronos or with third parties) or otherwise.
December 19, 2022
BAT to Close Swiss Plant

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BAT will close a cigarette manufacturing plant in Switzerland in 2023, reports Reuters.
The closure will cause the layoff of 226 workers. Employees will be given an “advantageous social package,” according to SwissInfo.
“BAT Switzerland confirms that a final decision has been made to transfer cigarette production from Boncourt to larger factories within Europe and to close the Boncourt site,” BAT said in a statement.
Boncourt Mayor Lionel Maitre said the closure is “a shock, a disappointment, a feeling of desperation and a mess.” The factory closure will cause Boncourt to lose its biggest taxpayer.
“Let’s be clear—this is a hard blow, but we will overcome it, and the situation is not hopeless,” said Jura government President David Eray. “This decision brings us face-to-face with the painful consequences that we feared.”
In 2014, BAT closed a research and development facility in Boncourt, laying off about 15 people.
December 16, 2022
GPS-Based App to Launch in India

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India’s Tobacco Control Cell will soon launch its GPS-based app “StopTobacco” that the population can use to lodge complaints of smoking in public places, reports The Hindu.
The Cigarettes and Other Tobacco Products Act 2003 (COTPA) was initiated to reduce smoking in public places and protect nonsmokers from involuntary tobacco smoke exposure. Anyone violating the COTPA can now be turned in using the new app—users simply upload a picture of the public place where the smoker is located and the state’s anti-tobacco squad will respond to the area and issue a penalty to the violator.
“We cannot be waiting for the police or municipal enforcing agency to be overburdened. This app will give us the opportunity to increase awareness about COTPA law and rules in public places, increase social responsibility for the citizens and impact positive health. This app draws a fine balance for awareness and enforcement,” said Vishal Rao, member of the state’s High Power Committee on Tobacco Control.
A similar pilot system was launched in 2019, allowing COTPA violations to be lodged via email in 10 districts. It could not be implemented across the state, however, due to the pandemic.
“After downloading the app, the photo of the public place where the violation is happening, such as a shop, bakery, hotel, school/college, bus station, railway station, playground, etc., can be clicked and uploaded. Then there will be an option to enter the district, taluk and mobile number of the complainant. The photo will reach the district tobacco control unit and be forwarded to the taluk tobacco control unit. As the app is GPS-based, the location from where the complaint has been lodged will be highlighted on the map, and the squad will rush to the spot,” said a senior official, adding that seven-member squads have been set up in every taluk to act on the complaints.
December 15, 2022
Study: PMI Uses Ad Loopholes in Israel

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Philip Morris International has exploited loopholes in smoking product advertisement bans in Israel, a new study shows, reports The Jerusalem Post.
The study, published in Tobacco Control, analyzes PMI’s advertising expenditure over four years across the general population, the ultra-Orthodox (haredi) public, Arab speakers and Russian speakers.
“We conducted a comparison among the advertising expenditures for all Philip Morris cigarette brands and the IQOS brand (a heated-tobacco stick that entered the local market in December 2016) in light of regulatory changes that restricted the advertising of tobacco products,” said doctoral student Amal Khayat.
Advertising restrictions led to a reduction in PMI’s marketing expenditures, but it exploited legal loopholes in the printed press, according to the study.
“Even after the law came into effect, the company continued to spend almost NIS3 million [$872,566.93] on advertising with a focus on the printed press,” said Yael Bar-Zeev, lead researcher. “While the law restricted print advertising to one advertisement in each newspaper, 40 percent of the IQOS adverts placed were giant, two-page ads, effectively doubling the product’s advertising space while still being considered a single advert as allowed by the letter of the law.”
PMI also used QR codes, allowing consumers to scan and view additional information. Before the law went into effect, according to the study, PMI significantly increased its advertising to the studied population groups, particularly the Haredi population, which previously had the lowest smoking rates in Israel.
“Our data shows that since the introduction of the IQOS e-cigarettes, 216 targeted ads were published, of which 55 percent were created for the Haredi public, 6 percent for the Arab public and the rest for the Russian-speaking public,” said Bar-Zeev. For regular cigarette brands, 87 percent of advertisements were targeted at the Haredi population.
“We expected that the company would focus on populations with the highest rates of smoking in Israel—Arab men—and not on the population that had hardly any smokers,” said Bar-Zeev.
Following the study, the 24th Knesset decided to remove the printed press advertisement exception but deferred implementation for seven years. In the interim, coupons, QR codes and advertisements featuring cigarette packs that do not have mandatory plain packaging are banned in the printed press.
December 15, 2022
Ohio Passes Ban on Cities’ Flavor Bans

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The Columbus City Council in the U.S. state of Ohio voted unanimously in favor of banning the sale of flavored tobacco and vaping products within city limits on Monday, Dec. 12. On Wednesday, the Ohio Senate approved a bill that would make what the Columbus City Council did illegal.
The Ohio Senate passed H.B. 513 by a vote of 23-8. It includes an amendment that will prohibit local governments in Ohio from enacting any laws regarding tobacco or vaping products that are stricter than state law, a mechanism known as preemption, according to Halfwheel.
Because of this amendment, the bill now heads back to the Ohio House of Representatives, where it must be approved before heading to the desk of Governor Mike DeWine. Reports indicate that the House vote is expected this week.
If approved, the state law will effectively void the law passed by the Columbus City Council on Monday. The Columbus city law is set to take effect on Jan. 1, 2024.
Preemption clauses have been a successful tool in blocking bans on the sales of flavored vaping products and other tobacco products. The city of Philadelphia lost a federal lawsuit that overturned its flavored tobacco ban due to Pennsylvania’s preemption clause.
December 15, 2022