Tag: e-cigarettes

Vaping Retailers Cautious on Outlook of Category

Credit: Jet City Image
Goldman Sachs Managing Director Bonnie Herzog highlighted some key concerns and risks identified by retailers in the survey, along with some key positives for the nicotine industry.
A recent survey shows convenience-store retailers, distributors and others who sell vaping and other tobacco products are cautious on the outlook for the category.
This finding comes from Goldman Sachs’ second-quarter 2023 Nicotine Nuggets survey, based on feedback from the New York-based company’s retailer and wholesaler contacts representing about 60,000 locations across the United States, according to CSP Daily.
Overall, 43 percent of respondents are more negative than the previous quarter in their outlook for the total tobacco/nicotine category in the last few months, citing economic constraints on the consumer, pressure on discretionary incomes, regulations, and tobacco list price increases driving consumers to trade down to cheaper products or exit the category.
Key concerns and risks that survey respondents identified included price elasticity and downtrading, Goldman Sachs Managing Director Bonnie Herzog highlighted in a report on the survey.
Recent price increases are forcing consumers to buy less, buy cheaper products or exit the category, she said. One respondent said the current pricing environment is not sustainable for the core tobacco consumer, and that pricing is starting to cut into demand above and beyond the industry 3-5 percent volume declines. In July, Altria took its third cigarette list price increase of 2023.
As manufacture list price increases reduce consumer options for affordable tobacco products, smokeless nicotine and e-cigarettes are benefitting, survey respondents said.
Respondents also expressed concern about the proliferation of black-market activity in flavored e-cigarettes as the FDA struggles to remove non-compliant products from the market, Herzog said. Continued premarket tobacco product application (PMTA) delays and marketing denial orders from the FDA on flavored products is benefiting the illicit market, respondents said. Significant traffic is moving to disposable flavored e-cigarettes.
Key positives from the report included growing sales of non-combustible alternatives and cigarettes continuing to drive store traffic, despite volume declines.
Several retailers pointed out accelerating trends for flavored disposable vapes and alternative oral nicotine pouches and e-cigarettes.
And while cigarettes are increasing in price, the segment remains an important category and traffic driver for retailers, as cigarettes make up more than a quarter of total inside sales, Herzog said.
July 28, 2023
Golden, Colorado Passes Ban on Flavored Nicotine

Welcome to Golden sign along Washington street in Golden, Colorado (Credit: PaBrady63)
Council members in the city of Golden, Colorado, this week voted 6-0 to approve an amended ordinance to ban the sale of flavored vaping and other tobacco products.
Councilors listened to nearly an hour and a half of public comment before voting on the proposed ordinance, according to media reports.
Ordinance No. 2216 amends the city’s municipal code to revise business regulations and licensing requirements for nicotine and tobacco product retailers, prohibiting the sale of flavored tobacco products within city limits.
The new ordinance originally had an effective date of Sept. 1, 2023. The council decided to amend that date to Jan. 1, 2024.
July 28, 2023
Bill Banning Flavored Vaping Products in Maine Dies

Maine State House (Credit: Jovannig)
The Maine Legislature has tabled a bill to end the sale of flavored tobacco products statewide. In the U.S., when a bill is tabled it is no longer up for debate for the current term.
It’s been a hot topic in Maine with some health advocacy groups claiming flavored vaping and other tobacco products are marketed toward children while many business owners say banning it would be a big blow, according to media reports.
The bill sought to make statewide prohibitions that are already in place in Portland, South Portland, Brunswick, Bangor and Bar Harbor.
A similar statewide effort failed last year when lawmakers adjourned without taking up the bill.
The bill could be taken up again next year.
July 28, 2023
FDA Warns 3 Major Flavored Disposable Distributors

The U.S. Food and Drug Administration today issued warning letters to three distributors for selling and/or distributing multiple brands of unauthorized e-cigarette products.
The illegal products listed in the warning letters sent to ABS Distribution Inc., EC Supply, Inc. and Easy Wholesale, LLC include the popular and youth-appealing e-cigarette products Elf Bar/EB Design, Esco Bars, and Puff Max (Puff Bars).
“FDA is committed to keeping a finger on the pulse of the rapidly evolving e-cigarette landscape, including through a variety of scientific assets equipped to quickly identify products with high youth appeal,” said Brian King, director of FDA’s Center for Tobacco Products (CTP). “We will continue to use this data-driven approach to inform actions across the entire supply chain, including against those who distribute illegal products between manufacturers and the point of sale.”
The distributors receiving warning letters sell and/or distribute e-cigarettes in the United States that lack authorization from FDA, which is a prohibited act under the Federal Food, Drug, and Cosmetic Act, according to an FDA release.
All of the brands cited in these warning letters have been identified as being among the most popular e-cigarettes among U.S. youth.
“Warning letters are generally the first step once an inspection reveals a violation of the law,” said Ann Simoneau, director of the Office of Compliance and Enforcement within CTP. “We will monitor to ensure these violations are corrected, and if they are not, the recipient is at risk of further actions such as civil money penalties, seizures, and injunctions.”
The FDA has stepped up enforcement of flavored disposable products after several lawmakers complained the agency wasn’t fulfilling its duties.

Credit: Pastel Cartel
July 27, 2023
New Categories Boost BAT Half-Year Revenues

Photo: BAT
British American Tobacco reported revenue of £13.44 billion ($17.35 billion) in the first six months of 2023, up 4.4 percent over the figure recorded in the comparable 2022 period. Growth was driven by the company’s “New Categories” segment. Revenue from noncombustible products now accounts for 16.6 percent of group revenue, up 180 base points (bps) versus fiscal year 2022.
BAT’s Vuse and Velo brands enjoyed strong revenue growth, and New Categories’ financial delivery significantly improved, contributing a £201 million increase to group profit as losses reduced.
Reported profit from operations was up 61.4 percent (with reported operating margin up 1,560 bps to 44.2 percent). Adjusted profit was up 3.6 percent at constant exchange rates. Adjusted operating margin was up 40 bps to 44.3 percent.
“Having been in my new role for 10 weeks, I’m pleased with the resilient performance of BAT in the first half of 2023 and the renewed sense of energy across the organization,” said BAT Tadeu Marroco, who assumed the top job in May. “It is a challenging external environment. High inflation and slower global growth are impacting consumers and business. Yet our revenue, profit from operations and earnings are all up.
“We are making great progress in New Categories. Revenues are up by 29 percent, and we are now close to break[ing] even, with consumers of noncombustible products up by 1.5 million versus FY 2022. While it’s encouraging to see continued good performance in vapor and modern oral, we recognize more work is required in heated tobacco.
“I remain confident that New Categories will deliver a positive contribution in 2024. However, we do not expect contribution growth to be linear, as levels of investment will align with the phasing of our big innovation platforms.
“While more focus is required in the U.S., our sequential performance improvement in the critical premium U.S. combustibles business since January 2023 is encouraging.
July 26, 2023
Amicus Brief Supports Limiting ‘Chevron Deference’

Image: Tobacco Reporter archive
Keller and Heckman has filed an amicus brief with the U.S. Supreme Court on behalf of members of the electronic nicotine-delivery system (ENDS) industry in support of petitioners in a case to overturn or limit the so-called Chevron deference.
Named after a landmark Supreme Court decision dating from 1984, the Chevron deference is a legal doctrine that generally requires courts to defer to an administrative agency’s interpretation of ambiguous statute so long as that interpretation is reasonable.
In practice, Chevron deference often gives agencies broad leeway to reach beyond the limits of a statute’s plain language, often bypassing the rulemaking process otherwise required under the Administrative Procedure Act and making it more difficult to challenge an agency action in court.
In the years since ENDS became subject to Food and Drug Administration regulation, the vast majority of courts reviewing ENDS industry challenges to premarket application denials, as well as FDA rulemakings and guidance documents, have rubber-stamped the agency’s interpretation of the Family Smoking Prevention and Tobacco Control Act (TCA) and the “appropriate for the protection of the public health” standard, Keller and Heckman wrote on its blog.
Critics contend that the Chevron deference has enabled the FDA to impermissibly interpret the TCA to implement a de facto ban on all nontobacco-flavored ENDS products without any requisite notice and comment rulemaking or congressional amendments to the TCA.
The filers on the amicus brief urge the Supreme Court to at least restrict the application of Chevron deference so that it is the exception, not the rule. The Supreme Court will hear oral arguments in the case in its fall 2023 term.
The petition to overturn or limit the Chevron deference was brought by a group of fishing companies challenging the National Marine Fisheries Service’s construction of the Magnuson-Stevens Act to require the industry to pay the salaries of federal monitors.
The ENDS industry amici include the American Vaping Manufacturers Association, the American Vapor Group and Bidi Vapor.
July 25, 2023
FDA Makes Next TPSAC Meeting Materials Available

The U.S. Food and Drug Administration’s Tobacco Products Scientific Advisory Committee (TPSAC) met on May 18 to discuss the “Requirements for Tobacco Product Manufacturing Practice” proposed rule. All the meeting materials, including the recording, transcript and summary minutes, are now available online.
The proposed rule, if finalized, lays out the FDA’s requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of tobacco products.
Comments on the proposed rule must be submitted by 11:59 p.m. Eastern Time on Sept. 6, 2023.
July 25, 2023
U.S. Congress Committee to Discuss CBD Thursday

A U.S. congressional committee is scheduled to talk about hemp this week as lawmakers presumably will increase pressure on the U.S. Food and Drug Administration to establish guidelines to regulate the CBD market.
A hearing set for 2 p.m. Thursday will look at “Hemp in the Modern World: The Yearslong Wait for FDA Action.”
The House Oversight and Accountability Subcommittee on Health Care and Financial Services session is open to the public and also may be viewed online, according to Hemp Today.
The session is also likely to address what some say is a lack of regulatory clarity and concern about the safety of synthetic delta-8 THC products.
The oversight committee, chaired by Rep. James Comer, is investigating the FDA’s failure to regulate hemp-derived CBD products as dietary supplements.
Lawmakers and the FDA have danced around CBD for nearly five years, with Congress repeatedly calling on the agency to set rules for the unregulated products, which emerged beginning late last decade and grew into a flourishing gray market.
“We are going to investigate why exactly the FDA has decided to ignore their regulation responsibilities related to CBD and other areas of jurisdiction,” said Rep. Lisa McClain, who serves on the committee.
“Without these regulations, dangerous products could make their way to the shelves while safe and credible CBD products could be prevented from entering the market,” McClain said.
July 25, 2023
Michigan Recalls THC Vapes for Banned Chemical

The Cannabis Regulatory Agency in Michigan is recalling certain THC vape cartridges due to the possible presence of banned chemical residue exceeding the established limits, the agency announced.
The vape cartridges — manufactured under the name “FLIGHT LIVE RESIN DISPOSABLE” — were manufactured by the Mount Morris-based marijuana processor Sky Labs near Flint and include three batches called “Grease Monkey,” “Space Ether” and “Bubblegum,” according to the Detroit Free Press.
More than 13,000 of these vape cartridges have been sold, David Harns, a spokesperson for the CRA said, and about 2,200 of them are currently available for sale at 59 dispensaries.
The banned chemical residues that are possibly in the products include Bifenthrin (an insecticide), Myclobutanil (a chemical used as a fungicide), Bifenazate (a pesticide), Paclobutrazol (an organic compound used as a plant growth retardant and fungicide) and Permethrin (an insecticide), he said.
July 25, 2023
Study Linking Vaping and Liver Disease Retracted

A study linking nicotine vapes to liver disease was retracted from Gastroenterology Research after the authors failed to reply to concerns about the researchers’ methods and findings, reports Filter.
The retraction stated that “concerns have been raised regarding the article’s methodology, source data processing, including statistical analysis, and reliability of conclusions.” The study was published in June 2022.
A letter was sent to the editor raising concerns, and the authors were given time to respond but failed to do so. “As is our journal and publisher’s policy, because there was no response or rebuttal from the authors, the manuscript was retracted, and the letter to the editor was not published,” said Robert Wong, editor-in-chief of Gastroenterology Research. “Typically, if there is an author response or rebuttal, we publish both the letter to the editor and the response.”
“This is a greater problem than just one study,” said Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, noting a 2020 retraction by the Journal of the American Heart Association of a study connecting vaping to heart attacks. The 2020 retraction letter to the journal was made public, but the issue with the Gastroenterology Research paper is less clear because “there is silence around why it was retracted,” said Conley.

It’s gratifying that the journal took the step to retract the paper. There’s just a lot of things going on with this study that make it seem kind of weird.
Ray Niaura, epidemiology professor at New York University’s School of Global Public Health
The 13 co-authors of the study drew from the National Health and Nutrition Examination Survey and analyzed participants’ responses for associations between liver disease and the use of cigarettes or vaping products.
They claimed the results showed “e-cigarette users … were associated with higher odds of having liver disease compared to nonsmokers.”
“I already have a bunch of questions just off the top of my head, basically, just looking at this paper,” said who studies tobacco dependence and treatment. He said there were issues with the data, noting that the only survey question on vaping is broad, asking “Have you ever used an e-cigarette?” Questions on combustible tobacco included “Do you now smoke cigarettes?” and if someone has smoked “at least 100 cigarettes” in their life.
“That’s kind of a weak variable,” Niaura said. “What does it mean? It doesn’t mean much.”
The data also didn’t allow for analysis around timing, which means it’s not possible to tell whether liver disease was developed before or after smoking/vaping. “What’s the resolution of the information in studies like this?” Niaura asked. “It’s tricky.”
“It’s gratifying that the journal took the step to retract the paper,” he said. “There’s just a lot of things going on with this study that make it seem kind of weird.”
July 24, 2023