The escalating conflict between Israel and Hezbollah is forcing tobacco farmers in Lebanon to abandon their fields, reports Xinhua.
Hezbollah launched hundreds of missiles into Israel in retaliation for the killing of its commander, Fouad Shokor, in an Israeli airstrike on Beirut last month.
In response, Israel reported conducting numerous preemptive airstrikes targeting Hezbollah’s rocket launchers in southern Lebanon.
Amidst the turmoil, tobacco farmers in border villages were forced to abandon picking and drying their leaves.
“This is the first time in more than 40 years that I have abandoned tobacco cultivation in my fields,” Jamal Abdallah, a 60-year-old displaced farmer, told Xinhua. Abdallah said around 85 percent of tobacco farmers in southern Lebanon have left their fields due to the ongoing conflict.
According to the Lebanese Regie for Tobacco (RLTT), between 15,000-16,000 families cultivate tobacco in southern Lebanon, covering an area of some 90 square km.
While the annual production usually exceeds 5 million kg, RLTT said initial estimates show this year’s production will dip to 2 million.
The value of Mozambique’s tobacco production dropped 71.7 percent to MZN200 million ($3.13 million) year-on-year in the first six months of 2024, according to the Club of Mozambique. The organization did not provide a reason for the decline.
The revenues amounted to 2.7 percent of the target set for the whole year and 1 percent of Mozambique’s industrial output from January to June.
The government expects growers to cultivate 129,321 hectares and 81,223 tons of tobacco this year.
According to a 2023 World Health Organization report, Mozambique had the eighth largest tobacco-growing area in the world and the third largest tobacco-growing area in Africa, after Zimbabwe and Malawi.
Brazil, with a cultivation area of 357,230 hectares, and Mozambique are the only Community of Portuguese Speaking Countries nations mentioned in the WHO report.
A leaked plan to drastically extend smoking restrictions in Britain to outdoor spaces has sparked outrage among activists and some politicians.
According to The Sun, ministers have been “plotting” to make beer gardens, outdoor restaurants and other open-air spaces smokefree. The proposed restrictions exempt private homes, along with large open spaces such as parks or streets.
Reform UK leader Nigel Farage said: “It’ll be the end of pubs.”
“Imposing nanny state regulation like this on pubs and restaurants would not only be wrong but economically damaging,” said Former Home Secretary Priti Patel.
“These are small businesses, run by hardworking people, that provide jobs up and down the country.”
Simon Clark, director of the smokers’ rights group Forest vowed to fight any attempt to extend smoking bans to outdoor areas.
“Smoking bans must be evidence based and there is no evidence that smoking in the open air is a significant threat to the health of nonsmokers,” he said.
“The indoor smoking ban did enormous damage to the pub industry. Extending the ban to beer gardens could force many more pubs to close.”
Accusing the ruling Labour party of using “bully state” tactics to force adults to quit smoking, Clark said, “If it’s true that the government intends to extend the smoking ban to a raft of outdoor areas, Britain will no longer be a nanny state.
“We will have crossed a line and become a bully state in which people are punished for the terrible crime of lighting a cigarette outside a pub or in a park.”
Keller and Heckman will hold its nineth Annual E-Vapor and Tobacco Law Symposium Jan. 27-28, 2025, in Las Vegas, right before the Total Product Expo. This two-day seminar is designed to provide in-depth knowledge on legal, regulatory and scientific issues that are essential for tobacco, nicotine and CBD/hemp product manufacturers, suppliers, distributors and retailers.
Registration for this seminar, which will be held at the Hilton-Conrad Resorts World Las Vegas, will launch in September 2024.
The U.S. Food and Drug Administration announced a final rule raising the minimum age for certain restrictions on tobacco product sales. The requirements are in line with legislation signed in December 2019, which immediately raised the federal minimum age for the sale of tobacco products in the United States from 18 to 21.
Once implemented, the requirements are expected to help decrease underage tobacco sales.
Beginning Sept. 30, retailers must verify with photo identification the age of anyone under the age of 30 who is trying to purchase tobacco products, including e-cigarettes. Previously, this requirement applied to anyone under the age of 27. It’s important for retailers to request and examine photo IDs to verify age from anyone under 30, regardless of appearance, as research has shown that it is difficult for retailers to accurately determine the age of a customer from appearance alone.
Additionally, starting Sept. 30, retailers may not sell tobacco products via vending machines in facilities where individuals under 21 are present or permitted to enter at any time. Previously, this prohibition applied to facilities where individuals under 18 were present or permitted to enter at any time.
These changes, and the other changes made by the final rule, aim to maximize the public health impact of the original December 2019 legislation, according to an agency press release.
“Today’s rule is another key step toward protecting our nation’s youth from the health risks of tobacco products,” said Brian King, director of the FDA’s Center for Tobacco Products. “Decades of science have shown that keeping tobacco products away from youth is critical to reducing the number of people who ultimately become addicted to these products and suffer from tobacco-related disease and death.”
The Further Consolidated Appropriations Act, signed into law on Dec. 20, 2019, increased the federal minimum age for selling tobacco products from 18 to 21 across the United States. Since then, it has been illegal to sell tobacco products, including e-cigarettes, to anyone under 21. The law also directed the FDA to take action today, increasing the age of certain requirements for tobacco product sales, as explained above.
The agency also continues to provide retailers with resources to improve compliance with tobacco laws and regulations, including age of sale restrictions. For example, the FDA has developed a voluntary education program, “This is Our Watch,” which offers free resources to assist retailers in calculating the age of customers, including a digital age verification calendar and an age calculator app. Retailers can also find information on tobacco products that may be legally marketed in the United States through the Searchable Tobacco Products Database. Updated resources, including further information on these latest requirements, will be made available on the FDA’s website in the near future.
banning the commercial sale of all disposable vapes;
banning all nontobacco vape flavors;
prohibiting the use of all imagery, coloring and branding for both the packaging and vape device, similar to current restrictions on cigarettes;
further restrictions on all advertising and marketing, and ensuring vapes are kept behind the counter and not on display in shops and retail outlets; and
government education campaigns for the public on the dangers of vapes to reduce appeal, especially among children and young people.
While the BMA recognizes that vapes can be a useful tool in helping some people to stop smoking cigarettes, the organization stresses that they offer a less dangerous rather than a risk-free alternative. “Vaping can lead to nicotine addiction, with nicotine having the potential to cause health problems such as high blood pressure and increased risk of COPD,” the BMA wrote in a statement. “Further, some e-cigarettes have been found to contain other harmful substances such as lead.”
Vaping industry representatives cautioned that the proposed measures could have unintended consequences.
“The UKVIA [U.K. Vaping Industry Association] agrees that stronger measures are needed to cut off the supply of youth vaping and illicit products; however, actions laid out in this report would sooner supercharge the black market and push the nation’s smoke-free ambitions further out of reach by deterring adult smokers from making the switch and driving current vapers into the hands of underground sellers or back to cigarettes,” said John Dunne, director general of the UKVIA, in a statement.
“The BMA undersells the quitting power of vapes when it says the reduced-risk alternative ‘can be useful in helping some people to stop smoking.’ The latest data from leading public health charity Action on Smoking and Health (ASH) U.K. found more than half of ex-smokers in Great Britain who quit in the past five years used a vape in their last attempt—ASH also reports that current and ever use of vapes among 11[-year-olds to] 17-year-olds has decreased since last year.”
While FDA menthol market authorizations are rightly seen as a victory, they may be pyrrhic.
By Rich Hill
The flavored electronic nicotine-delivery systems (ENDS) road has been a bumpy ride. Going back to pre-deeming days, flavored ENDS were ubiquitous, as were unquantified, anecdotal reports of their cigarette-smoking cessation efficacy. Following the accelerated premarket tobacco product application (PMTA) submission timeline, as everyone knows, the Center for Tobacco Products’ (CTP) decisions decimated flavored ENDS. Likewise, even the most sophisticated companies were receiving marketing denial orders (MDOs) for menthol ENDS. Throughout this bloodbath, the CTP oft repeated that flavored products need to demonstrate a cessation benefit to adult smokers weighed against the risk of youth initiation. Until recently, this had not played out.
Njoy’s marketing granted orders (MGOs) for menthol Ace and Daily products was a watershed moment demonstrating that an ENDS product with a flavor other than tobacco could be granted marketing authorization status. However, the authorization does leave some questions unanswered.
CTP’s Menthol Positioning
In 2022, the CTP staked out its position on menthol in the cigarette context with the product standard prohibiting menthol in cigarettes. The center asserted that menthol reduces irritation and harshness of smoking, increases appeal and makes cigarettes easier to use—especially for youth, increases nicotine’s sensory effects in the brain and makes it more difficult to quit smoking. While the first points on irritation and harshness are unique to cigarettes, the CTP’s other points arguably apply to menthol and nicotine more generally—a dour omen for ENDS and other products.Given this position, particularly on youth initiation, it came as little surprise that several menthol ENDS products received MDOs over the past several years.
An About Face?
The Njoy Ace and Daily menthol product MGOs were a surprise considering the CTP’s menthol position and flavored vapor product denials. What was different about Njoy’s applications that tipped the scales?
Beyond Njoy’s successful showing of product characterization, toxicology and abuse liability data, according to the Njoy Ace Technical Project Lead Review (TPLR), behavioral studies and marketing restrictions appear to have made the difference. Alongside other behavioral studies, Njoy simply did what the CTP required and conducted a longitudinal study comparing cigarette smoking cessation efficacy between tobacco and menthol ENDS products. Per the TPLR, “[t]he applicant’s findings and additional analyses conducted by statistics demonstrate a statistically significant added benefit of using menthol-flavored Njoy Ace compared to classic tobacco flavor … in achieving past-30-day [combustible cigarette] smoking cessation ….” Among other data in the TPLR, Table 3 reports that in the Intention to Treat Analysis, initial flavor at baseline analysis resulted in 26.6 percent past-30-day abstention rates for menthol versus 19.3 percent for tobacco at 6 months. When analyzed by flavor at time of switching, past-30-day cessation rates of 27.1 percent for menthol versus 19.3 percent for tobacco at 6 months were reported.
Along with the adult cessation data, Njoy agreed to a long list of marketing restrictions—beyond what is observed in other applications. The restrictions included limitations on advertising means including no radio, television, outdoor, print, search engine advertising, social media promotions, product placements, engagements or activations or influencers, sponsors, etc., among others. Talent portrayals would be limited to models over 45 years of age. Njoy identified a range of sales restrictions as well.
Ultimately, after assessing the youth data and risks, the TPLR executive summary states, “[t]he PMTAs contain sufficient evidence to show that the new products have the potential to benefit adults who smoke combustible cigarettes and who switch completely or significantly reduce their combustible cigarettes use …. The applicant also proposed robust marketing plans that include restrictions beyond those required with PMTA authorization. The Office of Health Communication and Education has determined that these restrictions may help further limit youth exposure to the new product, the products’ labeling, advertising, marketing, and/or promotion, and the potential for youth initiation.”
Questions Remain from the Njoy Decision
The MGO, however, raises two interesting questions. First, how much adult benefit is enough to overcome youth uptake? And second, what impact do marketing restrictions have on marketing authorization decisions?
The Math on Youth Use vs. Adult Cessation – How Much Differential is Enough?
The TPLR reports youth Njoy use data from both applicant data and national surveys and concludes that “[w]hile ENDS with nontobacco flavors and high nicotine delivery may help adults who smoke switch from CC to ENDS, these same characteristics may facilitate initiation and continued nicotine use by youth.” The cost-benefit analysis is troubling because CTP provides no real quantitative measure comparing youth use rates to adult cessation rates. Rather than a numerical comparison, the analysis seems to rely upon the totality of the evidence. As the TPLR states, “the totality of evidence provided by the applicant suggests that the menthol-flavored [product] … is associated with significantly higher smoking cessation rates than tobacco-flavored Njoy Ace products, and epidemiology concluded that the new products are highly beneficial to adults who smoke CC.” The close of the TPLR user population synthesis states that menthol-flavored new products pose a risk to youth but went on to assert that the data “demonstrate added benefit of using menthol-flavored compared to classic tobacco-flavored … Njoy Ace in achieving past-30-day smoking cessation—a showing required to outweigh the risks associated with flavored ENDS among youth.”
For some time, many in industry have wondered how much cessation difference between tobacco and flavored ENDS would be enough to outweigh risk to youth. While the balancing test is not numerically quantified, this marketing decision does provide some level by which to assess menthol products.
Are Marketing Plans Back on the Table?
In the White Lion Investments dba Triton Distribution v. FDA5th Circuit Court of Appeals decision from January 2024, the majority opinion found that the FDA ignored marketing plans in the Triton PMTAs: “[w]orse, after telling manufacturers that their marketing plans were ‘critical’ to their applications, FDA candidly admitted that it did not read a single word of the 1 million plans.”
Njoy’s marketing plan, however, seems to have an effect on the outcome. Reviewers remarked that the Njoy plan was “robust and is expected to limit youth exposure” to marketing materials. Interestingly, the TPLR states that the marketing plan was “not considered in the APPH assessment,” but then goes on to refer to the plan positively, stating, “the applicant’s approach to marketing may help further limit youth exposure to the new products.”In Njoy’s case, the marketing plans may not have moved the APPH needle but were considered as a net positive in youth prevention.
Are marketing plans important to your application? Beyond being a required part of the PMTA submission, it appears that in this case, the restrictions at least supplemented the adult benefit data to good effect.
Will Menthol MGOs Have an Impact in This Market?
While the menthol market authorizations are rightly seen as a victory, such a victory may be a pyrrhic one.
The presence and consumer acceptance of flavored disposable ENDS products looms over this seminal marketing authorization. The fact is that many menthol-flavored ENDS products with pending PMTAs remain on the market. Even in the face of the availability of menthol ENDS, flavored disposable ENDS sales have skyrocketed.
The Centers for Disease Control and Prevention published a Morbidity and Mortality Weekly Report (MMWR) in 2023 assessing e-cigarette unit sales across the various categories of products and flavors using scan data from brick-and-mortar retailers only. The MMWR reported that “the percentage of disposable e-cigarette sales more than doubled, from 24.7 percent in January 2020 to 51.8 percent in December 2022.” The predominant disposable flavors reported were “flavors other than tobacco, menthol or mint” (71.4 percent in 2020 and 79.6 percent in 2022). At the same time, menthol ENDS sales overall did not significantly change, while tobacco and mint flavors declined. With half of the market occupied by flavors that consumers clearly want, the growth space for a couple of menthol products seems limited.
VV Archives
While the FDA continues to publicize enforcement efforts, the flavored disposable ENDS trend will not abate anytime soon. Given that flavored disposables are crushing the category, it seems unlikely that the MGOs for Njoy’s menthol products will play a significant role in shifting market share in the near term.
Where Does This Leave Us?
Foremost, good on Njoy for cracking the code—most observers have been very skeptical that an ENDS product with any flavor would ever be granted marketing authorization. Ultimately, Njoy demonstrated what the industry knows to be true from ENDS consumers—flavors, including menthol, are a net positive for adults who smoke to transition away from higher-risk combustible cigarettes. However, questions remain about how the risk-benefit test will be applied—how that math actually works and who, other than the largest companies, can afford to produce such evidence.
Rich Hill is senior director and new product compliance counsel at E-Alternative Solutions.
The U.K. Vaping Industry Association (UKVIA) has cautioned consumers about an increase in illegal “Spice vapes” and called for urgent government action to protect young people.
The warning follows reports of people misusing “open” vape devices—which allow consumers to add e-liquid—to deliver synthetic cannabinoids such as Spice and the psychoactive chemical THC, which is found in cannabis. Spice is a nickname for a substance containing one or more synthetic cannabinoids.
UKVIA stated that the regulated nicotine vape industry is in no way connected with the trend of using open vape devices as a delivery mechanism for illegal drugs.
“Consumers can feel confident that when they buy regulated products from any reputable vape supplier, that they will be getting nicotine vapes which are designed to help them transition from cigarettes,” said UKVIA Director General John Dunne in a statement.
“I am worried, however, that there are vape devices available from unofficial sources which may contain illegal drugs and that those who buy them may have no idea what is contained in these products.”
According to Office for Health Improvement & Disparities statistics, of the 12,418 young people under 18 in contact with alcohol and drug services between April 2022 and March 2023, cannabis was the most common substance (87 percent) for which young people sought treatment. While 10,837 young people reported having a problem with cannabis only 1,737 said they had a problem with nicotine.
“We need the government to step on now with a nationwide education campaign in traditional and social media to highlight the dangers of obtaining vape devices from unofficial sources and explaining the differences between legal and illegal vape products,” said Dunne.
“Unless a clear distinction is made between the regulated vape market supplying adult smokers with products which are 95 percent less harmful than cigarettes and the unofficial supply of illegal products, then people will become wary of all vapes with the potential to drive smoking rates back up again.”
Pyxus International has retired the remaining $20.4 million aggregate principal amount of its 10 percent senior secured notes due 2024 at maturity. This payment, along with the company’s recently completed discounted repurchases under a privately negotiated agreement with Monarch Alternative Capital of its 8.50 percent senior secured notes and its senior secured Pyxus term loans both due in 2027, completes the planned elimination of $142.9 million of long-term debt from Pyxus’ capital structure, as announced March 25, 2024.
“We are pleased our sustained, disciplined approach to working capital management has resulted in the completion of our planned elimination of approximately a quarter of our long-term debt,” said Pyxus President and CEO Pieter Sikkel in a statement.
“These efforts have enabled us to steadily strengthen our business, improve our balance sheet and reinforce our position in the global marketplace. We remain focused on reducing our borrowing costs and believe the ongoing improvement in our credit profile positions us to decrease financing costs through our global lending partners, as well as evaluate a range of opportunities to deliver a more cost-effective capital structure.”
The retired notes are the remainder of an original $280.8 million principal amount of 10 percent Senior Secured Notes due 2024 that were issued in 2020. As part of the company’s debt exchange transactions completed in February 2023, it successfully exchanged 92.7 percent of the then-outstanding principal amount of those notes for its 8.50 percent senior secured notes due Dec. 31, 2027.
U.S. cigarette smoking has dropped to an all-time low of 11 percent, according to a new Gallup poll. Smoking is even less common in young Americans, with 6 percent of people under 30 saying they smoke.
“The U.S. is on the verge of having a smoke-free Gen Z generation, yet instead of celebrating, vaping is under attack,” said Michael Landl, director of the World Vapers’ Alliance in a statement. “This doesn’t make any sense. The latest smoking rates clearly show that the myth of vaping being a gateway to smoking needs to be put to rest. Vaping is not a gateway to smoking; it’s a gateway away from smoking. Harm reduction works, even though politicians are making it harder for smokers to switch. It’s time to wake up!”
Low smoking rates may be a result of decades of scientific data and warnings that the products are dangerous to use, according to a New York Post article. About 80 percent of American adults who were surveyed said that cigarettes are “very harmful” compared to 57 percent of respondents who said that e-cigarettes are “very harmful.”
Most respondents also said chewing tobacco is “very harmful,” but few said the same for cigars, pipes or nicotine pouches, though seven out of 10 Americans believe the products are “somewhat harmful.”
Smokers are also less inclined than nonsmokers to say that cigarettes are harmful; 80 percent of nonsmokers said cigarettes are harmful while 58 percent of cigarette smokers said the products are harmful. In comparison, 63 percent of vapers said e-cigarettes are harmful while 79 percent of nonvapers said e-cigarettes are harmful.
Keller and Heckman will hold its nineth Annual E-Vapor and Tobacco Law Symposium Jan. 27-28, 2025, in Las Vegas, right before the Total Product Expo. This two-day seminar is designed to provide in-depth knowledge on legal, regulatory and scientific issues that are essential for tobacco, nicotine and CBD/hemp product manufacturers, suppliers, distributors and retailers.
The Njoy Ace and Daily menthol product MGOs were a surprise considering the CTP’s menthol position and flavored vapor product denials. What was different about Njoy’s applications that tipped the scales?
