December 24, 2021

Exclusive-U.S. to lift travel curbs on eight African countries – source

Published by
Reuters

By David Shepardson (Reuters) – The Biden administration will lift travel restrictions on eight southern African countries imposed last month over concerns about the fast-spreading COVID-19 Omicron variant, a senior administration official told Reuters. Foreign nationals who are barred from the United States because they have been in one of the eight countries within the prior 14 days will again be allowed on U.S.-bound flights leaving after 12:01 a.m. ET on Dec. 31, the official added. The United States on Nov. 29 barred nearly all non-U.S. citizens who had recently been in South Africa, Bots… Continue reading “Exclusive-U.S. to lift travel curbs on eight African countries – source”

December 24, 2021

FDA Authorizes Marketing of 22nd Century Group’s VLN® as a Modified Risk Tobacco Product

VLN® Cigarettes

VLN® King & VLN® Menthol King

VLN® Is World’s First and Only Combustible Cigarette to Receive FDA MRTP Designation
FDA Adds Evidence-Based, Headline Claim “Helps You Smoke Less” to Company’s Requested Claims

VLN® 95% Reduced Nicotine Content Cigarettes to Launch in the U.S. Within 90 Days
VLN® to Launch Outside the U.S. in First Quarter 2022

BUFFALO, N.Y., Dec. 23, 2021 (GLOBE NEWSWIRE) — 22nd Century Group, Inc. (Nasdaq: XXII), a leading agricultural biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco, and improving health and wellness through modern plant science, announced today that the U.S. Food and Drug Administration (FDA) has authorized the marketing of the Company’s VLN® King and VLN® Menthol King reduced nicotine content cigarettes as modified risk tobacco products (MRTPs). In doing so, the Agency found that VLN® – which smokes, tastes, and smells like a conventional cigarette but contains 95% less nicotine than conventional, highly addictive cigarettes – “help reduce exposure to, and consumption of, nicotine for smokers who use them.”

“Today’s decision to authorize VLN®’s MRTP application places the FDA and 22nd Century together at the vanguard of transforming the tobacco industry. With 60% of adult smokers in our U.S. market research telling us they are likely to try VLN®, this is a complete game-changer for 22nd Century, the tobacco industry, public health, and adult smokers looking to change their relationship with nicotine – the addictive chemical found in all tobacco products. This is the first, and most likely will be the only, combustible cigarette to ever carry the FDA’s MRTP designation. The FDA’s decision to require the additional headline claim ‘Helps You Smoke Less’ alongside our requested headline claim of ‘95% Less Nicotine’ gives adult smokers a crystal-clear reason to replace their conventional and highly addictive cigarettes with VLN®,” said James A. Mish, chief executive officer at 22nd Century Group.

“Our mission is to find ways to stop tobacco-related disease and death. We know that three out of four adult smokers want to quit and the data on these products show they can help addicted adult smokers transition away from highly addictive combusted cigarettes,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “Having options like these products authorized today, which contain less nicotine and are reasonably likely to reduce nicotine dependence, may help adult smokers. If adult smokers were less addicted to combusted cigarettes, they would likely smoke less and may be exposed to fewer harmful chemicals that cause tobacco-related disease and death.”

“Having secured this FDA marketing order, we are fully prepared to launch VLN® with select retail and marketing partners in our pilot markets in the U.S. within the next 90 days and in the first of several global markets by the end of the first quarter of 2022. We are also in discussions with additional retail trade, marketing, and strategic partners to scale VLN® sales in the U.S. and internationally, including through potential licensing of our technology to facilitate the broader industry transition to RNC products. We will provide additional details on strategic partners and the rollout of VLN® in the coming months,” said Mish.

The FDA authorized the marketing of VLN® with the following MRTP claims:

“Helps you smoke less.”
“95% less nicotine.”
“Helps reduce your nicotine consumption.”
“…Greatly reduces your nicotine consumption.”

The FDA’s decision to authorize the Company’s MRTP claims and to require the additional claim of “Helps You Smoke Less” on every VLN® pack and in every VLN® advertisement where any of the other authorized claims are also used was based on an extensive body of science consisting of dozens of independent scientific and clinical studies using 22nd Century’s reduced nicotine content (RNC) tobacco cigarettes. These studies, which were funded largely by the FDA, the National Institutes of Health (NIH), and other U.S. federal government agencies, as well as studies funded by 22nd Century, show that smokers who use RNC cigarettes – even those with no intention of quitting at the beginning of the studies – reduce their nicotine exposure and dependence, smoke fewer cigarettes per day, increase their number of smoke-free days, and double their quit attempts – all with minimal or no evidence of nicotine withdrawal symptoms or compensatory smoking.

In its announcement of its decision today, FDA explained, “The data also showed it is reasonably likely that using these products reduces nicotine dependence, which is anticipated to lead to long-term reductions in exposure to the smoking-related toxicants associated with morbidity and mortality by reducing smoking. Published studies have shown that significantly reducing the number of cigarettes smoked per day is associated with lower risk of lung cancer and death, with greater reductions in cigarettes per day resulting in less risk. Additionally, as required for authorization, the FDA found that the applications supported consumer understanding of the claims that VLN® cigarettes contain much lower levels of nicotine than other cigarettes.”

VLN® is also the first and only combustible cigarette to come to market that complies with the FDA’s proposed nicotine cap for conventional cigarettes in its Comprehensive Plan for Tobacco and Nicotine Regulation as well as New Zealand’s recently proposed reduced nicotine content mandate.

“We believe today’s announcement by the FDA is a clear indication that the FDA is moving forward with its Plan to address the incredible harms caused by smoking. This plan includes the authorization of less toxic tobacco products such as e-cigarettes and other non-combustible products along with a nicotine cap of 0.5 mg of nicotine per gram of tobacco in combustible tobacco products. This level of nicotine content, which the FDA has described as being ’minimally or non-addictive,’ has already been achieved by 22nd Century in its VLN® products,” said Mish.

The FDA reiterated in its announcement today that it is “committed to moving forward with the rulemaking process to ban menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars and remains on track to issue proposed rules in the spring of 2022” and that both VLN® King and VLN® Menthol King cigarettes “could help addicted cigarette smokers reduce their nicotine consumption and the number of cigarettes they smoke per day.”

“As the FDA also looks to ban menthol in highly addictive cigarettes, we fully expect the FDA will allow our VLN® Menthol cigarettes, which offer little appeal for youth and former smokers because of their reduced nicotine content, to be allowed by the FDA to remain on the market to provide an off-ramp for adult smokers of menthol cigarettes,” added Mish.

The FDA’s decision further builds on research projecting that an industry product standard to lower nicotine content in cigarettes to minimally or non-addictive levels would significantly change the trajectory of cigarette addiction, which is the leading cause of preventable disease and death in the U.S. Approximately five million adult smokers would quit within just one year of implementation, more than 33 million people would avoid becoming regular smokers, and more than eight million premature deaths from tobacco could be avoided. With almost half a million Americans dying from smoking and more than $300 billion spent per year on smoking-related diseases, there is a clear and urgent need for substantial change in the tobacco industry.

22nd Century is ready to supply the market with RNC tobacco and finished products such as VLN® to enable both 22nd Century and other manufacturers to comply with the proposed nicotine caps in the U.S., New Zealand and other countries as they embrace this innovative and highly effective approach to tobacco harm reduction first proposed by the WHO in 2015. 22nd Century’s plant-based technology and products are superior to costly extraction and similar de-nicotinization technologies because those technologies typically use chemicals that strip out not just nicotine but also flavor and aroma compounds, resulting in a product that has been found unacceptable to smokers because it delivers no smoking satisfaction. In contrast, 22nd Century’s reduced nicotine tobacco naturally grows with very low levels of nicotine resulting in products that smoke, taste and smell like conventional cigarettes but contain 95% less nicotine than conventional, highly addictive cigarettes. This is critical to creating an acceptable solution and “off-ramp” for current smokers looking to change their relationship with nicotine.

22nd Century remains committed to licensing its technology and products to every manufacturer to enable industry wide compliance with the proposed nicotine caps.

About 22nd Century Group, Inc.
22nd Century Group, Inc. (Nasdaq: XXII) is a leading agricultural biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco and improving health and wellness through plant science. With dozens of patents allowing it to control nicotine biosynthesis in the tobacco plant, the Company has developed proprietary reduced nicotine content (RNC) tobacco plants and cigarettes, which have become the cornerstone of the FDA’s Comprehensive Plan to address the widespread death and disease caused by smoking. In tobacco, hemp/cannabis, and hop plants, 22nd Century uses modern plant breeding technologies, including genetic engineering, gene-editing, and molecular breeding to deliver solutions for the life science and consumer products industries by creating new, proprietary plants with optimized alkaloid and flavonoid profiles as well as improved yields and valuable agronomic traits.

Learn more at xxiicentury.com, on Twitter @_xxiicentury, and on LinkedIn.

Learn more about VLN® at tryvln.com.

Cautionary Note Regarding Forward-Looking Statements
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Forward-looking statements typically contain terms such as “anticipate,” “believe,” “consider,” “continue,” “could,” “estimate,” “expect,” “explore,” “foresee,” “goal,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” “would,” and similar expressions. Actual results might differ materially from those explicit or implicit in forward-looking statements. Important factors that could cause actual results to differ materially are set forth in “Risk Factors” in the Company’s Annual Report on Form 10-K filed on March 11, 2021. All information provided in this release is as of the date hereof, and the Company assumes no obligation to and does not intend to update these forward-looking statements, except as required by law.

Investor Relations & Media Contact:
Mei Kuo
Director, Communications & Investor Relations
22nd Century Group, Inc.
(716) 300-1221
mkuo@xxiicentury.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f2454099-23c6-4b74-a46b-28fbb97124d5

December 24, 2021

COVID Outlier Japan Searches for Reasons for Its Success

While many countries are fighting off their worst coronavirus outbreaks yet, Japan is detecting hardly any COVID-19 infections at all. Observers are trying to figure out why.

As recently as late summer, Japan’s coronavirus outlook wasn’t great. An outbreak coinciding with the Tokyo Olympics was killing dozens per day and overwhelming hospitals.

Starting in September, though, as Japan ramped up its vaccination campaign, the country saw a dramatic plunge in the number of reported cases and eventually the number of deaths.

Since then, the situation has only improved. Japan this month has reported an average of less than one COVID-19 death per day – a shockingly low number for a country of 126 million.

No one knows exactly why Japan has experienced such success — especially while other countries, even its immediate neighbors, have been hit by serious winter waves of the coronavirus.

There are many possible explanations. Nearly 80% of Japan’s population is fully vaccinated. Virtually everyone wears masks. Even after the government relaxed restrictions this autumn, people continued to socially distance themselves.

Some researchers have pointed to Japan’s low rates of obesity. Several recent studies have concluded that COVID-19 is more severe in obese individuals.

Cultural customs may also play a role. For instance, Japanese do not typically kiss, hug, or even shake hands during greetings. Many Japanese are also relatively quiet in public settings, points out Kentaro Iwata, an infectious disease specialist at Japan’s Kobe University.

“Masking and keeping silent in public places is very important [for fighting the virus]. Everybody knows it, but practicing it can be very difficult in some parts of the world, maybe due to cultural reasons,” said Iwata, who has dealt with infectious outbreaks for more than 20 years, by email.

Those factors, however, do not explain why neighboring South Korea, which shares many cultural traits, is dealing with its worst COVID-19 outbreak yet.

One possible explanation is that Japan is testing far fewer people, Kenji Shibuya, an epidemiologist and researcher at the Tokyo Foundation for Policy Research, said.

In the first half of December, Japan tested an average of 44,623 people per day, according to government data. South Korea, whose population is less than half that of Japan, conducted an average of 238,901 tests per day during the same period, according to official data.

Because of Japan’s lack of testing, it is difficult to believe that official case figures reflect reality on the ground, Shibuya told VOA in an email.

If the lack of testing were a major factor, though, Japan would have likely seen a surge in other indicators, such as the number of hospitalizations or deaths from respiratory illnesses, as other experts have noted.

In the absence of any definitive explanation, some researchers have tried to identify a so-called X-factor. One study even suggested many Japanese people share a genetic feature linked to white blood cells that helps the fight against COVID-19. Others theorize that the coronavirus variant spreading in Japan may have mutated itself into extinction.

Whatever the reason for Japan’s success, the battle is not over, said Shibuya, who said he still expects the country to see a winter wave of infections.

In a possible ominous sign, Japan this week identified its first cases of community transmission of the omicron variant, which scientists say spreads much faster than previous iterations of the virus. Many of those found to be infected with omicron had no history of overseas travel, officials said.

Source: Voice of America

December 24, 2021

Christmas Celebrations Continue in Bethlehem Despite Omicron Travel Ban

Despite a second year of travel restrictions because of COVID-19, the town of Bethlehem, the site of Jesus’ birth, is reviving its annual Christmas Eve celebration.

“Last year, our festival was virtual, but this year it will be face to face with popular participation,” Bethlehem Mayor Anton Salman told the Associated Press.

On a typical Christmas, the biblical town is a popular destination for tourists from around the globe. An average of 3 million tourists come each year. Much smaller crowds attended the holiday celebrations in Bethlehem on Friday, accompanied by gloomy weather.

“It’s very strange,” said Kristel Elayyan, a Dutch woman married to a Palestinian, who came to Bethlehem from Jerusalem. “If it’s one year, it’s an interesting experience,” she told Agence France-Presse. “But because this is the second year and we don’t know what is going to come in the future, it’s a huge loss for the people here.”

Events included traditional marching band parades and street celebrations. Scout bands with drums and flags gathered in Manger Square to celebrate the holiday.

While celebrations are scaled down this year, Salman is hopeful that 2021’s festivities will exceed last year’s, when residents were forced to celebrate inside their homes because of lockdown restrictions, the AP reported.

Israel’s ban on nearly all incoming air traffic, which has lasted two years, continues to prevent tourists from entering the occupied West Bank, and subsequently, the historic town.

The travel ban to curb the spread of COVID-19 was lifted in November to allow foreign tourists in but was soon reimposed with the emergence of the highly contagious omicron variant. Coinciding with the holiday season, the disease’s newest strain has hampered Christmas celebrations.

Without the flood of tourists, local authorities hoped that the Holy Land’s small Christian community would keep the holiday spirit alive.

Latin Patriarch Pierbattista Pizzaballa, the top Roman Catholic clergyman in the Holy Land, celebrated a midnight Mass at the Church of the Nativity, the grotto where Jesus is said to have been born.

“Compared to last year’s Christmas, the participation is much greater, and this is an encouraging sign,” he told the masked congregation, but regretted the absence of foreign worshippers because of the pandemic.

“We pray for them and at the same time ask for their prayers, so that all this may end soon and that the city of Bethlehem may once again be full of pilgrims,” he said, according to AFP.

Source: Voice of America