Category: Featured

Ninth Circuit Denies Lotus MDO Review

Entrance to United States Court of Appeals for the Ninth Circuit . Headquartered in San Francisco, California, the Ninth Circuit is by far the largest of the 13 courts of appeals. (Credit: Eric BVD)
The U.S. Court of Appeals for the 9th Circuit on June 30 declined to review a Food and Drug Administration marketing denial order for Lotus Vaping Technologies’ flavored e-liquid products.
The FDA issued marketing denial orders for Lotus’ flavored products, finding that the petitioners’ applications lacked sufficient evidence showing that the flavored products would provide a benefit to adult users that outweighs the risks such products pose to youth.
Lotus challenged the ruling in court, but the judges held that the text of the Family Smoking Prevention and Tobacco Control Act authorizes the FDA to require that manufacturers submit comparative health risk data, which necessarily includes comparisons of flavored e-liquids to tobacco-flavored e-liquids.
The judges also held that the FDA did not arbitrarily or capriciously deny Lotus’ applications and that any error the agency committed by failing to consider Lotus’ marketing plans was harmless.
July 8, 2023
Nigeria Suspends Taxes on Tobacco

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Nigeria’s president, Bola Tinubu, has suspended excise taxes on some locally produced goods, including tobacco, and telecommunications services that were introduced two months ago, reports Bloomberg.
Tinubu signed the executive orders to “address business unfriendly fiscal policy measures and multiplicity of taxes,” according to his spokesman, Dele Alake.
The order includes certain imported vehicles, single-use plastic products and domestically manufactured alcoholic drinks and tobacco. The excise taxes were introduced by Muhammadu Buhari in his last weeks in office.
Tinubu “promised to run a government that will not make life difficult for Nigerians or asphyxiate corporate entities,” Alake said.
July 7, 2023
India: Sale of Excess Tobacco Allowed

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India’s Ministry of Commerce and Industry has permitted the sale of excess flue-cured Virginia (FCV) tobacco via auction platforms, according to The New Indian Express.
The orders follow Chief Minister YS Jagan Mohan Reddy’s letter to Union Minister for Commerce and Industry Piyush Goyal requesting farmers be allowed to sell excess FCV after being negatively affected by the Mandous cyclone.
“Of the total tobacco grown in 53,000 hectares, more than 50 percent of the area was severely damaged, due to which the farmers replanted the crop as there is no alternate crop,” Reddy wrote. “Mandous cycle caused tobacco growers to incur additional costs on the production of the crop during this year as the farmers were forced to go for replanting, which also forced the farmer to irrigate the crop during the season to save the crop. Cost of production increased heavily due to replanting, irrigation and increased labor costs.”
FCV tobacco farmers affected by the cyclone are not in a monetary position to pay penalties for excess tobacco produced beyond authorized quantities. Reddy requested orders similar to those in Karnataka allowing the sale of excess FCV be issued to help tobacco growers in Andhra Pradesh.
July 7, 2023
PMI to Supply Below-Cost Vapes Down Under

Image: PMI
Philip Morris will supply some Australian pharmacies with VEEV products at an 80 percent margin “introductory offer” if the pharmacies sign a supply deal directly with the company, according to The Guardian.
The offer is on condition that pharmacies do not sell a pack of two VEEV pods for more than $14.90 or VEEV devices for more than $19.90, which is cheaper than the prices wholesalers can offer.
Simon Chapman, emeritus professor of public health and tobacco control at the University of Sydney, accused PMI of “playing a long game here to wreck the prescription access model by disrupting the competition.”
“PMI [has] been implacably opposed to the provision of nicotine vaping products via prescription, actively lobbying for a consumer model,” Chapman said.
“Their efforts in Australia to eliminate competition via the 80 percent margin to pharmacists need to be considered in the context of its global ambitions to oppose prescribed access. Any tobacco company still actively marketing tobacco products and opposing effective tobacco control while ostensibly trying [to] promote a product with claims to move significant customers away from its tobacco products is trying to walk on both sides of the street.”
PMI has been lobbying Members of Parliament to overturn the country’s ban on vaping.
Pharmacy and health groups should urge members not to prescribe VEEV products or enter into agreements involving VEEV, said Chapman.
The pharmaceutical Society of Australia (PSA) urged pharmacists to be skeptical of PMI’s offer. “There are currently no nicotine vaping products registered on the Australian Register of Therapeutic Goods, and no company should be advertising unregulated products to Australian healthcare professionals,” a PSA spokesperson said.
Nick Zwar, chair of the Royal Australian College of General Practitioners smoking cessation advisory group, said general practitioners “would want to know if it was a product that was owned by a tobacco company.”
“Our view is that medicine should be distributed through national wholesalers because that provides comfort to the doctors and the pharmacies that these products are being treated as medicines as they should be,” said Richard Lee, CEO of Liber Pharmaceuticals. “Anybody can present a script anywhere, whereas under the Philip Morris arrangement, people will have to present a script at a pharmacy that has done a deal with Philip Morris to get that product.”
“We have always been open and transparent about the fact we will work within whatever legal and regulatory framework exists for these products in Australia,” a PMI spokesperson said. “This is in stark contrast to dozens of other vaping companies who are providing their product via the black market.”
July 7, 2023
Court Sets Wrongful Death Timeline

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The Supreme Judicial Court of Massachusetts ruled that family members of a deceased individual cannot file wrongful death suits if the death occurred more than three years after the injury that caused the death, reports Reuters. This ruling upholds the dismissal of claims against Philip Morris USA and R.J. Reynolds Tobacco Co.
Under Massachusetts law, according to Justice David Lowy, wrongful death claims are “derivative” of personal injury claims that the deceased could have brought in life. If the three-year statute of limitations has run out at time of death, family members have no wrongful death claims.
This latest decision follows two lawsuits, one against Philip Morris USA in 2017 (Fabiano v. Philip Morris USA Inc and others, No. SJC-13282) and one against R.J. Reynolds in 2016 (Fuller v. R.J. Reynolds Tobacco Co and others, No. SJC-13346). Both were brought by the wives of men who became sick and died after lifetimes of smoking. The lawsuits accused the companies of breach of warranty, negligence and conspiracy. These wrongful death claims were dismissed by different trial judges, who stated that both men would have been time-barred from bringing their own claims when they died, meaning their family members were not able to file wrongful death claims.
The Supreme Judicial Court agreed to hear both cases. The court previously decided that wrongful death claims are derivative of the deceased’s claims but had not addressed how that would affect the statute of limitations, according to Lowy’s opinion.
The statute of limitations for the deceased’s underlying injury claims determines whether surviving family can bring a wrongful death claim, according to the language of the Massachusetts wrongful death law.
Lowy wrote that the decision “in no way changes what has long been true of persons suffering from serious injuries,” in a footnote addressing an argument by plaintiffs that the decision creates a “fundamental unfairness” by forcing sick individuals to bring lawsuits while they are suffering or forfeit their heirs’ rights to recovery.
“Once those injuries are knowable, plaintiffs must assert their rights within a specified period of time or lose their ability to recover for their injuries,” Lowy wrote.
July 7, 2023
Supreme Shares Soar After Elf Bar Agreement

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Shares in the U.K. vaping company Supreme rose 5 percent after the company announced it is now the “master distributor” for two leading U.K. vaping brands—Elf Bar and Lost Mary, reports City AM.
The London-listed company expects the partnership to generate revenues of £25 million ($36.06 million) to £30 million over the next fiscal year ending March 2024.
The news comes amid a political crackdown on vape products—especially for those underage.
Sandy Chadha, CEO of Supreme, said the agreement will allow the group to “fully leverage its unique technical, regulatory, compliance and quality assurance capabilities within the vaping sector.”
“We have seen a hugely positive response from both established and new retailers who view Supreme as an ideal partner to supply these products across the U.K.,” Chadha added.
Supreme says its strong market presence, distribution network and compliance capabilities provide Elf Bar and Lost Mary with a “ready-made blueprint” distribution strategy.
The company will report sales of the newly added brands separately from its existing vaping category, which includes Supreme’s proprietary 88Vape brand.
Supreme nearly doubled revenues to £76.1 million this year, while posting an £8.6 million increase in gross profit.
July 7, 2023
WHO Releases Provisional Agendas

Photo: Alexey Novikov
The World Health Organization has released its provisional agendas for the 10th session of the Conference of the Parties (COP10) to the Framework Convention on Tobacco Control and the third session of the Meeting of the Parties to the Protocol to Eliminate Illicit Trade in Tobacco Products (MOP3), the FCTC announced on its website.
Held in Panama, COP10 will take place Nov. 20-25 and MOP3 will take place Nov. 27-30.
The provisional COP10 agenda is here and the provisional MOP3 agenda is here. Participants in COP10 can register here and participants in MOP3 can register here.
Guidance on registration is also available on the FCTC website.
The FCTC is the first international treaty negotiated under the auspices of the WHO. It was adopted by the World Health Assembly on May 21, 2003, and entered into force on Feb. 27, 2005.
The Protocol to Eliminate Illicit Trade in Tobacco Products is the first protocol to the FCTC, and a new international treaty in its own right. The Protocol builds upon and complements Article 15 of the FCTC, which addresses means of countering illicit trade in tobacco products. It was adopted by consensus on Nov. 12, 2012, at the fifth session of the Conference of the Parties to the FCTC in Seoul and entered into force on Sept. 25, 2018. The Protocol currently includes 67 Parties.
July 6, 2023
Plant-Based Biologics Market Thriving

Photo: Kentucky Bioprocessing
The global plant-based biologics market is anticipated to generate a revenue of $182.9 million by 2031, expanding a compound annual growth rate of 4.8 percent from 2022, according to a new report published by Research Dive.
Plant-based biologics are medical products that are produced by utilizing bioengineered plants to create complex molecules like proteins, antibodies, and vaccines. These biologics are produced more sustainably and economically than conventional animal cell-based biologics. The use of plant-based biologics may have substantial effects on the pharmaceutical industry by lowering the costs of medicine development and production and addressing ethical concerns about the use of animals in medical research.
Tobacco continues to be the most widely used plant for the manufacture of pharmaceuticals. Due to their high biomass yield, ease of genetic modification and quick growth rate, tobacco plants are well-suited for biologics production. Several companies, including Medicago, Baiya Phytopharm and Kentucky Bioprocessing have used tobacco to developed vaccines and other medical treatments.
According to Research Dive, North America dominated the global plant-based biologics market in 2021. Not only does the continent offer a sizable market, but it also offers a supportive regulatory environment and strong research infrastructure.
Tobacco Reporter explored tobacco’s potential as a “green bioreactor” in its April 2022 issue.
July 6, 2023
Investors Buy 22nd Shares ‘Above Market’

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22nd Century Group has entered into definitive agreements with certain investors for the purchase and sale of 778,634 shares of common stock and warrants at a price of $3.80 per share in a registered direct offering priced above market.
The company expects the offering to generate gross proceeds of $3 million before deducting the placement agent’s fees and other offering expenses payable by the company. 22nd Century intends to use the net proceeds from this offering for the continued commercial expansion of its VLN reduced-nicotine content tobacco cigarettes in additional markets, working capital related to its commercial activities and general corporate purposes.
“We are encouraged by the confidence investors have demonstrated in our path forward through the participation in our latest offering of securities, which corresponds with the inflection point we are experiencing in critical aspects of the business,” said CEO James A. Mish in a statement. “In turn, we are pleased to have strengthened our capital position, deliver[ed] continued operational momentum and taken successful steps toward regaining compliance with Nasdaq listing standards.”
The Special Equities Group, a division of Dawson James Securities, acted as the sole placement agent for this transaction.
As part of the transaction, the company agreed to issue to the investors warrants to purchase up to 1,557,268 shares of common stock. The warrants have an exercise price of $3.80 per share and are exercisable six months from the date of issuance. The closing of the offering is expected to occur on or about July 10, 2023, subject to the satisfaction of customary closing conditions.
July 6, 2023
Istanbul Bans Public Shisha Smoking

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Istanbul has banned shisha smoking in public places in order to mitigate risks of forest fires and other potential hazards, reports Xinhua News.
“Smoking shisha will be strictly prohibited in various locations, including beaches, forests, recreational areas and parks throughout Istanbul,” wrote Governor Davut Gul on Twitter. “However, it is important to note that licensed shisha lounges operating outside of these designated areas are not affected by this ban.”
July 6, 2023