Tag: news

U.S. FDA Sends 11 Warning Letters for Illegal Products

The U.S. FDA issued warning letters today to 11 firms who manufacture and sell unauthorized e-liquids for premarket tobacco product application (PMTA) violations. The regulatory agency advised the manufacturers that selling products which lack PMTA authorization is illegal, and therefore cannot be sold or distributed in the U.S. The firms did not submit PMTA by the Sept. 9, 2020 deadline.
The firms receiving warning letters are Jojo’s Smokeless World Inc. d/b/a Mod Shield; Sugar Vapor Company; DC Vapor, Inc.; Take Off Corp; The Vapor Spot, LLC; Premium Vapor Technologies LLC; Vaping Xtreme, LLC; Vapes Gone Wild Juice, LLC; Vapeoholic LLC; Vaporescence LLC d/b/a Vape King USA; and Elemental Vapor Bar, LLC.
Credit: Premium Vapor Technologies
While each warning letter issued today cites specific products as examples, collectively these companies have listed a combined total of more than 150,000 products with the FDA, according to a to the FDA’s website.
Following an initial set of such warning letters announced earlier this year, FDA has continued to issue additional warning letters for these types of products. The FDA sent 10 warning letters in mid-January.
“Per a court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016—including e-liquids—were required to be submitted to FDA by Sept. 9, 2020. For companies that submitted applications by that deadline, FDA generally intends to continue to defer enforcement for up to one year pending FDA review, unless there is a negative action taken by FDA on the application,” the agency wrote. “In line with the agency’s stated enforcement priorities, after Sept. 9, 2020, FDA is prioritizing enforcement against any ENDS product that continues to be sold and for which the agency has not received a timely product application.”
February 12, 2021
PACT Act Forces DuraSmoke Manufacture Out of Business
Securience, LLC, parent to the DuraSmoke, Forge, AmericaneLiquidStore, and VapeMoar brands, will be going out of business at the end of March 2021.
Credit: Durasmoke
In a letter to its partners, the company states that the recent passing of the Prevent All Cigarette Trafficking (PACT) Act, which prohibits the shipping of vapor products through the U.S. Postal Service (USPS), was the catalyst for the decision to close the company’s doors. The company cites its inability to mail product to consumers, however, the PACT Act also prevents B2B shipments by USPS, according to a representative from the Bureau of Alcohol, Tobacco and Firearms (ATF) who spoke during the recent Tobacco and Vapor Law Symposium presented by the law firm of Keller Heckman.
“Because of the complexity of these new shipping rules, FedEx, UPS, and DHL have all informed us that they will stop shipping vaping products completely — including our shipments to you, our wholesale vape shop customers, and distributors,” wrote Securience owner Don Muehlbauer. “While we have looked at some alternatives, given the geographic locations of our customers, the significant increase in compliance costs, and our capabilities as a small business, we have been unable to find a feasible alternative and have been left in a situation that makes continuing business impossible.”
Securience opened its doors in 2008 and has since been a staple in the vaping industry. Muehlbauer stated that he anticipates the PACT Act will not only impact his company, but many small e-liquid manufacturers. “Those manufacturers who are able to afford the increased compliance costs will have increased shipping costs that may impact [retail] shops,” he wrote. “The last day we will be able to accept orders for shipping is March 25 or until supplies run out.”
February 12, 2021
Counterfeit Juul Factory Shut Down by Chinese Authorities

Chinese authorities have shut down an illicit enterprise involved in the manufacture and international distribution of counterfeit Juul products in China, Juul Labs announced in a press release. The operation resulted in the seizure of more than 110,000 counterfeit products, closure of the production facility and arrest of criminal actors behind the illicit enterprise.
Through its global enforcement operations, Juul Labs was able to identify individuals who were offering suspected counterfeit Juul products at wholesale from China. After in-depth surveillance and monitoring, the company was able to locate a clandestine factory manufacturing counterfeit Juul products for international distribution. Juul Labs then shared this information with Chinese law enforcement and supported its efforts to investigate and raid the illicit factory.
In addition to seizures of counterfeit Juul products, packaging and labeling, officials were able to retain a significant amount of documentation on businesses and individuals with purchase history, which will be used in follow-up investigations and enforcement actions. As a result of the raid, both the factory owner and manager have been arrested and will be subject to criminal prosecution.
The raided factory had thousands of counterfeit packaging for Juul products at 5.0 percent nicotine by weight in various flavors, with production runs ongoing for counterfeit Juul pods in menthol flavor. Juul Labs suspects the that the products were intended for the U.S. market. In addition, the factory appeared to have been manufacturing disposable vapor products under various brand names.
February 11, 2021
ReStalk Partners With Fiber Company to Process Hemp
ReStalk, Inc has entered into a licensing agreement with Sustainable Fiber Technologies (SFT) enabling the company to utilize the SFT’s suite of IP to process hemp into cellulose pulp and biopolymers. These polymers are used to make vapor product packaging, among many other items.
Credit: ReStalk
The partnership allows SFT to assist ReStalk in the developing hemp-based pulp and board products. “ReStalk is an excellent company with the foresight into both the paper and packaging arena. Their team and expertise of hemp cultivars makes ReStalk a perfect licensee for the Phoenix Process,” said Mark Lewis CEO of SFT. “Domestically, the demand for hemp pulp has never been higher, it provides a quality non-wood fiber that competes with softwood fiber.”
ReStalk’s first project with the SFT license will be building a a pulp mill capable of producing100 tons-per-day of pulp. “We’re eager to provide the infrastructure needed to stabilize this re-emerging crop,” said Lucas Hildebrand, ReStalk’s chief strategy officer. “This project will strengthen the supply chain and manufacturing of hemp’s downstream products here in the US. We’re excited to get to work and lay the foundation for a more regenerative model of production.”
As the pandemic caused by COVID-19 continues to disrupt global supply chains, the need for scalable sustainable solutions has never been more necessary, according to a press release. The mill positions ReStalk as the largest supplier of American manufactured hemp pulp.
“Consumer demand for new sources of sustainable packaging is accelerating worldwide. Along with forest-based fibers, we see tremendous interest in hemp and similar alternative agricultural fibers,” said Warren Pullen, executive vice president for Central National Gottesman, a pulp, paper, packaging, tissue and non-wovens distribution. “We believe ReStalk has the potential to successfully address unmet demand for hemp fiber and take green packaging to the next level.”
February 11, 2021
PMI: Smokefree More Than Half of Income by 2025

Photo: PMI
Philip Morris International (PMI) wants smokefree products to account for more than half of its revenues by 2025, up from its earlier target range of 38-42 percent. The new goal was announced during PMI’s 2021 investor day on Feb. 10., a virtual event broadcast from the company’s operation’s center in Lausanne, Switzerland, during which senior management presented PMI’s business strategies and growth outlook.
The company shared its 2021 to 2023 targets, including net revenue and adjusted diluted earnings-per-share (EPS) compound annual organic growth of more than 5 percent and 9 percent, respectively, and 2023 heated tobacco unit shipment volume of 140 to 160 billion units.
PMI plans to launch IQOS ILUMA, the next generation of its IQOS heat-not-burn product featuring internal heating based on Smartcore induction technology, in the second half of 2021.
In addition, the company intends to launch IQOS VEEV, its MESH technology vapor product, in more than 20 markets this year. PMI expects to commercialize IQOS in a total of 100 markets by the end of 2025, from 64 markets at the end of 2020.
Also at the investor day, PMI announced its target of at least $1 billion in net revenues from “beyond nicotine” products in 2025.
With the right regulatory frameworks, dialogue and support from civil society, the company said cigarette sales can end within 10 to 15 years in many countries.
Andre Calantzopoulos
“In just five years, we have thoroughly transformed our company, building IQOS into a top-5 global nicotine brand—with nearly $7 billion in net revenues and over 17 million users across 64 markets—while maintaining our leadership position in the international cigarette category,” said PMI CEO Andre Calantzopoulos in a statement.
“We are now embarking on our next growth phase, further shifting to a better, more sustainable business by driving the development of the smokefree category and leveraging our leading commercial model, which places the consumer at the core, to switch more adult smokers to our smokefree products.”
“This next growth phase is underpinned by our unmatched portfolio of innovative products. We are very excited to announce the planned launch of IQOS ILUMA—the next generation of our IQOS heat-not-burn product featuring a new internal heating induction technology—during the second half of this year.”
“As outlined today, we are well positioned to deliver excellent top- and bottom-line growth, as well as strong shareholder returns. We now aim to be a majority smokefree product company by 2025, an important milestone toward our ambition to deliver a smokefree future, to the benefit of adults who would otherwise continue to smoke, society, the company and our shareholders.”
Philip Morris reaffirmed its full-year 2021 guidance for earnings per share in the range of $5.90 to $6.00. For the three-year period between 2021 and 2023, Philip Morris is guiding for net revenue and adjusted EPS compound annual growth of 5 percent to 9 percent. Cigarette volume is expected to decline in that period. Philip Morris stock has fallen 3.5 percent over the last year while the benchmark S&P 500 index SPX, -0.03 percent is up 16.7 percent for the period.
A transcript and slides of the Investor Day are available at www.pmi.com/2021InvestorDay. An archive of the webcast will be available until 5 pm ET on March 11, 2021.
February 10, 2021
Study: Youth Access to THC Vaping Videos Troubling
The cannabis vaping industry may be making some of the same mistakes as the nicotine vaping industry. A study led by University of Queensland researchers finds that YouTube videos glorifying cannabis vaping as fun and joyful are widely available and easily accessible by youth. The videos studied showed elements of risk-taking behavior including vaping a whole cartridge of THC—the main psychoactive compound in cannabis—in a single setting, and 52 percent of videos had no age access restrictions.
photo: Jeremynathan | Dreamstime
Lead author Ph.D. student Carmen Lim from UQ’s National Centre for Youth Substance Use Research said the volume and accessibility of YouTube videos promoting cannabis vaping was concerning. It was also an issue faced by nicotine vaping companies and is often labeled as a cause for the rise in youth vaping.
“There’s been an increase in the potency of cannabis over the last two decades, and more recently, there has been a significant rise in the number of young people who are vaping cannabis,” Miss Lim said. “Unrestricted access to the large volume of YouTube videos portraying cannabis vaping as fun and joyful could increase uptake among adolescents.”
The UQ research team searched for cannabis vaping videos on YouTube between 2016 and 2020 and categorized these into prominent themes—advertisement, product review, celebratory, reflective, how-to, and warning.
Metrics around the number of views, likes, dislikes, and comments for each video were recorded, according to an article in MedicalXpress. Co-lead author Dr. Gary Chan from UQ’s National Centre for Youth Substance Use Research said many of the YouTube videos on vaping cannabis had no age restrictions, meaning children and adolescents could easily access them.
“Only around 25 percent of cannabis vaping-related videos communicate the potential harms of cannabis vaping,” Chan said. “The videos with a ‘how-to’ theme were viewed more than five million times and videos with a ‘celebratory’ theme, expressing the fun and joy of cannabis vaping, were viewed more than seven million times. As YouTube has become a popular source of accessing cannabis-related information, we need to reduce the accessibility of cannabis-related content to adolescents.”
This is the first study to examine the availability of cannabis vaping videos on YouTube since cannabis became legal in many jurisdictions in North America. The researchers hope the study results are used to inform a future regulatory framework on YouTube and other social media platforms around mandating age restrictions on videos promoting cannabis use.
This research is published in Addiction.
February 10, 2021
South Carolina School District Not Joining Juul Lawsuit
South Carolina’s fifth-largest school district, Richland 2 school district will not be joining a class-action lawsuit against Juul Labs the board voted Tuesday. In October, Lexington 1, a neighboring school district, became the first school district in S.C. to join the Juul Labs class-action. It was later joined by Greenville School District in December.
The lawsuit alleges Juul Labs engaged in deceptive marketing practices and marketed its product to minors. Juul Labs has said it has curbed advertising, is less harmful than alternatives and that its customer base is adults.
Board member Amelia McKie made a motion to join the lawsuit, which saw support from district Superintendent Baron Davis, according to an article in The State.
“Sometimes you take on an issue and lend your voice so others who don’t have a voice can have the strength to do so,” Davis said. “So we wanted to join the collective group of school districts that say ‘we believe vaping is wrong and we want to do something about it.’”
The motion to join the suit was a 3-3 vote, meaning it fails. McKie, Cheryl Caution-Parker and Manning voted for joining the suit. Lashonda McFadden, Agostini and Elkins voted against joining the lawsuit. Board member Teresa Holmes was not present at the meeting because she was sick, board chair James Manning said. The board may revisit the issue at a later date.
Board members Monica Elkins and Lindsay Agostini voted against joining the lawsuit because Richland 2 has no data to back up how many students in the district are using Juuls or vapes, they said.
“Richland 2 is a data-driven school district,” Elkins said. “I can’t support something in the dark.”
February 10, 2021
Bidi Vapor Announces PMTA Acceptance Letter
After submitting its PMTA application to the U.S. FDA on Sept. 8, 2020, Bidi Vapor, the producer of the Bidi Stick closed system, announced yesterday that it had received a PMTA acceptance letter from the regulatory agency.
“It has always been our goal to provide a premium vape experience as an option to traditional, combustible tobacco that meets the needs of every adult smoker, age 21 and older,” said Niraj Patel, the president and CEO of Bidi Vapor and Kaival Brands Innovations Group, global distributor of all Bidi brand products “We couldn’t be more pleased that we are one step further in achieving this goal.”
The company now waits for a filing letter from the FDA. The Bidi Stick PMTAs would then move on to the Substantive Review phase where the scientific data is analyzed. The Bidi Stick, is the fastest-growing closed system vaping product in the U.S., based on Goldman Sachs’ equity research report on the Nielsen data for total nicotine volumes in 2020. Nielsen data showed the Bidi Stick as the second-largest disposable electronic nicotine-delivery system (ENDS) offering based on retail sales for previous 52-week period.
The acceptance letter covers all 11 flavors in the Bidi Stick lineup. “Moving to the filing and, we anticipate, to the substantive review phase of the PMTA process is where our months of extensive data collection, investment and hard work assembling 285,000 pages of science-based evidence will pay off,” Patel said. “Receipt of the acceptance letter is a major step, as we await the FDA’s filing letter and then substantive review of our products.”
The press release also states that the Bidi Stick is also the only adult-focused vape product on the market with an ecologically friendly, mass-recycling program. Kaival Brands also recently launched Bidi Vapor ‘s Bidi Pouch, a tobacco-free nicotine pouch.
February 10, 2021
22nd Century and KeyGene Launch Cannabis Platform

Photo: surfwiz17 | Pixabay
22nd Century Group has developed and launched a technology platform that will enable the company and its strategic partners to quickly identify and incorporate commercially valuable traits of hemp/cannabis plants to create new, stable hemp/cannabis lines. The platform incorporates a suite of proprietary molecular tools and a large library of genomic markers and gene-trait correlations. The platform was developed in collaboration with researchers at KeyGene, a global leader in plant research involving high-value genetic traits and increased crop yields.
“This is a major breakthrough. Quickly and easily identifying the genes responsible for specific traits in a plant is a powerful tool for 22nd Century Group and the hemp/cannabis industry as a whole,” said James A. Mish, chief executive officer of 22nd Century Group, in a statement.
“That is why we are even now beginning discussions to license this platform to strategic partners to help them improve their plant breeding techniques and to optimize their hemp/cannabis cultivars. We continue to make great advancements through our partnership with KeyGene, and this newly developed molecular breeding platform has the potential to result in exponential growth for the company’s revenues and create new value opportunities for our stakeholders, including shareholders.”
“Using traditional breeding techniques, it typically takes at least eight to 10 years to develop new varieties of hemp/cannabis plants that consistently express important traits,” said Juan Sanchez Tamburrino, vice president of research and development at 22nd Century Group.
“Our new molecular breeding platform can dramatically reduce our development time for new high-value varieties of hemp/cannabis and allows 22nd Century scientists to identify plant lines that carry high levels of major therapeutic cannabinoids, such as cannabidiol, cannabichromene, and other minor therapeutic cannabinoids, like cannabidivarin and tetrahydrocannabivarin.”
Demonstrating how this technology can be used, 22nd Century and KeyGene scientists can now accelerate the selection of specific traits yielding novel cannabinoid profiles. For example, the team was able to select specific markers that predict the gender of hemp/cannabis plants with 99.6 percent accuracy.
February 10, 2021
Pyxus Releases Improved Quarterly Results

Pieter Sikkel (Photo: Pyxus International)
Pyxus International, parent to e-liquid manufacturer Purilum, announced results for its fiscal quarter ended Dec. 31, 2020.
Sales and other operating revenues were $379.6 million for the three months ended Dec. 31, 2020, up from $363.3 million for the three months ended Dec. 31, 2019.
Gross profit as a percent of sales increased to 16.5 percent for the three months ended Dec. 31, 2020, from 15.2 percent for three months ended Dec. 31, 2019.
Net loss improved 62.7 percent to $8.2 million for the three months ended Dec. 31, 2020.
Adjusted EBITDA improved 64.9 percent, to $39.9 million for the three months ended Dec. 31, 2020, from $24.2 million for the three months ended Dec. 31, 2019.
Inventory decreased 11.5 percent to $771.8 million as of Dec. 31, 2020.
“Fiscal year 2021 continues to be a year of evolution for our business,” said Pieter Sikkel, Pyxus’ president and CEO, in a statement. “Since the completion of our financial restructuring, we have undergone a strategic review of all business units and categories in which we operate in order to develop a stronger, more streamlined strategy to improve financial performance.”
The developments in the e-liquids category following the September 2020 PMTA submission deadline, paired with increased enforcement of PMTA regulation, provide an encouraging opportunity for potential future growth.”
In January, Pyxus International announced plans to divest its cannabis business in order to focus on its more profitable tobacco and e-liquid businesses.
Despite recent challenges, the company continues to manage its working capital closely, according to Sikkel. “At Dec. 31, 2020, inventory decreased $100.1 million, or 11.5 percent, to $771.8 million when compared to Dec. 31, 2019,” he said. “Additionally, we expect our uncommitted inventory to be near the midpoint of our stated range of $50 [million] to $150 million by fiscal year end.”
February 10, 2021