More than $2 million worth of vaporizers, components, e-liquids and other illegal tobacco products have been seized in Singapore. Authorities are calling the discovery the “largest haul” in the city-state to date.
Credit: Richie Chan
Acting on a tip-off, officers from the Health Sciences Authority (HSA) inspected an industrial storage facility located north, towards the border with Malaysia. They discovered 10,057 vapes, 48,822 vaporizer components, and large quantities of vape juice, according to a press release.
“This is the largest seizure haul of tobacco products by HSA, in terms of the volume and street value of e-vaporizers,” officials said in a statement, adding that the products had an estimated street value of $2,260,825. No arrests have been made but HSA said that three people were currently “assisting in investigations.” The authority also revealed that more than 170 vape raids were carried out between 2018 and 2020.
The problem, according to Norcia, is that TPB’s premarket tobacco product application is not publicly available, so that other manufacturers are left to guess how the company managed to get the agency to backtrack.
At least 27 manufacturers and distributors, including Avail Vapor, Triton Distribution, Gripum LLC and My Vape Order (MVO), have filed petitions asking federal circuit courts to review their MDOs. MVO and Gripum has had their motions to stay the MDO granted by courts. Avail is rumored to have had its MDO rescinded.
In his article, Norcia details the travails of MVO, which on Oct. 20 petitioned a federal court of appeals for “an emergency motion for a stay pending a review and for expedited consideration” on the company’s vapor products that have been removed from the market.
Lawyers for MVO revealed that their client had shared studies and data with TPB and other companies, essentially arguing that the company did not receive the same treatment as TPB, even though the applications contain some of the same information.
A group of tobacco harm reduction experts will hold a round-the-clock broadcasting event Nov. 8-12, coinciding with the Ninth Session of the Conference of the Parties (COP9) to the World health Organization Framework Convention on Tobacco Control (FCTC).
Dubbed “sCOPe,” or “streaming Consumers On Point everywhere,” the five-day livestream will be simulcast via YouTube and Facebook. Presenters and panelists will challenge and scrutinize COP9, questioning, for example, who is influencing and funding its efforts to demonize vaping.
“Before the Covid-19 pandemic, consumers were planning to front up to COP in person and show media our increasing anger for being shut out, once again, from the proceedings,” said sCOPe organizer Nancy Loucas, executive coordinator of the Coalition of Asia Pacific Harm Reduction Advocates. “The FCTC’s decision to delay COP9 and host it exclusively online, with no discussions to be publicly released, meant consumers had to take alternative action. Hence, the development of sCOPe,”
“sCOPe is our response to being excluded from the table, as the main stakeholders, of the discussion and decision-making process that directly impacts our health and our right to make informed decisions,” she said.
Hong Kong has banned the sale of e-cigarettes and other heated tobacco products but personal use is still allowed. The ban will come into effect as soon as mid-2022, Secretary for Food and Health Sophia Chan Siu-chee said. The maximum penalty for offenders will be a HK$50,000 fine and six-month imprisonment.
Lawmakers passed the bill banning the import, sale and manufacture of electronic nicotine-delivery systems (ENDS) but some legislators say bill goes too far in targeting the business of vaping, will hurt the import sector and will deny a potential area for innovation.
Credit: TS Donahue
The long-delayed Smoking (Public Health) (Amendment) Bill 2019 passed Thursday, “delivering a major victory for health activists and educators who have blamed the devices for encouraging smoking among young people,” according to theSouth China Morning Post.
While the new law targets only vape shops and the local business of vaping, consumers will still be free to use the devices, prompting some politicians to call for more aggressive measures to curb tobacco use, including banning smoking in all public places except for designated areas. Others, however, argued Hong Kong should allow reshipment of vaping products and warned the ban would hurt logistics companies.
The bill was approved by a vote of 32 to three in the Legislative Council. Two lawmakers abstained.
Mi-One Brands has announced the launch of its Mi-Pod 2.0, a refillable liquid pod-based system. The new device offers a “thin, sleek form factor, a larger battery for maximum battery life, new laser-cut mesh coil pods with no leaking, longer coil life and incredible flavor production,” according to a press note. The device is one of the few sub-OHM pod systems on the market. The device is designed to be used with nicotine salt-based e-liquids.
The Mi-Pod 2.0, Mi-One Brand’s Next Generation Salt Nic Vaporizer
“We have always designed products with attention to detail of all the five senses to create the ultimate user experience,” said Geoff Habicht, co-founder of Mi-One Brands, ” With Mi-Pod 2.0, we not only incorporated the five sense and years of customer feedback into the design, but we also added sacred geometry designs to symbolize the ‘connection to self’ which we have found so vitally important on the journey to live a smoke-free life.”
The Mi-Pod 2.0 is a new revolutionary design combining luxury materials and user-inspired ergonomics.
A slimmer profile, made for vaping by vapors.
A larger high-density 1250 mAh battery for increased battery life.
The new laser-cut mesh magnetic coil pods feature our patented OAS system (Oil and Air Separated) with no leaking, longer coil life and incredible flavor production.
Combined with the Mi-Pod 2.0’s ultra-sensitive airflow switch for both MTL and DTL vaping provides an entirely new and upgraded vaping experience that enhances the entire sensory experience.
New physical on /off Switch for ease of use and increased battery life.
Four Responsive LED Battery Indicator Lights placed on side for easy viewing while smoking.
Tighter Draw by design, means more flavorful hits.
The Mi-One Brands US Team
Headquartered in Phoenix, Mi-One Brands started in 2008 as Smoking Vapor. Mi-One Brands is the official home of Mi-Pod PRO, Wi-Pod, Mi-Salt, and VaporLax. Co-founders Amir Hakak and Habicht created Mi-One Brands “with the simple mission to eradicate the harm caused by smoking and improve the lives of adult smokers with simple, efficient designs and convenient, high-quality devices,” the release states.
Altria Group Distribution Co. and Juul Labs have announced their support of TruAge, a new digital solution that enhances current age-verification systems and protects user privacy.
Developed by the National Association of Convenience Stores and Conexxus, TruAge makes it easier and more accurate to verify a customer’s age when purchasing age-restricted products. At the same time, the system makes identity theft difficult. One-time-use tokens are used to share only the most important elements to confirm the purchaser is of legal age, which also protects the user’s privacy.
TruAge is free to retailers, consumers and POS providers, and its relevant intellectual property will be placed in the public domain—removing barriers to adoption.
“We are excited to join this important initiative because TruAge deepens our trade partners’ support of underage prevention and helps establish retail as the most trusted place to responsibly sell tobacco products,” said Scott Myers, president and CEO of Altria Group Distribution Co., in a statement.
“Over the past few years, we have worked closely with our retailer partners across the United States to implement enhanced access controls for the sale of Juul products, automatically requiring electronic ID scanning to verify the purchaser is at least 21 years of age and limiting the amount of product sold to reduce social sourcing,” said Parker Kasmer, vice president of regulatory engagement for Juul Labs.
“We are eager to support TruAge and the extension of technologically based age-verification solutions across all vapor and other age-restricted products to combat underage use and support a more responsible marketplace.”
TruAge is also supported by more than 130 retail companies that represent 22,000-plus convenience store locations in the United States, plus four industry point-of-sale providers.
The ban on mailing vapor products through the United States Postal Service (USPS) takes effect tomorrow. After more than six months, the USPS has finally posted for public inspection its rules for mailing e-cigarettes with the Federal Register. The rules will publish tomorrow, Oct. 21, and go into effect immediately.
There is not an exemption for any vaping cannabis products, as many in the industry had hoped. The USPS is leaving it up to the U.S. Congress to carve out an exemption for hemp-based vaping products. The rules were originally set to go into effect in March and then April, however, the USPS held back publishing the rule while it went under agency review.
The rule states that Congress’s use of “nicotine” in the term “electronic nicotine delivery systems,” makes clear that “nonmailable ENDS products include those containing or used with not only nicotine, but also ‘flavor[s]’ or any other substance … It goes without saying that marijuana, hemp, and their derivatives are substances,” the rule states. “Hence, to the extent that they may be delivered to an inhaling user through an aerosolized solution, they and the related delivery systems, parts, components, liquids, and accessories clearly fall within the [Preventing Online Sales of E-Cigarettes to Children Act’s] scope.
“Conversely, THC-containing substances that are excluded from the [Controlled Substances Act] CSA—that is, hemp and hemp derivatives with no more than 0.3 percent THC by dry weight—are not subject to CSA-based mailability restrictions, and items used with such substances (and not with controlled substances) may fall outside the definition of drug paraphernalia … As such, those substances continue to be mailable generally, to the extent that they are not incorporated into an ENDS product or function as a component of one. To the extent that they do comprise or relate to an ENDS product, however, then that product is now nonmailable under the PACT Act and POSECCA, except pursuant to a PACT Act exception.”
Credit: Wolterke
UPS and FedEx already have bans in place for vaping products. Many in the industry have also moved on to new ways of mailing vaping products to customers through third-party shippers. Numerous other companies have since gone out of business since the U.S. Food and Drug Administration started sending out marketing denial orders (MDOs) last month.
When a 5,000-plus page omnibus bill, the Consolidated Appropriations Act of 2021, was signed into law on Dec. 28, 2020, buried deep within the bill (page 5,136) was the Preventing Online Sales of E-cigarettes to Children (PACT) Act. It was a provision that effectively bans the USPS from shipping ENDS products.
Retail customers will no longer be able to receive vaping products by way of USPS delivery, according to the USPS. However, the USPS rule states that the agency will mail vapor products under narrowly defined circumstances:
Noncontiguous states: intrastate shipments within Alaska or Hawaii;
Business/regulatory purposes: shipments transmitted between verified and authorized tobacco industry businesses for business purposes, or between such businesses and federal or state agencies for regulatory purposes;
Certain individuals: lightweight shipments mailed between adult individuals, limited to 10 per 30-day period;
Consumer testing: limited shipments of cigarettes sent by verified and authorized manufacturers to adult smokers for consumer testing purposes; and
Public health: limited shipments by federal agencies for public health purposes under similar rules applied to manufacturers conducting consumer testing.
The USPS rules also state that the listed exceptions cannot feasibly be applied to inbound or outbound international mail, mail to or from the Freely Associated States, or mail presented at overseas Army Post Office, Fleet Post Office, or Diplomatic Post Office locations and destined to addresses in the United States. Because of this inability, all ENDS products “in such mail are nonmailable, without exception.”
Excluded from the statutory definition are products approved by the FDA for sale as “tobacco cessation products or for other therapeutic purposes and marketed and sold solely for such purposes.” The USPS also proposes to treat ENDS as a standalone category, “albeit one generally subject to the same restrictions and exceptions as cigarettes, consistent with the statute.”
According to the PACT Act legislation, anyone selling vaping products must:
Register with the U.S. Attorney General;
Verify age of customers using a commercially available database;
Use private shipping services that collect an adult signature at the point of delivery;
Register with the federal government and with the tobacco tax administrators of the states if selling in states that tax vaping products;
Collect all applicable local and state taxes, and affix any required tax stamps to the products sold;
Send each taxing state’s tax administrator a list of all transactions with customers in their state, including the names and addresses of each customer sold to and the quantities and type of each product sold; and
Maintain records for five years of any “delivery interrupted because the carrier or service determines or has reason to believe that the person ordering the delivery is in violation of the [PACT Act].”
Retailers can be cited by states for not following their individual requirements for tax payments and filings, and they may have to purchase tobacco and other licenses or hire a registered agent in the state. The cost for being PACT Act compliant can range anywhere from $40 to $250 or more per year per state, according to previous news reports.
This story will be updated as the published rules are reviewed
Forty-two public health leaders have signed onto a letter urging the U.S. Food and Drug Administration Center for Tobacco Products (CTP) to review and update the 20-year old Clearing the Smoke report so that it can address the evolved tobacco and nicotine marketplace.
Two decades ago, the Institute of Medicine (now the National Academy of Medicine) issued its landmark report Clearing the Smoke—Assessing the Science Base for Tobacco Harm Reduction. The report had been compiled at the request of the FDA as it considered—even before Congress gave it the authority to do so—how best to regulate the growing tobacco and nicotine marketplace.
The signatories of the letter point out that much has changed in the tobacco and nicotine marketplace since the report was first published. Science, technology and innovation have dramatically advanced over the past two decades. Consumers can now choose from a range of nicotine delivery products spanning the entire continuum of risk—from deadly combustible cigarettes on one hand to less-harmful noncombustible products such as snus, e-cigarettes and tobacco heating products.
However, a slow product approval process means these products are not being made available to the public at a pace that would help significantly reduce the harms of cigarette smoking. What’s more, a lack of education efforts means consumers remain uninformed about the less-risky product choices available to them.
The signatories maintain that an update of the Clearing the Smoke report will help put all stakeholders on a track that will collectively advance public health objectives. They believe that the National Academy of Medicine, which produced the original report, is the most appropriate body to undertake such a review on behalf of the CTP.
The letter’s signatories include Scott Ballin, former vice president and legislative counsel of the American Heart Association; K. Michael Cummings, professor in the department of psychiatry and behavioral sciences at the Medical University of South Carolina; David Abrahams, professor in the department of social and behavioral science, at the College of Global Health at New York University; Aaron Biebert, former president and CEO of Clear Medical Solutions; Allan C. Erickson, former president for public education and tobacco control at the American Cancer Society; Ray Niaura, professor of public health global studies at New York University; and John R. Seffrin.
Broughton has unveiled a rebrand that reflects its evolving service offerings to support clients through their whole product life cycle journey. The company states that it is on a mission “to help our clients deliver life-enhancing products to market, by providing the most trusted integrated services in the world.”
Building on years of experience in the pharmaceutical and next generation nicotine products space, Broughton offers its clients fully integrated scientific and regulatory consultancy, combined with comprehensive in-house laboratory services. The launch coincides with the announcement that the business is expanding its services into the rapidly evolving cannabinoids industry.
Moving forward the company will focus on accelerating life-enhancing products to market within strategic markets including pharmaceuticals, nicotine and cannabinoids. Its combined expertise in formulation science, device technology, software applications and aerosol science makes Broughton the ideal strategic outsourcing partner to support client pipeline portfolios of future next generation products.
“The launch of the Broughton brand formalizes our rapidly developing position as a full-service solutions provider to the life sciences sector,” said CEO Paul Moran, who founded Broughton Laboratories in 2006. “We will continue our commitment to investing further into global operations delivering scientific and regulatory consultancy combined with comprehensive product development and laboratory services.
“This next phase of our expansion is a natural evolution to grow capacity and capabilities into the broad life sciences sector as technologies improve to target unmet market needs.”
“One exciting aspect of this change is that it facilitates the expansion of our existing pharmaceutical quality and product stability services to support providers of pharmaceutical inhalation products,” said Broughton Chief Scientific Officer Chris Allen. “With expertise in device optimization, human factor studies, navigating complex regulatory pathways for combination products and a track record of quality compliance, our broad expert team can support device development from concept to commercialization.’’
“The expanding team at Broughton hold extensive knowledge of their specialist fields,” said Moran. “This rebrand brings together this expertise with a fresh focus on the journey of our clients’ products to meet an unmet market need. This is an exciting time for the business that will enable us to continue to innovate as we contribute to global health and wellbeing.”
The U.S. Food and Drug Administration has authorized the marketing of four oral tobacco products that are no longer on the market—Verve Discs Blue Mint, Verve Discs Green Mint, Verve Chews Blue Mint, and Verve Chews Green Mint, manufactured by Altria subsidiary U.S. Smokeless Tobacco Co.
“We are pleased that FDA has determined that Verve oral nicotine products are appropriate for the protection of public health,” said an Altria spokesman. “While we discontinued selling Verve on Feb. 2, 2019, we applied learnings from this successful application to our on! submissions, which remain under review by FDA. Oral nicotine products play an important role in our vision of moving beyond smoking and remain an important part of our portfolio of products to transition adult smokers away from cigarettes.”
In a press release dated Dec. 17, 2018, Altria said it would stop the production and distribution of Verve oral nicotine products based upon the expected financial performance of these products and the regulatory restrictions that burdened the company’s ability to quickly improve these products. “We do not see a path to leadership with these particular products and believe that now is the time to refocus our resources,” wrote Chairman and CEO Howard Willard at the time.
It its Oct. 19, 2021, marketing order, the FDA said it had determined the marketing of Verve products would be consistent with the statutory standard, “appropriate for the protection of the public health.” This includes a review of data showing that youth, nonsmokers and former smokers are unlikely to initiate or reinitiate tobacco use with these products.
“Ensuring new tobacco products undergo a robust premarket evaluation by the FDA is a critical part of our mission to protect the public—especially kids,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products, in a statement.
“While these are mint flavored products, data submitted to the FDA show the risk for youth uptake of these particular products is low, and stringent marketing restrictions will help prevent youth exposure. Importantly, evidence shows these products could help addicted smokers who use the most harmful combusted products completely switch to a product with potentially fewer harmful chemicals.”
Altria Group Distribution Co. and Juul Labs have announced their support of TruAge, a new digital solution that enhances current age-verification systems and protects user privacy.
