China-based Shenzhen IVPS, the parent to SMOK brand vaping devices, filed the appeal after with the New Orleans, Louisiana-based U.S. Court of Appeals for the Fifth Circuit, and was joined in the suit by a Dallas, Texas-based distributor of the SMOK products that were denied marketing.
The FDA claimed that it had issued the MDOs for the premarket tobacco product applications (PMTAs) for the SMOK products because the applications “failed to provide sufficient data to characterize constituent delivery, product stability, and product abuse liability.” The agency also stated that SMOK failed to provide a specific e-liquid and consumers could use any e-liquid in the devices.
Shenzhen IVPS strongly challenges those assertions, as the company “invested more than $30 million in its applications, which totaled well over 600,000 pages in all, and collaborated with the world’s leading laboratories to conduct robust harmful and potentially harmful constituent aerosol testing, in vitro toxicology testing and toxicological analysis, accelerated and 24-month storage and stability testing, and rigorous clinical pharmacokinetic studies to test the products’ potential abuse liability profiles,” according to a press release.
Welfer Ouyang, Shenzhen IVPS CEO, said he was “very concerned” that the agency issued marketing denial orders on open-system devices that are sold without any nicotine-containing e-liquid.
“FDA is using isolated data from testing of the devices with e-liquid formulations that the products’ instruction manuals specifically warn are not compatible with these devices, and ignoring the overwhelmingly positive toxicological and safety profile of these products,” said Ouyang.
The 9-5 decision by the New Orleans-based 5th U.S. Circuit reversed a July 2022 decision by a three-judge panel of that court.
The agency “sent manufacturers of flavored e-cigarette products on a wild goose chase,” telling them what would be needed to approve their products, and then denying all applications, the court said in an opinion by Judge Andrew S. Oldham. The FDA “never gave petitioners fair notice that they needed to conduct long-term studies on their specific flavored products,” Oldham wrote.
The Solus 2 series was launched by SMOK, Shenzhen IVPS Technology’s main brand, at a global product launch event in Jakarta, Indonesia.
In attendance were local distributors, vape shop owners, and key influencers. The Solus 2, an upgraded version of the Solus series, has been in development for nearly 200 days and has come to represent improved vaping experiences and cost-effectiveness, according to a press release.
SMOK collected user feedback from hundreds of global vapers and used the data to make improvements and upgrades to address the cons of the first Solus series. The Solus 2 has improved the user experience and product details with regard to various functions (Southeast Asia version):
Battery & Charging: The strong performance of the 700mAh & Type-C cable meets the needs of long-lasting vaping.
Pod Compatibility: Compatible with both Solus 2 Pod & Solus Pod.
Wattage & Airflow: Max of 15W, dual airflow design, both RDL and MTL are available simply by switching the installation of the pod.
Appearance & Design: All-in-one design, slim body, comfortable grip. Designed for both aesthetics and practicality.
Price: Continuing the product concept of “Affordable Luxury”, SOLUS 2 also benefits user groups with a higher cost performance.
“It is widely believed that the launch of Solus 2 will lead to exciting new changes in the vaping industry. Southeast Asia is one of the world’s most important e-cigarette markets and is also a very important part of SMOK’s globalization strategy,” Holly Yang, a SMOK spokesperson said at the event. “In the future, as a leading international vaping brand, SMOK will dig deep into demand and continue to enrich product lines while developing the Southeast Asian market. The company is committed to empowering global vapers to enjoy good products with guaranteed quality and safety.”
Smok is one the most well-known and respected hardware manufacturers in the vaping industry. Now, Shenzhen IVPS Technology, the firm behind the brand Smok, is considering an initial public offering to raise at least $500 million in Hong Kong as soon as next year, people with knowledge of the matter said.
According to a Bloomberg report, the company is working with a consultant in preparation for a potential share sale, said sources who asked not to be identified as the information is private. The offering could raise between $500 million and $1 billion. Deliberations are at an early stage and details of the potential offering such as timing and size may change, the people said. IVPS didn’t immediately respond to requests for comment.
Smoore International Holding’s stock (HK: 6969), parent to the Vaporesso, FEELM and CCELL brands, grew by nearly 150 percent on its opening day of trading on the Hong Kong Exchange. However, after China’s Ministry of Industry and Information Technology proposed a draft regulation in March that would apply the same rules for the conventional tobacco industry to the e-cigarette sector, shares of several Chinese e-cigarette companies plunged and Smoore shares are down about 40 percent this year.
While rising regulatory scrutiny of the vaping industry could impact investor appetite for listings in the sector, according to the article. IVPS could be less affected because it makes the device rather than the e-cigarette liquid, one of the sources said. However, Smoore also produces hardware and shares still fell after the Chinese government’s regulatory announcement.
Smok’s NexMESH pod system offers a convenient small size and great battery life without sacrificing quality.
By Mike Huml
Smok and OFRF have teamed up to create the NexMESH pod system. It’s a compact mod-style pod system, and as its name suggests, it utilizes a stainless steel mesh coil for improved performance. The NexMESH incorporates a few options to allow for some fine-tuning and customization, but the device remains simple and accessible to a multitude of vapers with varying vaping styles.
The NexMESH is a relatively simple looking device with no unnecessary flare. One side has a nice looking mesh cage attached while the other side houses the fire button right in the center of the “O” in OFRF. An OLED screen is located on one of the narrow sides and displays all relevant information at a glance, including power output, output voltage, coil resistance and remaining battery life.
Two buttons underneath the screen allow for wattage adjustment, and when both are pressed simultaneously, the NexMESH will enter a locked state in which it cannot be fired inadvertently. Pressing this same button combination again will unlock the device. Pressing the fire button and the top button at the same time will flip the LCD screen’s orientation, and hitting the fire button five times in quick succession will turn the NexMESH on or off. This simple and user-friendly system will be familiar to most vapers, and if not, the most useful functions, such as power adjustment, are intuitive.
The NexMESH is small and convenient, making it great for taking on the go. It’s refillable and holds 2 mL of e-liquid but also makes use of replacement coil heads. This means that instead of needing to purchase and replace the entire pod, the pod can be reused indefinitely. Two coils are available for the NexMESH. Both are 0.40 ohms, but one is made with standard round wire with a smaller diameter for mouth-to-lung vaping. The primary coil is made with the stainless steel mesh and makes for comfortable direct-lung vaping. Mesh “coils” have multiple advantages that contribute to a superior vape experience.
Mesh is generally superior to round wire for several reasons. Being flat and thin, the mesh covers more area than round wire. This means the heating area is less concentrated, which reduces the occurrence of dry hits. Additionally, it provides better flavor and more consistent vapor due to a larger surface area. Since the mesh is thinner than round wire, it also heats up more quickly. As such, ramp-up time is virtually nonexistent, even at lower wattages.
Cumulatively, this results in a wide range of viable operating wattages and better flavor and vapor production with no ramp-up time. The improvements are admittedly nuanced but noticeable and perfect for pod systems. Being able to reduce the power output of the device without a significant impact to the overall vape quality means that the battery is less taxed and will last longer.
The NexMESH has an internal 1200 mAh battery, which is significant for a pod system. Depending on the power setting, this can last from half a day to two days of constant use. The NexMESH can be adjusted from 5 watts to 30 watts, but both the round wire and mesh coil types work best between 12 watts and 25 watts, which leaves some headroom on either end. The device is charged with the included micro-USB cable and can achieve a full charge in approximately two hours, perhaps fewer if the battery is not completely depleted.
Each NexMESH coil head screws into a base unit where the user can adjust airflow by rotating a small ring. Once the coil is attached and the airflow is set, the assembly slides into the bottom of the pod. The pod is filled by removing the silicone plug on the side of the pod.
The plug is easily removed, but the fill port is relatively small and is best suited for e-liquid bottles with needle or narrow tips. As is the standard, it is recommended to let the full pod rest for at least five minutes before use to ensure that the wicking material is completely saturated. Once ready, the entire pod assembly slides into the opening at the top of the device and is held in place securely with magnets.
The airflow path starts at the top of the pod next to the mouthpiece, but it’s never impeded by the user’s mouth while in use. The airflow is consistently smooth with minimal turbulence, and there is no spitback. Coupled with the fact that there is no ramp-up time when using the mesh coils, the overall vape experience is fantastic. Vapor is produced easily with varying heat levels depending on the wattage setting, and the airflow is smooth.
All different e-liquid types are viable with the NexMESH, but some considerations need to be considered. When lung hitting with the mesh coils, users should avoid e-liquids with high nicotine concentrations. Also, thick liquids may not wick fast enough at high wattages when using the round wire coils. Apart from these extremes, most liquids will work perfectly, which sets up the NexMESH to be a great device for many types of vape styles.
There are many pod systems on the market these days, and it can be difficult to stand out. However, a quality vape experience is more important than making a splash, and the NexMESH is among the best in terms of both flavor and vapor production.
While the amount of vapor is more than reasonable, it’s the ease at which the vapor is produced that really makes the NexMESH impressive. The mesh coils allow for a range of temperatures without sacrificing flavor or vapor volume, and it can’t be understated how much of a difference mesh can make.
Most new vapers nowadays tend to start the vaping journey with a pod system that closely represents the smoking experience, and the NexMESH can provide that with the round wire coils. Generally, moving to upgrade involves an entirely new device, but the NexMESH includes the “upgrade” right out of the box with the mesh coil.
It allows new users to experience high-quality mouth-to-lung vaping as well as direct-lung vaping without having to make the choice between two different devices on the spot. This level of versatility is a huge selling point, especially for beginners who are unsure of what vaping style they prefer.
The only things standing in the way of the NexMESH being a sure thing for new customers are the fact that it doesn’t resemble an analog cigarette in any way and that it doesn’t have a draw-activated switch. While this may dissuade the most stubborn of clientele, it is far outweighed by the versatility and quality of the device.
Often, this fact can turn a sale when communicated effectively. Most vapers find that a better vape experience is preferable to a replication of the look and feel of smoking an analog cigarette. Too many features are compromised in the pursuit of the perfect cigalike, but sometimes this must be experienced rather than told. However, most reasonable people are more than willing to heed the advice of experienced vapers.
Overall, the NexMESH offers quite a bit for vapers of all levels and types. Even more enthusiast vapers are being won over by the convenience of pod systems, making features such as mesh coil heads even more appealing. Being a small device with great battery life, advanced users will find that they need not sacrifice quality in order to have a vape that’s more convenient and portable.
Smok and OFRF have undoubtedly succeeded in creating a pod system that has the potential to appeal to a wide market. It’s easy to use, caters to multiple vape styles, is small and portable and has great battery life. Vapers of all levels can find something to love about the NexMESH, and even as a first device, new vapers that can forego the look of a traditional cigarette will find that vaping doesn’t need to be a precise reproduction of smoking in order to be satisfying. In a time when prefilled pods are on the way out, many are looking for newer and better options, and the NexMESH provides everything that other pod systems can and more.
After a brief shutdown of all operations, vapor hardware manufacturers in China are now operating at more than 80 percent of pre pandemic production.
By Timothy S. Donahue
It’s not the same as it was this time last year. However, vapor hardware manufacturers in China that produce products for the world market are back in service after a brief hiatus due to the Covid-19 pandemic. Mostly based in Shenzhen, the e-cigarette capital of the world, companies say that they are working hard at implementing new standards and processes in order to keep employees and customers safe.
They are also playing catch-up in collecting data for premarket tobacco product authorizations (PMTA) in the U.S. market. “The coronavirus is indeed having an impact on the PMTA process,” says Welford Ou, CEO of Smoktech, a major manufacturer. “For example, the behavioral investigations have been stopped, and it is also taking more time for us to prepare all the products for the PMTA.” As of this writing, PMTA applications are due to the U.S. Food and Drug Administration (FDA) on May 12.
Smoore Technologies, the parent to Vaporesso and Feelm, says it “took strong and comprehensive measures” in advance of the virus’ outbreak. “We set up disease prevention and control teams in each of our facilities before the Chinese Spring Festival holiday. Dating back to the 20th of January, Feelm teams started to collect information, investigate employees’ conditions, prepare epidemic prevention supplies and disinfect public areas,” said Sofia Luo, marketing director for Feelm. “Before getting back on track, Feelm handed out a Covid-19 prevention and control booklet to each employee, providing scientific support to enhance health security.”
All Smoore facilities are now back up to at least 85 percent of pre-pandemic production, according to Luo. She says Feelm is already shipping goods to the U.S. and has been since the middle of February. “Smoore and its subsidiaries have enough key materials inventory, and all of our supply chain has recovered and is back in production,” she said. When asked whether there was a supply shortage, Luo replied, “In general, the impact of supply shortage is under control.”
Smoktech is getting back to its normal operations and more workers are expected to be hired as the virus outbreak is brought under control, according to Ou, who added that the company is awaiting the return of some workers from Wuhan (located in the Hubei province and the epicenter of the pandemic) where the quarantine was officially lifted on April 8.
“The sales are doing well even with the Spring Festival and a long time staying at home for virus control,” says Ou. “Our challenge is to get more skilled workers in [a] short amount of time to meet the growing demand. My concern for the world market is [that] hopefully they will embrace vaping and see it is better and safer than smoking cigarettes.”
Smoore took early action in order to prevent a massive global disruption in the vapor and e-cigarette market, according to Luo. She said that the company started to communicate frequently with its clients at the early stages of the pandemic. “We reminded customers to pay great attention to the epidemic. With the development of Covid-19 worldwide, most of our customers have been prepared (in terms of staff safety and inventory),” Luo stated. “The [virus] was a black swan event of great magnitude.” A “black swan” event refers to an unforeseen occurrence that typically has extreme consequences; in contrast, a “gray rhino” event is an obvious yet ignored threat.
Luo says that, although Covid-19 is spreading all over the world, the demand for e-cigarettes hasn’t changed. “Vapor stores in many countries remain open. And we know some brands are increasing the online sales and e commerce service,” she said. “We forecast [that] the 2020 industry will be the same size or a slight increase compared with 2019. And after PMTA, [the industry] will get a big increase.”
When it comes to issues like the limitation of freight and whether the virus could be on packaging, Feelm says the information from official sources are that there’s no limitation of freight, and the World Health Organization (WHO) confirms coronaviruses do not survive for extended periods on objects such as letters or packages and that it’s safe for people to receive packages from China.
Luo says Feelm will continue to stay updated on related information and adds that the company will spare no efforts to guarantee each product is clean and safe in all aspects from purchasing raw materials to exporting goods. Feelm products have been approved by several international quality and safety systems, according to Luo. “As a leading company in the automatization area, Feelm has the strength to embrace health and security first,” she says. “Disease prevention and control is our responsibility. Feelm is well prepared to protect employees’ safety to recover production and to win the battle.”
At its factories, Smoore and its other entities’ staff are well-equipped with protection products such as masks, gloves and other safety equipment, according to Luo. “Disinfection in public areas is proceeded twice a day. Exclusive dust bins for used face masks are placed throughout the facilities,” explains Luo. “All these measures lay a solid foundation to protect Feelm and all Smoore employees’ safety. This allows for the greatest possibility for full production recovery.”
THE NEW NORMAL
United we stand, together we win. Since the outbreak of Covid-19 at the end of last year, the Chinese government has implemented a series of powerful measures that have effectively controlled the spread of the virus, according to Sofia Luo, marketing director for Feelm, a major atomizer company based in Shenzhen, China.
“At present, production recovery has become the top priority. Allied with government regulations and a corporate plan, Feelm employees started to work online at the beginning of February. Now, all facilities serving Feelm clients are getting back on track,” explains Luo. “Thanks to Feelm’s advantages with having a strong supply chain and the ability to deal with emergencies, Covid-19 has had little impact on production. Once getting back to work, the production capacity will recover soon.”
In order to ensure the prevention of a recurrence of the virus within the company, Feelm has implemented an eight-step policy to enhance protocols and address health and security concerns for its employees. According to Luo, the first step requires all employees to register their current health status and any other conditions they may have.
“They must also inform us of the dates they are returning/returned to Shenzhen, the people they have met, etc.,” she says. “They must archive related documents setting up an exceptional first line of defense. Step two: any employees returning to Shenzhen from other places must isolate themselves at home for 14 days. They must work from home or online if applicable, according to Luo. Only if without any suspected symptoms like fever and coughing, are they permitted to return to the office. All employees must wear a face mask at [the] factory.”
Step three is all factories must have epidemic prevention supplies ready, according to Luo. Employees must wear a face mask while going out and have their temperature taken before stepping into the factory. They must also wash their hands after touching anything and always have disinfectants at hand.
Step four involves having strict Allied Social Sciences Association (ASSA) access control systems in place. Employees must wear identification badges and have their temperature taken twice a day. “Anyone whose body temperature is over 37.3 degrees Celsius should stay at home for medical observation,” says Luo. “Protecting yourself is protecting others.”
Luo explains that step five is one of the most vital steps. She says the company actively disinfects all public areas in factories twice a day. “Office areas are disinfected once a day after work. Public space and dormitories are also once a day,” she says. “Production area disinfection is arranged by departments.”
Step six involves maintaining the cleanliness in production workshops. “Enter the air shower room after disinfection, no more than six persons at one time. [The] distance between two workstations should be wider than one meter,” says Luo. “Reduce the number of employees at one production line. Add extra production lines if necessary. Spare no efforts to guarantee production safety.”
The final two steps are more lifestyle changes, according to Luo. Step seven centers on employees keeping a one-meter distance from each other while dining. “Dining out is temporarily prohibited. Keep [a] one-meter distance while queueing (getting in line) and dining. Wash hands before and after dinners,” Luo explains. “[A] disposable tableware policy has also been adopted. We also disinfect tables and chairs after using three times a day. Eat at ease, work at ease.”
Step eight asks for Feelm employees to avoid crowds while commuting. “Walk, ride or drive to work. Try to avoid public transport, if possible,” she says. “If you must, avoid touching anything. Clean phones and keys with wet tissue or medical alcohol often.”
One of the world’s most successful vapor brands, Smok, has set its sights on the OEM/ODM sector as well as the marijuana and cannabidiol industries.
By Timothy S. Donahue
Change is coming. One of the world’s largest vapor hardware manufacturers is expanding into new markets. Shenzhen IVPS Technology Company (Smok) is growing its OEM/ODM division as well as strategically focusing on the the marijuana (specifically THC) and cannabidiol (CBD) markets, according to Luna Wang, general manager of Smok’s ODM and CBD division.
In early 2018, Smok made the OEM/ODM market the emphasis of its new approach toward future growth, says Wang. The company was already cooperating with several major tobacco companies and e-liquid manufacturers, including several CBD and THC oil manufacturers. Smok has long been one of the most successful hardware manufacturers in the vapor industry; however, after watching the rapid growth of the THC and CBD markets, Wang says Smok needed to place a stronger concentration on those industries.
“We have been a force in the vapor industry, and this new focus is very important to the future of Smok,” says Wang. “It can have a very positive effect on further promoting Smok’s product quality and industry recognition.”
ODM stands for original design manufacturing, and OEM refers to original equipment manufacturing. An OEM company designs and builds product according to its own specifications. The company then sells the products to another company or agency, which is responsible for its distribution. An ODM company, however, uses the specifications of another company—its client—when designing and building a product.
Wang says that the decision to move into the CBD and THC markets was easy. After all, Smok was already one of the leading brands of open systems and had a deep understanding of vapor hardware. The company was also responsible for several industry-changing innovations in both tanks and devices.
“We have produced several of the bestselling products in the industry,” says Wang. “Smok has a very broad and deep understanding of the research and development trends. “We are now preparing to open a new factory that will meet current good manufacturing practice [cGMP] standards. It will also be capable of fulfilling high-level production requirements with stringent quality-control [QC] standards in order to satisfy our clients’—both new and existing—needs. We have established this new factory in order to meet the dust-free workshop requirements of cGMP standards, and we can guarantee that we will continue to produce first-class hardware.”
Smok’s new 20,000-square-meter (215,278-square-foot) factory will house approximately 2,000 employees. In its early stages, the factory will work with clients who have similar product and design concepts as the Smok brand, according to Wang. Smok’s new division will produce both open and closed systems that will be able to be used with various mediums. From an R&D perspective, Smok expects to continuously introduce new products that can reach the higher level of standards that comes with years of R&D experience and the history of successful products that Smok has brought to the market.
“We believe that the trend towards future products will be devices that can be used for both nicotine salts as well as CBD/THC oils,” says Wang. “There will be various open and closed systems because our clients all have different needs and expectations. Smok has already produced products for the CBD/THC market that have found significant success. We expect to build on that trend.”
Founded in 2010, Smok started out producing 510 stick batteries, 510 atomizers, cartridges, cartomizers, and other primitive e-cigarettes and components. In those days, there were countless e-cigarette manufacturers making cheap products. What started with only seven employees in a 2,600-square-meter building has grown into a power player with about 5,000 employees and 20,000 square meters of combined office/factory space (not including the soon-to-be-finished factory).
Smok found its niche by offering quality products at reasonable prices. The company secured its success by bridging the gap between expensive high-end devices and the borderline-defective inexpensive devices flooding the market. Smok wanted to maintain affordable price points while maintaining a portfolio of high-quality, reliable products.
From the beginning, Smok has been improving upon successful trends. It was among the first to offer longer-lasting batteries, multiple sizes of cartomizers and a variety of LED colors. It was the first to introduce dual-coil cartomizers. As the name suggests, these cartomizers contain two separate heating elements that increase the surface area for better flavor and vapor production while reducing the chance of a burnt flavor. The dual-coil cartomizers were a big factor in Smok’s success.
As the vapor industry has grown, so has Smok. The company offers everything from less expensive versions of popular products to its own new, innovative products. When clearomizers became the rage, for example, Smok not only improved the product and its performance but also reduced production costs through its growing manufacturing skill set. The company then improved upon the basic clearomizer design by offering bottom-coil clearomizers and tanks. Bottom coils are now the industry standard.
Due to the varying characteristics of how CBD/THC oils are vaporized, Smok intends to produce its own as well as ODM products that can help its clients achieve specific desired results under the multitude of mediums used in producing the oils and concentrates. “For example, different marijuana strains have different terpenes. This means that only ODM products can maintain the best and most beneficial taste profiles,” says Wang. “Therefore, our CBD/THC products will be part of Smok’s OEM/ODM business because this is the best way to give our clients the high-quality products that they have come to expect from Smok.”
Several studies have shown that terpenes work with cannabinoids (like THC and CBD) to enter the bloodstream more easily, thereby lowering the blood-to-brain barrier. Terpenes help users feel more or less of a cannabinoid’s effects. Some terpenes can increase the potency of a THC high while others can mitigate it, according to Wikileaf.com. Numerous studies have shown that terpenes play a role in how the THC/CBD users feel. Terpenes can be likened to how hops influence an India pale ale.
Smok also maintains strict control over the quality of its raw materials and has specific standards in the procurement of its raw materials, according to Wang. She says that there must be “very high standards in the QC area throughout the entire production process. This is the only way to reduce a product’s defective rate to a minimum.”
In order to meet its goals, Smok has also hired a new team to help run its enhanced ODM/OEM divisions, including THC and CBD, according to Wang. “We have spent a lot of time and a lot of effort on securing some of the best minds in the industry in order to help our clients meet their various goals of quality and performance in their products,” she says. “The most important part of being a high-end OEM/ODM manufacturer is the quality of the staff that goes into producing the products. We believe we have created the strongest team in order to meet these goals.”
Moving forward, Wang says she expects the THC and CBD markets to explode over the next two years. She hopes that Smok’s products can be an influential factor in that growth and that Smok can achieve the same level of brand awareness as it has in the e-cigarette industry.
“Smok has been manufacturing quality, affordable vapor hardware since the early days of vaping,” says Wang. “The company creates products catering to vapers of every level, from beginners to enthusiasts. It has improved upon popular trends and created several of its own. We expect to carry on that tradition with our much-improved OEM/ODM division, including our service to the THC/CBD industries.”
