The U.S. Food and Drug Administration will hold a public hearing tomorrow, April 12, concerning its proposed guidelines for vaping product manufacturers. When finalizing its rules, the agency weighs the public’s perspective and the perspective of stakeholders like the vapor manufacturing companies that produce the products.
The FDA will also bring together its Tobacco Products Scientific Advisory Committee on May 18 to get the opinions of those independent experts. The proposed rules would apply to all FDA-regulated bulk and finished tobacco products, including cigarettes, cigars, chewing tobacco and e-cigarettes.
When announcing the hearing, the FDA said speaking spots were limited, and the agency could not guarantee that it would be able to accommodate all requests. The agency asked groups and organizations to select a single spokesperson to help the agency hear as many different perspectives as possible.
Registration to provide oral comments closed on March 31, 2023. The oral session will be recorded, and a transcript will be added to the docket of the proposed rule.
Following the removal of nicotine e-liquid or gel from the Poisons Act 1952 to allow for e-cigarettes and vaping products to be taxed in Malaysia, local manufacturers producing e-liquid or gel products containing nicotine must register their manufacturing activities with the Customs Department by April 30, according to the Ministry of Finance (MOF).
“Early registration within this prescribed period may prevent manufacturers from being charged a compound for the offense of late registration. This early registration will ensure comprehensive industry compliance and smooth tax collection by May 2023,” the MOF said in a statement on April 2, according to The Edge Markets.
This follows the imposition of an excise tax of 40 sen ($0.004) cents per milliliter on nicotine e-liquids or gels.
rime Minister and Finance Minister Datuk Seri Anwar Ibrahim announced the government’s plan to impose an excise tax on liquid or gel products containing nicotine when he re-tabled Budget 2023 in February.
The previous government under Datuk Seri Ismail Sabri Yaakob’s administration also proposed to extend tax collection from gel or liquid products containing nicotine for vapes and e-cigarettes in the tabling of Budget 2022 by imposing a tax of RM1.20 per ml. However, the plan was postponed, because nicotine vape liquid was still classified as a Class C poison under the Poisons Act.
The new excise duty, the MOF said, would enable the government to tax the vape industry which is estimated to be worth over RM2 billion ($454 million), and at the same time help discourage the use of vapes.
It will also help improve rules and control of excise duty goods by the customs to avoid leakage of national income, according to media reports.
Registration is open for U.S. Food and Drug Administration’s upcoming public oral hearing on April 12, 2023, from 9:30 am to 5 pm.
The hearing is an opportunity for the public to verbally comment on the agency’s proposed rule “Requirements for Tobacco Product Manufacturing Practice.” The FDA is proposing new requirements for vaping and other tobacco product manufacturers regarding the manufacture, design, packing and storage of their products. Registration also includes a “listen-only” option for those who want to attend the session but do not want to request to speak.
Speaking spots are limited, and the FDA says it cannot guarantee that it will be able to accommodate all requests. Groups and organizations should select a single spokesperson to help the agency hear as many different perspectives as possible. While speaking spots are limited, listening spots are unlimited. Registration to provide oral comments will close on March 31, 2023.
The oral session will be recorded, and a transcript will be added to the docket of the proposed rule.
The U.S. regulatory agency will seek input on the proposed rule from both its advisory committee and the public.
The U.S. Food and Drug Administration is proposing new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of vaping and other tobacco products.
The proposed requirements would help protect public health by, among other things, minimizing or preventing contamination and limiting additional risks by ensuring product consistency, according to an FDA statement.
“While no tobacco product is safe, this proposed rule is intended to minimize or prevent additional risks associated with these products,”
Brian King / Credit: FDA
said Brian King, director of the FDA’s Center for Tobacco Products. “Once finalized, it would establish requirements for tobacco product manufacturers that will help protect public health.”
The proposed new requirements would help manufacturers comply with the Federal Food, Drug, and Cosmetic Act by helping minimize or prevent the manufacture and distribution of tobacco products contaminated with foreign substances—such as metal, glass, and plastics—which have been found in tobacco products. T
The proposed rule would also help address issues related to inconsistencies between e-liquid product labeling and the actual concentrations in e-liquids, “Such variability can be misleading to consumers, potentially intensifying addiction and exposure to toxins,” the agency states.
The proposed rule would also establish several requirements related to the identification, tracing and corrective actions for tobacco products that don’t meet specifications or are contaminated, including for tobacco products that have already been distributed.
In the event of an issue, these requirements would require manufacturers to take corrective actions, which may include conducting a recall.
The proposed requirements apply to manufacturers of finished and bulk vaping and other tobacco products. As laid out in the proposed rule, a finished tobacco product is a tobacco product, including any component or part, sealed in final packaging; for example, an e-cigarette, a pack of cigarettes or a can of moist snuff.
A bulk tobacco product is a tobacco product that isn’t sealed in final packaging, but is otherwise suitable for consumer use.
The proposed rule establishes a framework for manufacturers to adhere to, including:
establishing tobacco product design and development controls;
ensuring that finished and bulk tobacco products are manufactured according to established specifications;
minimizing the manufacture and distribution of tobacco products that don’t meet specifications;
requiring manufacturers to take appropriate measures to prevent contamination of tobacco products;
requiring investigation and identification of products that don’t meet specifications to institute appropriate corrective actions, such as a recall; and
establishing the ability to trace all components or parts, ingredients, additives and materials, as well as each batch of finished or bulk tobacco product, to aid in investigations of those that don’t meet specifications.
The FDA will hold a public oral hearing on April 12 to gather additional comments from stakeholders, including industry, the scientific community, advocacy groups, and the public.
The proposed rule also will be available for public comment for 180 days. The agency will review all comments as part of the rulemaking process for this foundational rule.
“We remain committed to transparency and stakeholder engagement, including providing clarity to industry so that they are equipped to comply with the law,” said King. “We encourage all interested individuals and organizations to participate in the rulemaking process. When the public submits a comment based on sound grounds, that can make an important difference in the agency’s decision-making.”
The FDA will also hold a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) on May 18 to seek recommendations from the agency’s outside panel of experts on the requirements laid out in the proposed rule. As part of the TPSAC meeting, the public will have an opportunity to make oral presentations. The FDA intends to make TPSAC meeting materials available on its website no later than 48 hours before the meeting.
E-Liquid manufacturer Zinwi Bio-Tech is set to unveil its new logo at the Total Products Expo (TPE) in Las Vegas from Feb. 22 – 24. The company will also be highlighting 15 of its most popular e-liquid flavors for TPE attendees to experience.
Zinwi, a global integrated e-liquid solutions provider, upgraded its branding in December to better reflect the company’s dedication to providing high-quality products and the brand’s entry into a new development phase.
“In this new phase, Zinwi will place more emphasis on product research and development, and provide diversified products to meet the needs of global markets,” a Zinwi spokesperson told Vapor Voice. “Zinwi is committed to continuing to explore e-liquid technology, pursue innovation and provide cutting-edge integrated e-liquid solutions.”
Zinwi’s new logo resembles a drop of e-liquid oil, which alludes to the company’s unwavering commitment to product research and development. The Zinwi “Z” and oil design are integrated to symbolize the company’s dedication to continuous product research and development, according to a press release. The light blue color of the logo features Zinwi’s laboratories that conduct its scientific product research and development in the background.
Currently, new nicotine salt and glycerol alternatives are two major topics of research for Zinwi. The company’s product research and development team has produced a new nicotine salt that has distinct advantages compared with the traditional benzoic acid nicotine salt.
“This new innovation brings with it a significant reduction in the number of impurities released. Zinwi is also in the process of researching and developing glycerol alternatives,” the spokesperson said. “The research and development of glycerol alternatives is an effort to reduce the toxins released during atomization and to allow the products to be more environmentally friendly.”
The 15 e-liquid products Zinwi is set to showcase at TPE include five tobacco flavors and 10 non-tobacco flavors. They are Zinwi’s best-selling flavors and have been widely recognized by the company’s global client base. One of the flavors, Caramel Tobacco, has a distinctive caramel flavor along with a mild tobacco accent.
In order to allow the show attendees to experience the different flavors, Zinwi will provide disposable vaping devices pre-filled with the Zinwi e-liquids in the 15 flavor profiles. “Trade show attendees will be able to try out the different flavors in different devices with a variety of settings, enabling them to reach the optimal puff experience,” the spokesperson said.
Concept Photo of Huachengda Precision cotton products (Credit: Huachengda Precision)
Flavor bans are challenging e-liquid and hardware manufacturers to produce adaptive products.
By Ellesmere Zhu, 2Firsts
Since China’s e-cigarette control measures took effect on Oct. 1, 2022, consumers can legally purchase only tobacco-flavored vapes in that country. Meanwhile, on the other side of the globe, several U.S. states and cities have banned flavored e-cigarettes. The European Union passed a ban on flavored heated-tobacco products recently, perhaps signaling what may come for flavored e-cigarettes. The once wide range of flavored electronic nicotine-delivery system (ENDS) products is now rapidly narrowing.
Many industry insiders believe the move to ban flavors could expand globally, pushing tobacco flavors into the mainstream market. The current wave of tobacco flavors are testing the tolerances of both e-liquids and the hardware (vaporizers). Manufacturers are now challenged with producing a flavor that customers are willing to purchase and enjoy in markets where any flavor other than tobacco is outlawed.
Reproducing the taste of traditional tobacco in an e-cigarette is no easy matter. It is one of the major hurdles that many enterprises are working on currently. The key to emulating the flavor and taste of traditional tobacco is the vaporizer (coil), a core component of any e-cigarette product. If a vaporizer manufacturer wants to tackle the flavor challenge, it must focus on hardware and software strength.
Technical Troubles
In the face of the global trend of enforcing tobacco-only flavors, e-cigarette manufacturers are having a difficult time making the transition. Most manufacturers rely on diluted tobacco flavors to help customers who have traditionally preferred fruit flavors through the transition, which results in the homogenization of tobacco-flavored vapes. This has many manufacturers trying to determine what features are necessary for a true tobacco flavor. Complicating the issue, no country regulates which combination of flavors make up a tobacco flavor nor how a tobacco flavor should taste.
A representative from Shenzhen Huachengda Precision Industry Co., a global vaping manufacturer specializing in R&D, says that any juice aiming to achieve a global presence must have several characteristics. High recognition, rich fragrance and superior taste are the key to building memorable experiences for customers while dry burning, burnt core, condensation and exploding juice (spitback) are issues to avoid.
Ceramic wick surface under electron microscope
The vaporizer, meanwhile, should have a stable structure, which can be achieved by proper assembly and material selection. An unstable liquid absorption rate causes dry burning and burnt cores while unstable heating leads to inconsistency of taste.
Currently, the two most popular vaporizer materials on the market are ceramic wick and cotton wick. The current ceramic wick is hard in texture and easy to assemble, but due to technical limitations, its fine and small-size pore textures result in unstable liquid discharge as the juices with a higher viscosity (such as tobacco flavors) cannot flow through smoothly, according to Chen Ping, CEO and chief engineer for Huachengda.
Cottonwick surface under electron microscope
In comparison, the cotton wick is fully permeable and has a larger pore size, which allows the juice to pass smoothly (see Figure 2). However, for all cotton wicks offered on the market today, there is a risk of the wicking being burnt if the temperature on the device is set too high.
“There is a great difference between the characteristics of tobacco-flavored and fruit-flavored e-liquids. If we apply the vaporizer designed for fruit flavor to tobacco flavor, the taste performance and performance of the core is completely different, really an unsatisfactory reproduction of the tobacco flavor,” says Chen. “Taking into consideration the different features between tobacco-flavored and fruit-flavored juice, Huachengda has come up with optimized tobacco flavor through its vaporizers. Ideally, different flavors of juice require different vaporizers, just like one key can only open one lock.”
The Next Generation
After the instability issues are resolved, manufacturers like Huachengda must still find the proper hardware to truly unleash the authentic tobacco flavor in e-liquids. To this end, Chen says his company has invested heavily in R&D. The vaporizer’s structure, materials, formulations and heating element must all be optimized, he explains.
For example, the previous generation of vaporizers were heated by wires, causing overheating, scorching and even burning. However, the heating element comprising a mesh coil can heat the core evenly, thus producing a richer vapor. It has a solid structure that is not easy to burn off, and the flavor can still be maintained at the initial level of quality over long periods of use, according to Chen.
Looking forward on the path of innovation, Huachengda has been developing its new “fiber wick” for which the company applied for a patent in 2021. The manufacturing process of the fiber core is to break the fiber into a pulp and then “stick it together” with a binder to ensure the consistency of the material while improving uniformity, stability and vaporization, according to the company.
However, there is still room for improvement in this technology. When mixed with e-liquid, the fiber wick will absorb the juice and expand gradually. This affects the liquid absorption speed. More performance and material testing are needed before the technology can be applied on a mass scale. As for now, Huachengda has COTTONX, a larger coil that is suitable for disposable e-cigarettes, and its still-in-development fiber wick, a smaller, more compact coil suitable for pod system ENDS products.
“Improving the user experience has always been the focus of the entire industry,” says Chen, adding that a good example is how cotton dividers on the edge of coils were designed to prevent leakage; however, consumers complain of waste because it would absorb some of the liquids. The need to limit wasted e-liquid has spurred further innovation.
The development of the vaporizers differs from that of the microchip, clarifies Chen. “For chips, from 10 nm [nanometers] to 5 nm to 2 nm, the smaller the better,” he says. “But for vaporizers, the development direction is still to be explored. We need to develop and customize the products according to specific laws and regulations and user needs in a decentralized manner. This means that only manufacturers with a large pool of technology reserves and strong R&D can go far in this industry.”
Exterior view of Huachengda, a global professional vaporizer manufacturing base
Philip Morris International’s Indonesian subsidiary, Sampoerna, inaugurated a factory for the production of IQOS HEETS consumables in Karawang, West Java, on Jan. 12, reports The Jakarta Post.
The facility, which started operations in the fourth quarter of 2022, represents an investment of more than $186 million.
The new HEETS factory, which will serve customers in Indonesia and the Asia Pacific region, fits with the government’s policy to encourage investment and increase the export of finished products. Speaking at the inauguration, Coordinating Minister for Economic Affairs Airlangga Hartarto said the investment will encourage innovation and create value in other sectors, such as retail, agriculture and R&D.
According to PMI, the Indonesian plant is the company’s seventh factory for innovative smoke-free products worldwide and its first in Southeast Asia.
During the inauguration, Sampoerna President Director Vassilis Gkatzelis conveyed his appreciation to the Indonesian government for the conducive investment climate, as well as the government’s commitment to maintaining national economic stability.
“As a company that has been operating for almost 110 years, we aim to continue to contribute to the national economy through continuous investment as well as the economic impact on the national tobacco industry supply chain and ecosystem,” he said.
Vassilis also noted PMI’s considerable investment in smoking alternatives. The company, he said, has invested more than $9 billion to develop, scientifically substantiate and commercialize innovative smoke-free tobacco products.
IQOS debuted in Indonesia through limited market testing since 2019 and is available in Jakarta, Surabaya, Denpasar and Bandung, among other cities.
The open-system vaping system manufacturer Vaporesso announced that it has been registered as an authorized e-cigarette brand by the Ministry of Industry and Advanced Technology (MoIAT) of the United Arab Emirates (UAE).
The move makes the subsidiary of Smoore International, the world’s largest vaping manufacturer, the first open-system vaping device brand to obtain the ability to market and sell its e-cigarettes in the UAE.
“We are thrilled by the MoIAT’s decision to grant our flagship products the marketing and sales authorization, this has boosted our confidence in obtaining the approval for other seven premium products, including Luxe X and GEN PT SERIES, that are in the process of application,” said a spokeperson for Vaporesso’s Middle East team.
The UAE has enforced laws that aim to regulate all nicotine-containing components used in e-cigarettes, refill packages, e-liquids, and tobacco products sold in the country.
The regulations demand that the manufacturers and companies of vaping devices must meet Emirates Authority for Standardization & Metrology (ESMA) standards, which set out strict quality and safety requirements for e-cigarettes and related products, before placing them on the market.
“The initial approval by the MoIAT, which allows the company to establish legal sales channels, both online and offline, for Vaporesso’s Xros Nano, Xros Mini, Xros 2, and ZERO S across the UAE, is the testimony to the company’s commitment to offering market-leading vaping products with unmatched quality and functionality, allowing the global vapers to enjoy the fun and flavors unique in Vaporesso’s products,” a press release states. “The market authorization also marks a significant step forward in its effort to further expand its presence in the Middle East.”
Snowplus has obtained a production license from China’s State Tobacco Monopoly Administration, which grants the company a quota to produce 80 million pods annually, according to a press release. The company stated that it will now takes on the “challenge and responsibility to help lead the development of a healthy and sustainable vaping industry.”
While the U.S. government has strict regulations for vaping products, there has been a rise in fake or counterfeits of popular brands in the country, which has led to an increase in incidents relating to poorly manufactured variations, according to Snowplus. This highlights the importance of using a reputable, tested and certified vape product.
For Snowplus Tech, a China-based e-cigarette manufacturer, equipment safety and quality are top priority. Snowplus products are designed in-house, developed by experts in specialist R&D centers, and manufactured in one of the largest, most advanced e-cigarette facilities in the world, according to the release.
Established in Jan 2019, backed by investors such as Zhen fund and Sequoia, Snowplus has more than 60 criteria for testing, ensuring highest standards of safety and quality. With three CNAS certified research laboratories, its safety protocols are recognized and interoperable by 65 institutions in 50 countries, according to the release.
“There is an increasing trend for cheap counterfeit vapes on the market, which we find deeply concerning,” said Derek Li, Snowplus co-founder and head of overseas markets. “That is why we have invested heavily in product research to create products that enhance the vaping experience while ensuring it is as safe as possible.”
Snowplus has invested over $2 million in quality and safety research and to help prevent e-liquid from leaking out of products, it conducts impact tests in variable temperature, humidity and pressure conditions, according to the release. In addition, Snowplus’ batteries pass two tests before assembly to “guarantee that devices can operate in different environments.”
The British Standards Institution has developed a fast-track informal standard, PAS 8855, to address quality, performance and safety issues related to vaping products, reports ECigIntelligence.
The new PAS (publicly available specification), sponsored by Juul Labs, recognizes the progress made in the construction and use of e-cigarettes since PAS 54115 was issued in 2015.
Snowplus has obtained a 
