Earlier this year, The Vapor Chef informed its customers of ongoing difficulties with federal regulators. The company has been a stalwart in the e-liquid manufacturing segment.
In a recent update, the business has confirmed that it will no longer be able to continue operations following extensive discussions with the U.S. Food and Drug Administration.
As a result, The Vapor Chef has decided to liquidate its remaining inventory, offering a 50 percent automatic discount on all products on its website. As supplies dwindle, specific flavors will be removed from the online store.
The company has assured customers that any outstanding orders they cannot fulfill will be refunded.
Operations are expected to cease entirely by Sept. 30th, and the website will be taken down on that date or sooner if stock runs out.
Customers are encouraged to take advantage of the discounted sale before the business is closed.
Missouri regulators have raised the allowable limit for vitamin E acetate in regulated marijuana products from 0.2 parts per million to 5 parts per million, sparking concern from stakeholders, including the state’s chapter of the National Organization for the Reform of Marijuana Laws (NORML).
Previous regulations required vitamin E acetate testing for cannabis concentrates and inhalables, but the updated rule applies to concentrates, infused plant material, pre-rolls and vapes, according to media reports.
Vaping industry operators might remember vitamin E acetate as having caused the EVALI (e-cigarette or vaping use-associated lung injury) crisis of 2019-20, when nearly 70 people died and more than 2,500 vape consumers were hospitalized for a mystery lung illness eventually tied to the chemical, which some product manufacturers used as a thickening agent for vape oil.
After medical professionals sounded the alarm in 2019 about patients becoming gravely ill from vaping, it took months before scientists were able to identify the culprit.
According to Kansas City TV station KCTV, the Missouri Department of Health and Senior Services’ rules for licensed marijuana operators took effect March 1 and allow 25 times more vitamin E acetate in finished marijuana products, including vapes.
Missouri NORML Coordinator Dan Viets told KCTV that “there appears to be no rational explanation for why the state of Missouri would dramatically increase the amount of a very toxic substance in legal cannabis products when none of it whatsoever should be present in them.”
The health agency wrote in a letter to state marijuana business license holders that the Missouri Division of Cannabis Regulation “determined the good cause for granting this variance is that it provides accurate standardization of the method reference material for testing licensees, reduces the risks for false failures, and to ensure Vitamin E Acetate is not added to marijuana product.”
Ispire Technology received ISO9001: 2015 Quality Management System, ISO14001: 2015 Environmental Management System and ISO13485: 2016 Quality Management System Medical Device certifications for its 31,000-square-foot manufacturing facility in Malaysia.
Credit: Ispire
Ispire offers a complete line of vape cartridges, pod systems, disposables and batteries.
“Earning three ISO certifications at our Malaysian manufacturing facility is a testament to our team’s ability to quickly bring the facility up to some of the highest standards in the industry, allowing us to expand our gross margins, geopolitically de-risk our production and service other businesses who need manufacturing for their vape hardware,” said Ispire Technology Co-CEO Michael Wang in a statement.
“Currently, our Malaysian manufacturing facility has already received initial orders and is quickly moving into production readiness. As the facility ramps up production, our gross margin is expected to increase due to the lack of a tariff when assembling products in Malaysia and then shipping them to the U.S.
“This is in contrast to the 25 percent tariff incurred when shipping finished products from China. Additionally, by owning the factory, we also expect to be able to realize a profit on product assembly, which was formerly outsourced to a third party. We anticipate that these efficiency improvements will help drive gross-margin growth across the company’s full array of high-quality vaping products.”
The largest vaping company in the world, Smoore, says that it will no longer partner with brands that use flavor names, packaging or product designs that are attractive to youth.
The announcement comes during the U.K. Government’s consultation on e-cigarettes that has a focus on addressing youth vaping currently underway. The consultation closes on Wednesday.
A press release states that Smoore wants to help end the use of flavor names such as cotton candy, gummy bear, watermelon bubblegum, and blueberry popsicle. Additionally, the company would like to see an end to the manufacturing and sales of “stealth products” which are vaping products designed to mimic school supplies, toys, soft drinks or cartoon characters.
Smoore has created a list of flavors that it considers youth-friendly and is also creating a vapor flavor detection squad to monitor the market for new flavors that could be considered as being appealing to youth.
“The vape industry represents the best chance the world has ever seen to eradicate deadly cigarettes and we cannot allow this opportunity to be squandered,” Rex Zhang, Strategy Smoore’s strategy director, said. “Vaping was invented for this very purpose and we need to ensure that it is focussed on the adult smoking market.
“There is absolutely no place for any vaping product to look like a child’s toy, be shaped like a much-loved cartoon character or iconic children’s game or be filled with liquid called ‘gummy bear, cotton candy, strawberry milkshake or starry violet.”
Every company under Smoore’s umbrella has been ordered to undertake a root and branch review to ensure that none of its products or customers on the OEM and ODM side of its business could be seen as producing youth-appealing products.
The list of flavors so far includes:
Skittles
Rainbow
Cotton Candy
Donut
Gummy Bear
Bubblegum
Slushy
Starburst
Pink Pop
Ice Cream
Milkshake
Popsicle
Starry Violet
Reindeer
Snow
Christmas
Fruit Smash
Dr Reptile
Sour Patch
Oreo
Jolly
If the company finds brand owners with products that Smoore deems to be child-friendly, Smoore will work with the company to take immediate corrective action, however, if no action is taken Smoore could ultimately discontinue all cooperation with the brand.
The Smoore release also suggested a “no-fly list” to be used by retail and distribution companies around the globe that list the manufacturers of child-friendly products to prevent their products from being sold.
“We want other companies to follow our lead on this because we have to ensure that we stop young people vaping and we strongly believe that this must happen regardless of what the government ends up doing,” Zhang said. “We cannot squander this opportunity to help secure a smoke-free generation and, in order to do this, we need both the general public and governments on our side.
“It is only by uniting as an industry from beginning to end and making a clear commitment to doing all in our power to tackle youth vaping that we will be able to achieve this. The UK has always been seen as a world-leading example in fair and proportionate regulation of the vape industry and let’s not give them any reason at all to move from that position.”
Smoore is also calling for more standardization of product sizes and shapes. The company believes standardization will help create faster “disassembly at waste treatment sites, helping to increase recycling rates of vapes.”
The company is calling for every batch of disposable vapes and pre-filled pods to be randomly sampled for product compliance with whole batches being rejected if any number of non-compliant products are identified.
Such measures are necessary to motivate the compliant brands and producers while punishing the offenders,” the release states. “A strict, yet open, marketplace will encourage more innovations in the industry to create products that will serve its job even better with every new generation.”
The United Arab Emirates Ministry of Industry and Advanced Technology (MoIAT) has licensed Vaporesso to sell in the country, the company announced in a press release.
After nearly a year of strategic planning and application, Vaporesso received MoIAT certification for over 10 models of its products, including the Luxe XR, XROS 3 Mini, XROS 2, XROS 3, XROS Mini, XROS Nano, Zero S, Luxe X, Luxe QS, OSMALL 2, and GEN PT 60.
“As the first open-system vaping device brand licensed by the MoIAT, we will continue our commitment to providing market-leading vaping products with unmatched quality and functionality,” said Jimmy Hu, vice president of Vaporesso.
The first batch of MoIAT-certified products with compliant packaging has now arrived in the UAE and gone through taxation. This allows distributors, retailers and consumers to legally sell, stock and buy Vaporesso products with assured quality. Meanwhile, all future Vaporesso products will undergo MoIAT registration, ensuring quality and innovation for partners and consumers.
The UAE government has enforced strict regulations to govern all nicotine-containing components used in e-cigarettes, refill packages, e-liquids and tobacco products sold in the country. The regulations demand that manufacturers and companies of vaping devices must meet Emirates Authority for Standardization and Metrology standards, which set out strict quality and safety requirements for e-cigarettes and related products before placing them on the market.
Port of Manila, Philippines. Seaport loading cranes in sunset light. (Credit: Tupon Gato)
The Bureau of Internal Revenue (BIR) in the Philippines said it will require importers of raw materials for vaping products to seek special clearances to release their shipments.
The agency cited the need to impose order on an industry with many emerging players, according to media reports.
“For vape products, we are going to require them to (apply for) the authority to release imported goods for raw materials,” BIR Commissioner Romeo Lumagui, Jr. said. “We are thinking of ways to regulate because there are so many vape products now. The production of vape products is a backyard industry, so we’re thinking of ways to regulate it.”
In its latest revenue memorandum circular, the BIR announced that it is now requiring importers or manufacturers of raw materials and equipment used to make heated tobacco products and vapor products to apply for an authority to release imported goods.
“The raw materials specially used for the manufacture of heated tobacco products and vapor products shall include but are not limited to: propylene glycol, vegetable glycerin, organic sweetener, artificial flavoring, and nicotine,” according to the circular.
Devices used for the manufacture of these products will also include but are not limited to mechanical or electric heating elements/atomizers, circuits, cartridges, reservoirs, pods, tanks, mods, and mouthpieces.
Apart from the authority to release imported goods, importers and manufacturers must also apply for a permit to operate. Lumagui said that the BIR is working on addressing the shortfall from excise tax collections, which is mainly due to illicit tobacco.
“We’re targeting to minimize that 20 percent (shortfall). Within the year, we can cut that by more than half… ultimately, I want to make sure to fully resolve that shortfall,” he said.
The Malaysian Substance Abuse Council (Masac) has recommended that only locally made vape liquids in sealed glass bottles be allowed for sale in the country, reports The Star. Using glass bottles will minimize the risk of undesirable substances being added, according to Masac’s secretary-general Raja Azizan Suhaimi.
A joint study by Masac, the Asian Center for Research on Drug Abuse and Universiti Sains Islam Malaysia found that teenage girls are increasingly using vape liquids laced with psilocybin, a psychoactive compound found in fungi such as “magic mushrooms.”
Raja Azizan suggested that the age limit for vaping should be raised from 18 to 21 to minimize the abuse of vape liquids, which may contain drugs. So far, only 10 manufacturers producing liquid nicotine are registered with the Customs Department, despite the registration deadline ending on April 30, 2023.
Masac also suspects that the three 13-year-old girls who were allegedly gang-raped by four teenagers in Kota Kinabalu on April 26, 2023, may have been given a vape liquid laced with psilocybin. The Malaysian government attempted to regulate the use of vapes among youth in October 2022 through the Tobacco and Smoking Control Bill, but it was referred to a Special Parliamentary Select Committee for refinement.
Prime Minister Datuk Seri Anwar Ibrahim revealed during the revised Budget 2023 in February that vape liquids containing nicotine are still illegally sold in the country with estimated sales of MYR2 billion.
Meanwhile, Health Minister Zaliha Mustafa has stated that the Generational Endgame Bill—a piece of legislation that aims to gradually raise the smoking age until it covers the entire population—will be expedited and retabled.
The major complaint against the proposed U.S. rules for vape manufacturing is that they took too long.
By Maria Verven
The U.S. Food and Drug Administration published a new set of proposed requirements for tobacco and vape product manufacturers in March 2023 with the goal of ensuring product consistency and ostensibly protecting public health. But vape industry experts say the new rules should have come out years ago. And for most vape manufacturers, it’s simply too late.
The FDA held a public hearing on April 12, and stakeholders can still comment on the proposed rule until sometime this fall before the regulatory agency issues the final guidance. In the meantime, Vapor Voice spoke with several industry experts to gather their perspectives.
Minimizing the risks
The proposed requirements apply to all manufacturers of nicotine vaping products and tobacco products designed for consumer use, whether complete and sealed in packaging or simply their parts or components. Applied to the manufacture, design, packing and storage of these products, the rules are designed, among other things, to ensure product consistency and prevent contamination with foreign substances.
“While no tobacco product is safe, this proposed rule is intended to minimize or prevent additional risks associated with these products,” 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.”
Key aspects of the proposal affecting vape manufacturers cover product design and development controls, manufacturing specifications, potential contamination and the traceability of components, ingredients and materials. Any inconsistencies between e-liquid product labeling and the actual nicotine concentrations are also addressed in the proposed rule.
Finally, the rule includes what corrective actions the FDA will take for products that fail to meet these specifications, such as issuing a recall for incorrectly produced products that have already been distributed.
What took so long?
The FDA’s proposed rule was at least 10 years in the making. Sometime in 2012, a group of 13 tobacco manufacturers submitted to the FDA a list of recommendations for good manufacturing practices—a system for ensuring that products are consistently produced and controlled. The following year, the FDA created a public docket to obtain input on the recommended regulations for good manufacturing practices that had been submitted by the tobacco companies.
And in 2017, an expanded group of manufacturers submitted proposals following the FDA’s 2016 Deeming Rule, which brought vaping manufacturers and products under the FDA’s jurisdiction, according to Patricia Kovacevic, general counsel for Cryomass Technologies Inc. A nicotine/cannabis regulatory consultant, Kovacevic has over 20 years’ experience in legal and regulatory affairs.
“Tobacco product manufacturing practices (TPMPs) are not unexpected or new to the industry,” Kovacevic said. “Most reputable manufacturers already have a quality management system in place and design their manufacturing facilities to comply with the general principles of current good manufacturing practices (CGMPs).
“The 2023 proposed rule on TPMPs is consistent with the manner in which the FDA regulates the practices, design and construction of personal hygiene products,” she said. As early as 1969, the FDA established CGMPs for foods as well as dietary supplements, infant formula and the like, added Kovacevic.
This is a positive step in the right direction, both for the industry and the FDA, agreed Azim Chowdhury, a partner with Keller and Heckman LLP. Chowdhury advises domestic and international corporations on regulatory compliance with the FDA, focusing on vapor, nicotine, tobacco product and cannabis/CBD regulation.
“This proposed rule is long overdue,” Chowdhury said. “This proposed rule should have come out years ago following the industry-proposed TPMPs that were submitted back in 2012. The vapor industry in particular has been in dire need of this type of regulation, which can only benefit public health.”
In essence, the principles are not substantially different from other FDA-regulated industries, Kovacevic said, adding that some manufacturers also comply with ISO quality standards, the world’s best-known quality management standards for companies of all types and sizes.
“It’s important to understand that TPMPs do not impose a certain product or manufacturing facility design or even dynamic of reporting,” Kovacevic said. “TPMPs are not prescriptive. They allow great latitude to manufacturers; thus, they should not be a great burden to be implemented.”
As with all CGMPs, the common components are documenting procedures for business operations and outcomes, ensuring that personnel are appropriately trained, work procedures are followed and a document trail is created. This allows manufacturers to design the day-to-day practices for maintaining their equipment and facilities to maximize product quality, cleanliness, consistency and employee safety.
TPMPs and PMTAs
While the general reaction to the FDA’s proposed rule is positive, frustrations remain that the FDA has already banned most vaping manufacturers through the premarket tobacco product application (PMTA) process. Large manufacturers (with 350-plus employees) will be subject to the TPMP rule as soon as it is finalized, according to Chowdhury. Smaller companies have four years after the effective date to meet the requirements.
“However, the question is will the small vape industry even be around in four years?” Chowdhury said. “The way things are going with the PMTA process and FDA enforcement, it seems that only the larger players will survive to see the implementation of this rule.”
“As it became evident from the vast number of PMTAs that were denied or refused to file, small manufacturers and even some of the large ones did not meet FDA’s expectations regarding premarket review of vaping products and are consequently out of business for now,” Kovacevic said.
“The vaping industry has tried in vain for more than a decade to work with the FDA on sensible manufacturing standards only to be ignored while the agency recklessly vilified nicotine vaping,” said Gregory Conley, president of the American Vaping Association. “While the FDA’s proposed requirements are a step in the right direction, the larger issue of the PMTA process disproportionately affecting smaller manufacturers and limiting market diversity must be addressed.”
“The FDA needs to strike a balance between ensuring public health and maintaining a diverse and competitive market,” he said. “Without PMTA reform, there won’t be many companies left to be impacted by this proposed rule. It’s highly likely that vaping product manufacturers that received marketing orders under the PMTA pathway already have rather robust quality systems. So, complying with TPMPs will not represent a meaningful burden to them.
“These regulations do not appear to differ a great deal from what would already be contemplated in a PMTA. But if the FDA’s Center for Tobacco Products does not reform itself, the real-world impact of this rule will be small, as companies with PMTAs will have no issue meeting just about any standard the FDA issues,” he said, adding that he wouldn’t recommend any manufacturer put themselves on the FDA’s radar at this junction.
Kovacevic agreed. “Compliance with TPMPs, when effective, should not require a massive effort for responsible manufacturers, who by now should have a robust quality management system,” she said.
Monica Schick, CEO and regulatory consultant with North Guide Solutions, predicted that the new rules could impact the industry financially. Smaller companies that are holding onto their market share with the rise of illicit products might need to increase their price points to add quality processes and/or testing requirements, according to Schick.
“My concern is are we bringing out the cart when we are sending the horse to slaughter? With illicit products still being marketed and sold and open systems getting continuously MDOed [marketing denial orders from the FDA], what will be left to hitch this cart to?” she asked. “I would like to see this as FDA’s attempt to work with the industry and possibly see some increase in the number of legal products on the market.”
What about foreign manufacturing?
The FDA’s new regulations will also apply to Shenzhen and other foreign-based e-cigarette manufacturers, although just how they will exercise enforcement is in question as the FDA currently doesn’t conduct regular foreign tobacco product manufacturing site inspections.
“Unlike domestic manufacturers, this rule does not require foreign manufacturers to register their establishments, submit a product list or be subject to regular biennial inspections,” Chowdhury said. “However, FDA’s unified agenda of upcoming rulemakings indicates the agency may soon propose another rule that extends the Tobacco Control Act’s registration and product listing requirement to foreign establishments,” he said.
The TPMP rule also highlights the FDA’s existing authority under Section 801(a) of the Federal Food, Drug and Cosmetic Act to refuse the importation of tobacco products that are manufactured, processed or packed under unsanitary conditions, are adulterated or misbranded and/or are forbidden or restricted in sale in the country where they were produced or exported, Chowdhury explained.
Chowdhury said he doesn’t believe the FDA has ever exercised its authority under this provision to deny entry of imported vapor products, such as open-system devices or nontobacco-flavored vapes that are prohibited from domestic sale in China, as this would require the agency to evaluate imported tobacco products not only with respect to the FDA’s own rules but also on the importing country’s applicable laws and regulations. That could prove to be highly inefficient and impractical.
“Furthermore, provisions concerning unsanitary conditions and adulteration/misbranding suggests that the FDA’s overall intent may be to control the quality of tobacco products rather than the specific legal status of tobacco products in their country of manufacture,” he said. “That said, members of Congress, public health groups and even Big Tobacco have been pressuring FDA to find a way to prevent illegal and counterfeit disposable vapor products from continuing to enter the country.
“The TPMP rule could be highlighting that FDA already has the ability to accomplish this.”
Final ruling could take years
A final rule could take at least a year or more. First, the FDA needs to address all the comments from industry stakeholders. And even after that, it’s likely the final rule will be similar if not outright identical to the proposed rule, predicted Kovacevic.
Chowdhury expects that thousands of comments will be submitted over the next six months, which the FDA will need to review carefully before finalizing the rule. “All in all, this rule will likely take at least one [year] to two years to become final. While it won’t directly impact pending PMTAs, companies should be reviewing this rule carefully and bolstering their existing practices to ensure compliance,” he said. “We now know what FDA expects.”
“It is disappointing, but not at all surprising, that the FDA would wait to propose these regulations until it had already committed itself to banning 99.99 percent of the vaping market,” Conley said. “Our recommendations for the FDA include reconsidering the PMTA process, as its current review standards will shutter most legally operating manufacturers.
“We also want the FDA to focus on how to support smaller manufacturers that are committed to producing high-quality, compliant products. The millions of Americans who rely on vaping to stay off cigarettes could benefit from the FDA’s proposal but only if the agency stops thumbing its nose at its critics and starts to regulate the category in good faith.”
The original “Vaping Vamp,” Maria Verven owns Verve Communications Inc., a public relations and marketing firm specializing in the vapor industry.
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.
The Queensland Parliament will hold an inquiry into the health risks, use, and prevalence of e-cigarettes, amid concerns that some vaping products marketed as “nicotine free” contain the addictive chemical.
Queensland laws allow the sale of nicotine-free vaping devices in tobacco shops. E-cigarettes containing nicotine are only available with a prescription, according to The Guardian.
But the state health minister, Yvette D’Ath, said on Sunday that “we know” that some products sold off the shelf in Queensland contain nicotine and other chemicals like nail polish remover.
She offered no evidence of or support for the claim.
The premier, Annastacia Palaszczuk, said the inquiry would examine measures to discourage children from vaping.
“Critically, we need to have greater knowledge about what vaping devices contain,” Palaszczuk said.
The parliament’s Health and Environment Committee will carry out the inquiry.
