Tag: news

The Smoker’s Alternative Receives FDA Warning No. 104
The agency isn’t slowing down. In the U.S. Food and Drug Administration’s (FDA) quest to relieve the market of illegal vapor products, the regulatory agency has issued 104 warning letters since Jan. 1, 2021. The latest recipient is Texas-based The Smoker’s Alternative. The letters were sent today May, 11, and posted the FDA’s website the same day.
The FDA states that The Smoker’s Alternative did “manufacture, sell, and/or distribute to customers in the United States The Smoker’s Alternative Vanilla Custard 60 ml 3mg e-liquid product without a marketing authorization order.” In order to legally sell vaping products, a company must have submitted a premarket tobacco product authorization (PMTA) to the FDA’s Center for Tobacco Products by Sept. 9, 2020.
The FDA often only lists a product or two that a company is selling as illegal. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products. The agency states that it is the responsibility of the company to only sell products with a submitted PMTA. Companies have until Sept. 9, 2021 to sell product unless the agency makes a decision on the PMTA approval or grants an extension.
:Your firm is a registered manufacturer with over 1,800 products listed with FDA,” the FDA letter to The Smoker’s Alternative states. “It is your responsibility to ensure that your tobacco products comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to adequately address this matter may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction.”
Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.
May 11, 2021
Study: New Juul Pods Carry More Consistent Voltage
The latest version of Juul pods are superior to there predecessors, according to new research. Juul Labs began marketing in the European Union “new technology” Juul pods that incorporated a new wick that the company claimed provided “more satisfaction.” The wick system, Juul stated, would deliver more consistent voltage and provide a better experience to users.
Credit: Juul Labs
In new study, published in BMJ, the researchers compared design and materials of construction, electrical characteristics, liquid composition and nicotine and carbonyl emissions of new technology Juul pods to their predecessors. The study concluded that the pods were “consistent with manufacturer’s claims, we found that the new pods incorporated a different wicking material. However, we also found that the new pod design resulted in 50 percent greater nicotine emissions per puff than its predecessor, despite exhibiting unchanged liquid composition, device geometry and heating coil resistance.”
The study also found that when connected to the new technology pods, the Juul power unit delivered a more consistent voltage to the heating coil. This suggests that the new coil-wick system resulted in better surface contact between the liquid and the temperature-regulated heating coil. “Total carbonyl emissions did not differ across pod generations,” the report states. “That nicotine yields can be greatly altered with a simple substitution of wick material underscores the fragility of regulatory approaches that center on product design rather than product performance specifications.”

May 9, 2021
Governor Inks Bill to Regulate Vapor Products in Florida
Florida lawmakers have overwhelmingly passed a bill signed by Governor Ron DeSantis Friday that will create a state regulatory framework for the sale of electronic cigarettes. The bill (SB 1080) will take effect Oct. 1. Among other things, the bill will raise the state’s legal age to vape and smoke tobacco to 21, a threshold already established in federal law.
Credit: Giban
It also would create a state regulatory framework for the sale of vapor products. The bill would ban vaping or smoking tobacco within 1,000 feet of a school and makes it illegal for local communities to create any regulations impacting the “marketing, sale, or delivery of, tobacco products.” It would also require retailers to obtain a “tobacco” permit.
House sponsor Jackie Toledo, R-Tampa, said before the bill passed that it is aimed at preventing minors from using electronic cigarettes. “This bill is necessary to stop youth vaping,” Toledo said.

May 8, 2021
Myst Raises ‘Tens of Thousands’ in New Funding
Myst Labs, a Chinese e-cigarette maker co-founded in 2019 by Chenyue Xing, a chemist who was part of the team at Juul that invented nicotine salts, recently raised “tens of thousands of dollars” from a Series B funding round. The financing was led by its existing investor, IMO Ventures. Thomas Yao, CEO and another co-founder of Myst, is a founding partner of IMO Ventures.
Credit: Myst
The news comes after of one of China’s top tech policy makers that published a set of draft rules that would bring e-cigarettes under the same regulatory scope as traditional tobacco, which means vaping companies will need licenses for production, wholesale and retail operations in the world’s largest manufacturer and exporter of e-cigarettes.
These changes, announced in March, will deal a blow to small producers with poor quality control, leaving the industry with a handful of established and compliant players, Fang Wang, head of marketing at Myst, told TechCrunch.
For one, standardizing production is costly, Wang said. From ceramic coils, to batteries, to fragrance, every component and ingredient of a vape will need to meet stringent requirements. E-cigarette companies will also need to pay tobacco taxes, an important source of tax revenue for the Chinese government.
The other challenge is how to lower nicotine content. Many current products on the market have a relatively high nicotine concentration at 3-5 percent, so if China is in line with the European Union standard of 1.7 percent, many small brands will be forced out of business because they lack the know-how to produce low-nicotine vapes that still satisfy users’ crave, suggested Wang.
“We’ve received a lot of investor interest in the past few months. Before that, professional, institutional investors often avoided e-cigarette companies, but they are showing more willingness now as regulations take shape,” Wang added.
Myst declined to list its other investors but said they include high-profile individuals involved in the e-bike sharing company Lime, Facebook and the bitcoin industry.
Most of Myst’s current sales are from China, where it has opened 600 stores and plans to reach a footprint of 1,000 stores in the next few quarters. Overseas, the startup has a retail footprint in Malaysia, Russia, Canada and the United Kingdom, where it’s selling in over 30 shopping malls and a few hospitals through its distribution partner, Ecigwizard.
The new funding will allow Myst to further expand its sales network and strengthen its research and development. The company prides itself on its product containing 1.7 percent nicotine, which it claims can deliver the effect of a 3 percent counterpart. At her lab, Xing is currently working on e-liquids with “natural tobacco contents” and without organic acids, additives that allow nicotine salts to vaporize and be absorbed.
Myst is still a relatively small player compared to China’s market dominator Relx, which went public in New York earlier this year and submitted a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration to sell in the U.S. But Yao is optimistic about Myst’s future. Vaping, he said, is one of the fastest-growing consumer categories in China. Myst’s recent sales are tripling every three months.
“In other consumer areas, you rarely see a top player commanding 60-70 percent of the market, so there is still a lot of room for the top 10 players to grow,” the CEO said.
May 7, 2021
FDA Issues 103rd PMTA Warning to Custom Vapes
Since Jan. 1, 2021, the U.S. Food and Drug Administration (FDA) has issued a total of 103 warning letters to firms selling or distributing over 904,000 unauthorized vaping products and who did not submit premarket tobacco product applications (PMTAs) by the Sept. 9 deadline.
Credit: Marcus Krauss
In April alone, the regulatory agency issued a total of 24 warning letters to companies that manufacture and sell unauthorized e-liquids, advising them that selling products which lack premarket authorization is illegal and therefore they cannot be sold or distributed in the U.S. While each of these 24 warning letters cites specific products as examples of tobacco products that lack the required premarket authorization, collectively these firms have listed a combined total of more than 154,000 products with the FDA, according to an FDA statement.
The 103rd warning letter was issued on March 6 and posted to the FDA’s website on the same day. The 103rd letter was received Mississippi-based Custom Vapes. The FDA states that the company did “manufacture, sell, and/or distribute to customers in the United States Custom Vapes Amaretto 3MG 3ML 70VG/30PG e-liquid product without a marketing authorization order.” The company is a registered manufacturer with over 2,300 products listed with the regulatory agency.
Unfortunately, the FDA often only lists a product or two that a company is selling as illegal. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products.
Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.
May 7, 2021
PMI Investigated for Smoke-Free ‘Advertisement’

Photo: Arkadiusz Fajer
The Dutch food safety body NVWA is investigating a campaign by Philip Morris International (PMI) to promote smoke free alternatives, reports DutchNews.
PMI has launched a new website for the products and promoted it with a page advert in the Telegraaf at the weekend. In that advert, the company said Dutch smokers have the right to information about smoke-free alternatives.
While not mentioning the products by name, the advertisement does include the company’s brand name. Advertising tobacco products is illegal in the Netherlands.
The NVWA investigation follows complaints by anti-smoking groups. If found to have broken the ban, PMI could be fined up to €450,000 ($546,010).
May 7, 2021
Alabama Medical Marijuana Bill Faces Filibuster
Legislation to authorize medical marijuana in Alabama stalled Tuesday in the state House of Representatives after Republican opponents used a filibuster to at least temporarily delay a vote.
Credit: Sharon McCutcheon
Representatives adjourned shortly before midnight without a vote after nearly 10 hours of debate on the Senate-passed bill. The bill is expected to return to the House floor on Thursday, according to the AP.
The lengthy debate brought impassioned discussion that included lawmakers expressing fervent opposition or how they changed their minds on the issue after the illnesses of family members
The bill would allow people with a qualifying medical condition to purchase marijuana after getting a recommendation from a doctor. More than a dozen conditions, including cancer, a terminal illness, depression, epilepsy, panic disorder and chronic pain would allow a person to qualify. The bill would allow marijuana in forms such as pills, skin patches and creams but not in smoking or vaping products.
May 6, 2021
Group Says South Africa Needs ENDS for Harm Reduction
For years, anti-tobacco lobbyists have summarily and very aggressively painted electronic nicotine-delivery systems (ENDS) with the same brush they use to condemn combustible cigarettes, turning an intentional blind eye to the important role that ENDS play in tobacco harm reduction. According to Asanda Gcoyi, CEO of the Vapour Products Association of South Africa (VPASA), this is in spite of the fact that highly reputable agencies such as the Royal College of Physicians and Public Health England have published evidence that ENDS are 95 percent less harmful than smoking.
“This unscientific one-size-fits-all rhetoric by anti-smoking lobbyists has influenced certain governments around the world to pass legislation restricting the marketing and distribution of [ENDS] under the exact same legislation that applies to normal cigarettes,” Gcoyi said. “In South Africa, with the debate currently open around the impending Control of Tobacco Products and Electronic Nicotine Delivery Systems Bill (2018), we need to ensure that we do not head the same way.”
In an editorial for IOL, Gcoyi states that, besides the damage this myopic approach does to the adult smoker who is trying desperately to find a less harmful alternative (or, at the very least, cut down) by using vaping devices, the broad-brush approach creates highly contradictory misunderstandings around possible underage users. “What our organization aims to do is to bridge the gap between government and the vapor products industry. To this end, we educate and engage the former, set standards for the latter, and collaborate with both,” said Gcoyi.
This collaboration is currently specifically aimed at developing legal regulations that will ensure adult consumers continue to enjoy access to vapour products in order to use them for the purpose for which they were invented: as a harm reduction tool that may ultimately enable them to give up smoking altogether.
“This means ensuring that EVPs are recognised for what they are, and the important role they have to play in terms of adult smokers. However, where we definitely don’t have a difference of opinion with the legislators is when it comes to restricting their access to the youth.”
As a result, while waiting for the Bill to play out, VPASA launched its own youth access prevention campaign in March 2021, to institute self-regulation in the meantime. An important part of the campaign lies in training EVP retailers about the restriction of sales to young people. This also means combating the misinformation being distributed by anti-smoking lobbyists in terms of young users.
“It is alarming enough that anti-smoking lobbyists purposely draw false parallels between combustible cigarettes and vaping products,” said Gcoyi. “But even more concerning is the misinformation around vaping products and youth. It can completely obliterate what organizations such as ours are doing in trying to ensure adult access, while also restricting sales to youth.”
May 6, 2021
Paul Hardman Joins Broughton as Head of Scientific Affairs
Broughton Nicotine Services has appointed Paul Hardman as head of scientific affairs, the latest in a series of senior level appointments, as it continues to expand its services.
The business, which has helps electronic nicotine device companies bring noncombustible products to market, is currently expanding its full-service regulatory consultancy into modern oral nicotine products, heated tobacco products and Cannabidiol products.

A scientist with extensive experience in inhaled product development across pharmaceutical and consumer products, Hardman will have the task of growing the scientific affairs team to enable the business to grow and offer a premium consultancy experience for clients in the industry.
“We’re delighted to have welcomed someone of his caliber into this new role,” said Nveed Chaudhary, chief regulatory officer of Broughton Nicotine Services. “His addition to the Broughton team will strengthen the business further as we look to expand our full-service regulatory consultancy. Paul will take responsibility for delivering product development and optimization activities, drawing on his years of industry leadership and experience.”
Prior to joining Broughton, Hardman was scientific lead with Imperial Brands, where he was responsible for designing the testing strategy for the chemistry of inhaled and oral next-generation nicotine products, from assessing a variety of prototypes at the early stages of development through to characterization of products for submission through the U.S. Premarket Tobacco Product Application process.
He began his career working at a specialist pharmaceutical company where he gained experience of dry powder and metered dose inhaler development, including for the treatment of local lung conditions and systemic absorption. Hardman also has experience leading the quality control department in a multinational pharmaceutical company involved in the production of generic nicotine lozenges.
Paul’s addition to the Broughton team will strengthen the business further as we look to expand our full-service regulatory consultancy.
Nveed Chaudhary, chief regulatory officer, BNS
He began his career working at a specialist pharmaceutical company where he gained experience of dry powder and metered dose inhaler development, including for the treatment of local lung conditions and systemic absorption. Hardman also has experience leading the quality control department in a multinational pharmaceutical company involved in the production of generic nicotine lozenges.
“I am passionate about the opportunity to work with multiple clients and really get to the heart of their products so that Broughton Nicotine Services can best serve these businesses by championing those points in their regulatory submissions,” said Hardman.
“My role will involve growing the team to enable us to deliver a highly effective offering as Broughton moves into new areas, and I am eager to build on the success the business has already achieved.”
May 5, 2021
No Update on When USPS Expects to Publish Vape Rules
The industry is still in flux. Many businesses closed or found more expensive shipping options. Some companies stopped shipping and then started again knowing that it could all end at any minute. As of this writing, however, the United States Postal Service (USPS) has yet to publish its final rule for mailing vaping products.
Credit: Tomasz Zajda
On April 19, the USPS issued guidance for exemptions to the requirements for mailing all vapor products, including cannabis. This was in response to the U.S. Congress placing electronic nicotine-delivery systems (ENDS) under the stringent mailing requirements of the Prevent All Cigarette Trafficking (PACT) Act. That guidance only references that a rule could be published at any time and the ban on mailing vaping products to consumers would take effect immediately after the rule is published.
“A forthcoming final rule will determine whether electronic nicotine-delivery systems (ENDS) may continue to be mailed pursuant to certain statutory exceptions that are currently administered through an application process,” the guidance states. “Until the final rule is issued, ENDS are not subject to the PACT Act …”
Many businesses ended shipping to consumers on or before April 26, a day before the assumed effective date of the USPS rules. The comment period closed March 22 and the USPS stated that it had received “numerous comments” pertaining to its proposed ENDS mailing rules. An e-mail to USPS media relations did not receive a response by this writing.
The USPS is required to use a definition of ENDS so broadly that it can be interpreted to include and inhalable electronic delivery system for any product. These means restrictions also apply to ENDS products such as: “an e-cigarette; an e-hookah; an e-cigar; a vape pen; an advanced refillable personal vaporizer; an electronic pipe; and any component, liquid, part, or accessory of a device described [ENDS], without regard to whether the component, liquid, part, or accessory is sold separately from the device,” according to the law.
Many in the industry think Congress overreacted placing ENDS under the PACT Act requirements. The PACT Act was intended to stop manufacturers from avoiding taxes on combustible tobacco products, not keep them out of the hands of youth. Congress said it amended the PACT Act to protect kids from vaping. There has been no evidence that youth can easily purchase vaping products online.
This USPS says its just following the orders of Congress. It’s also turning out to be more complicated than just ending all vape mail. The USPS was inundated with exemption applications, none of which will be addressed until the final rule is published, according to the USPS.
“Despite our best efforts, in order to ensure thorough and thoughtful consideration of the complex issues and voluminous comments by industry, individual, and governmental stakeholders, the Postal Service is unable to publish a final rule by today’s target date,” said David P. Coleman, a USPS spokesperson, in an email to Marijuana Business Daily, adding that his agency would “finalize the rule as soon as possible” and “mailers should be prepared for implementation upon publication anytime.”
May 5, 2021