Tag: vaping

FDA ‘Public List’ of Products has Critical Flaws
By Bryan Haynes, Troutman Pepper
On February 16, 2021, the Food and Drug Administration (FDA) published the long-awaited “public list” of “deemed” tobacco products that: (1) were on the US market on August 8, 2016, (2) are currently on the US market, and (3) were the subject of a request for marketing authorization submitted to FDA by September 9, 2020.
The stated intent of the “public list” is to advise stakeholders of “deemed” tobacco products that can be legally sold in the United States. However, FDA’s approach to the list leaves critical gaps that, in many cases, fails to apprise stakeholders of unlawfully marketed products and, in other cases, fails to identify products that are lawfully marketed.
The initial version of the list includes cigar, pipe tobacco and waterpipe tobacco products that were the subject of substantial equivalence (SE) or exemption from substantial equivalence (EXSE) applications filed by September 9, 2020. However, the list expressly does not include any submissions for electronic nicotine delivery systems (ENDS), apparently because FDA has not yet completed its intake review of the thousands of Premarket Tobacco Applications (PMTAs) submitted for ENDS products.
This omission is striking, given what appears to be the plethora of ENDS products that are currently on the market and for which no PMTA was submitted by the manufacturer or importer. Although FDA has issued a few warning letters to sellers of these unauthorized products, it appears that these warning letters have only scratched the surface of unauthorized products.
The “public list” is also underinclusive in that it does not contain “deemed” products that are grandfathered from the premarket review process. Under the Family Smoking Prevention and Tobacco Control Act, products sold in the US as of February 15, 2007 (and unchanged since then) are not subject to premarket review. There are thousands of grandfathered deemed products that are not subject to premarket review.
Although FDA has published a separate database of products that have received standalone grandfather determinations, industry stakeholders are rightly concerned that distributors and retailers may conclude a product is not legally marketed if it does not appear on the “public list.” Distributors and retailers would need to separately consult the grandfather database, which is itself underinclusive because there are many grandfathered products that have not received formal FDA determinations.
The “public list” is also underinclusive in that it does not contain “deemed” products that have actually received FDA marketing authorization. For that, stakeholders would need to consult separate databases of products that have received either SE, EXSE or PMTA marketing orders. However, those databases are not current. Indeed, to our knowledge, there are scores of deemed products that obtained FDA marketing authorization months ago, and those products have not been identified in any of FDA’s databases.
The “public list” was ostensibly designed to be a tool for stakeholders to understand products that can, and cannot, be legally marketed in the United States. In order to better advise the public as to which products can legally be sold, FDA will need to expedite the inclusion of ENDS products on the list, as well as consider better ways to advise the public of products that are exempt from premarket review or that have obtained marketing authorization.
The above opinion may not be the same as Vapor Voice or it’s staff. Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
This article first appeared on tobaccolawblog.com.
February 23, 2021
RLX Technology Hires Citigroup Dealmaker as CFO
The China-based vapor company RLX Technology Inc. has hired Lu Chao, Citigroup’s top Asia health-care investment banker, as its chief financial officer, according to people with knowledge of the matter.
Credit: RLX Technology
Lu, a managing director and head of Asia health-care investment banking at Citi, is expected to join the U.S.-listed e-cigarette maker as soon as March, the people said. Lu will help RLX Tech to identify expansion and investment opportunities in the health care industry that could apply its vaping technology, said the people, who asked not to be named as the information is private. He will still be based in Hong Kong, they said, according to an article by Bloomberg.
Lu, a Princeton University graduate, joined Citi in December 2013, according to his LinkedIn profile.
The company, which is known for its RELX-branded devices, raised about $1.4 billion in an initial public offering in the U.S. last month, according to data compiled by Bloomberg. Lu was a lead banker on the deal, the people said, as Citi and China Renaissance Holdings Ltd. arranged the offering.
Shares in RLX Tech have risen more than 75 percent since its January debut, giving the company a market value of about $32.7 billion.
Representatives for Citi and RLX Tech declined to comment.
February 22, 2021
Utah Lawmakers Want Control of Nicotine Limits
The a new bill in the U.S. state of Utah seeks to un-do some vaping restrictions in the state. S.B. 134 would raise the standard of 24 mg/ml to 65 mg/ml if passed. Senator Curtis Bramble, the lawmaker behind the bill, says that the current standard bars 70 to 80 percent of all vape products on the market.
Credit: Tyler Moore
“We’ve done everything prudent to limit access of these products to youth; the question is if these are legal products in the US, should it be by administrative rule that they are prohibited or should it by an affirmative vote of the legislature that we limit the market?” Senator Bramble asked during a senate committee.
Over the last few years, Utah’s state legislature has given the Utah Department of Health (UDH) the power to limit nicotine sales and quantities in Utah. Beginning in 2020, UDH set a standard of 24 mg/mL of nicotine in vaping products sold in the state.
Beyond raising the nicotine standards, the law would also strip UDH of the ability to create these kinds of limits. Opponents to S.B. 134 say the more limits to nicotine the better, no matter where those limits are coming from.
“We have a youth addiction problem with nicotine; we have 30,000 youth in Utah vaping. Why on earth would the legislature want to increase the amount of nicotine?” asked Walter Plumb, the president of Drug Safe Utah, said, according to a story on abc4.com.
The bill has passed in a Senate committee and is waiting for a vote by the full Senate.
February 22, 2021
SnowPlus Teams With Canadian Manufacturer Dvine
SnowPlus has started to re-allocate certain aspects of its production to Canada. The China-based vaping hardware manufacturer confirmed its partnership with Canadian manufacturing company, Dvine Laboratories, in a recent press release.
Credit: SnowPlus
“We are incredibly excited to partner with Dvine Laboratories to have SnowPlus products manufactured in Canada under the stringent standards of quality,” said Brad Jemmett, general manager of SnowPlus Canada “Having a trusted local manufacturing partner will not only improve our supply chain, but also allow SnowPlus to offer premium quality e-Liquids made by Canadians, for Canadian adult vapers.”
The outpost will be located in Lindsay, Ontario. The company states that localization has become an important part of its growth strategy and it no longer needs to rely on one region or producer to be responsible for all of its production needs. An estimated 90 percent of the world’s vaping and e-cigarette devices are designed and manufactured by about 1,000 factories throughout Shenzhen, China, with thousands more companies forming the supply chain throughout Guangdong province.
The move makes SnowPlus the only domestic and international source for vape products and accessories in Canada. “We’re thrilled to have a partner like SnowPlus. Not only are they as committed to quality standards as we are, they share in our values of giving back to the communities we serve,” stated Nick Paparamborda, vp of sales at Dvine Laboratories. “This partnership will create more jobs for Canadians and opportunities for small business owners.”
SnowPlus and Dvine Laboratories have stated that e-liquid for Canadian SnowPlus products will be produced in Canada, as well as filling pods, final assembly and packaging. “This ensures that product output is consistent to our government specifications and testing standards. The result is a Canadian vetted product that can be purchased locally,” the release states.
February 19, 2021
Public Comment Begins for USPS ENDS Mail Rules
Interested parties will have 30 days to comment on the U.S. Postal Service rules for mailing electronic nicotine-delivery systems (ENDS). The USPS posted the rules on Wednesday and they were published in the Federal Register today. Comments must be submitted by March 22. The rules will presumably go into effect on March 27.
Credit:USPS
“The Postal Service proposes to revise Publication 52, Hazardous, Restricted, and Perishable Mail, to incorporate new statutory restrictions on the mailing of electronic nicotine delivery systems,” the listing reads. “Such items would be subject to the same prohibition as cigarettes and smokeless tobacco, subject to many of the same exceptions.”
The Preventing Online Sales of E-Cigarettes to Children Act, which placed ENDS under the PACT Act, was enacted on December 27, 2020 and becomes effective 90 days after enactment (March 27, 2021). The USPO rule states that the agency will only mail ENDS products under narrowly defined circumstances:

Noncontiguous States: intrastate shipments within Alaska or Hawaii;

Business/Regulatory Purposes: shipments transmitted between verified and authorized tobacco industry businesses for business purposes, or between such businesses and federal or state agencies for regulatory purposes;

Certain Individuals: lightweight shipments mailed between adult individuals, limited to 10 per 30-day period;

Consumer Testing: limited shipments of cigarettes sent by verified and authorized manufacturers to adult smokers for consumer testing purposes;

Public Health: limited shipments by federal agencies for public health purposes under similar rules applied to manufacturers conducting consumer testing.
Many business were unsure if B2B mailing would be allowed. The unpublished rules say they will be allowed. According to Azim Chowdhury, a partner at Keller and Heckman, the PACT Act has historically exempted businesses-to-business deliveries from the USPS ban.
Specifically, the USPS ban does not extend to tobacco products mailed only for business purposes between legally operating businesses that have all applicable state and federal government licenses or permits and are engaged in tobacco product manufacturing, distribution, wholesale, export, import, testing, investigation, or research.
“Companies seeking to use USPS for business-to-business deliveries must first submit an application to the USPS Pricing and Classification Service Center and comply with several other shipping, labeling, and delivery requirements,” said Chowdhury.
Email comments, containing the name and address of the commenter, may be sent to: PCFederalRegister@usps.gov, with a subject line of “E-Cigarette Restrictions.” Faxed comments are not accepted.
February 19, 2021
Targeted Blitz Finds Fake Juul Products in South Florida
Juul Labs is seeking out retailers selling illegal counterfeit and compatible Juul pods and devices.
Juul Labs announced today that it recently initiated an enforcement campaign in South Florida to identify retailers trafficking counterfeit and other illicit vapor products. A press release states that the company obtained intelligence on upstream suppliers and took expansive enforcement action to address a growing black market.
“We need to be a responsible and trusted steward of vapor products,” said Adrian Punderson, vice president of Brand Protection at Juul Labs. “As such, it is our obligation to support enforcement against illicit and illegal products as we strive to reset the vapor category and earn a license to operate in society.”
Juul Labs’ Brand Protection Team conducted an investigation of 917 retailers in Miami-Dade County and Broward County [Florida], representing a major urban area that comprises various classes of retailers, including convenience stores and specialty vape shops, the release states. “These South Florida counties also are in close proximity to a U.S. port-of-entry and international-mailing facility — known entry points for the importation of illicit products.”
With the support of a third-party compliance auditor, Juul Labs conducted product surveillance and obtained samples from the retailers. The surveillance identified 30 retail outlets (3.3 percent of all surveilled outlets), as selling illicit counterfeit, diverted or unauthorized Juul-compatible products.
“Unauthorized Juul-compatible products are designed and marketed to be used with authentic Juul products without the company’s authorization. Counterfeit and compatible products violate intellectual-property rights and may raise additional health and safety risks given their untested ingredients and lack of manufacturing and quality controls and unsanitary conditions in which they are produced,” the release states. “Illicit vapor products actively undermine underage-prevention measures given their ease of access.”
Of the 30 outlets in South Florida selling illicit products, 6 outlets sold counterfeit Juul Pods, primarily offered in illegally marketed flavors, while 1 sold counterfeit Juul devices, 10 outlets sold diverted Juul Pods, primarily diverted from Canadian and Russian markets, and 13 outlets sold illegal and unauthorized compatible pods, with the majority of these compatible brands subject to International Trade Commission exclusion orders.
“Insights into these illicit activities will inform broad enforcement actions against these violating retailers, including cease-and-desist letters, training and education, and litigation as needed. But these actions are just a starting point: The Brand Protection Team will collect additional records and information from the violating retailers to identify upstream suppliers and sources of the illicit products,” the release states. “This will result in further enforcement action to disrupt the illicit trade of black market vapor products that are impacting local communities. Juul Labs will deliver these findings to law enforcement authorities and support their efforts to bring legal action.”
February 18, 2021
VPR Brands Enforcing its ‘Auto Draw’ Patent
VPR Brands has started to identify and notify over 50 vapor industry companies that are using its “Auto Draw Technology” that VPR intends to enforce its patent. These companies were prioritized, based on sales volume and popularity, according to a press release.
Credit: VPR
VPR recently filed litigation against three of the companies: Jupiter Research, Cool Clouds Distribution and XL Vape. Additional lawsuits will continue to be filed as necessary to protect the company’s intellectual property (IP) rights, according to the release.
“Having personally been in the vape industry since its infancy for more than 10 years and witnessing the evolution of ecig and vapor technology, it is befitting that our company owns this US utility patent for what has grown to be a multibillion-dollar market,” said Kevin Frija, CEO of VPR Brands. “The inner construction of an e-cigarette is quite simple and fairly standard, and it is obvious as to what our auto draw technology patent covers, and potential infringement is rather clear when you see it.”
The company owns IP for one of the original patents filed for e-cigarette technology, dating back to 2009. It includes “independent claims covering electronic cigarette products containing an electric airflow sensor, including a sensor comprised of a diaphragm microphone. The sensor turns the battery on and off, and covers auto-draw, button-less e-cigarettes, cigalikes, pod devices and vaporizers using an airflow sensor. The technology is covered under electronic cigarette utility patent US 8205622,” the release states.
“The surge of the vaping category for nicotine, cannabis and CBD in the last few years has reached billions of dollars in sales. That has created opportunities for our patented auto-draw technology, which we believe is now preferred by many, if not most consumers,” said Frija. “Infringement can be avoided by simply adding a button to the battery however the preferred option by consumers to simulate smoking is our button-less auto draw technology and we believe this is an opportune time to consider licensing, enforcement or potentially a sale of our intellectual property to one of the larger players in the space. Our Patent could be a huge windfall for the company.”
The company may also seek a buyer for this patent in the future. “In recent years, our patented technology has surged back into popularity making our patent potentially very valuable,” ” said Dan Hoff COO of VPR. “I am happy to see our company and legal team actively litigating to enforce our intellectual property.”
February 18, 2021
Germany to Tax Vapor Based on Amount of Nicotine

Photo: Theerapan Bhumirat | Dreamstime.com
The German government has proposed a new tax for nicotine-containing vapor products, which would be effective in summer 2022.
The new tax is “a response to current market developments.” It would include a tax of €0.02 ($0.02) per mg of nicotine for e-liquids, effective July 1, 2022. Beginning Jan. 1, 2024, the tax would double by the end of 2026.
“This is appropriate for reasons of fair taxation since only nicotine-containing substances in e-cigarettes are to be regarded as substitutes for cigarettes,” the draft of the proposed Tobacco Tax Modernization Act states. Authorities are also justifying the decision based on the “existing risk potential” of vapor products compared to traditional tobacco products.
“They are not harmless consumer products and can cause serious illnesses,” the draft bill states.
Lawmakers expect the new tax to bring in €135 million in 2022 and up to €2.9 billion by 2026.
The German Alliance for Tobacco-free Pleasure (BfTG) says the plan “makes no sense.”
“The tax would make smoking cheaper than vaping and make e-liquids many times more expensive,” BfTG chairman Dustin Dahlmann told ECigIntelligence, warning that it could lead to a flourishing black market and a collapsing legal industry, such as in Italy and Estonia. The BfTG believes taxation should be left at the EU level.
Currently, vapor products are not specially taxed. They are subject to the 19 percent value-added tax, however.
A decision is expected by the end of 2021.
February 18, 2021
Nveed Chaudhary Joins Broughton Nicotine Services

Nveed Chaudhary (Photo: BNS)
Broughton Nicotine Services has appointed Nveed Chaudhary as chief regulatory officer.
This appointment is the latest in a series of high-profile additions to the team at the contract research organization specializing in electronic nicotine delivery systems (ENDS), as it embarks on its next phase of growth.
Having built a leading reputation for advancing a smoke-free future by helping ENDS companies bring non-combustible products to market, the business is now also moving into modern oral nicotine products, heated tobacco products and cannabidiol products.
“We are absolutely delighted to have brought Nveed on-board,” said Paul Moran, CEO of Broughton Nicotine Services. “He is one of a small number of experts in the industry to have developed scientific and regulatory strategies that have delivered the highly sought-after marketing order for both premarket tobacco product application (PMTA) and modified risk tobacco product (MRTP) applications. Nveed’s depth of knowledge and experience will further help Broughton’s clients shape the future of next generation nicotine products.”
Previously head of harm reduction science at Imperial Brands and director of strategic communications at Philip Morris International, Nveed was a core team member of the successful IQOS PMTA and MRTP regulatory submissions and director for the Myblu PMTA submission program. He is a recognized expert in the nicotine sector, author of over 25 peer-reviewed publications and speaker at international lung disease and tobacco harm reduction conferences.
“My career goal has always been to reduce the burden that lung disease has on patients, society and public health,” said Chaudhary. “To combat the harm effects caused by smoking it’s important to offer consumers high quality, rigorously tested and regulated non-combustible products.
“Broughton Nicotine Services act as the bridge between the industry and global regulators. By applying experience and knowledge we partner with manufacturers to help them secure Marketing Orders for safer next generation products.
“It’s clear that the business shares my drive to accelerate the creation of a smoke-free future and I’m excited to be part of the team.”
February 18, 2021
U.S. FDA has Processed PMTAs for 4.8 Million Products
The U.S. Food and Drug Administration (FDA) said it received thousands of premarket tobacco product application (PMTA) submissions covering millions of tobacco products, the majority of which came in very close to the Sept. 9, 2020 deadline. The submissions varied substantially in number of tobacco products contained in each submission, size, format and organization, including paper submissions and even hard drives and CDs, according to a press release.
Mitch Zeller speaking at a TMA annual meeting. Photo: Taco Tuinstra
FDA Center for Tobacco Products (CTP) director Mitch Zeller stated as of mid-January 2021, the agency has completed the Processing step of applications for more than 4.8 million products from over 230 companies. “We have accepted applications for about 84,000 products and refused to accept applications for about 3,100 products submitted through the PMTA pathway,” wrote Zeller. “As of mid-January 2021, of the applications submitted by Sept. 9, we have filed applications for about 29,000 products and refused to file applications for about 1,650 products submitted through the PMTA pathway.”
He also stated that several factors have slowed the agency’s progress in getting application’s into the system. Companies submitted PMTAs differently, for example some applicants provided information on one product per submission while other applicants provided information for all of the company’s products within one submission.
“One firm submitted information on more than 4 million tobacco products within a single submission,” Zeller wrote. “The amount of content in each submission also greatly varied, with some applications including up to 2,000,000 files where each file contains multiple pages of content for FDA to review.” The letter is part of a pledge Zeller made that the agency would keep interested stakeholders updated on the agency’s progress.
FDA is prioritizing enforcement against any ENDS product that continues to be sold and for which the agency did not receive a product application. To date, the FDA has sent warning letters to 30 firms who manufacture and operate websites selling electronic nicotine delivery system (ENDS) products, specifically e-liquids, which lack premarket authorization, according to the letter.
The agency also stated that the likelihood of FDA reviewing all the applications by Sept. 9, 2021 is low. Because of the sheer number of applications, the agency has set aside the products with the greatest market share and will push those products through the process more quickly. “[We will] focus resources on products where scientific review will have the greatest public health impact, based on their market share, while also committing to providing an opportunity for review to all companies,” Zeller wrote. This could prove positive or negative as a quick denial would force the product off the market.
The agency can still not confirm when it would release a list of products that are approved to be on the market. Zeller wrote that the agency continues to work on processing submissions and verifying the dates of initial marketing and current marketing status of products that submitted a timely PMTA.
“We have already verified this information for around 86,000 products received through the PMTA pathway,” he wrote. “Due to the size and volume of the PMTA submissions and the variable quality, format and presentation of these submissions, processing these submissions and verifying this information will take more time.”

February 16, 2021