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.
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.
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.
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.”
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.”
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.
The United States Postal Service (USPS) is scheduled to publish in the Federal Register its rules for mailing electronic nicotine-delivery system (ENDS) products tomorrow, Feb. 19. The unpublished rule states “that the prohibition on mailing ENDS will apply immediately ‘on and after’ the date of the final rule.”
Credit: F. Muhammad
However, 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 mail vapor 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.
The USPS rules also state that the listed exceptions cannot feasibly be applied to inbound or outbound international mail, mail to or from the Freely Associated States, or mail presented at overseas Army Post Office (APO), Fleet Post Office (FPO), or Diplomatic Post Office (DPO) locations and destined to addresses in the United States. Because of this inability, all ENDS products “in such mail are nonmailable, without exception.”
In addition to the non-mailing provisions, the PACT Act requires anyone who sells cigarettes or smokeless tobacco to register with the ATF and the tobacco tax administrators of the states into which a shipment is made or in which an advertisement or offer is disseminated, according to Chowdhury. Retailers who ship cigarettes or smokeless tobacco to consumers are further required to label packages as containing tobacco, verify the age and identity of the customer at purchase, use a delivery method (other than USPS) that checks ID and obtains an adult customer signature at delivery, and maintain records of delivery sales for a period of four years after the date of sale, among other things.
Excluded from the statutory definition are products approved by the U.S. Food and Drug Administration (FDA) for sale as “tobacco cessation products or for other therapeutic purposes and marketed and sold solely for such purposes.” The USPO also proposes to treat ENDS as a standalone category, “albeit one generally subject to the same restrictions and exceptions as cigarettes, consistent with the statute.”
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.”
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.”
Update: 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, according to a press release.
More than 15,000 premarket tobacco product applications (PMTA) were submitted to the U.S. Food and Drug Administration (FDA) during fiscal year 2020, according to data provided on the regulatory agency’s website.
In August 2020, the FDA received 10,184 applications and in September 2020 it received 4,567. Prior to August, the FDA had only received 686 applications. The FDA does not distinguish how many of those products are electronic nicotine-delivery system (ENDS) devices.
Of the 15,437 applications turned in during fiscal year 2020 (October 2019 to September 2020), 767 PMTAs were closed, according to FDA data. An application is considered closed after the FDA issues an order letter, a refuse-to-accept letter or the PMTA is withdrawn by the applicant.
Companies that submitted a PMTA by the Sept. 9, 2020 deadline and were previously on the market before Aug. 8, 2016, can remain on the market for up to one year while the FDA reviews the PMTA. The FDA said it will release a list of the deemed new tobacco products that were subject to the Sept. 9 PMTA deadline, however, no date has set for the list’s release.
