Category: Regulation

FDA Accepts Halo Market Application
Photo: Nicopure
The U.S. Food and Drug Administration has accepted all Halo products’ premarket tobacco product applications (PMTA) for the substantive scientific review phase.
Just over six months after submission, Nicopure Labs’ PMTAs for Halo Turkish Tobacco E-liquid, Halo Triton II Starter Kit, Halo ZERO Starter Kit and all supporting consumable components have been accepted and advanced to the final phase, substantive scientific review, by the FDA.
Halo’s first round of products was accepted and advanced three days after submission.
“Halo’s more than 12 years of commitment to producing the highest quality vaping products available for adult consumers has been our organization’s mission for more than a decade,” said Jeffrey Stamler, co-founder of Nicopure Labs, in a statement.
“We believe in science, and we believe in transparency; we are honored to continue to work with the FDA, and as always, in the best interest of the industry and the most important thing of them all, our loyal customers.”
Halo FDA accepted premarket tobacco product applications include:
Halo Tribeca Tobacco e-liquid
Halo SubZero Menthol e-liquid
Halo Turkish Tobacco e-liquid
Halo Fusion Unflavored Tobacco e-liquid
Halo Triton II Starter Kit (and supporting consumable components)
Halo ZERO Starter Kit (and supporting consumable components)
March 19, 2021
Vapor Voice Publishes PMTA Tracking Tool
Thousands of vapor companies submitted premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration (FDA) by the Sept. 9, 2020, deadline to keep their products on the U.S. market. But which products exactly are under review and how all those submissions have fared in the process is less clear. A comprehensive list promised by the FDA has yet to materialize.
In the absence of an official database, Tobacco Reporter’s sister publication, Vapor Voice, decided to create its own tracker. As a news outlet, Vapor Voice already receives many press releases relating to PMTA submissions. In addition, its editors continuously monitor corporate websites, social media platforms and other industry sources. Individually, the pieces of information gathered during those endeavors make for interesting news announcements; taken together, they provide a coherent dataset to track PMTAs.
Of course, this approach has its limits. The data is self-reported, and at present, Vapor Voice cannot fully verify the veracity of all claims made in the announcements used to compile the list. The quality of the information that reaches the magazine also varies greatly, from exact counts in all list categories to more general statements on a brand or brand family without further elaboration. As per Vapor Voice’s protocol, these issues are noted in the list.
While the dataset should not be taken as a representative sample, it paints as coherent a picture as possible. Vapor Voice recommends using this tool to gain a directional understanding and as a starting point in a comprehensive due diligence search regarding products.
Check out the Vapor Voice PMTA tracker here.
March 16, 2021
UKVIA Proposes Regulatory Changes
The U.K. Vaping Industry Association (UKVIA) has unveiled a landmark package of recommendations to government aimed at maximizing the public health benefits of vaping and bolstering ambitions for a “Smokefree 2030.” The document, A Blueprint for Better Regulation, urges government to use its post-Brexit independence to become a world leader in harm reduction.
The U.K.’s Tobacco and Related Products Regulations (TRPR) are currently being reviewed, with a crucial consultation due to close on March 19. The resulting decisions made by government are set to shape public health and smoking cessation policy for years to come.
Former Health Minister Norman Lamb, also a former chair of Parliament’s science and technology committee, praised the recommendations.

The TRPR review offers a great opportunity to improve public health across the U.K. by tackling misinformation about vaping.
Former Health Minister Norman Lamb
“I welcome the launch of the UKVIA’s blueprint document responding to the government’s consultation—the TRPR review offers a great opportunity to improve public health across the U.K. by tackling misinformation about vaping.
“It also presents an opportunity for the industry to build on the evidence-based approach, which the government has consistently taken on vaping products, and to support smokers who want to switch to a less harmful product.”
“The current public consultation on TRPR and SPoT is an ideal opportunity to highlight how less harmful products have improved public health,” said former Labour MP Kevin Barron, who is also a former chair of Parliament’s health and social care select committee.
“The current lowest recorded smoking rates have been achieved by numerous avenues, including switching from tobacco to less harmful products. The opportunity to bring in legislation to further encourage the move to products that can satisfy an addiction using products 95 percent less harmful than burning tobacco should not be missed.”
The opportunity to bring in legislation to further encourage the move to products that can satisfy an addiction using products 95 percent less harmful than burning tobacco should not be missed.
Former Labour MP Kevin Barron
Developed by the sector’s leading businesses, the recommendations aim to help adult smokers quit while increasing vaping’s economic contribution and even addressing environmental concerns. The UKVIA blueprint, among other things, calls for:
The use of government-approved, expert health claims on products to encourage smokers to switch
Greater opportunities to engage with smokers, as current restrictions also deter those who may otherwise make the switch
The extension of certain regulations to cover additional vaping products, such as non-nicotine e-liquids, thereby supporting a highly responsible industry
Product size changes that reduce prevalence of single-use plastic
John Dunne
“The recommendations published today are the result of intense collaboration among vaping’s leading experts and entrepreneurs,” said John Dunne, director general of the UKVIA. “This is truly a landmark moment in the history of our industry, which has grown to be a genuine market disrupter and a route out of smoking for people all over the world. With the adoption of these recommendations, the U.K. could take its place as a progressive, global leader on public health.
“The government has claimed that post-Brexit regulatory independence will mean a new, and better, way of doing things. Now is the time for this pledge to become a reality. By embracing this evidence-based approach, we can empower consumers, revitalize businesses and put the ‘Smokefree 2030’ ambition within our grasp.”
March 15, 2021
More Liquid Makers Receive Warnings

Photo: Eugene Onischenko | Dreamstime.com
On March 12, the U.S. FDA sent warning letters to 13 firms that manufacture and sell unauthorized e-liquids. The regulatory agency advised the companies that selling products lacking a premarket authorization is illegal, and therefore, the products cannot be sold or distributed in the U.S.
According to the FDA, the firms did not submit a premarket tobacco product application (PMTA) by the Sept. 9, 2020, deadline. The recipients of the warning letters are VapinUSA, Vapor Springs, Vapor Cigs, Vegas Vapor Emporium, Vape 911, The Philosopher’s Stone, The Clean Vape, Tooters Vape Shop, Cloudchasor, Boardwalk Elixir, Dieselbycg-Hometown Vape Lounge, Blue Lab Vapors and Revolution Vapor.
“While each warning letter issued today cites specific products as examples, collectively these companies have listed a combined total of more than 75,000 products with the FDA,” the agency wrote in its statement.
Following an initial set of such warning letters announced earlier this year, the FDA has continued to issue additional warning letters for products that failed to submit a PMTA.
Per a court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016—including e-liquids—were required to be submitted to the FDA by Sept. 9, 2020. For companies that submitted applications by that deadline, the FDA generally intends to continue to defer enforcement for up to one year pending FDA review, unless there is a negative action taken by the FDA on the application.
March 15, 2021
FDA Asked to Help Correct Misperceptions

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The Altria Group has asked the U.S. Food and Drug Administration (FDA) for help in convincing Americans that nicotine isn’t linked to cancer. In a letter to the regulatory agency, the maker of IQOS and Juul products asked for the FDA to assist in combatting misperceptions about nicotine as part of a proposed $100 million advertising campaign to reduce the harm caused by tobacco.
According to a letter seen by Bloomberg, Altria writes that nearly three-fourths of U.S. adults incorrectly believe nicotine causes cancer, citing government research. Clearing up the drug’s health risks will be key to the agency reducing smoking combustible cigarettes because it will help convince cigarette users to switch to noncombustible options for nicotine, the company said.
While there are at least 60 carcinogens in cigarette smoke, nicotine isn’t the direct cause of many of smoking’s ills. The drug has even been touted as a way to ease tension and sharpen the mind. But nicotine is the ingredient that addicts people to tobacco products, and it has risks, according to the National Institute on Drug Abuse.
The FDA “should commit resources and expertise to correct the deeply entrenched public misperceptions regarding the health risks of nicotine,” Paige Magness, Altria’s senior vice president of regulatory affairs, said in the letter dated Feb. 25. Such a campaign would help the agency by getting more smokers to use noncombustible offerings that “may present lower health risk,” according to the letter.
The FDA declined to comment, according to Bloomberg.
March 5, 2021
Alarm About Proposed Open System Ban

Photo: Olgacanals | Dreamstime
Millions of vapers could feel forced to return to smoking if national governments adopt a proposal from the World Health Organization (WHO) on e-cigarettes, warns the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA)
A new report published by the WHO’s tobacco regulatory committee recommends nearly all vapes—especially “open systems”—be banned. It also demands existing restrictions on cigarettes be applied to emerging products, presumably so smokers won’t learn about them.
In the open system, which is the preferred way of vaping for many people across Asia, the consumer manually refills the liquid to be vaporized. According to the WHO, this system allows for the addition of substances that could make the product more harmful.
“The latest recommendation from WHO defies all logic,” said Nancy Loucas, the executive coordinator of CAPHRA, in a statement. “If countries adopt the recommendation to ban open system vapes, years of hard work by ex-smokers as well as good public policy will be rendered meaningless.”
“Let there be no doubt: Vapers will then go back to cigarettes, which is the worst possible outcome.”
“Banning any product is not the answer nor is applying blanket cigarette rules to all emerging products. Bans encourage the black market. Bans do not allow for proper consumer protection,” Loucas said.
CAPHRA is calling on governments to adopt evidence-based, common sense regulations for all vaping products.
“Just last week, the U.K.’s leading health agency, Public Health England (PHE), concluded that nicotine vaping products were the most popular aid used by smokers trying to quit,” Loucas said.
“On the one hand, you have a local public health agency looking into the evidence and ways in which smokers can be encouraged to quit smoking and vape, and on the other, you have a global agency stuck in their old ways of believing prohibition is the answer to everything.”
“WHO’s attitude to e-cigarettes has been devastating for millions and millions of smokers and vapers alike all around the world,” Loucas said.
CAPHRA said it’s only through regulating products that vapers can remain protected, encouraged to stop smoking and, as a result, achieve good public health outcomes.
March 5, 2021
Chinese Lawmaker Calls for Smoking Ban

Photo: Tobacco Reporter archive
A Chinese lawmaker has called for a nationwide ban on smoking in indoor public places.
The proposal was brought by Chen Jingyu, a cardiothoracic surgery expert and deputy at the 13th National People’s Congress.
As of February, 20 cities had adopted regional laws to restrict indoor smoking in public venues, but that is not adequate for China to achieve its Healthy China Action Plan, Chen told The Global Times. The Healthy China Action Plan aims for more than 80 percent of China’s population to be covered by smoke-free protections by 2030.
Currently, there are more than 300 million smokers in China, and more than 1 million people die of smoking-related diseases annually, according to Xinhua News Agency.
Allowing special smoking areas in indoor public places, such as restaurants, entertainment venues and airport terminals, violates the WHO’s Framework Convention on Tobacco Control (FCTC), Chen noted. Scientific research shows that there is no safe level of exposure to tobacco smoke, and the only way to effectively prevent nonsmokers from suffering from secondhand smoke is to completely ban smoking in indoor environments.
The FCTC requires all indoor public places, public transport facilities and indoor workplaces to be smoke-free.
China signed the FCTC in 2003, ratified it in 2005, and the treaty came into legal force in China in 2006.
In a survey conducted by the China Association for Smoking Control, 91.9 percent of respondents expressed support for a smoking ban.
March 4, 2021
Relaunched Puff Bar Under Scrutiny

Photo: Tobacco Reporter archive
The U.S. Food and Drug Administration (FDA) is investigating Puff Bar’s redesigned fruit-flavored disposable vaporizers, reports The Hill.
In early 2020, the Trump administration banned fruity flavored e-cigarettes in reusable devices like Juul, the blockbuster brand that helped trigger the teen vaping craze in the U.S. Under that policy, only menthol and tobacco flavors were allowed for those devices. But the flavor ban did not apply to disposable vaping products like Puff Bar, which is offered in more than 20 flavors, including pina colada and pink lemonade.
Following the ban, Puff Bar quickly emerged as the vape of choice among young people.
In mid-2020, the FDA told Puff Bar to stop selling its fruity vaporizers as part of a broader crackdown on underage vaping. In a letter to Puff Bar, the FDA’s Center for Tobacco Products said Puff Bar products hadn’t been authorized for sale by the agency and that the company had made unauthorized claims on its website that its vaporizers were less harmful than traditional cigarettes. In July 2020, Puff Bar announced that it would cease all online sales and distribution in the U.S. until further notice.
However, the brand resumed sales on its website last month with a changed product. To get around the ban, Puff Bar is now using tobacco-free nicotine, according to The Wall Street Journal.
The FDA said it was aware of Puff Bar’s move but would not say whether the agency’s ban was still applicable, citing the ongoing investigation.
Puff Bar has fallen to No. 3 in the disposable category this year, after Bidi Stick and Blu, according to Nielsen data.
It’s unclear who owns Puff Bar. Previous owners include Cool Clouds Distribution in California and DS Technology Licensing in China.
March 3, 2021
Researcher Urges Vapor Regulation

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Health researchers have called on the South African government to revive legislation intended to regulate e-cigarettes, saying the products don’t help people quit smoking as advertised, reports Business Day.
The Control of Tobacco Products and Electronic Delivery Systems Bill was released for public comment in 2018, but the legislation has yet to be submitted to Parliament. As a result, e-cigarettes and other nicotine-delivery devices remain unregulated in South Africa.
Presenting recent research on e-cigarette use in South Africa, Lekan Ayo-Yusuf, director of the Africa Centre for Tobacco Industry Monitoring and Policy Research at the Sefako Makgatho Health Sciences University, said that more than 95 percent of e-cigarette users continued to smoke and few of them managed to stop smoking for more than six months.
Compared to people who had never used e-cigarettes, the likelihood of kicking the smoking habit for six months to 12 months was 77 percent lower among regular e-cigarette users.
“While the tobacco and e-cigarette industry likes to position e-cigarettes as cessation aids, the limited effectiveness of these products for long-term quitting, the health harms associated with usage and the industry’s clear and targeted marketing to youth are facts which are conveniently omitted from their narrative,” said Ayo-Yusuf.
According to one of the prevalence studies, 2.71 percent of adults, or 1.09-million people, used e-cigarettes daily or occasionally during 2018. Almost all these people (97.5 percent) were regularly smoking cigarettes as well. A separate study found vape shops were clustered in the wealthier parts of urban centers, and two-thirds were within a 20 km radius of a university or college campus.
E-cigarettes have been available in South Africa for more than 10 years but remain untaxed. Recently, the treasury department said it plans to release a discussion paper on tax proposals for electronic nicotine devices.
The recent research has not been published in a peer-reviewed journal.
March 2, 2021
FDA Sends Fresh Round of Warning Letters

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The U.S. Food and Drug Administration issued warning letters to 18 manufacturers selling unauthorized e-liquids. The companies did not submit premarket tobacco product applications (PMTAs) by the Sept. 9, 2020, deadline.
The companies that received warning letters include Square Vape Labs, The Vapor Emporium, Tally Ho Vapor Tonic, The Vape Corner., Dripco d/b/a Dripco Vape Co., VaporIce, Vapor Maven E-Juice, Vapor City Plus, Vapor Invasion, Vaporatory, Chuckin’ Clouds Vape Shop, Black Dog Reserve, California Vaping Company, The Chubby Baker, Smooth, Bulldog Vapor, Adore eLiquid and E-Cig Outlet.
While each warning letter issued cites specific products as examples, collectively these companies have listed a combined total of more than 234,000 products with the FDA.
Per a court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016—including e-liquids—were required to be submitted to the FDA by Sept. 9, 2020. For companies that submitted applications by that deadline, the FDA generally intends to continue to defer enforcement for up to one year pending review unless there is a negative action taken by the FDA on the application.
The FDA recently published an update on its progress on the processing and review of the applications received by Sept. 9, including a list of companies that submitted timely applications.
March 1, 2021