Respira Technologies plans to submit an inhaler device to the U.S. Food and Drug Administration by late 2021 for authorization as nicotine-replacement therapy.
The company aims to disrupt a $618 billion market dominated by decades-old gums and patches from pharmaceutical companies as well as tobacco companies’ electronic nicotine-delivery devices with a nebulizer that converts nicotine to an aerosol.
Based in West Hollywood, California, USA, Respira Technologies says that the Covid-19 pandemic has sparked new interest in quitting, and today’s users of vapor devices and e-cigarettes need updated cessation products.
“The reality is we have folks who are addicted to nicotine who never tried combustible products before,” Respira CEO Mario Danek told Bloomberg Technology, referring to tobacco products that are burned like cigarettes and cigars.
“They’re used to sleeker products, and we have that design.”
The health department in the U.S. state of Montana is proposing a permanent ban on the sale of flavored vaping products in response to increasing youth e-cigarette use, the agency said Tuesday.
“This is a serious health issue in Montana that is causing major health consequences for our youth, driving a lifelong addiction to nicotine,” Sheila Hogan, director of the Department of Public Health and Human Services said in a statement.
An estimated 22,500 Montana middle and high school students currently vaping, the health department said in supporting the ban.
“Sadly, most individuals who are currently addicted to nicotine started using these products before the age of 18, and youth are enticed by the flavors,” Todd Harwell, the health department’s Safety Division administrator, said in a statement.
The department has the authority to adopt and enforce rules regarding public health issues. The agency will take public comments on the proposed rule during a virtual hearing on July 16, as well as by mail, fax or email through July 24.
Vaping is a safer alternative to smoking, according to a Hong Kong health advisory group. The Hong Kong Legislative Council (Legco) has suspended all discussions on a proposed ban on vaping products. Legco says the products provide smokers with safer smoke-free alternatives.
Legco’s Bills Committee on Smoking announced it had ceased discussions over the proposed ban on electronic cigarettes, heat-not-burn tobacco products (HTPs) and other electronic nicotine delivery systems on June 2, according to a press release.
The committee ended its work after nine meetings, including three public hearings, since it was established in March 2019 to tackle the bill that aimed to amend the Smoking Ordinance and impose a blanket ban on vaping or the use of e-cigarettes, HTPs and the likes.
Hong Kong’s vaping ban was strongly opposed by some members of the committee who cited scientific studies showing that e-cigarettes, HTPs and the likes have much lower levels of toxicants compared to combustible cigarettes.IQOSER, a heated tobacco concern group in Hong Kong, said the end of discussions on the proposed ban on HTPs could hopefully bring lawmakers’ attention to the more important task of addressing the smoking problem. “Smoking incidence remains at more than 10 percent in Hong Kong, which means a tenth of our population is exposed to the health risks brought about by toxicants found in tar, the by-product of tobacco smoke,” said Joe Lo of IQOSER, which is also a member of the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA).
“As we have been saying all along, nicotine is not the problem, but the smoke, which is responsible for thousands of deaths globally each day. Unlike combustible tobacco, e-cigarettes and HTPs do not involve combustion or burning, because they only heat tobacco to a certain degree that is not harmful to humans,” said Lo.
Nancy Loucas, Executive Coordinator of CAPHRA, noted that Hong Kong, like Japan and Korea, has a high number of former smokers who have switched to reduced-harm products, such as heat-not-burn (HnB) devices.“It was pleasing to see that some of the officials involved in the process to decide the fate of the products strongly opposed the ban based on science that proves that [HnB devices] have a lower level of toxicants compared to cigarettes, whilst addressing the concerns of creating black market in illicit trade in the products,” Loucas said.
In Hong Kong, many heated tobacco users were forced back to combustible tobacco because of the inability to access the product in the past year, according to Loucas. “Others, with the means, have risked being caught buying through illicit channels. Legislators such as Peter Shui, Raymond Chan and Cheng Chunt-tai, have repeatedly argued that a ban was neither logical nor feasible. More importantly, all three pointed out that adult smokers should not be deprived of the right to choose tobacco harm reduction,” she said.
Asa Ace Saligupta, who runs consumer group ENDS Cigarette Smoke Thailand, said the country should follow the lead of Hong Kong in putting to rest the discussions on vaping ban. “Lifting the ban on e-cigarettes, HTPs and the likes will provide Thai smokers representing more than 20 percent of our population an opportunity to switch to reduced-risk alternatives. At present, nearly 40 percent of Thai males are at risk of suffering from illnesses caused by the smoking epidemic,” he said.
Photo Credits: Timothy S. Donahue
Stephanie Thuesen, director of stakeholder engagement at The Progressive Public Health Alliance, said any restrictive policy on e-cigarettes and HTPs will exacerbate the smoking problem as this will discourage smokers from switching to reduced-risk alternatives. “Tobacco harm reduction should be viewed as a progressive health policy by all countries to put an end to the smoking problem,” she said.
Kulthida Maneechote of SmokeFree4Life campaign asked tobacco harm reduction advocates and vapers to unite against bans and restrictive policies imposed by countries based on alleged lies fed by the World Health Organization to deprive smokers of less harmful alternatives.
“Let us challenge the fallacies and unscientific guidelines being spread by the World Health Organization on electronic cigarettes especially with the upcoming WHO Framework Convention of Tobacco Control (WHO FCTC) in November this year [the convention has since been cancelled for 2020]. If left unchallenged, e-cigarettes might be banned by governments altogether. This will put many smokers at risk of not being able to choose a better alternative,” she said.
Australia’s Therapeutic Goods Administration (TGA) on June 10 in an interim decision rejected a request by Philip Morris Australia to adjust nicotine regulations in a manner that would allow the company’s heat-not-burn product (HTP) reach store shelves.
Currently, only combustible tobacco products such as cigarettes and cigars are permitted to be sold in Australia.
Philip Morris (PM) spokesperson Simon Breheny called the decision disappointing. “It puts Australia at odds with many other countries who have decided to regulate heated-tobacco and smoke-free alternatives,” he said.
“The right decision was made,” said Becky Freeman, a researcher from Sydney University’s School of Public Health. “They [HNB products] are not some miracle product that reduces smoking.”
While Breheny noted that PM will not challenge the interim decision, he maintained that a regulatory mechanism is the appropriate way forward. “People who are looking for these alternatives will continue to make the case for why they are important,” he said.
The TGA is scheduled to release its full final decision in August.
Colorado lawmakers introduced a measure Thursday to put a tobacco and vaping tax measure on the November ballot.
The bill — an effort to avoid a costly and difficult campaign to put the measure on the ballot via petition — comes a day before the session was scheduled to conclude. If it clears its first hurdles, lawmakers will need to meet Saturday for a final vote, according to an article in the Denver Post.
It would also create a tax on nicotine products such as on vape products that would be equal to 50% of the manufacturer’s list price until July 1, 2024; 56% until July 1, 2027; and 62% after.
House Bill 1427 calls for smaller increases in taxes than the citizen-led Initiative 292, but it comes with a commitment from the governor and proponents that there will be no more taxes on the products for six years, according to a document obtained by The Denver Post.
The bill calls for asking voters to increase the cigarette tax from 1 cent to 6.5 cents until July 1, 2024; increasing it to 8 cents until July 1, 2027; and then increasing it to 10 cents. It would make the minimum price for a cigarette pack $7 and $70 for a carton until July 1, 2024, and then going up to $7.50 and $75, respectively.
For the first two and a half years of the tax, $450 million would go toward the state’s general fund and after that, the money would toward preschool education.
Vaping with a child in the will be illegal in Louisiana on August 1.
Louisiana law already prohibited drivers and passengers from smoking cigarettes, pipes or cigars if a child’s in the vehicle. A bill by Gretna Rep. Joe Marino, who has no party affiliation, adds vaping to that list.
Gov. John Bel Edwards announced Tuesday that he signed the measure into law. The new prohibition takes effect in August.
The House voted 80-19 for the measure in the regular session that ended June 1, while the Senate agreed 30-0.
A newly enacted Palmdale city ordinance banning the sale of flavored e-cigarette products has vaping advocates fighting back, according to court papers.
The suit, filed by the California Smoke & Vape Association and tobacco retailer Cigs Plus against the city, alleges the law is “overbroad” and will “destroy Palmdale’s nicotine vapor product industry, and damage the livelihoods of the workers that it employs,” according to a story on pe.com.
The Los Angeles federal court complaint, filed Sunday, also contends that the ordinance “will likely precipitate a public health crisis, as vapor products users turn either to combustible cigarettes or to black market sources to obtain vapor tobacco products.”
A message seeking comment from Palmdale’s city attorney was not immediately answered, according to the story.
The law intends to curb tobacco use among youth, and also prohibits the sale of tobacco- and menthol-flavored vaping products, which have “little to no effect on the recent increase of youth tobacco consumption,” the lawsuit alleges.
The ban, approved by the City Council six months ago, is aimed at the fruit- and candy-flavored products popular among high school-aged youth.
The vape association is comprised of wholesalers, manufacturers of nicotine-containing flavored e-liquids, and brick-and-mortar retailers. The suit alleges that Cigs Plus and its employees “now face financial ruin as a result of the ordinance.”
The complaint seeks a court order permanently halting enforcement of the law, and reimbursement of legal fees.
Lawmakers have submitted a bill to Estonia’s Parliament that would stop the collection of excise duty on tobacco e-liquids for two years.
The legislators hope the measure will help to control the border trade and black market.
In the draft explanation, the bill’s authors note that stopping the collection of excise duty will give entrepreneurs an opportunity to cut the price of e-liquids and encourage the sale of legal products.
If passed, the legislation will enter into force on Dec. 1, 2020.
The Canadian Province of Alberta has introduced new legislation on vaping that would include a ban on anyone under 18 from using e-cigarettes.
Health Minister Tyler Shandro says there is mounting evidence on the health risks of vaping and statistics show more young people in Alberta are indulging, according to a story in the Eckville Echo. “Strong action needs to be taken to address significant increases in youth vaping,” Shandro said Tuesday prior to introducing the bill in the house.
Shandro’s ministry says that in the last five years, vaping rates among high school students has risen to 30 per cent from eight. It also says evidence continues to show health risks, including lung damage and nicotine poisoning.
Alberta is the only province without vaping legislation. If the bill passes, there would be restrictions — matching those in place for traditional tobacco products — on displaying and promoting vaping products in stores. Speciality vape stores would be exempt.
The province said it does not intend to ban or restrict flavors for e-cigarettes, but the bill proposes cabinet be allowed to make such restrictions once the law is passed and proclaimed.
The legislation would also expand the list of places where traditional smoking and vaping would be banned — adding playgrounds, sports fields, skateboard and bicycle parks, and public outdoor pools — to further avoid exposing youth to products and second-hand smoke.
The legislation follows a review of vaping that began last year. The government said 250 people were consulted and another 9,500 provided online comments, according to the story.
Lawmakers in the U.S. House asked the U.S. Food and Drug Administration (FDA) to ban Puff Bar. The disposable device is the fastest-growing vapor product on the market and has quickly replaced Juul as the vape of choice among young people, according to a story in The New York Times.
The disposable devices come in more than 20 flavors, among them piña colada, pink lemonade, watermelon and O.M.G. Puff Bar, which launched last year, has been the key beneficiary of an FDA loophole allowing flavors in disposable devices. Based on data used only for tracked channels, which include convenience stores and some other retailers but not online sales or vape shops, Puff Bar sales have consistently been over $3 million a week since April, with volumes now over 300,000 sticks per week.
“Puff Bar is quickly becoming the new Juul,” Rep. Raja Krishnamoorthi, Democrat of Illinois, wrote in a letter to the F.D.A. on Monday. Mr. Krishnamoorthi, the chairman of the House Subcommittee on Economic and Consumer Policy, accused the e-cigarette company of exploiting the coronavirus to sell its products to schoolchildren.
To make his case, the lawmaker included a copy of a Puff Bar advertisement featuring a photograph of a bedroom, with the words: “We know that the inside-vibes have been … quite a challenge. Stay sane with Puff Bar this solo-break. We know you’ll love it. It’s the perfect escape from the back-to-back zoom calls, parental texts and WFH stress.”
Mr. Krishnamoorthi said that “this advertisement is designed to convince children home from school to vape in their rooms without their parents noticing.”
A second advertisement included in the complaint features an attractive young woman wearing a tight T-shirt and spewing big clouds of vapor. The same picture was used in a separate advertisement that suggested vaping a Puff Bar as a way to relax over spring break.
Todd Eric Gallinger, a lawyer who represented a company called Cool Clouds Distribution in a trademark application for the Puff logo, did not return a call seeking comment. The Puff Bar website does not list the names of any of the company’s executives. Indeed, since it began, the provenance of the Los Angeles-based business has been a secret. Its website states: “Who makes Puff Bar? Everyone wants to know the mastermind team behind the latest craze in the world of electronic cigarettes. Where did the Puff Bar team come from and where do they plan to go from here?”
Wherever it is, the company isn’t telling. The only details revealed indicate that the product is made in China and the flavors are developed in Malaysia.
The F.D.A. declined to discuss Puff Bar. Still, in an email, Mitchell Zeller, the director of the agency’s Center for Tobacco Products, wrote that the agency intended to take action against any electronic nicotine product “if it is targeted to youths, if its marketing is likely to promote use by minors, or if the manufacturer fails to take adequate measures to prevent minors’ access, according to the story.
In recent weeks, the agency has blocked the importing of two e-cigarette products from China: EonSmoke, which sold disposable e-cigarettes in a number of flavors before shutting down, and RELX, available in flavors including Drunk in Mexico, Naked in Iceland and Mango
IQOSER, a heated tobacco concern group in Hong Kong, said the end of discussions on the proposed ban on HTPs could hopefully bring lawmakers’ attention to the more important task of addressing the smoking problem. “Smoking incidence remains at more than 10 percent in Hong Kong, which means a tenth of our population is exposed to the health risks brought about by toxicants found in tar, the by-product of tobacco smoke,” said Joe Lo of IQOSER, which is also a member of the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA).
“It was pleasing to see that some of the officials involved in the process to decide the fate of the products strongly opposed the ban based on science that proves that [HnB devices] have a lower level of toxicants compared to cigarettes, whilst addressing the concerns of creating black market in illicit trade in the products,” Loucas said.
