vaping - Tobacco Reporter

Juul: FDA ‘Overlooked’ Aerosol Data

The U.S. Food and Drug Administration overlooked a key part of Juul’s premarket tobacco product application (PMTA) when the agency ordered Juul Labs’ products off the U.S. market, according to court documents.

In court filings Tuesday, Juul said the agency overlooked more than 6,000 pages of data that the company had submitted to the FDA on the aerosols that users inhale, according to the Wall Street Journal.

Juul also said the agency failed to consider the totality of Juul’s evidence, which the company said established that the public-health benefits of Juul products significantly outweighed the potential risks.

“FDA’s order acknowledged that ‘exposure to carcinogens and other toxicants present in cigarette smoke were greatly reduced with exclusive use’ of Juul products compared with combustible cigarettes,” Juul Labs stated in court documents.

A federal appeals court last week granted Juul Labs a temporary stay of the FDA’s marketing denial order that requires the vaping company to pull its e-cigarettes off the U.S. market.

“The purpose of this administrative stay is to give the court sufficient opportunity to consider petitioner’s forthcoming emergency motion for stay pending court review and should not be construed in any way as a ruling on the merits of that motion,” the court wrote.

The FDA has until July 7 to respond to Juul’s motion and Juul Labs has until July 12 to reply to the FDA response if submitted.

June 28, 2022

Marketing Approvals for NJOY ‘Daily’ Vapes

The U.S. Food and Drug Administration has approved the premarket tobacco product applications (PMTA) for NJOY’s Daily Rich Tobacco 4.5% and NJOY Daily Extra Rich Tobacco 6%.

“It should be noted that our determination that the marketing of these products is APPH [appropriate for the protection of public health] is based in part on the submitted microbial stability data,” the agency wrote in its marketing granted order (MGO).

The designation does not mean the products are safe and they are not “FDA approved,” the agency said, but the MGOs allows the NJOY to legally market the authorized products in the United States.

While approving NJOY’s Daily Rich Tobacco 4.5% and NJOY Daily Extra Rich Tobacco 6%, the FDA denied authorization for multiple other Daily e-cigarette products. These are presumed for products with nontobacco flavors. Any of those products that remain on the market must be removed or risk FDA enforcement, the agency said. Applications for two menthol-flavored Daily products remain under FDA review.

Additionally, the authorization imposes marketing restrictions on the company to greatly reduce the potential for youth exposure to advertising for these products. The FDA said it will closely monitor how these products are marketed and will act as necessary if the company fails to comply with any applicable statutory or regulatory requirements, or if there is a notable increase in the number of non-smokers—including youth—using these products.

On April 26, the FDA authorized four NJOY Ace products through the PMTA pathway.

June 10, 2022

Marketing Orders for Vuse Vibe and Vuse Ciro

The U.S. Food and Drug Administration on May 12 gave R.J. Reynolds Vapor Co. (RJRVC) permission to continue marketing the original-flavor varieties of its Vuse Vibe and Vuse Ciro products. In October 2021, the FDA authorized the marketing of Vuse Solo original flavor.

“These authorizations represent the broadest portfolio of market authorizations provided to any company in the U.S for premarket tobacco product applications (PMTA),” said David O’Reilly, director of scientific research at RJRVC’s parent company, BAT, in a statement. “Continued focus on science and innovation has supported the robust submissions, which have enabled FDA to evaluate and authorize the marketing of these products.

“We are proud of the work undertaken by the team to achieve this significant regulatory milestone and are confident in the quality of our applications.”

While approving the original-flavor varieties, the FDA denied RJRVC’s applications for the marketing of Vuse-branded products with other flavors. Those flavored vapor products are not currently marketed or sold in the U.S., according to BAT. The company says it is reviewing the FDA’s decision on those applications to determine next steps.

RJRVC’s application to market menthol-flavored Vuse products remains under FDA review and those products can remain on market pending a decision from the agency.

May 12, 2022

Study Shows Vaping Alters Mouth Microbes

Researchers at New York University led by Deepak Saxena and Xin Li conducted a study to compare oral microbiomes of smokers and vapers, according to the National Institutes of Health.

During the study, 27 smokers, 28 e-cigarette users and 29 nonsmokers were examined over six months. All participants had at least mild gum disease at the beginning of the study, and none had their teeth cleaned during the study period.

Researchers compared the types of bacteria found where the gums meet the teeth at the beginning and end of the six-month study. They also compared markers of inflammation and immune cell activity.

The number of unique bacterial species living in and around the gums increased for all participants during the study. This can be a sign of gum disease getting worse.

The specific types of microbes found in the oral microbiomes differed substantially between the three groups. There was a core set of species common among the groups, but each also had unique features. They were so distinct that a machine-learning program could use the oral microbiome to predict which group people were in with 74 percent accuracy.

However, the program was least accurate at picking out e-cigarette users. The patterns of their oral microbes shared characteristics with both smokers and nonsmokers, with slightly more similarities to smokers. Unique traits among e-cigarette users included enrichment with Fusobacterium and Bacteroidales species, both of which are linked to gum disease.

“We are now beginning to understand how e-cigarettes and the chemicals they contain are changing the oral microbiome and disrupting the balance of bacteria,” Saxena says.

March 18, 2022

Imperial Launches Vaping Campaign

Imperial Tobacco Canada has launched a campaign called Let’s Clear the Smoke with the goal of educating Canadian adults on the facts about vapor products and the role these products can play in reducing risks compared to cigarettes, according to BAT.

Let’s Clear the Smoke provides information about the latest in vapor product science and aims to allow Canadian adults to take a more informed view when considering their stance on vaping products and other less risky alternatives to smoking.

This campaign is driven by a combination of mass out of home media placements and digital ads to drive awareness and website traffic. The campaign lasts for 10 weeks and will be the first of a range of initiatives to drive the acceptance of tobacco harm reduction in Canada.

“There is a lack of understanding out there about vapor products, especially when it comes to the positive role they can play in tobacco harm reduction,” said Ralf Wittenberg, president and CEO of Imperial Tobacco Canada. “I think this misunderstanding is due to the fact that the vast majority of people don’t have access to accurate, credible and independent information.

“The purpose of this campaign is to educate Canadian adults on the facts about vapor products by providing access to credible, factual and independent information.”

March 18, 2022

Australia Urged to Include Vaping in Smoking Strategy

Australia is lagging well behind many other countries in the Asia-Pacific region when it comes to successfully tackling smoking through vaping, says the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA).

The CAPHRA’s observation comes as Australia’s Department of Health seeks feedback on its Draft National Smoking Strategy 2022–2030, with public submissions closing on March 24.

“We encourage vapers and supporters of a progressive tobacco harm reduction (THR) approach to have their say. Australians desperate to quit smoking and those keen to stay off deadly cigarettes need all the help they can get,” says Nancy Loucas, executive coordinator of the CAPHRA.

On Oct. 1, 2021, Australia’s Therapeutic Goods Administration expanded its prescription-only model with customs clamping down at the border on personal imports of nicotine vaping liquids from overseas websites.

Not only does Australia’s draft strategy ignore the potential of safer nicotine products, it also lacks ambition, according to Loucas. The strategy aims for a smoking rate of 10 percent or less by 2025 while New Zealand is pursuing a 5 percent smoke-free goal and looks on target to achieve it. “Instead of banning vaping, New Zealand has regulated it, making it tough for minors to access but available to all adults keen to keep off the cancer sticks. New Zealand is seeing its overall smoking rate tumble, yet the Australian government fails to accept that the most effective smoking cessation tool available is staring it in the face,” says Loucas.

“Australia is well down the world rankings when it comes to adopting effective THR policies and is light-years behind the U.S. and U.K. Subsequently, Australia’s overall smoking rate has fallen very little over the past decade, and without reasonable access to vaping, Australia will struggle to even achieve its 10 percent smoking goal,” says Loucas.

March 11, 2022

South Africa Proposes New Vaping Tax

The South African government will propose a new tax on vaping products to take effect in 2023, according to Vaping360.

The move follows the government’s announcement last year that it intended to tax e-liquids.

South African Finance Minister Enoch Godongwana outlined the new tax proposal as part of a package of new and increased excise taxes on tobacco, alcohol and high-sugar products. The vaping tax will appear in the 2022 Taxation Laws Amendment Bill, though it could be changed by Parliament before the bill is finalized. It is expected to be in place by Jan. 1, 2023, according to Godongwana.

The new tax would apply to all e-liquid products, regardless of whether they include nicotine, and it would be “at least” ZAR2.90 ($0.19) per mL, essentially doubling the price of retail e-liquid. The taxation rate is supposed to be equivalent to 40 percent of the most popular brand’s retail price.

South Africa currently has no specific governance on vaping products but is working to regulate the products under its tobacco laws.

February 25, 2022

Study Claims Patches Better Than Vapes

A new study claims that those using e-cigarettes to quit smoking found them to be less helpful than more traditional smoking cessations aids such as patches and gum.

The study, published Monday in the journal BMJ, analyzed the latest 2017 to 2019 data from the Population Assessment of Tobacco and Health (PATH) Study, which follows tobacco use among Americans over time.

“This is the first time we found e-cigarettes to be less popular than FDA-approved pharmaceutical aids, such as medications or the use of patches, gum, or lozenges,” said John Pierce, the director for population sciences at the Moores Cancer Center at the University of California, San Diego, according to CNN.

A three-month randomized trial in the United Kingdom, published in 2019, found e-cigarettes, along with behavioral interventions, did help smokers quit tobacco cigarettes. In guidance published in late 2021, the UK National Institute for Health and Care Excellence decided to recommend that smokers use e-cigarettes to help them quit.

Another recent study, published in JAMA Network Open, found adult smokers with no plans to quit are more likely to stop smoking if they switch to daily vaping, according to new research led by Roswell Park Comprehensive Cancer Center.

The Roswell Park study also used data collected from 2014 to 2019 as part of the PATH study.

February 9, 2022

Broad Support for Philippine Vape Bill

Nine out of 10 smokers in the Philippines support the country’s proposed vaping bill, according to a study, reports the Manila Times. A majority of respondents said the government should enact policies to encourage adult smokers to switch to less harmful alternatives while also ensuring these products are not used by minors.

In 2021, the Senate and House of Representatives approved their respective versions of the measure. The bills must be reconciled by a bicameral conference committee and ratified by the two chambers. If President Rodrigo Duterte then signs the bill into law, the Vaporized Nicotine Products Bill will regulate e-cigarettes, heated-tobacco products and other vaporized nicotine products while ensuring that they contribute to government revenues.

The study was conducted by Acorn Marketing and Research Consultants and commissioned by consumer advocacy group Vapers PH in August 2021. The survey sampled 2,000 legal-age smokers.

January 10, 2022

Tag: vaping