Category: Global Regulation

FDA Hands Court PMTA Status Report
Photo: Tobacco Reporter Archive

The U.S. Food and Drug Administration has submitted a status report for products that currently have a premarket tobacco product application (PMTA) under review. The regulatory agency states that it expects to have resolved 63 percent of the applications set out in its original priority by June 30, 2022, and 72 percent of the applications in its original priority set by the end of this year.
“The FDA’s progress largely reflects the review priorities that the agency established in 2020, when review began. Given the large influx of concurrent applications, the FDA prioritized review of applications from manufacturers with the greatest market share at the time because decisions on those applications were expected to have the greatest impact on public health,” the report states. “As a result, the FDA allocated significant resources to review applications from the five companies whose brands represented over 95 percent of the e-cigarette market at that time: Fontem (blu), Juul, Logic, Njoy and R.J. Reynolds (Vuse).”
In the order requiring the FDA to submit status reports, the Maryland court stated that covered applications are limited to applications for products that are sold under the brand names Juul, Vuse, Njoy, Logic, blu, SMOK, Suorin or Puff Bar. Additionally, any product with a reach of 2 percent or more of total “Retail Dollar Sales” in Nielsen’s Total E-Cig Market & Players or Disposable E-Cig Market & Players reports.
To determine which applications are for products sold under the listed brand names, the FDA used its internal PMTA database, which organizes applications by manufacturer, according to the agency. The FDA searched its database for the brand names to identify the manufacturers related to each relevant brand name and then searched its database to identify applications submitted by the manufacturers.
The FDA stated that it had conferred with the plaintiffs in the case who agreed that only one brand beyond those listed meets the 2 percent threshold. That brand was not identified. Of those applications the FDA deems requiring status reports, the agency stated that it had identified 240 covered applications. The agency estimates that, based on current information, the FDA will take action on:
51 percent of covered applications by June 30, 2022;
52 percent of covered applications by Sept. 30, 2022;
56 percent of covered applications by Dec. 31, 2022;
56 percent of covered applications by March 31, 2023; and
100 percent of covered applications by June 30, 2023.
The agency also states that not every covered application has an equal potential impact on the public health. For example, more than 25 percent of the covered applications are for products not currently on the market.
The FDA identified two applications for products sold under the relevant brand names where the applicant stated that the products were not on the market as of Aug. 8, 2016. The FDA also identified three other applications for products sold under the relevant brand names where the applicant did not state whether the products were on the market as of Aug. 8, 2016. The FDA has not included information about these five applications in the current status report.
“Also, some e-cigarette devices consist of a small number of components, resulting in a small number of individual product applications for the entire system. A disposable prefilled device, for example, could constitute a single product with one application. Other e- cigarette devices, by contrast, consist of many components with separate tanks, coils, tubes and pods, resulting in dozens of separate product applications for a single system,” the status report states. “Of the covered applications that the FDA anticipates will remain to be resolved beyond the end of 2022, more than half are for components of a limited number of e-cigarette device systems representing under 2.5 percent of the e-cigarette market. The FDA has made and will continue to make significant progress in reviewing and resolving applications for e-cigarette products to achieve the greatest impact on public health.”
The agency stated that it will file another status report by July 29, 2022, that will include any revisions to the estimates disclosed in the first report.
May 17, 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
PMTA Deadline Approaching

Courtesy: US FDA

Manufacturers of nontobacco nicotine (NTN) products on the market as of April 14, 2022, that wish to continue to market their products are required to submit a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration by May 14, 2022.
The May 14 deadline is only for applicants submitting electronically, as required by the FDA. Applicants can, however, request a waiver from the FDA to submit a PMTA in a different format. An application submitted in hard copy must be received by the FDA no later than 4 p.m. Eastern Daylight Time on Friday, May 13.
The FDA received from the U.S. District Court of Maryland a 14-day extension to file the first PMTA status reports required by the court’s revised remedial order on April 29.
“The extension request is supported by good cause. Compiling the information needed for the status report has required considerable time and effort, and defendants have been working with plaintiffs to resolve any ambiguities about which applications will be covered in the status report,” the motion states.
The new law additionally provides that an NTN product with a tobacco-derived “previous version” that received a negative action on a PMTA from the FDA, such as a refuse-to-file or marketing denial order, may not continue to be marketed after May 14, 2022, without receiving a marketing granted order from the FDA.
Such products must be removed from the market, even if a new PMTA is submitted, until the marketing granted order is received, according to the agency. Products on the market after July 13, 2022, without an FDA marketing granted order are in violation of section 910 of the Food, Drug and Cosmetic Act and may be subject to FDA enforcement.
For products not on the market on April 14, 2022, a PMTA must be submitted to the FDA and marketing authorization must be received before the product can be sold in the United States.

May 12, 2022
Finland Tightens Tobacco Laws

Photo: sezerozger

On May 1, 2022, a revised Tobacco Act took effect in Finland as part of a long-term strategy to eliminate smoking, according to reports by YLE News and Business Standard.
Smoking at playgrounds and on public beaches is now banned. The beach ban is in effect annually from the beginning of May to the end of September.
The ban aims to protect youth from secondhand smoke as well as reduce littering and environmental damage related to smoking.
Tobacco flavoring products including flavor cards are also banned under the revised legislation. Characterizing flavors such as menthol or strawberry in cigarettes were illegal already. The new rules are targeted at products that enable consumers to flavor their unflavored tobacco products.
Products already in stores and warehouses have until the end of April 2023 to be sold.
By May 2023, stricter regulations on product packaging will go into effect. Brand images will no longer be allowed on packaging, with the goal of reducing the appeal of tobacco products.
Finland has been gradually restricting public smoking since 1976, starting with bans on public transport and later extending to all public indoor areas.

May 3, 2022
FDA Gets Until May 16 to File PMTA Reports

Courtesy: US FDA

UPDATE: The order has been granted. First reports are due May 16.

The U.S. Food and Drug Administration is asking the U.S. District Court of Maryland for a 14-day extension to file the first status report required by the Court’s revised remedial order.

The plaintiffs in the case consent to the requested extension, according to the motion filed today.

“The extension request is supported by good cause. Compiling the information needed for the status report has required considerable time and effort, and Defendants have been working with
Plaintiffs to resolve any ambiguities about which applications will be covered in the status report,” the motion states. “Also, a number of FDA employees helping to prepare the status report were out of the office on pre-planned leave last week, and a key FDA employee responsible for the status report will be out of the country on pre-planned leave next week.

“Defendants do not seek to modify any other deadline, and the FDA’s second status report would remain due July 28, 2022. Defendants are prepared to have this letter serve as their consent motion for a 14-day extension.”

Judge Grimm is expected to grant the motion’s request. The new deadline for first PMTA status reports would be May 16 if motion is granted.

April 29, 2022
Smoore Flattered by FDA Marketing Orders

Photo: Timothy S. Donahue

When the U.S. Food and Drug Administration authorized the NJOY Ace vaporizer and its tobacco-flavored e-liquid pods on April 26, the Ace became the first e-cigarette authorized by the FDA equipped with a ceramic coil. That coil is manufactured by FEELM, Smoore International’s flagship atomization tech brand.
The Ace marketing orders mark the first approval by the FDA of a pod vaping product. It is also the first approval of any vaping product manufactured by a company that is independent of the tobacco industry.
Smoore products have a good record of securing FDA authorizations. The first brand to receive marketing orders through the premarket tobacco product application (PMTA) pathway, Vuse Solo, is a strategic partner of Smoore, a Smoore representative told Tobacco Reporter’s sister publication, Vapor Voice. The second set of approved electronic nicotine-delivery system (ENDS) products, produced by Logic, are also manufactured by Smoore.
“NJOY has partnered with Smoore since 2009. The NJOY Ace was launched in 2018 and is powered by FEELM inside, the world’s first black ceramic atomization coil with metallic film. As the first ceramic coil e-cigarette and pod vape authorized by the FDA, NJOY Ace’s approval for sale fully showcases the harm reduction potential of FEELM ceramic coil,” the representative said.
“According to the FDA, NJOY Ace is authorized for sale because ‘chemical testing was sufficient to determine that overall harmful and potentially harmful constituent (HPHC) levels in the aerosol of these products is lower than in combusted cigarette smoke.’”
Based on PMTA requirements, Smoore established a comprehensive analytical testing and safety assessment system, including the vaping industry’s first corporate toxicology laboratory, which explores the health impacts of exposure to e-cigarette vapor by means of cytotoxicity test, evaluating the reaction of living cells to different components of e-cigarette vapor, according to Smoore.
The company has also developed the third generation of in-house safety standards—Smoore 3.0—that covers all of the PMTA tests, including harmful and potentially harmful constituents (HPHCs) listed by the FDA.
“The principle of PMTA is to scientifically and systematically substantiate harm reduction performance of the vaping product and show it is appropriate for the protection of the public health (APPH),” said Long, director of the Smoore Analytical Testing and Safety Assessment Center. “The manufacturer must demonstrate the product’s potential to switch adult smokers while preventing youth and non-smokers from nicotine addiction.”
Long said this could explain why all the FDA-authorized vaping products so far have been for tobacco flavors, and popular flavored products the agency has said promote youth use have been issued marketing denial orders. It is also an indication that vaping manufacturers should focus on “tobacco flavor reproduction and improve harm reduction performance” in order to be approved under the PMTA pathway.
According to Nielsen, for the two weeks ended April 9, 2022, Vuse has now surpassed Juul and become No.1 in U.S. e-cigarette sales with a market share of 35 percent. Its flagship product Vuse Alto is also equipped with FEELM ceramic coils.
As the No. 3 player in the U.S., NJOY accounts for approximately 3.1 percent market share. Moreover, a federal judge has required the FDA to provide progress reports on PMTAs submitted by major vaping brands and the first reports are due on April 29.
The FDA also found that the risk to youth initiation with NJOY’s Ace was outweighed by the benefit to adult smokers, warning that NJOY must comply with strict post-marketing requirements.

April 27, 2022
Activist: Minister Won’t Stop Legalization

Asa Saligupta
Tobacco harm reduction advocates remain optimistic that Thailand will legalize e-cigarettes, despite vocal opposition from the country’s health minister.
On April 26, Public Health Minister Anutin Charnvirakul said he opposes legalization of vapor products in the country, citing concern about underage consumption and the plight of tobacco farmers.
Asa Saligupta, director of ENDS Cigarette Smoke Thailand (ECST), suggested Charnvirakul was playing politics. “After his abysmal handling of the pandemic, among other things, he could easily lose his seat at Thailand’s upcoming general election. He’s simply panicking but has completely underestimated the wide support for legalizing and regulating vaping,” said Saligupta.
With draft legislation to legalize e-cigarettes currently before a sub-committee, the ECST director remains confident that the vaping bill will be passed by Thailand’s parliament this year.
“The Thai government can and will regulate safer nicotine products regardless of what one minister says,” said Saligupta. “Let’s not forget that Digital Economy and Society Minister Chaiwut Thanakamanusorn, government officials and public health experts have all been key to finally confronting Thailand’s failed tobacco control policies,” he says.
According to Saligupta, Thailand’s harsh ban and penalties on vape imports and sales have failed.
“Smoking continues to kill about 50,000 Thai people each and every year. Too many smokers have been stuck with cigarettes or are forced onto the black market for vapes where there’s no control over the purchase age or product safety standards. An effective public health minister would not accept this dire situation, let alone support it,” he says.
ECST believes it’s no surprise the minister made his anti-vaping statement to ThaiHealth board members. Its senior adviser, Prakit Vathesatogkit, recently received the Dr Lee Jong-wook Memorial Prize by the World Health Organization for his work against tobacco. He has also been a high-profile voice against legalizing vaping.
“ThaiHealth along with some local conservative health voices continue to publicly scaremonger, conveniently ignoring the growing tobacco harm reduction success globally,” said Saligupta. “By joining the minority, Thailand’s Public Health Minister is now among an increasingly isolated crowd who continue to follow the WHO’s discredited anti-vape agenda,” he says.
According to Saligupta, nearly 70 countries have now adopted regulatory frameworks on safer nicotine products despite the WHO position, leading to dramatic declines in their overall smoking rates. The Philippines and Malaysia are also set to legalize vaping.
“Thankfully the Thai government remains on the right side of the debate,” he said. “Regulating will give consumers better protection, encourage more smokes to quit deadly cigarettes, and ensure we have much better control over youth vaping with a strict purchase age,” he says.

April 27, 2022
Thailand Health Minister Says No To Vaping

Photo: kikujungboy

Public Health Minister Anutin Charnvirakul insisted that Thailand’s Public Health Ministry will not support legalizing electronic cigarettes in the country, reports The Bangkok Post.
He made his remark on Monday during a meeting with board members of the Thai Health Promotion Foundation (ThaiHealth) to discuss tobacco control.
Anutin, in his capacity as chairman of the ThaiHealth board, said he has noticed e-cigarettes trending among teenagers, and some of them are aiming to have sales legalized.
To help boost e-cigarette control, Anutin said he has assigned a tobacco control panel under the Department of Disease Control (DDC) to review current regulations to determine whether they should be revised or new rules should be issued.
However, current laws can still suppress the rise of e-cigarettes, he said.
“The DDC has also been instructed to coordinate with police to come up with a solution in preventing e-cigarettes from becoming more popular in the future,” he said.
Surachet Satitniramai, second deputy chairman of ThaiHealth, said that currently, many business operators are attempting to legalize the import of e-cigarettes to the country, which is a topic of concern among members of the committee.
“E-cigarettes will have a widespread effect on tobacco farmers in the country,” he said. “As the materials of e-cigarettes don’t consist of tobacco but chemical, farmers will suffer income loss.”

April 25, 2022
FDA to Provide PMTA Updates Every Three Months

Photo: Niroworld

The U.S. Food and Drug Administration will be required to give premarket tobacco product application (PMTA) status reports every 90 days. The first reports are due on April 29, according to a revised order from District Judge Paul Grimm for the United States District Court for the District of Maryland.
The revised order, signed on April 15, granted a motion filed by American Academy of Pediatrics (AAP) and other plaintiffs that requires the FDA to “forecast the percentages of such products for which it expects to have taken ‘action’ by June 2022 and quarterly thereafter.” Subsequent reports will also be required to state any revisions to prior estimates.
The order states that “covered applications” means all applications for newly deemed tobacco products “sold under the brand names Juul, Vuse, NJoy, Logic, Blu, Smok, Suorin or Puff Bar.” Additionally, any product with a reach of 2 percent of more (vaping product brands deemed to have the greatest public health impact) in “Retail & Sales” in Nielsen’s “Total E-cig Market & Players” or “Disposable E-Cig Market & Players.”
The FDA has approved some products from Vuse and Logic, while denying applications for Blu’s Myblu products.
The decision was expected by the vaping industry. Speaking during Keller and Heckman (K&H) annual E-Vapor and Tobacco Law Symposium Feb. 2–3, K&H Partner Azim Chowdhury said the FDA had appeared to concede to the requested requirement to submit status reports on many of the remaining submissions under review, adding that the updated requirements requested by the anti-vaping groups appeared to be even broader than the original.
It’s been more than eight months since the 12-month continued compliance policy for products subject to timely submitted PMTAs ended, but the agency is still sitting on some 88,000 reviews, including some of the vaping products with the highest market shares as measured by Nielsen.
Requiring the FDA to provide the status reports comes with some controversy. Chowdhury says that it wouldn’t be appropriate for the protection of public health (APPH) or positive for the vaping industry if a requirement for status updates forced the regulatory agency to make PMTA decisions only to appease the anti-vaping groups or politicians.
“These status reports could be used as a tool to pressure FDA to act—i.e., deny— applications quickly,” Chowdhury told Tobacco Reporter’s sister publication Vapor Voice. “Rather, we want FDA to review the science carefully and take the time it needs to determine whether a particular product is APPH.”
In November 2021, the anti-vaping organizations whose lawsuit brought forward the deadline for filing PMTAs asked U.S. District Judge Paul Grimm to reopen the case. The plaintiffs asked him to require the U.S. Food and Drug Administration to regularly report on the status of the applications for the 10 bestselling vapor brands according to Nielsen rankings.

April 17, 2022
China Releases Vapor Product Standards

Photo: Taco Tuinstra

China’s market regulator today unveiled technical standards for e-cigarettes that will go into effect starting Oct. 1.
In a public document, the State Administration for Market Regulation listed the requirements for design, chemical compounds and the mechanics for e-cigarettes that domestic manufacturers must meet in order to sell their products, according to Channel News Asia.
In March, Chinese tobacco authorities issued a finalized version of rules that stipulate other requirements for e-cigarette companies in China.
Most notably, the rules state that e-cigarette companies may only sell their products through authorized channels, and also bar vendors from selling e-cigarette flavors other than tobacco.
The Beijing Business Today revealed that many flavored vape products have seen prices increase up to CNY30 ($4.72). The Forward Industrial Research Institute has recently reported that in China there are approximately 1,500 vape manufacturers and brand enterprises, and over 100,000 e-cigarette supply chains and related service enterprises, providing employment to an estimated 5.5 million people.
The research firm also found that in 2021, domestic e-cigarette sales totaled about CNY19.7 billion, with an annual growth of 36 percent.

April 12, 2022