Global Regulation - Tobacco Reporter

Activist: Minister Won’t Stop Legalization

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

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

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

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

Malaysia Poised to Legalize E-Cigarettes

Malaysia’s longtime ban on the sale of vaping products is set to end, according to the Malaysian Organization of Vape Entities (MOVE).

Taking effect on Aug. 3, the regulation of vaping devices precedes the imminent legalization of vape sales. It follows years of campaigning by MOVE and other tobacco harm reduction supporters.

The Malaysian government has now moved to gazette the Trade Descriptions (Certification and Marking) of Electronic Cigarette Devices Order 2022 under the Trade Descriptions Act 2011. Manufacturers and importers will need to ensure all devices are certified and labeled to show consumers that safety standards have been met and the products are safe to use. All e-liquids will need to be registered.

“This is historic news after a long-fought battle. It paves the way for a legalized market and safer products. Regulating vaping products, restricting sales to adults and applying significant penalties to any breaches will help many more Malaysian smokers to quit deadly cigarettes,” said Samsul Kamal Ariffin, president of MOVE.

Ariffin said that in recent months there have been frustrating parliamentary delays in progressing the Tobacco and Smoking Control Bill—not helped by the pending general election. However, with the safety standards now gazetted, it sets in train the legalization of vape sales.

Regulating, not banning, vaping will not only save smokers lives, [but] it will generate much-needed tax revenue for our country.

Samsul Kamal Ariffin, president, MOVE

“Regulating, not banning, vaping will not only save smokers lives, [but] it will generate much-needed tax revenue for our country, which is desperately needed post-pandemic,” said Ariffin. “This is not only good news for smokers and their loved ones, but every Malaysian will benefit from the extra revenue gained from vape manufacturing, importing and sales. Up until now, it has been a black market with unapproved products not contributing tax and with no safety assurances.”

“The government has done well in preparing the legislation and regulation of products deemed 95 percent less harmful than combustible tobacco. It fully understands that making safer nicotine products legally accessible is the only way to seriously reduce Malaysia’s unnecessarily high smoking rates,” said Ariffin.

The Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA), too, expects Malaysia’s smoking rates to decline after the legalization of vapor products. “Malaysia will join 67 other progressive countries worldwide which have adopted regulatory frameworks on safer nicotine products. Importantly, all of them have subsequently registered a dramatic decline in smoking,” said Nancy Loucas, executive coordinator of CAPHRA.

“We’re particularly proud of our member organization MOVE and Samsul’s tireless advocacy over many years. The third of August is worthy of a big celebration and will be well noted across the Asia-Pacific region. Vaping bans fail badly—as Australia is discovering the hard way,” said Loucas.

April 11, 2022

FDA Denies Market Access to Myblu

The U.S. Food and Drug Administration issued marketing denial orders (MDOs) to Fontem US for several Myblu electronic nicotine delivery system (ENDS) products after determining their applications lacked sufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health.

According to a notice published on the FDA’s website, the currently marketed products receiving MDOs include Myblu Device Kit, Myblu Intense Tobacco Chill 2.5% and Myblu Intense Tobacco Chill 4.0%.

In reviewing premarket applications for tobacco products, the FDA evaluates the risks and benefits of those products to the population as a whole, including users and nonusers of the tobacco product, and considers, among other things, the likelihood that those who do not currently use tobacco products will start using those tobacco products.

Based on the information submitted by Fontem US for these Myblu products and the available evidence, the applications lacked sufficient evidence regarding design features, manufacturing, and stability, according to the FDA. Additionally, the applications did not demonstrate that the potential benefit to smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth, the agency said.

Tobacco products subject to an MDO may not be offered for sale, distributed or marketed in the U.S.

April 8, 2022

EU Rules Thwart Danish Plan to Restrict Smoking

The Danish government’s plan to ban those born after 2010 from buying nicotine products has been blocked by the European Union’s rules, reports EURACTIV.

The Danish government’s health reform package was introduced in March of this year but immediately faced feasibility questions.

EU rules make it impossible for member states to ban or restrict tobacco marketing. “The ministry of health, therefore, considers that a ban on the sale of tobacco and nicotine products to people born in 2010 or later would require an amendment to the European Tobacco Products Directive,” wrote Health Minister Magnus Heunicke in a parliamentary answer earlier this week.

April 8, 2022

Canada Proposes Federal Vape Tax

The Canadian government has proposed the country’s first federal vape tax, which would take effect Oct. 1 if passed, according to Vaping360.

The tax applies only to nicotine-containing products, including pod-style and cartridge-style refills, disposable vapes and bottled e-liquids as well as nicotine base for DIY liquids. It does not apply to hardware that is sold without e-liquids. The tax also includes an option for Canadian provinces to add on their own, equally large, taxes.

Vaping products would see a tax of CAD1 ($0.97) per 2 mL for the first 10 mL of e-liquid in any sealed container and $1 per 10 mL for additional liquid in the same container. Sealed pods would be taxed separately at a minimum of $1 per pod.

Retailers would have until Jan. 1, 2023, to sell any untaxed stock they still have on Oct. 1 when the law would go into effect.

The tax is awaiting a vote by Parliament’s House of Commons, which is expected to take place either at the end of April or beginning of May.

April 8, 2022

Brazil Mulls Legalizing E-Cigarettes

E-cigarettes may become legal in Brazil later this year as ANVISA, the federal health sanitary agency, plans to revisit its regulations regarding the products. Proponents of vaping have been pushing the government to legalize the products to help smokers quit combustibles, but critics are concerned about youth usage as well as potential higher rates of vaping that could follow legalization.

Electronic tobacco products have been banned in Brazil since 2009, but there are currently shops that sell the products anyway, often with statements that the products are safe, according to The World.

“Once the product is legally allowed to be commercialized, it gets into the distribution network of the tobacco companies, which have one of the best distribution systems around,” said Stella Bialous, a Brazilian expert on tobacco issues and a professor from the University of California, San Francisco. She fears that more people would likely take up vaping if the products are allowed to be commercialized. In 2019, less than 1 percent of Brazilians used e-cigarettes. However, if the products are commercialized, they would become more easily available, and that percentage could quickly rise.

“Considering that these products are attractive to youth and that we can’t affirm that they really work for tobacco cessation, we believe that we must prioritize the public policies to prevent smoke initiation and also to promote health for the Brazilian population,” said Monica Andreis, the executive director from ACT Promocao da Saude, a nongovernmental organization that focuses on tobacco control policies.

“Brazil has a leadership role in Latin America and also around the world related to tobacco control policies. I believe that the decision from ANVISA has the potential to influence other countries in Latin America,” Andreis said.

ANVISA has not commented on the situation, stating that it is still analyzing data. “Up to this point, there are still uncertainties and controversies related to the risks attributed to these devices,” the agency stated in February.

April 1, 2022

Canada Opens Consultation on Tobacco and Vaping Act

The government of Canada has opened public consultation on the Tobacco and Vaping Products Act (TVPA) ahead of its mandatory parliamentary review. Stakeholders can provide input until April 27, 2022.

In 2018, the TVPA was amended to protect youth and nonsmokers. The amended act recognized that vaping was significantly less harmful than smoking, and smokers that switched to vaping could reduce their exposure to thousands of chemicals. The act introduced measures to protect youth through various labeling and promotion regulations.

Tobacco harm reduction advocates welcomed the consultation. “Vaping has helped millions of smokers quit and has the potential to help millions more if it weren’t for the misrepresentations of the industry by media and misperceptions surrounding the product itself. It is imperative that Parliamentarians have the opportunity to hear from a wide range of experts as part of the TVPA review process,” said Darryl Tempest, government relations advisor to the Canadian Vaping Association (CVA).

Health Canada’s discussion paper states, “For adults who smoke, there appears to be a lack of awareness that vaping products are a less harmful source of nicotine for those who currently smoke and switch completely to vaping. A 2020 survey found that only 22 percent of current smokers recognized that vaping is less harmful than smoking cigarettes.”

In its consultation submission, the CVA will urge Health Canada to rectify this through the issue of relative risk statements for approved use by licensed specialty vape shops. In 2018, Health Canada proposed a “List of Statements for Use in the Promotion of Vaping Products.” According to the CVA, this proposal has been put on the back burner and has languished in Health Canada’s bureaucracy to the detriment of potential public health gains from smokers switching to vaping.

“Instead of issuing reasonable statements for use by specialty vape shops, the TVPA has effectively gagged the vape industry through Section 30.43,” the CVA wrote in a press release. Section 30.43 prohibits “the promotion of a vaping product in a manner that could cause a person to believe that health benefits may be derived from the use of the product or from its emission or by comparing the health effects arising from the use of the product or from its emissions with those arising from the use of a tobacco product or from its emissions. The purpose of this prohibition is to prevent the public from being deceived or misled with respect to the health hazards of using vaping products.”

“The CVA looks forward to actively participating in the review process and will advocate for enhanced measures to protect youth as well as increased smoker-targeted messaging on the benefits of switching to vaping. We encourage all stakeholders to submit feedback,” said Tempest.

March 24, 2022

Category: Global Regulation