Category: Regulation

FDA Denies Market Access to Myblu

Photo: Alex Kalmbach
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

Photo: Zerbor
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

Photo: Roman R
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

Photo: Rmcarvalhobsb
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

Photo: JHVEPhoto
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.
Darryl Tempest
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
Iceland Mulls New Restrictions on Nicotine

Photo: Buttenkow
Iceland’s Office of Health Promotion and Science launched a consultation on a draft law on nicotine products, which, if passed, would introduce age limits for nicotine consumption, ban e-cigarette flavors perceived to appeal to children and stipulate a permissible maximum nicotine concentration.
Currently, the minimum purchase age for vapes in Iceland is 18, and the proposed bill would implement the same age limit for other nicotine products.
Iceland currently has an adult smoking rate of 7 percent, the lowest in Europe apart from Sweden.
According to Filter, the misinterpretation that nicotine consumption and smoking go hand-in-hand has distorted perceptions. “Nicotine is not the cause of death from smoking,” according to Yorkshire Cancer Research in England. “Nicotine is not a carcinogen; there is no evidence that sustained use of nicotine alone increases cancer risk. Of the three main causes of death from smoking (lung cancer, chronic obstructive pulmonary disease and cardiovascular disease), none are caused by nicotine. The harm from smoking comes from the thousands of other chemicals in tobacco smoke.”
March 21, 2022
PactAct POS Wants to Help Businesses

Photo: PactAct POS
The Prevent All Cigarette Trafficking (PACT) Act has caused issues for some businesses trying to navigate the new regulatory landscape. PactAct POS is offering cloud-based software that includes integration with major e-commerce platforms like Shopify, BigCommerce and WooCommerce in hope of helping businesses remain in operation legally, according to a company press release.
“Pact Act vape compliance can be an overwhelming process for companies,” explained Terrence Johnathan, vice president of shipping and logistics for PactAct POS. “In some cases, the requirements are causing small businesses to shut down or stop shipping directly to consumers, which is hurting both consumers and manufacturers.”
PactAct POS provides registration, reporting, shipping and logistics, and government relations services.
PactAct POS is also releasing the PACT Act Survival Guide for 2022, a free e-book that focuses on PACT Act planning and strategies for 2022 and beyond.
“There are so many hoops to jump though,” said Johnathan. “We’ve worked with clients dealing with the vape mail ban [and] every kind of scenario, and we’ve been with them every step of the way. These companies don’t have to go at it alone. They just need to ask for help.”
PactAct POS is a cloud-based platform that automates PACT Act compliance for more than 250 businesses.
March 18, 2022
Denmark to Consider Sales Ban for Those Born After 2010

Photo: Tobacco Reporter archive
Denmark is considering a tobacco sales ban for anyone born after 2010, reports The Guardian and Geo News.
“Our hope is that all people born in 2010 and later will never start smoking or using nicotine-based products,” Health Minister Magnus Heunicke said. “If necessary, we are ready to ban the sale (of these products) to this generation by progressively raising the age limit.”
The current age of purchase is 18 years old. The health ministry stated that about 31 percent of 15-year-olds to 29-year-olds smoke.
A Danish Cancer Society poll showed that 64 percent of those surveyed were in favor of the proposed ban, with 67 percent being between the ages of 18 and 34.
Denmark’s proposed ban would be similar to that recently enacted in New Zealand, which will progressively raise the purchase age limit.
March 18, 2022
Sneak Peek at New Vapor Rules in China

Photo: Kajsym Yemelyanov
Starting May 1, China will begin enforcing the licensing rules for e-cigarette production, wholesale and retail entities. The new rules, the draft of which was first announced in December 2021, apply to all hardware and e-liquid products, including all components and ingredients.
“The administrative department in charge of tobacco monopoly of the State Council takes charge of national supervision and management of electronic cigarettes, and is responsible for the formulation and organization of implementing electronic cigarette industry policies,” the regulations state. “The administrative department in charge of tobacco monopoly of the State Council shall organize professional institutions for technical review of electronic cigarette products based on inspection and testing reports and other application materials.
“Electronic cigarette products not sold in China and only used for export shall comply with the laws, regulations and standards of the destination country or region,” the rules state. “If the destination country or region does not have relevant laws, regulations and standards, they shall comply with China’s relevant laws, regulations and standards.”
Critically the new rules also ban nontobacco flavors and the sale of open systems. The importation of any vaping related products, such as pre-mixed e-liquids, must also be approved by Chinese authorities, according to the regulations.
Any company that produces e-cigarettes in China must now get a license. If a company wants to expand its production or product portfolio, the company must garner approval from the State Tobacco Monopoly Administration. All nicotine must be tobacco derived and purchased from approved sellers in China. Chinese regulators will also establish a comprehensive e-cigarette traceability system to keep track of vaping products.
“Electronic cigarette wholesale enterprises shall not provide electronic cigarette products to units or individuals that are not qualified to engage in electronic cigarette retail businesses,” the regulation states.
The rules also specify that “enterprises or individuals that have obtained the tobacco monopoly retail license … shall purchase electronic cigarette products from local … wholesale enterprises, and shall not exclusively operate the electronic cigarette products sold on the market.”
According to an industry expert, this means all retail outlets must sell multiple brands and not just a single brand. Traditionally, companies such as RELX only sold their own brands in their stores.
Additionally, authorities will establish a “unified national electronic cigarette transaction management platform” that e-cigarette industry businesses that have obtained tobacco monopoly licenses must conduct all transactions through.
The rules also encourage stakeholders to report illegal activity. “Rewards will be given to units and individuals who have made meritorious deeds in reporting cases of illegal production and sales of electronic cigarette products, e-atomization material products and electronic cigarette nicotine,” the rules state.–T.S.D.
March 16, 2022
FDA Gets Authority Over Synthetic Nicotine

Photo: The White House
U.S. President Joe Biden on Tuesday signed into law a spending bill that gives the Food and Drug Administration authority over synthetic nicotine.
The language of the Tobacco Control Act will now change to define a tobacco product as “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption.”
The amendment comes into effect 30 days after the bill’s enactment. Manufacturers of products made with synthetic nicotine will then have an additional 30 days to submit a premarket tobacco product application (PMTA) to the FDA. If FDA has not authorized the product within 90 days after the effective date, the product must be removed from the market.
According to Bryan Haynes, a partner with Troutman Pepper, the measure could amount to an effective ban on synthetic nicotine products. “FDA is highly unlikely to authorize a PMTA in 90 days when other PMTAs for electronic nicotine delivery systems have been pending for more than two years,” he wrote on the law firm’s blog.
April Meyers, board president for the Smoke-Free Alternatives Trade Association (SFATA) suspects the bill will have little effect on youth vaping, which is already down significantly since highs in 2015. “Although the sponsors of the bill claim the intent was to close the loophole on synthetic nicotine-derived products from large companies now popular among youth, the reality is that this bill—and others like it—aren’t likely to have the intended effect,” she said. “Instead, consumers using these products as a harm reduction option will suffer, as will licensed small businesses in full compliance with federal, state, and local laws.
“The FDA created a problem by overregulating a product used by millions of adults who find vaping a safer alternative to smoking. When a market in high demand is overregulated, grey and black markets emerge where there are no regulations requiring safe products or ID checks.”
The FDA appears keen to crack down on synthetic nicotine. During his Senate confirmation hearing, FDA Commissioner Robert Califf vowed to close what he described as the synthetic nicotine “loophole.”
March 16, 2022