Global Regulation - Tobacco Reporter

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

Iceland Mulls New Restrictions on Nicotine

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

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

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

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

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

Taiwan: Stakeholders Debate Policy Proposals

A demonstrative policy debate event on whether e-cigarettes should be regulated was held on March 8, 2022, in Taipei, showing how different public policy viewpoints can be rationally discussed, according to The Taipei Times. The debate was held by the Chinese Debate Promotion Association (CDPA) at the Taipei NGO House.

CDPA Chairman and Founder Chia Pei-te said that the Executive Yuan in January approved a draft amendment to the Tobacco Hazards Prevention Act proposed by the Ministry of Health and Welfare for legislative review. The proposed regulations on emerging tobacco products have sparked discussions, he said.

The amendment would classify emerging tobacco products as “tobacco-like products” and “designated tobacco products.” E-cigarettes would be classified as “tobacco-like products” and be fully banned while heated-tobacco products would be classified as “designated tobacco products” and be subject to regulation.

The reasoning behind banning e-cigarettes includes keeping curious teenagers away from the products, preventing consumers from adding nicotine to e-cigarette e-liquids and lowering the risk of teenage users turning to smoking.

The debate participants went back and forth discussing the pros and cons of regulating e-cigarettes versus banning them, bringing up subjects such as public health, tax revenue options and teenage use.

National Yang Ming Chiao Tung University (NYCU) College of Pharmaceutical Sciences Dean Kang Jaw-jou said that he was moved by opinions for and against e-cigarettes. He said the affirmative side proposed to directly manage e-cigarette use through regulations and an approval system while the opposing side stressed their attitude to life—banning a substance if the public consensus deems it harmful to society.

Many aspects of the topic can be argued, but e-cigarettes can cause negative health effects, and supporters and opponents must clearly present this fact to the public in further discussions, stated Wang Hsiang-tsui, NYCU Faculty of Pharmacy associate professor.

March 11, 2022

Smoore Launches TPD Compliance Lab

Smoore has established a vaping products risk assessment laboratory for European Union Tobacco Products Directive (TPD) compliance. The lab is part of the Smoore fundamental research center.

Operational since the first half of 2021, the laboratory has already completed 52 product tests for leading vape brands. As China’s first corporate TPD-compliant risk assessment laboratory, it can generate test reports within five working days. Its laboratory equipment is benchmarked against those in world-class analytical testing laboratories, such as Labstat and Enthalpy, according to Smoore.

As the industry’s harm reduction and quality benchmark, the company complies with its in-house Smoore 3.0 safety standards. Based on the risk assessment guidance of the U.S. Environmental Protection Agency and Food and Drug Administration, Smoore 3.0 covers all of the premarket tobacco product application (PMTA) vapor safety tests and FDA-listed harmful and potentially harmful constituents. In addition to vapor safety, Smoore 3.0 also involves extractable and leachable substances of medical-grade atomization materials.

Smoore’s fundamental research center has developed a comprehensive analytical testing and risk assessment system, covering PMTA nonclinical testing and health risk assessment. Accredited by the China National Accreditation Service for Conformity Assessment (CNAS) in 2019, the system is now capable of up to 149 CNAS tests involving the chemical analysis of e-liquids and aerosols, electrical safety, material safety and battery safety.

Smoore entered the EU market in 2018 with its FEELM atomization brand.

March 11, 2022

Synthetic Nicotine Rule Clears Senate

Synthetic nicotine products will soon require U.S. Food and Drug Administration marketing approval. The U.S. Senate approved a $1.5 trillion spending bill that includes language that changes the definition of a tobacco product to include synthetic nicotine. The legislation now heads to President Joe Biden, who looks forward to signing it into law, according to White House spokesperson Jen Psaki.

Synthetic nicotine—nicotine that is made in a lab rather than derived from tobacco—has long existed in a legal gray area, and many companies started using it after their natural nicotine products were denied market access by the FDA. Public health groups have been warning that synthetic nicotine e-cigarettes, such as Puff Bar, have grown in popularity among teens while skirting FDA oversight.

The Food, Drug and Cosmetic Act, which includes the 2009 Tobacco Control Act, defines a tobacco product as “any product made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part or accessory of a tobacco product).”

At a time when FDA is under scrutiny from multiple federal courts for unlawful regulatory overreach on nicotine, handing the agency even more powers to prevent Americans from switching to vaping is like handing car keys and a bottle opener to your drunk uncle.

Amanda Wheeler, president of the American Vapor Manufacturers Association

Proponents of the policy change refer to it as closing a loophole. “By using synthetic nicotine, e-cig companies are avoiding public health protections for flavored tobacco products and still hooking teens,” tweeted billionaire philanthropist Michael Bloomberg. “With millions of kids still using e-cigs, we must get synthetic nicotine products off the market.”

Critics contend that, given the flaws and deficiencies in the FDA approval process, the new rules will likely result in the prohibition of products that smokers have been using to quit cigarettes.

Amanda Wheeler, president of the American Vapor Manufacturers Association, said banning synthetic products will drive millions back to combustible cigarettes.

“At a time when FDA is under scrutiny from multiple federal courts for unlawful regulatory overreach on nicotine, handing the agency even more powers to prevent Americans from switching to vaping is like handing car keys and a bottle opener to your drunk uncle,” she said.

March 11, 2022

Category: Global Regulation