Category: Regulation

  • Canada Opens Consultation on Tobacco And Vaping Act

    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.

  • U.S. Senators Pen Letter Urging FDA to Combat Youth Use

    U.S. Senators Pen Letter Urging FDA to Combat Youth Use

    Credit: Ekim

    U.S. senators Jeanne Shaheen and Maggie Hassan joined a bipartisan group of their Senate colleagues in calling on the Food and Drug Administration to take long-overdue action to combat the youth vaping crisis, which includes steps that could remove kid-friendly, addictive e-cigarettes from the market.

    The letter, which was signed by 13 additional legislators, including senators Mitt Romney and Elizabeth Warren, claims the FDA has not prioritized its review of e-cigarettes with the largest market share and “therefore greatest public health implication.” Instead, the agency has deferred its decisions on the most critical applications—including for those products that are most popular with youth—to the end, the Senators wrote to FDA Commissioner Robert Califf.

    “Now that FDA is six months past the court deadline, these unreviewed products are only being permitted to stay on the market due to the agency exercising enforcement discretion. It makes no sense, and runs contrary to the Tobacco Control Act’s statutory framework, that products that have not been granted authorization are being allowed to stay on the market and attract new, young users,” the letter states.

    “FDA has the authority and responsibility to halt this grace period today and restore the statutory burden of proof on manufacturers to demonstrate their product is ‘appropriate for the protection of public health’ prior to market entrance,” the Senators continued. “It is our hope and expectation that you can bring a new approach and commitment to using all of FDA’s tools and prioritizing public health to protect youth from the harms of tobacco and nicotine.”

  • Iceland Mulls New Restrictions on Nicotine Products

    Iceland Mulls New Restrictions on Nicotine Products

    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.”

  • Duterte Continues to be Urged to Veto New Vape Bill

    Duterte Continues to be Urged to Veto New Vape Bill

    New regulations for the vaping industry continue to sit on President Rodrigo Duterte’s desk in the Philippines. Again last week, the country’s Department of Education (DoE) urged Duterte to veto the Vaporized Nicotine Products Regulation Act approved by the Senate on third and final reading last December 2021.

    “As a government institution championing young Filipinos’ well-being, we are taking a stand against the so-called ‘anti-health’ vape bill, which will weaken existing law and the executive order against electronic nicotine delivery systems (ENDS) or electronic non-nicotine delivery systems (ENNDS) commonly known as e-cigarettes or ‘vapes,’” according to a DoE statement.

    Credit: Craitza

    If passed into law, the proposed legislation will lower the access restriction age from 21 to 18 years old. The bill also permits online sales, and allows flavors other than plain tobacco and menthol, the only two flavors currently allowed by law.

    The bill also prohibits celebrities or social media influencers from endorsing vapor products. Physical and online retailers or distributors must register with the Department of Trade and Industry and the Securities and Exchange Commission.

    To underscore the danger it poses to the youth, the DoE stated that for school year 2020-2021, at least 870,000 learners in the basic education sector were 18 years old, while close to 1.1 million learners in senior high school were 18 to 20 years old.

    “This is the number of learners who will become legally allowed to be marketed the harmful products once the bill becomes law,” the DoE stated, adding that young people are vulnerable to engage in risky behaviors such as substance abuse.

  • Survey Finds India’s E-cigarette Ban Taking Hold

    Survey Finds India’s E-cigarette Ban Taking Hold

    A recent survey shows that 94 percent of Indian vapers have given up e-cigarettes and other electronic nicotine-delivery systems (ENDS) following their ban in 2019, according to the BangaloreMirror.

    The survey, designed by the Campaign for Tobacco-Free Kids and conducted in collaboration with the National Law School of India University, Bengaluru, was disseminated online and targeted those aged 18 to 34. Most respondents were from Karnataka.

    The survey also showed that over 56 percent of respondents believed there was a health risk in using ENDS products while 24 percent were unaware of any risks.

  • Vape Groups Urge Duterte to Sign Latest Vaping Bill

    Vape Groups Urge Duterte to Sign Latest Vaping Bill

    Credit: Mongkolchon

    The Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA) has written to Philippine President Rodrigo Duterte asking him to urgently sign the Vaporized Nicotine Products Regulation Act into law.

    Both the Philippine Senate and House of Representatives have ratified the harmonized version of the act, which will regulate the use, manufacture, importation, sale, distribution and promotion of vaping and heated tobacco products. It now awaits the President’s signature or veto.

    “The weight of the scientific evidence shows that potentially thousands of Filipino lives can be saved by making this act the law of the land,” wrote CAPHRA, backed by its expert advisory group and member organizations throughout the Asia Pacific region.

    CAPHRA told Duterte that, when enacted, the legislation will provide 16 million Filipino smokers with the world’s most effective smoking cessation tool, saving the lives and enhancing the health of millions of Filipino smokers and their families, friends, and co-workers.

    “Hundreds of peer-reviewed international scientific studies have found innovative smoke-free products such as e-cigarettes and heated tobacco products to be far less harmful than combustible tobacco and offer the best options to make smokers switch or quit,” wrote Nancy Loucas, executive coordinator of CAPHRA. “The act will ensure the regulation of these products, so that they meet government standards to protect consumers and will contribute revenue, via taxation.”

    The letter said signing the act into law and giving Filipino smokers the option of choosing less harmful alternative nicotine products will create an enduring presidential legacy. It will prove to the world that Duterte is a leader who put the health and well-being of his people, based on science, above the special interests of foreigners.

  • Ontario MPP Reintroduces Anti-Youth Vaping Bill

    Ontario MPP Reintroduces Anti-Youth Vaping Bill

    A lawmaker in Ontario has reintroduced a bill to help prevent youth from taking up e-cigarettes. If passed, the bill would bump the legal age of selling products to 21, prohibit the promotion of vaping products, restrict sale to vape shops and require Ontario Health to do an annual report on vaping usage.

    Credit: FellowNeko

    The bill has earned praise from the Lung Health Association and the Canadian Cancer Society, which both say greater government oversight is required, according to CTV News. Both point to statistics from Health Canada that say the symptoms of vaping, or vaping-related illness, can include cough, fever, shortness of breath, chest pain, diarrhea and abdominal pain.

    “We limit the sale of cannabis, we limit the sale to specialty stores only, we don’t sell cannabis in convenience stores or gas stations, but we sell cigarettes and vaping products in gas stations — that shouldn’t be done,” said Rob Cunningham of the Canadian Cancer Society.

    The Canadian Vaping Association however says not so fast. It said the measures that are being introduced are short-sighted. Executive director Darryl Tempest said the problem is complex and the proposed legislation doesn’t target things like alcohol or tobacco.

    “Vaping is far more effective to get people off combustible tobacco and it’s been proven seven years in a row from the Royal College of Physicians to be 95 per cent less harmful than smoking — where is that consideration in this legislation?” said Tempest.

    He said the one thing we need to understand is that smoking, particularly combustible smoking, is the largest form of preventable death in the nation. According to his figures, there are more than four million smokers in Canada and 1.1 million have chosen a less harmful alternative.

  • Wisconsin Assembly Passes Bill Making 21 Age to Vape

    Wisconsin Assembly Passes Bill Making 21 Age to Vape

    Madison Wisconsin capitol building / Credit: Jryanc

    A bill that would bring the state of Wisconsin into compliance with federal law and raise the minimum age for purchasing tobacco and vaping products from 18 to 21 has passed the Wisconsin Assembly.

    Federal law changed in 2019 and Wisconsin retailers have been enforcing the higher age limit, according to the Associated Press.

    Because of that, the change in state law will have a minimal effect on how much tax revenue comes into the state, according to Wisconsin revenue officials.

    The Assembly passed the bill on a voice vote and it now heads to the Senate.

    If it passes there, it would head to Gov. Tony Evers for his consideration.

  • U.K. Regulators Release E-Cig Pricing Guidance

    U.K. Regulators Release E-Cig Pricing Guidance

    The U.K. Committee of Advertising Practice (CAP) and the Medicines and Healthcare products Regulatory Agency (MHRA) have released an enforcement notice for promotional online pricing of e-cigarettes.

    According to the notice, CAP writes the advertising rules, which are enforced by the Advertising Standards Authority, the U.K.’s independent advertising regulator.

    The enforcement notice relates to the manner in which e-cigarette pricing appears on websites. According to CAP, companies are allowed to present factual information but not in a way that would constitute promotion. The enforcement notice states that some companies are portraying pricing in ways that would be considered promotion, for example, emphasizing discounts and savings.

    “Please take immediate action to ensure your advertising complies,” the notice states. “We will be monitoring websites in the coming months. If we see continued problems in this area, we will take targeted enforcement action to ensure a level playing field. This may include—where advertisers are unwilling to comply—referral to our legal backstop.”

  • U.S. FDA Issues First Warning Letter for Vapor Hardware

    U.S. FDA Issues First Warning Letter for Vapor Hardware

    Sigelei Humvee 80 coil

    The U.S. Food and Drug Administration has issued hundreds of warning letters for vaping products, typically illegal e-liquids. On Tuesday, however, the regulatory agency posted its first warning letter for vaping hardware products. The letter was issued on Feb. 14 to China-based Sigelei Vapor for two coil brands.

    “Our review of the website http://sigelei.com revealed that you manufacture and offer for sale or distribution to customers in the United States ENDS [electronic nicotine-delivery system] products without a marketing authorization order including: Sigelei Humvee 80 and Sigelei 213 Fog Coil,” the warning letter states.

    The letter also states that Sigelei received a “refuse to accept” letter from the FDA on February 5, 2021 in response to the company’s premarket tobacco product applications (PMTAs) for six Sigelei products. “New tobacco products that do not have the required FDA marketing authorization order in effect, including your ENDS products covered by PMTA STN PM0001221 that resulted in a Refuse to Accept determination, are adulterated and misbranded,” the agency wrote.

    The move signals a shift in the FDA’s typical regulatory action against companies selling illegal vaping products. The agency has traditionally only issued letters for e-liquids, but now hardware manufacturers have been put on notice. One manufacturer, who asked to remain anonymous to avoid FDA scrutiny, said the recent action is worrisome.

    “The hardware segment has been operating almost at a near-normal, the same as before PMTAs were due. It hasn’t really hit home yet that FDA has the full intention to start enforcing hardware regulations too,” the manufacturer said. “This is going to hurt several companies and we are going to start to see smaller businesses end their marketing in the U.S.”

    The letter also suggests that the warning is for all Sigelei products and not just the rejected PMTA products. “The violations discussed in this letter do not necessarily constitute an exhaustive list,” the letter states. “You should address any violations that are referenced above, as well as violations that are the same as or similar to those stated above, and promptly take any necessary actions to bring your tobacco products into compliance with the FD&C [Food, Drug & Cosmetics] Act.”