Category: Regulation

  • Taiwan: Stakeholders Debate Policy Proposals

    Taiwan: Stakeholders Debate Policy Proposals

    Photo: Andrii Yalanskyi | Adobe Stock

    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.

  • Smoore Launches TPD Compliance Lab

    Smoore Launches TPD Compliance Lab

    Photo: Smoore

    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.

  • Synthetic Nicotine Rule Clears Senate

    Synthetic Nicotine Rule Clears Senate

    Photo: lazyllama

    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.

  • U.S. States Target Synthetic Nicotine

    U.S. States Target Synthetic Nicotine

    Georgia, Maryland and Mississippi legislators recently introduced bills in their respective states that would only allow the sale of vapor products that are authorized by or pending authorization from the U.S. Food and Drug Administration, according to a Filter article.

    The pieces of legislation would also establish directories to inventory authorized vapor products, which would eventually be made public. On the surface, these bills look like they are reiterating what the FDA is already doing through its premarket tobacco product application (PMTA) process, through which the FDA has denied millions of products. However, many have noted that the bills serve as a roundabout way to ban synthetic nicotine.

    Many manufacturers have turned to synthetic nicotine as a way to continue selling their products since synthetic nicotine is not currently regulated.  

    “The elected officials sponsoring these bills may be under the mistaken impression that their proposals are only targeted at illicit and counterfeit dealers,” Greg Conley, president of the American Vaping Association, told Filter. “The reality is that these bills would shut down licensed small businesses that are operating in full compliance with federal, state and local laws.”

    The Republican lawmakers who introduced the bills—Maryland State Senator JB Jennings, Georgia State Senator Jeff Mullis and Mississippi Representative Nick Bain—have all received campaign funds ranging from $500 to $4,800 from Juul Labs, according to Filter. Some feel that Juul and other large companies want to see synthetic nicotine (and competition) diminished.

    “To preserve the harm reduction opportunity for adult smokers, Juul Labs supports a fully regulated, science-based marketplace,” a Juul spokesperson said. “Illegally marketed and illicit products and products designed to evade federal and state oversight undermine harm reduction and a responsible e-vapor category.”

  • Sweden Wants to Prohibit Flavored Vapes

    Sweden Wants to Prohibit Flavored Vapes

    The Swedish government has proposed a ban on nontobacco-flavored vapes, including menthol, according to Vaping360.

    The proposed law includes nicotine and non-nicotine e-liquid and regulates all synthetic nicotine products, setting the purchase age to 18. If the law is passed, the sale of flavored vape products will be banned effective Jan. 1, 2023.

    The bill is currently being reviewed by the Council on Legislation, which considers the legal validity of proposed bills before they are considered by legislators. Parliament will vote on the bill as early as March 22.

    If the bill is passed, Sweden will be the eighth European country to prohibit flavors, following Estonia, Finland, Hungary, Ukraine, Denmark, Lithuania and the Netherlands.

  • Study: India’s E-cigarette Ban is Working

    Study: India’s E-cigarette Ban is Working

    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.

  • Duterte Urged to Sign Vaping Bill

    Duterte Urged to Sign Vaping Bill

    Photo: Gajus

    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.

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

    U.K. Regulators Release E-Cig Pricing Guidance

    Photo: kmitt

    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.”

  • EU Bill: Firms Liable for Supply Chain Violations

    EU Bill: Firms Liable for Supply Chain Violations

    Photo: weyo

    The European Commission has proposed a law that would hold large companies operating in the European Union for environmental violations or human rights abuses committed by businesses in their supply chains, reports The New York Times.

    “This proposal is a real game-changer in the way companies operate their business activities throughout their global supply chain,” said Didier Reynders, Commissioner for Justice, in a statement. “With these rules, we want to stand up for human rights and lead the green transition. We can no longer turn a blind eye on what happens down our value chains.”

    Under the legislation, businesses would need to establish mechanisms to detect, prevent and mitigate breaches of human rights, such as child labor, as well as environmental hazards in their supply chains. National governments would define the financial penalties for violators.

    Victims could sue for compensation in domestic courts of EU member nations, even if the harm occurred outside the bloc.

    According to the European Commission, the new rules will bring legal certainty and a level playing field. “For consumers and investors they will provide more transparency,” the Commission wrote on its website. “The new EU rules will advance the green transition and protect human rights in Europe and beyond.”

    The proposal would initially apply to companies with more than 500 employees and annual revenue over €150 million ($170 million). Around 2,000 companies based outside the bloc but doing business in the European Union, amounting to an annual revenue of more than €150 million, would also be covered.

    After two years, the range would be expanded to include smaller businesses in so-called high-impact sectors, such as textiles, food products and mining.

    The legislation will now be discussed by the European Parliament and the 27 national governments, with all parties able to modify the language. The final draft will require passage by the EU lawmakers and member nations. The whole process could take a year or more.

  • First FDA Warning for Vapor Hardware

    First FDA Warning for Vapor Hardware

    Photo: Sigelei

    The U.S. Food and Drug Administration posted its first warning letter for vaping hardware products on Tuesday. The letter was issued on Feb. 14.

    “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 agency wrote in its letter.

     On Feb. 5, 2021, the FDA sent Sigelei a “refuse to accept” letter regarding its premarket tobacco product application (PMTA) for six 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 warned.

    The move signals a shift in the FDA’s typical regulatory action against companies selling illegal vaping products. Thus far, the agency has 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,” the manufacturer said. “It hasn’t really hit home yet that FDA has the full intention to start enforcing hardware regulations too. 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.