Category: Regulation

  • FDA Denies Marketing of 2 Vuse Menthol Products

    FDA Denies Marketing of 2 Vuse Menthol Products

    Unsurprisingly, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Company.

    In a release today, the regulatory agency said that the products include the Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5%. Reynolds is now banned from marketing or distributing these products in the U.S. or they risk FDA enforcement action.

    The company may resubmit applications or submit new applications to address the deficiencies of the products that are subject to these MDOs. The company may also file a lawsuit against the agency’s denial.

    “Consistent with the authorities granted by Congress, the FDA remains committed to evaluating new tobacco product applications based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole,” said Brian King, director of the FDA’s Center for Tobacco Products, wrote. “The applications for these products did not present sufficient scientific evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.”

    The FDA isn’t expected to approve any flavored vaping products in the near future.

    Memos recently submitted to the U.S. Court of Appeals for the Third Circuit show that the U.S. Food and CTP King, reversed a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists, according to Logic’s lawyers. The new documents were made available to Logic after it had filed its motion for a stay of its marketing denial order (MDO) for its menthol vaping products.

    The Vuse products cannot be legally introduced into interstate commerce in the U.S. without risking FDA enforcement. In addition to ensuring that the manufacturer complies with this order, as with unauthorized products generally, the FDA intends to ensure compliance by distributors and retailers. Retailers should contact R.J. Reynolds Vapor Company with any questions about products in their inventory. 

    “Today’s decision pertains to the specific application submitted for review by FDA,” said King. “It is the responsibility of the applicant to provide sufficiently robust scientific evidence to demonstrate that the necessary public health standard has been met. In this case, the presented evidence did not meet that standard.”

  • New Chicago Vape Shops will Need Permit From City

    New Chicago Vape Shops will Need Permit From City

    Credit: Stephen VanHorn

    New businesses in the U.S. city of Chicago that get 20 percent of their income from the sale of vaping products will now be required to obtain a special city license. There is no moratorium clause.

    The ordinance from 41st Ward Ald. Anthony Napolitano, which passed by voice vote Wednesday, also restricts how closely such shops can operate from each other.

    “The devil is always in the details, but a model that permits new stores to open appears more consumer-friendly than the possibility of moratoriums,” said Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association.

    Napolitano’s original proposal would have given the City Council authority to place moratoriums in specified areas on future tobacco retail licenses, which are required in Chicago to sell cigarettes, vapes and other smoke products.

    The newest legislation, which exempts existing vape shops, comes as the city has moved to crack down on electronic cigarettes, which have lately been a target of a broad coalition of aldermen and Mayor Lori Lightfoot.

    But those working in vape shops have countered that their products have helped many adults quit traditional cigarettes, and existing constraints have failed to keep the electronic ones out of children’s hands. They worry the legislation would further hurt small businesses without making a dent in preventing youth addiction.

  • Fifth Circuit Grants Triton Rehearing Before Full Court

    Fifth Circuit Grants Triton Rehearing Before Full Court

    Fifth Circuit Court of Appeals

    The U.S. Court of Appeals for the Fifth Circuit granted Wages and White Lion Investments LLC, doing business as Triton Distribution, and Vapetasia LLC’s, request for the full court to re-hear Triton’s appeal of its marketing denial order (MDO), according to a court order handed down today.

    Triton lost before a three-judge panel in July, but attorneys for Triton then filed a petition for a rehearing en banc by the entirety of the Fifth Circuit.

    Most circuit court appeals are decided by a three-judge panel, however, the special circumstances surrounding the U.S. Food and Drug Administration’s denial of Triton’s premarket tobacco product applications (PMTAs) motivated the court to allow a majority of the active judges (an estimated 17 judges) to vote to rehear the case “en banc.”

    The FDA rejected applications to market 55,000 flavored e-cigarettes in August 2021, including Triton’s, and said applicants would likely need to conduct long-term studies establishing their products’ benefits to win approval.

    A Fifth Circuit panel in October then agreed with Triton’s claim that the new requirement for long-term studies differed from earlier FDA guidance and called the action a “surprise switcheroo” and the panel allowed Triton to keep selling its e-cigarettes until another panel could hear its appeal.

    The court then denied Triton’s request for review of the agency’s MDOs in a 2-1 decision.

    The Fifth Circuit will hear the en banc argument in Wages and White Lion Investments v. U.S. Food & Drug Administration in May.

  • Italy Announces Rules for Ban on Indoor Vaping

    Italy Announces Rules for Ban on Indoor Vaping

    New measures against nicotine products will be introduced in Italy to address the prevention and fight against vaping and smoking.

    Italy’s health minister, Orazio Schillaci, announced new measures against vaping and other tobacco products to achieve a “tobacco-free generation,” reports Euractiv.

    “Measures will have to be taken to guarantee all citizens maximum protection of their health, a fundamental right of the individual and an interest of the community,” said Schillaci.

    Smoking rooms indoors will be banned, and the ban on smoking in open-air places in the presence of minors and pregnant women will be extended.

    E-cigarettes and heated-tobacco products will also be included in the ban, taking into account “the constantly increasing diffusion of new products on the market and the growing evidence on their possible harmful effects on health.” Plans to extend the cigarette advertising ban to new nicotine-containing products are also in place.

    “This process aims to allow the different multiple interests related to tobacco products, involving economic ministries, not to override health protection,” Schillaci said.

  • Bangladesh Vape Group Calls for Stakeholder Input

    Bangladesh Vape Group Calls for Stakeholder Input

    Credit: Ser

    The Bangladesh Electronic Nicotine Delivery System Traders Association (BENDSTA) called on authorities to consult with all stakeholders before making any policy decisions on vaping at a press conference held in the capital city of Dhaka on Tuesday.

    The organization also called for excluding vaping and other electronic nicotine delivery systems (ENDS) products from the proposed amendment of the Smoking and Tobacco Products Control Act 2005 (amended in 2013), according to a press release.

    BENDSTA fears that if a decision to ban vapes is taken after ignoring credible scientific evidence, it will jeopardize the Prime Minister’s vision of making the country tobacco-free by 2040.

    Many former smokers who successfully quit smoking cigarettes using vaping devices might resort back to smoking traditional cigarettes again if vaping gets banned in the country.

    Not only will this increase the number of smokers in the country, but the government will also lose the opportunity to balance its health and revenue agenda from an emerging sector, BENDSTA speakers said.

    BENDSTA President Masud Uz Zaman criticized the country’s health authorities for not including the association as relevant stakeholders in the process of developing such a crucial policy framework.

    “If any amendment is proposed regarding vaping, we are definitely an important stakeholder. It is unreasonable to not take our opinion and completely exclude us from the law-making process. Despite sending letters to the Ministry of Health repeatedly, they have refrained to sit with us to discuss the issue,” Zaman said.

    Zaman stressed that these tobacco harm reduction products should be made legal and regulated sensibly to achieve the Prime Minister’s vision of a tobacco-free nation.

    The proposed amendments called for a total ban on vaping products.

  • UK to Consider New Regulations for Vape Disposal

    UK to Consider New Regulations for Vape Disposal

    Disposing of used vaping devices, especially disposable devices, has become a major issue. So much so that the UK is set to consider changes to ensure the vaping sector “plays its part” in financing the collection and treatment of vaping products as part of the upcoming review of the waste electrical and electronic equipment (WEEE) regulations.

    Fourteen million single-use vapes are bought each month and 1.3 million are thrown away every week, according to research from Material Focus, the not-for-profit organization funded by the WEEE compliance fee.

    Last week, the Department for the Environment, Food and Rural Affairs (Defra) published its response to its consultation on commonly littered single-use plastic items, which ran from November 2021 to February 2022, according to Let’s Recycle. Within its response, Defra noted it had not explored the issues around waste generated from disposable vapes.

    Defra says it is reviewing the current producer responsibility systems for WEEE and batteries and plans to publish the much-delayed consultations on both areas “this year”, and in doing so will look at vaping products.

    The UK Vaping Industry Association (UKVIA), the trade body representing the UK’s vaping industry’s interests, says it is in discussions along with its member with several waste companies to create a recycling solution that is “fit for purpose for the vaping sector.”

  • Mexico Bans Public Smoking, Vape Rules to Tighten

    Mexico Bans Public Smoking, Vape Rules to Tighten

    Credit: Sezerozger

    After banning the sale of all vaping products, Mexico has implemented one of the world’s strictest anti-tobacco laws by enacting a complete ban on smoking in public places.

    The move also includes a total ban on the advertising, promotion and sponsorship of tobacco products, which means that cigarettes cannot be displayed inside shops. The step was first approved in 2021.

    E-cigarettes and heated tobacco products are also facing tighter new restrictions, particularly indoors, as per BBC. Last year, Mexico banned the import, sale and distribution of vaping and heated-tobacco products.

    The existing 2008 law in Mexico is responsible for smoke-free spaces in bars, restaurants and workplaces. The same law extended to a total ban in all public spaces including parks, beaches, hotels, offices and restaurants.

    Several other Latin American countries have also passed legislation to create smoke-free public spaces. Last year for example, Panamanian President Laurentino Cortizo also signed legislation banning the sale of vapor products in his country.

    However, Mexico’s legislation is considered to be the most robust and wide-ranging in the Americas.

    However, some smokers are dismayed at the draconian nature of the new law. In essence, it means that many will only be allowed to smoke in their homes or other private residences.

    Others have raised questions about the practicalities of enforcing the law.

    With police corruption so rampant in Mexico, many fear that rather than issuing real fines or punishments for smoking in public, some officers will use it as a pretext for taking bribes.

  • Taiwan Bans Vaping, Heat-not-Burn to be Regulated

    Taiwan Bans Vaping, Heat-not-Burn to be Regulated

    Credit: sharafmaksumov

    Lawmakers in Taiwan passed a ban on vaping products for its third legislative reading Thursday. The measure was necessary to address the increasing popularity of vaping products with the country’s youths, according to officials.

    The sale, manufacture, and supply of e-cigarettes will be outlawed, however, heated tobacco products (HTPs) will only be subjected to tighter regulation, according to an amendment to the Tobacco Hazards Prevention Act, according to media reports.

    Manufacturers or importers of HTPs will have to submit a health risk evaluation report for review before they can receive a permit. The advertising of heating tobacco products will be banned, wrote CNA.

    Other changes involve raising the legal smoking age from 18 to 20, increasing the proportion of tobacco package warning messages from 35 percent to 50 percent, and designating childcare centers as well as schools as no-smoking/no-vaping areas.

    The move is hailed as a partial victory for anti-tobacco groups after years of calls for stricter control of cigarettes and novel tobacco products. The last time the Tobacco Hazards Prevention Act was amended in Taiwan was in 2009.

    Among the contentious parts of the amendment is how flavored tobacco products are to be regulated. Critics say the change is not bold enough as it only prohibits the use of banned additives, but this can present a loophole as the terminology is vague, wrote UDN.

  • U.S. FDA Says Misinformation ‘Leading Cause of Death’

    U.S. FDA Says Misinformation ‘Leading Cause of Death’

    The role of misinformation in the vaping industry was not mentioned when past and present commissioners of the U.S. Food and Drug Administration came together recently to discuss the role misinformation plays in public health.

    The group say the agency needs partners in combatting public health misinformation, and industry, clinicians, patient advocates and academic leaders all have a role to play.

    “Realistically, FDA needs help,” Mark McClellan, who served as FDA Commissioner from 2002-2004, said at the 2023 Innovations in Regulatory Science Summit sponsored by the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI).

    On the FDA’s own website there are youth vaping prevention posters available to be used by various groups including doctors, schools, and state and local public health agencies. These claim, amongst other dangers, that “[n]icotine can rewire a teen’s brain to crave more nicotine and can create addiction,” despite there being no scientific basis for this claim.

    While there is currently a lack of trust in officials from public health agencies, individuals still have trust in their own physicians, community leaders, and others who are “close to their experience,” McClellan said during a panel discussion among past and present FDA commissioners about how to counter the problem of misinformation and restore trust in the agency.

    However, a 2021 study in the International Journal of Environmental Research and Public Health found that more than 75 percent of U.S. physicians believe that nicotine directly contributes to cancer and cardiovascular disease.

    On the FDA’s website, the agency states, “while nicotine has a number of toxic effects on the body, it is not the primary cause of cancer and other chronic smoking-related diseases. More than 7,000 chemicals are present in cigarette smoke, including more than 70 that can cause cancer.”

    Janet Woodcock, the agency’s Principal Deputy Commissioner who served as Acting Commissioner from 2021-2022, said patient advocates are trusted and often aligned with FDA’s mission but that their reach is often limited to the disease areas where they are focused, leaving prevention and treatment of common diseases as areas where misinformation can proliferate, according to an article from Regulatory Focus.

    “I actually believe that misinformation is the leading cause of death right now in the U.S. because whether we’re looking at COVID or chronic disease, people are making bad choices driven by the information that they get,” said current FDA Commissioner Robert Califf, who also served in the role from 2016-2017. “We were just not prepared for what broad access to the Internet would do to communication channels.”

    Califf called out the academic community for not doing more on the misinformation front and said some of their criticism of FDA and other public health agencies is having unintended consequences.

    “As a public agency, we need to be critiqued, but I think often the people that are doing the critiquing assume that the agency’s going to be there in the future in the way that they expect it to be there,” Califf said. “So, they’re critiquing it to make it better. But to a lot of unsuspecting people that hear it, it just completely erodes their belief in the institution.”

    In an FDA-funded study last year, researchers found that the use of electronic cigarettes costs the United States $15 billion annually in healthcare expenditures—more than $2,000 per person a year. The study, published on May 23 in Tobacco Control, was the first to look at the healthcare costs of e-cigarette use among adults aged 18 and older, according to researchers at the University of California San Francisco School of Nursing.

    The study was found to be rife with misinformation after it claimed that healthcare expenditures for a person who uses e-cigarettes are $2,024 more per year than for a person who doesn’t use any tobacco products. Chuck Dinerstein, director of medicine at the American Council on Science and Health (ACSH), who has over 25 years of experience as a vascular surgeon, said that in order to get their data, researchers developed a model using the National Health Interview Survey (NHIS), a household survey of the general population in the U.S. that includes detailed questions on health and use of tobacco products.

    “The researchers point to a study using NHIS data that per smoker—meaning combustible—attributable healthcare expenditures are $5,602,” explained Dinerstein. “The finding of this study, for both those exclusively using e-cigarettes and the dual users, is roughly a third as much. E-cigarettes reduce healthcare utilization and costs.”

    Scott Gottlieb, who served as FDA Commissioner from 2017 to 2019, said rapid response to online misinformation is critical and floated the idea of giving industry more leeway to counter false or misleading information about products. It is currently illegal for any vaping product manufacturer to make health claims concerning e-cigarettes, including saying they are safer than combustible cigarettes.

    While commissioner, Gottlieb championed e-cigarettes as a way to help adults stop smoking. 

    “We’ve seen FDA weigh in, admirably, around some dangerous disinformation on specific products,” he said. “But that can’t be the business of the FDA.”

    Margaret Hamburg, who served as FDA Commissioner from 2009-2015, said that while some of the larger issues around misinformation are difficult to solve, FDA can take concrete steps to restore public confidence in its role. That boils down to showing why FDA matters, how the agency does its work and opening up some of the processes that have historically not been transparent, she said.

    “Despite so much that is going on that is hard for FDA to control, the work of the agency and its trustworthiness can be demonstrated,” Hamburg said.

    That transparency is especially important in areas where there is the most controversy, McClellan said.

  • Campaigners Slam Threat to Ban U.K. Cigarette Sales

    Campaigners Slam Threat to Ban U.K. Cigarette Sales

    Photo: Taco Tuinstra

    Campaigners have slammed the suggestion that a future Labour government could ban the sale of cigarettes to eradicate smoking by 2030.

    Speaking to the BBC, shadow health secretary Wes Streeting said Labour would consult on banning the sale of cigarettes.

    Simon Clark, director of the smokers’ rights group Forest, condemned the idea.

    “The health risks of smoking are well known but it’s a legitimate habit that millions of adults enjoy,” he said. “Banning the sale of cigarettes to future generations won’t stop people smoking. It would merely drive the sale of tobacco underground and into the hands of criminal gangs.”

    Unlike countries such as the U.S., regulators in the U.K. have embraced using vaping products to curb tobacco use and the strategy has been effective.

    Clark pointed out that current U.K. smoking rates are the lowest on record and an increasing number of smokers are switching voluntarily to reduced risk products like e-cigarettes without government intervention.

    “Given all the problems facing the NHS [National Health Service] and the country at large, it’s laughable to think that tackling smoking might be considered a priority for a future Labour government,” said Clark.

    During the BBC interview, Wes Streeting said more radical options were needed as the U.K. was set to miss its target of being “smoke-free” by 2030

    “One of the things that was recommended to the government in one of their own reviews was phasing out the sale of cigarettes altogether over time. We will be consulting on that and a whole range of other measures,” said Streeting.

    Streeting said he would pay close attention to the results of a recently announced law in New Zealand that makes it illegal to sell tobacco to anyone born on or after Jan. 1, 2009.

    Under the new rules, which take effect this year, the country’s smoking age of 18 would be raised year by year until it applied to the whole population. Beginning in 2023, those under 15 would be barred from buying cigarettes for the rest of their lives.

    “I am genuinely curious,” he said. “If we are going to get the NHS back on track, we need to focus on public health. 

    Streeting’s comments follow a review ordered by Sajid Javid when he was health secretary which listed 15 measures to give the U.K. its “best chance” of hitting a national target of making the UK smoke-free by 2030.