Tag: regulation

  • Companies File Suit Against California Flavor Ban

    Companies File Suit Against California Flavor Ban

    Credit: Niro World

    Vapor and other tobacco companies filed a lawsuit against California in federal court over the state’s ban on flavored products one day after voters backed the ban in a Nov. 8 referendum, reports the Courthouse News Service.  

    Though more than half the state’s ballots have yet to be counted, media outlets have declared that the referendum will pass. Unless a judge agrees to intervene, the ban is set to go into effect no later than Dec. 21, 2022.

    In their suit, the companies argue that the Family Smoking Prevention and Tobacco Control Act (TCA) of 2009 allows states and municipalities to regulate tobacco products, but not to ban their use or sale.

    “The ban falls under the TCA’s express preemption clause, ‘which preempts ‘any [state] requirement’ that is ‘different from, or in addition to,’  a federal requirement about a tobacco product standard,” the suit reads. “A flavor ban is a paradigmatic tobacco product standard.”

    In 2020, California lawmakers passed a ban on all flavored nicotine products except hookah, loose leaf tobacco (for pipes) and premium cigars. Menthol products are also covered by the legislation.

    Opponents of the ban collected more than 1 million signatures and forced the state to hold a referendum on the ban. Originally scheduled to take effect Jan. 1, 2021, the legislation was then suspended until the Nov. 8 vote.

    Vapor and tobacco companies already sued California over the flavor ban in 2021. But a federal judge dismissed the case, telling the plaintiffs to wait for the voters to weigh in before suing.

  • Hyde Maker Files Suit Against FDA for PMTA Denials

    Hyde Maker Files Suit Against FDA for PMTA Denials

    The manufacturer of Hyde and Juno brand e-cigarettes is suing the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services claiming the agencies violated the Administrative Procedure Act.

    New York-based Magellan Technology accuses the agencies of refusing to review company’s premarket tobacco product applications (PMTAs) for 12 products, a process which has cost the company $1 million. Magellan claims the FDA “arbitrarily” and “capriciously” rejected the applications, according to law360.

    “Magellan had already spent over $1 million on the PMTAs at the time the RTA [refuse-to-accept] order [was] issued and plans to spend over $10 million on the PMTAs in total,” the suit states.

    Texas-based retailer Vapor Train 2 LLC is also a plaintiff in the suit. The companies asked a Texas federal court to temporarily stay the RTA order the FDA issued to Magellan, according to the lawsuit filed Thursday.

    “FDA acted arbitrarily, capriciously, and otherwise not in accordance with applicable law in issuing the [refuse-to-accept] order,” the lawsuit states. “The agency invoked regulations governing [premarket tobacco product applications] acceptance that do not apply to Magellan’s [applications] and failed to consider timely amendments containing required content that Magellan properly submitted.”

    According to the suit, applications for Magellan’s products were submitted to the FDA on May 12 and 13 by a third-party company based in China, Skyte Testing Services Guangdong Co. Ltd., before the May 14 deadline.

    However leading up to the due date, the FDA made last-minute changes to what was required in an application, the suit claims. Specifically, on April 14, the agency used emergency powers to amend a document, Form 4057, which Magellan would need to include with its application.

    An amended version of this form wasn’t posted on the government’s website for almost two weeks, additionally, the FDA didn’t announce the change until May 16, two days after the applications were due.

    Magellan claims that at the time Skyte submitted the applications, the government’s website did not generate submission tracking numbers. Magellan claims didn’t learn those numbers until after the FDA issued its RTAs in October, according to the suit.

    Without the numbers, Magellan was not able to properly submit amendments to its application, specifically a new Form 4057. Skyte tried to submit updated documents on Aug. 18, explaining in the summary page that these documents were meant to be included with its May submissions, according to the suit.

    But the FDA later rejected these forms for not including the submission tracking number, the lawsuit claims. The agency specifically noted that “although you submitted additional submissions which may have been intended to amend your applications, [the submissions] did not specify the [tracking number] assigned to the original submission within FDA Form 4057,” according to the suit.

    Magellan claims the omission was not its fault.

    The FDA did not act “in accordance with law by failing to consider Magellan’s timely amendments submitted on Aug. 18, 2022, on the grounds that the amendments did not include or reference the submission tracking numbers assigned … when FDA itself failed to assign the original bundled applications corresponding submission tracking numbers,” the suit states.

  • California Bans Flavored Vaping, Tobacco Products

    California Bans Flavored Vaping, Tobacco Products

    Credit: Sharaf Maksumov

    Californians voted to uphold a state law ending the sale of most flavored tobacco products, including flavored e-cigarettes, menthol cigarettes and flavored cigars.

    Proposition 31, the ballot referendum to uphold the law, was ahead by a margin of 65 percent to 35 percent on Nov. 9. The Associated Press called the race, though official results will take longer to finalize. The state mailed ballots to all active voters. Ballots postmarked by election day have a week to arrive.

    In 2020, California lawmakers passed a ban on all flavored nicotine products except hookah, loose leaf tobacco (for pipes) and premium cigars. Menthol products are also covered by the legislation.

    “Proposition 31 is California’s antidote to the candy-flavored poison Big Tobacco has been peddling to our kids and communities of color,” said Fmr. Senator Jerry Hill, author of the original bill that became Prop. 31. “With the implementation of Prop. 31 comes a strong layer of protection against tobacco companies’ ability to lure kids into smoking and a lifetime of addiction to nicotine; and Californians will live longer, healthier lives as a result.”

    Opponents of the ban collected more than 1 million signatures and forced the state to hold a referendum on the ban. Originally scheduled to take effect Jan. 1, 2021, the legislation was then suspended until the Nov. 8 vote.

    Advocates for Proposition 31 argued the restrictions would deter tobacco use among kids by eliminating youth-friendly flavors such as bubblegum, cotton candy and cherry.

    Opponents said the ban would remove flavored electronic nicotine delivery systems as an effective tool to quit traditional cigarettes, and that some communities were unfairly targeted by the law. Black smokers, for example, are more likely to use menthol cigarettes.

    Supporters of the ban outspent opponents by a significant margin in the runup to the ballot. By mid-October, the billionaire anti-smoking and anti-vaping activist Michael Bloomberg had provided $15.3 million of the $17.3 million raised by the committee in favor of the ban, according to the San Francisco Chronicle. By contrast, the opposition had raised just over $2 million, almost entirely comprised of donations from Philip Morris USA ($1.2 million) and R.J. Reynolds ($743,000).

    California joins Massachusetts and the District of Columbia in ending the sale of flavored tobacco products, including flavored e-cigarettes, menthol cigarettes and flavored cigars. Three other states—New Jersey, New York and Rhode Island—prohibit the sale of flavored e-cigarettes. With local laws included, 25 percent of the U.S. population will now be covered by laws ending the sale of flavored e-cigarettes.

  • USVA Sues FDA for PMTA Impact on Small Business

    USVA Sues FDA for PMTA Impact on Small Business

    Credit: Sergin

    The United States Vaping Association (USVA) is suing the U.S. Food and Drug Administration for its handling of the premarket tobacco product application (PMTA) and its impact on small businesses.

    The USAVA, a trade association that represents the small businesses, suit alleges that the FDA failed to properly consider the impact the “seemingly impossible and expensive” PMTA process would have on small businesses.

    “In the deeming rule, the FDA spoke as if vapor applicants would be able to substantially rely on public data, or on 70 studies the FDA itself was conducting at that time,” the USVA wrote in a statement. “In the end, the FDA wrote an impossibly burdensome PMTA rule that is putting a lot of people in this industry out of business. Yet, in fact the FDA claimed that there would be no significant impact on small businesses.”

    The lawsuit asks for relief for the businesses that are members of the USVA that includes:

    • Declare the PMTA Final Rule in violation of the Regulatory Flexibility Act; 
    • Remand the PMTA Final Rule to the FDA; and 
    • Enjoin the FDA from enforcing the PMTA Final Rule against any members of the USVA, and to take such actions as are necessary and proper to remedy their violations deriving from any such actual or attempted enforcement.

    The suit also criticizes the FDA prioritizing manufacturers with the greatest market share, companies that were more well funded to tackle the PMTA process. Some of the larger companies also were allowed to make changes to issues with their PMTA submissions where smaller companies with the same issues received marketing denial orders for those issues.

  • Estonia Debates Ban on Disposable Vape Devices

    Estonia Debates Ban on Disposable Vape Devices

    Credit: Sharafmaksumov

    Estonia’s Minister of Labor and Health, Peep Peterson, says he will install measures to ensure that fewer novel tobacco products such as disposable, flavored e-cigarettes, fall into the hands of minors.

    Flavored e-liquids have been banned for purchase from outside Estonia since 2019, though initially it had not been clear whether the ban applied to flavored additives sold separately, according to ERR media reports.

    Peterson (SDE) says he has no leverage on e-cigarette paraphernalia entering the country, even in the case of banned items, telling ERR’s Madis Hindre that: “It is a classic role for customs to check and control commerce at the border.”

    Meanwhile Eerik Heldna, head of the Tax and Customs Board’s customs department said that the organization intercepts illicit tobacco products entering Estonia every day.

    Heldna said border checks: “Certainly do not comprehensively solve the social problem. Such a situation, where customs confiscates one hundred percent of illegal goods, no matter what the goods are, does not arise anywhere in the world,” adding that demand-side measures are key.

    Heldna said that the majority of illegal new tobacco products come to Estonia from another EU country, adding that for this reason, EU-level restrictions, such as those on heated tobacco products, will help.

    “Any such EU-level measures, which start to diminish this market, especially among young people would be very welcome. They will alter this picture significantly more than just one or another successful procedural action,” Heldna said.

    More legislation is likely to emanate from the social affairs ministry soon, to address the issue is single-use e-cigarettes, which have brought with them concern over their potential appeal to minors.

    “Hypothetically, a decision to ban disposable vapes, or e-cigarettes, is on the table,” the minister said, adding that retailers have not been at fault and are good at checking the age of customers where that would be appropriate.

    Measures might include retailers having to take back used-up e-cigarettes, though there are also environmental considerations regarding disposal.

    The disposable e-cigarette market is also booming, ERR reports, rising from 2.5 million sales of individual flavored e-cigarettes in 2020 in Estonia, to 35 million last year.

  • Lawyer: ‘Cloudy Logic’ Behind Canada’s Vape Tax

    Lawyer: ‘Cloudy Logic’ Behind Canada’s Vape Tax

    Photo: Roman R

    Canada is toughening up its regulatory regime over the manufacture and sale of vaping products.

    As of Oct. 1, manufacturers and importers must be licensed or registered with the Canada Revenue Agency, must label their product with a vaping excise stamp, and pay an excise duty. Oct. 1 to Dec. 31 will be a transition period, after which retail stores can only sell stamped vaping products. These changes came from amendments to the Excise Act, 2001 and its regulations under the 2022 federal budget.

    For taxation purposes, the changes mean that the feds effectively treat vaping products like tobacco products, says Robert Kreklewetz, an indirect tax, customs and trade lawyer at Millar Kreklewetz LLP.

    A 20-pack of cigarettes is subject to $2.91 of federal excise duties, while the “roughly equivalent” amount of vaping liquid, two millilitres, attracts a duty of $1. He adds that this applies to liquid that does not contain nicotine.

    “When vaping first came out, much like any new technology, the government was a little slow to react and slow to act,” says Kreklewetz. “It was a bit of a wild west situation in terms of how they were regulated from a product perspective and a wild west situation in how they were regulated from a taxation perspective. No special taxes, other than maybe our federal value added tax, would have applied – as it would to any other goods. But there were no special excise duties, and certainly no cigarette system in place for vapes. That’s all changed now.”

    Canada also regulates vaping products through the Tobacco and Vaping Products Act, as well as the Food and Drugs Act, and has regulations restricting nicotine concentration and making rules for packaging and labelling.

    Tax policy is usually aligned with public policy, and to attach excise taxes – sin taxes – to vapes, when they are a less harmful alternative to smoking, will provide less of an incentive for smokers to switch, says Kreklewetz.

    “If you were looking at vapes as a way to get current smokers off of smoking and on to an alternative consumption of nicotine… every dollar that you put into tax on vaping is just a financial disincentive to getting off smoking,” says Kreklewetz. “If it costs me as much to vape as it does to smoke, why would I make the change?”

    “That’s the cloudy logic that I see in the new taxation system,” he says. “The way the federal government is working these days, it’s running out of new sources of revenue. So, one might look at the vaping taxes as more of a tax grab than good public policy.”

  • ATR Submits Comment to Reagan-Udall FDA Review

    ATR Submits Comment to Reagan-Udall FDA Review

    Credit: Araki Illustrations

    Americans for Tax Reform (ATR) has submitted a comment to the Reagan-Udall Foundation as the Foundation continues its external review of the U.S. Food and Drug Administration‘s Center for Tobacco Products (CTP)’s policies and procedures.

    The ATR states that the FDA has “significantly and substantially failed” to fulfill the regulatory agency’s congressional mandate to act on behalf of the protection of public health.

    Tim Andrews, ATR’s director of Consumer Issues, wrote that his organization is hopeful that the Reagan-Udall Foundation’s review could help the agency better the PMTA review process.

    “[The PMTA] process has created impossible administrative burdens on applicants. When processes and requirements were changed, FDA failed to notify applicants and is alleged to have applied a new and different standard to certain applicants,” said Andrews. “FDA’s failures are structural. Our submission is cognizant of that and emphasizes that these issues can’t be solved with increased funding, especially not through user fees on small vape manufacturers.”

    In its comment, the ATR also offered seven FDA reforms that the ATR hopes the Reagan-Udall Foundation would consider:

    • FDA should introduce cross-disciplinary expert analysis factoring input from fields like psychology and behavioral economics, to increase public awareness and engagement in the decision-making process.
    • FDA must provide an easy, streamlined, PMTA pathway, as initially promised.
    • FDA’s PMTA process should focus on product safety and individual risk, not behavioral and population assessments that are better gathered by a singular post-market surveillance team.
    • FDA should be in regular, proactive contact with all PMTA applicants, as opposed to merely issuing MDO’s after year long periods of silence.
    • FDA should consider implementing product standards, to assist in the streamlining process, and look also to countries such as the United Kingdom as a model for a regulatory system that works.
    • FDA must urgently act to combat significant public misinformation that it admits exists in the community and is a barrier to smoking cessation.
    • FDA must reform its approach to youth risk behavior. FDA should accept that youth can benefit from harm reduction and properly evaluate the consequences of reduced vape access for both adults and youth.

    The ATR also complained about stringent rules vape manufacturers and retailers are forced to follow, such as being forbidden by law from sharing scientific studies about their products with consumers. The responsibility for correcting the public’s perception of reduced-risk products “lies at the feet” of the CTP.

    “There is a desperate need for widespread public messaging that vaping is safer than smoking and can save lives,” Andrews stated. “[The] FDA should be the agency that educates the public about the safer nicotine products that exist to help adults who smoke quit the deadly habit of cigarettes.”

    The ATR comment also mentions significant and fundamental structural problems at the agency. After numerous purported FDA staffers have revealed that FDA’s tobacco program “has a toxic internal culture, rife with racism, sexism, and unconscious bias. FDA employees have shared concerns that [the] FDA allows political pressure to influence scientific decisions and that scientific staff feel intimidated in the workplace.”

  • FDA Expected to Attack Names of E-liquids Next

    FDA Expected to Attack Names of E-liquids Next

    Photo: oxygen_8

    After rooting out ENDS flavors, regulators may turn their attention to flavor names.

    By Neil McKeganey

    In the world of illegal drugs, there are few substances that have become popular as quickly as 3,4-Methylenedioxymethamphetamine. If you are wondering what that awkwardly named substance is, you will almost certainly recognize it by its street name, Ecstasy. In advance of its marketing, the drug developers thought about calling it Empathy but decided on Ecstasy instead—who, after all, could turn down the opportunity of experiencing “ecstasy”? And so it proved with a drug that sold in the millions in countries around the globe. That anecdote tells you something that every marketing person worth his or her salt knows all too well: names matter. Indeed, when it comes to driving consumers to your product, names may matter more than the substance itself.

    In recent years, the vaping world has seen the heavy hand of regulatory intervention focused on limiting the range of flavors that can be legally sold. Senior health officials, sections of the media, lobbyists, parent groups and others have forcefully argued for banning “kid-appealing flavors.” Restrictions on flavors, though, have gone well beyond the flavors that are seen to be appealing to vulnerable groups.

    Out of some 1.6 million products for which premarket tobacco product marketing authorizations have been sought in the U.S., not a single flavor has been approved. Recent pronouncements from Brian King, head of the Food and Drug Administration’s Center for Tobacco Products, suggest that menthol is now in the regulatory agency’s crosshairs. In the face of such expanding regulatory action, it is by no means a stretch of the imagination to ponder a world in which only a single electronic nicotine-delivery system (ENDS) flavor—tobacco—remains, bringing vaping products that much closer to combustibles and in the process almost certainly weakening their capacity to offer a route out of smoking.

    In a mono-flavored ENDS world, flavor names may become the new fertile terrain—promising consumers a realm of limitless variations in taste that, like the world of expensive Hi-Fi, where differences in quality are barely discernible, nevertheless draw in consumers seeking particular sensorial and taste experience.

    With the removal of flavors from the market, next in line may be flavor names, with regulators galvanized by the belief that it is the names more than the flavors that are driving consumers to these products. In that event, it will become increasingly important for manufacturers to be able to present regulators with evidence that their specific-named tobacco-flavored products are not attracting young people and that those named flavors are assisting adults in quitting smoking.

    If anyone is inclined to think that this is an unlikely scenario, it is worth remembering that regulatory authorities within the U.S. already involve themselves in determining what words can and cannot be used when referring to tobacco products. Some states already ban the use of food terms when referring to tobacco products, and the Family Smoking Prevention and Tobacco Control Act bans words like mild, light and ultra-light when referring to tobacco products. In the face of such regulatory restrictions, companies replaced the names mild, light and ultra-light with terms such as gold, silver and blue. Research undertaken by Gregory Connolly and Hillel Alpert and published in Tobacco Control in 2014 showed that even in the face of such name-switching, smokers were still able to identify their preferred product.

    Within the world of ENDS, some e-liquid manufacturers have already chosen to move away from taste-based flavor names. Bidi Vapor, for example, uses product names such as Winter, Summer, Dawn and Marigold in describing its product range. Years before Bidi opted to anonymize the taste experience in its product names, e-liquid manufacturer Five Pawns opted to use words derived from chess, like Gambit and Grandmaster, to name its products. These are names that convey nothing about the taste or sensorial experience.

    In time, there may be a push from the anti-e-cigarette lobby to reduce the variety of tobacco flavor names even further, requiring manufacturers to differentiate their products by numbers alone. Seems unlikely? Probably not for those who remember Players No. 6, No. 10 and No. 555. Flavor names may be the next item on the regulatory hit list.

    Neil McKeganey is the director of the Center for Substance Use Research in Glasgow, Scotland.
  • Thailand: Activists Detect New ‘Teen Vaping Crisis’

    Thailand: Activists Detect New ‘Teen Vaping Crisis’

    Photo: samart boonprasongthan/EyeEm

    Tobacco control activists have expressed concern about the number of young people smoking e-cigarettes in Thailand, reports The Bangkok Post. While e-cigarettes are illegal in Thailand, they remain readily available across the country.

    According to a health survey conducted in 2019 and 2020, 5.3 percent of Thais aged 10 to 19 years have tried vaping and 2.9 percent do so regularly. Around 30 percent of people in this age bracket who smoke e-cigarettes are women, the study showed.

    Patcharapan Prajuablap, secretary-general of the Thailand Youth Institute, attributed the popularity of vaping in part to the fact that it is considered safer and more trendy than smoking cigarettes, especially among high school students.

    Over the past year, Thai lawmakers have mulled legalizing e-cigarettes to offer smokers a less harmful method of nicotine consumption and to tap a new source of tax revenue.

    Alarmed by the underage vaping numbers, Roengrudee Patanavanich, a lecturer at the Faculty of Medicine at Ramathibodi Hospital, urged the government to keep e-cigarettes illegal.

  • Hong Kong Considers Generational Cigarette Ban

    Hong Kong Considers Generational Cigarette Ban

    Photo: efired

    Hong Kong residents who were born in 2009 or after should be banned from buying cigarettes by 2027, the Council on Smoking and Health proposed on Nov. 3, reports the South China Morning Post

    The city’s smoking population dropped to 9.5 percent last year—hitting single digits for the first time since tracking began—but Chief Executive John Lee Ka-chiu has pledged to lower the rate to 7.8 percent in three years. 

    Other measures proposed include doubling the current tobacco tax by 2023-2024, which means a pack of cigarettes currently priced at HKD60 ($7.64) would rise to around HKD100. The council said the tax should be further raised in the following two years, so a pack of cigarettes would cost HKD200 by 2025-2026. 

    The council also recommended expanding the city’s nonsmoking areas to cover taxi and bus stands, as well as spaces that fall within 10 meters of hospitals, schools and community facilities. 

    Hong Kong currently does not allow smoking on public transport, including its interchanges, in hospitals, schools, parks and indoor areas of restaurants, bars and malls. 

    Some lawmakers expressed concern about the proposed measures. Representing the wholesale and retail sectors, Shiu Ka-fai, said poorer smokers would not be able to afford the product following the proposed tax increases.

    He also opposed the idea of “smoke-free generation” as the policy would limit freedom of choice. 

    The Long-term Tobacco Policy Concern Group, which represents smokers, opposed the tax hike, saying that consumers might buy illicit cigarettes instead of quitting, and that the measure would impact the city’s economic recovery. 

    Council Chairman Henry Tong Sau-chai also opposed a proposal to reverse Hong Kong’s ban on the re-export smoking alternatives as a means to boost the economy.

     In April, Hong Kong prohibited the import, sale or manufacture smoking alternatives, such as e-cigarettes, heated tobacco products and herbal cigarettes. 

     The legislation also prohibits smoking products from being transshipped through Hong Kong when brought in by truck or ship for transport onwards overseas, although air transshipment cargo and transit cargo that stays on a plane or ship are exempt. 

     Tong worried that the reverse would create a “loophole” where alternative tobacco products would slip to the community.