Category: Regulation

  • Opinion: Four-Month FDA Extension Not Sufficient

    Opinion: Four-Month FDA Extension Not Sufficient

    Doctor is comparing electronic vaporizer and conventional tobacc
    Photo: Vchalup | Dreamstime.com

    Consumers are staying home and spending less as COVID-19 and social distancing mandates sweep across the globe. The extreme, necessary steps to control the spread of the virus have already taken an economic toll, and there certainly will be a long-term impact on individual businesses and workers. One industry, in particular, will likely fail without swift federal action: e-cigarettes, according to Michelle Minton with the Competitive Enterprise Institute.

    Cigarettes may prove “pandemic-proof.” Since they are often sold at outlets deemed “essential” under the current lockdown, cigarettes continue to be available and big tobacco companies have so far remained financially unscathed. But the same is not true for their lower-risk competitors. Vape shops, which sell vapor products, like e-cigarettes, have not been universally recognized as essential businesses, so they have been forced to close.

    To maximize ways to fight the virus, many states have pressed pause on certain rules and regulations (leading many to wonder if they were #NeverNeeded in the first place.) For example, Vermont Governor Phil Scott signed an order lifting the state ban on home alcohol delivery. This was a pragmatic move, as Reason’s Guy Bentley aptly put it. Vermont lawmakers understand that people still want to imbibe, and at-home delivery discourages unnecessary booze runs.

    Yet that pragmatism hasn’t been extended to e-cigarettes, and Governor Scott’s online e-cigarette sales ban enacted last year remains in place. As a result, some adults now find themselves cut off from the products they rely on to stay smoke-free. Without swift federal action, they may be cut off permanently as vape shops go belly up, and many people will revert to smoking.

    The last year has already been difficult for those who sell and enjoy vapor products. Even as the evidence that e-cigarettes are relatively harmless for adults and highly effective for smoking cessation has become clearer, calls to ban or restrict e-cigarettes have only grown louder. Groups that oppose nicotine use, no matter how safe, ramped up attacks, spending millions to promote the idea that e-cigarettes are no different than cigarettes and to foment panic over the non-existent “epidemic” of youth vaping.

    Last summer, as scores of mostly young people fell ill with a mysterious lung ailment, anti-tobacco groups (with the aid of the CDC and news media) convinced people e-cigarettes were to blame, obfuscating the fact that the injuries were caused by black market THC vaping products, contaminated with vitamin E acetate (an oil that cannot be mixed into nicotine-containing e-cigarettes).

    By exploiting fear and confusion, e-cigarette opponents amassed support among the public and lawmakers for restrictions on e-cigarettes. Cities and states instituted onerous new rules, including banning all e-cigarette sales (but not traditional cigarettes), prohibiting flavored e-cigarettes, restricting sales to in-person transactions, and criminalizing possession of certain e-cigarettes.

    Some members of Congress tried to make these rules national, holding several hearings antagonistic toward vaping and considering a number of bills. Rep. Frank Pallone’s (D-NJ) bill, which bans all flavors except “tobacco,” prohibits online and mail-order sales and raises the national tobacco purchasing age limit to 21 (which it already is), passed the House. If enacted, it would make e-cigarettes less attractive, harder to get, and more expensive—leading some to label the bill a “win for cigarettes.”

    E-cigarette supporters battled threats to products they believe saved their lives. But unless federal regulators take immediate action there will be no industry left to save: By May 12, 2020 all vapor products must either submit a pre-market tobacco application (PMTA) to the Food and Drug Administration (FDA) for approval or exit the market. Filing a PMTA is an expensive and time-consuming task, which the FDA admitted would Eliminate 99 percent of the e-cigarette market. COVID-19 disruption could make that figure nearer to 100 percent.

    Last week, the FDA submitted a request to delay the PMTA deadline by four months, but even if granted, this would merely push the inevitable end of the e-cigarette industry to September 2020. The FDA should go further: Make the process, which vapor industry experts estimate takes over 1,700 hours and millions of dollars, quicker and cheaper for small companies. Although Health and Human Services Secretary Alex Azar announced plans in January to create a “streamlined” avenue for small businesses, that has yet to materialize.

    In the meantime, anti-nicotine advocates are still trying to spread misinformation, slip state-wide vaping bans around the normal legislative process, and, ludicrously, link COVID-19 deaths to e-cigarette use—for which there is zero evidence. Worse, some have even encouraged countries to reject critically needed medical equipment like ventilators if donated by Big Tobacco.

    The outbreak of COVID-19 should elevate the value of harm reduction—the idea that you can’t entirely stop people from engaging in risky behavior, but you can reduce harm by encouraging them to do so in the least risky way possible. E-cigarettes are the best way we know so far to reduce the harms related to nicotine use. They are vastly safer than smoking and more popular than most other forms of tobacco cessation. Lawmakers should do everything in their power to keep e-cigarettes a viable option for smoking cessation.

  • ITSA Initiates Recruitment Campaign to Fight Fraudulent Trade

    ITSA Initiates Recruitment Campaign to Fight Fraudulent Trade

    The International Tax Stamp Association (ITSA) is recruiting new members, including government authorities, universities, foundations, nongovernmental organizations (NGOs) and other associations, who can help fight the fraudulent trade of tobacco, alcohol and other products.

    All prospective associate members must have a legitimate and established interest in tax/security stamps or secure track-and-trace systems. Associate membership is not open to individuals or to organizations that collaborate significantly with manufacturers, distributors or sellers of excisable products or with their subsidiaries and associates.

    “We want to increase our influence in the fight against the illicit trade of tobacco and other products by forging closer links with NGOs, research bodies, government authorities and other key bodies,” said Juan Carlos Yanez, chairman of the ITSA. “Tobacco fraud in particular leads to a rapid increase in poor health and costs revenue authorities millions of pounds in lost excise duty.”

  • U.S. FDA to Announce Sept. 9 PMTA Deadline

    U.S. FDA to Announce Sept. 9 PMTA Deadline

    While not yet official, the deadline for submitting premarket tobacco product authorizations (PMTA) to the U.S. Food and Drug Administration (FDA) is one step closer to being delayed from May 12, 2020 to Sept. 9, 2020 due to the Covid-19 pandemic.

    Judge Paul Grimm of the U.S. District Court for the District of Maryland issued an “indicative ruling” granting the FDA’s request to delay the deadline by 120 days.

    The ruling is not yet final, however, due to procedural issues that are expected to be resolved expeditiously. Due to appeals filed by several organizations, including the Vapor Technology Association and the FDA itself, Grimm no longer has the authority to modify his original ruling which moved the deadline to May 2020. That power now lies with the U.S. Court of Appeals for the Fourth Circuit.

    For the ruling to become valid, the Fourth Circuit must remand the case back to Grimm’s court where Grimm says he would modify the order to allow the FDA to delay the change. The FDA will then need to update its regulations to move the PMTA date to Sept. 9, 2020.

  • U.S. House Subcommittee Asks FDA to Ban Vapor

    U.S. House Subcommittee Asks FDA to Ban Vapor

    Photo: Srdjan Randjelovic | Dreamstime.com

    In what turned out not to be an April Fool’s Day joke, Rep. Raja Krishnamoorthi, the Chairman of the Subcommittee on Economic and Consumer Policy, sent a letter urging the U.S. Food and Drug Administration (FDA) to use its authority to clear the market of e-cigarettes for the duration of the coronavirus pandemic and use all available tools to encourage Americans to stop smoking and vaping.

    Earlier this week, FDA asked a federal court to delay by four months its order requiring e-cigarette manufacturers to submit applications to remain on the market by May 12, 2020, according to a statement from, according to a statement for the House Committee on Oversight and Reform. 

    The Subcommittee did not oppose this request, but instead asked FDA to take the following steps for the duration of the coronavirus crisis: 

    (1)  use all available tools to encourage Americans to stop smoking combustible cigarettes and using e-cigarettes;|
    (2)  suspend all approvals of Premarket Tobacco Product Applications; and
    (3)  commit to immediately clearing the market of all e-cigarettes by prioritizing enforcement against them.

  • U.S. FDA Asks District Court for PMTA Extension

    U.S. FDA Asks District Court for PMTA Extension

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    The US Food and Drug Administration (FDA) has submitted a letter to the U.S. District Court for the District of Maryland asking Judge Grimm to extend the May 12, 2020 court-ordered PMTA deadline by 120-days to September 9, 2020 “in light of the global outbreak of respiratory illness caused by a new coronavirus.”

    The FDA explained in its submission that “the global coronavirus outbreak poses unforeseen challenges and has made the May 12 deadline a public health risk to those who cannot comply with the deadline through telework.” In addition, FDA explained that telework also will complicate and delay FDA’s review of applications, according to a release by the Vapor Technology Association (VTA).

    In deciding to request a 120-day extension, the FDA noted that it had received requests from numerous trade associations and companies, including consultants involved in the PMTA process, for extensions “between 8 weeks and 180 days, with the majority of requests for 180 days.” The VTA was one of those entities that submitted a request to FDA and did so on March 20, 2020 outlining the basis and necessity for deadline extensions for large manufacturers and small manufacturers.

    At this point in time, no one can predict the length and severity of the COVID-19 commercial shutdown. The FDA explicitly recognized this point in the Second Declaration of Director the FDA’s Center for Tobacco Products (CTP) Mitch Zeller which accompanied the letter to the Court.

    In his Declaration, Zeller stated that “it is not clear at this point what the precise impact of the COVID-19 outbreak will be on the scope of FDA’s ability to complete application reviews within the 12-month period of time once applications are filed.” 

    That is precisely why VTA requested a new deadline of November 2020 (or at least 180 days from business resumption) for large manufacturers, and a new deadline of February 2021 (or at least 270 days from business resumption) for small manufacturers, according to the VTA statement. “To that end, VTA explained that ‘the question of whether these deadline changes are sufficient or ultimately realistic can and must be re-evaluated in the coming months as more information comes to light about the length and severity of the commercial shutdown due to COVID-19.’”

    In its letter to the District Court, FDA notes that the plaintiffs (American Academy of Pediatrics, et al.) will not oppose the FDA’s request, though the plaintiffs have requested the opportunity to “express their misgivings about the extension on the record.”  In order to rule, Judge Grimm still will have to have the case remanded to him by the Fourth Circuit and then he would need to make his decision on whether or not to grant the FDA’s request.  

    However, given the strong case made by the FDA, the obvious insurmountable obstacles created by the coronavirus, and the apparent lack of opposition by the plaintiffs, a ruling extending the deadline is reasonably likely though still not certain.

  • Altria Seeks PMTA Extension From U.S. FDA

    Altria Seeks PMTA Extension From U.S. FDA

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    Altria has sent a letter to the U.S. Food and Drug Administration (FDA) requesting that the agency push back the May 12 authorization deadline by eight weeks due to the coronavirus outbreak.

    In order to keep certain tobacco and nicotine products on the market, companies must submit applications to the FDA by May 12, but many companies have been disrupted due to the virus outbreak; many companies have asked employees to work from home, factories have temporarily closed and Altria’s CEO contracted the virus.

    Altria has requested that the FDA seek an extension following the eight-week social distancing recommendation from the U.S. Centers for Disease Control and Prevention.

    “Although we make this request and raise these issues given these unprecedented times, we remain committed to working with the agency on these important product submissions,” Paige Magness, Altria’s senior vice president, said in a letter. The company has asked that if an extension is not possible the FDA allow companies to submit data and product samples after the deadline if they are affected by the outbreak.

  • Nicotine Alliance Pens U.K. Government Over India’s Illegal Vape Seizures

    Nicotine Alliance Pens U.K. Government Over India’s Illegal Vape Seizures

    The New Nicotine Alliance (NNA) has written to the UK Government about a situation in India. The country that receives over three quarters of a million UK visitors every year has taken to confiscating legal vaping equipment. Despite a ban on the sale of vape equipment, the act of vaping remains legal – but Indian officials are not following the legislation.

    The NNA is a registered UK charity staffed by consumer volunteers, formed to increase understanding about the benefits of “new” risk-reduced nicotine products and a better recognition of long-term recreational use of nicotine as a powerful incentive for smoking cessation, according to story on planetofthevapes.co.uk. It has noted:

    The Indian government has passed a law banning e-cigarettes, but it excludes personal consumption. The Indian Civil Aviation Ministry has misunderstood the law and is seizing and destroying the property of unsuspecting UK visitors.

    Thousands of UK citizens potentially affected; the NNA has asked the Foreign and Commonwealth Office to update travel advice. The NNA states: “UK visitors to India who use e-cigarettes to improve their health on the advice of British health organisations are having their devices confiscated at airports.”

    The NNA says it has become aware of five travellers who have suffered hard-line and unsanctioned action, but those affected could stretch to tens of thousands more UK citizens who have chosen vaping as a way of stopping smoking.

  • Vape Shop Inspections Suspended by U.S. FDA Due to Covid-19 Concerns

    Vape Shop Inspections Suspended by U.S. FDA Due to Covid-19 Concerns

    The U.S. Food and Drug Administration (FDA) has ended activities such as domestic compliance checks and vape shop inspections, the health regulator said, as its staff switch to teleworking amid the fast-spreading coronavirus outbreak.

    The health regulator has been scaling back domestic and foreign inspections in the wake of the outbreak, which has infected more than 227,700 people across 175 countries, based on a Reuters tally, according to a story on Reuters.com.

    In the United States, the virus has infected over 10,000 people and caused 150 deaths, according to the U.S. Centers for Disease Control and Prevention.

    The FDA has already temporarily deferred all domestic routine surveillance facility inspections and postponed most foreign inspections through April.

    Although the inspections stop immediately, administrative work can continue for two weeks, the FDA’s Center for Tobacco Products said

  • Turkey Bans Importation of All E-cigarettes and Vapor Related Products.

    Turkey Bans Importation of All E-cigarettes and Vapor Related Products.

    Turkey banned the import of e-cigarettes and related products on Feb. 25.

    The ban covers e-cigarettes, accessories, spare parts and solutions as well as e-cigarette products that use heating or incineration, like electronic hookahs. The country had already banned the sale of electronic cigarettes.

    In 2019, 17.6 million illegal cigarette packages and 140,000 electronic cigarettes were seized at the country’s border.

    “We will not give passage to illegal trafficking of cigarette[s] and electronic cigarette[s],” said Ruhsar Pekcan, Turkey’s minister of trade. “I wish the best for our country with this serious measure for the good health of our fellow citizens.”

    About 14.5 million adults and 252,000 children in Turkey use tobacco every day, and about 83,100 people die from tobacco-related diseases, according to the Tobacco Atlas.

  • A Flavored Vapor Ban Bill has Passed in the US House of Representatives

    A Flavored Vapor Ban Bill has Passed in the US House of Representatives

    The U.S. House of Representatives passed a ban on flavored vapor and tobacco products, including menthol cigarettes, on Friday, reports The Hill.

    Sponsored by Energy and Commerce Committee Chairman Frank Pallone Jr. and Representative Donna Shalala, the legislation aims to curb the rise of youth vaping rates by banning nontobacco flavors such as mint and mango that public health experts say lure children into smoking.

    Democrats hope to pass the bill to present a contrast to the Trump administration’s approach to youth vaping rates. The Food and Drug Administration began enforcing a limited ban earlier this month on flavored pod-products with exemptions for menthol and tobacco flavors. It also exempted open-tank and disposable e-cigarettes.

    Leading public health groups, including the American Cancer Society, American Heart Association and the American Lung Association, argue the bans represent the best way to tamp down rising youth vaping rates.

    “This legislation is exactly what’s needed to reverse the youth e-cigarette epidemic and end the tobacco industry’s long and lethal history of targeting kids and other vulnerable groups with flavored products,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids

    The Senate is unlikely to consider the bill, however, and President Donald Trump’s advisers said Thursday they would recommend he veto it in its current form.

    While most Democrats supported the measure, some voted against the bill, worrying it could give police a way to target African Americans. Menthol cigarettes are disproportionately used by African Americans.

    “Law enforcement would have an additional reason to stop and frisk menthol tobacco users because menthol would be considered illegal under this ban,” said Representative Yvette Clarke, a member of the Congressional Black Caucus.

    She also took issue with the fact that the bill exempts premium cigars favored by white people but took aim at products used by black people.