Category: News This Week

  • Stier: E-cigarette Bans Would Harm Public Health

    Stier: E-cigarette Bans Would Harm Public Health

    Public health policy should be guided by science, data and a large dose of common sense. The promised benefits of any policy should be weighed against the known risks and possibility of unintended consequences.

    Last February, the House of Representatives passed legislation that would ban the sale of flavored e-cigarettes to adults. The bill, sponsored by Rep. Frank Pallone Jr., D-N.J., did not advance in the Senate, but is sure to rear its draconian head in the next Congress, write public health experts Jeff Stier and Henry Miller.

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    Jeff Stier / senior fellow at the Taxpayers Protection Alliance

     

    The prohibition of the legal sale of flavored e-cigarettes to adults is not supported by science, is undermined by an analysis of the available data, and lacks common sense.

    Federal law already bans the sale of all e-cigarettes to anyone under 21, so the Pallone legislation would only change the legal status of the sale of flavored e-cigarettes to adults. That would harm public health, because the data tell us that adult smokers can significantly reduce their health risks if they switch from smoking to vaping. Vaping exposes users to fewer toxic chemicals than smoking cigarettes, and a British study found that long-term cigarette smokers who switched to vaping were halfway toward achieving the vascular health of a non-smoker within a month.

    And because e-cigarettes are estimated to be 95 percent less harmful than cigarettes, according to Public Health England, they can be a boon to public health if adult smokers are able to completely and permanently make the switch. But achieving long-term benefits from the shift to vaping from cigarettes requires adherence, and survey after survey has found that adult smokers are better able to maintain the switch if they use flavored vaping products.

    Flavors play a critical role in helping smokers quit. A 2018 study published in the Harm Reduction Journal found that, “Adult frequent e-cigarette users in the USA who have completely switched from smoking cigarettes to using e-cigarettes are increasingly likely to have initiated e-cigarette use with non-tobacco flavors and to have transitioned from tobacco to non-tobacco flavors over time.” The authors concluded that e-cigarette flavor bans “may discourage smokers from attempting to switch to e-cigarettes.”

    The U.S. Food and Drug Administration (FDA) is aware of the potential life-saving nature of e-cigarette flavors, noting that “certain flavors may help currently addicted adult smokers switch to potentially less harmful forms of nicotine-containing tobacco products.”

    But what about kids using flavored e-cigarettes?

    Recent survey data from the U.S. Centers for Disease Control CDC) reinforces what we’ve known for a long time: Kids are curious and experiment with risky products. But it’s not the flavors that induce teens to vape. According to the 2019 National Youth Tobacco Survey, fewer than a quarter of teens who ever used e-cigarettes cited the availability of flavors as a reason for using them.

    Although adults and youth equally prefer flavored e-cigarettes to those with tobacco flavor, adults quit smoking in large part because of flavors. Kids vape for lots of reasons, but the availability of flavors isn’t high among them.

    Therefore, banning the sale of flavored e-cigarettes to adults in order to prevent youth vaping would be detrimental to public health overall. It would do little, if anything, to curb youth vaping, while it would make it harder for adults to quit smoking.

    As misguided as the legislation was when the House voted for it in February, it is even more inappropriate today, now that the Sept. 9 deadline for e-cigarette manufacturers to submit pre-market tobacco applications (PMTAs) to the Food and Drug Administration has passed. As of that date, it is illegal to sell e-cigarettes whose manufacturer has not submitted to the FDA a substantial (and costly) application for each individual product it wishes to sell.

    E-cigarettes that are the subject of these applications must meet stringent conditions, including: (1) “[r]isks and benefits to the population as a whole, including people who would use the proposed new tobacco product as well as nonusers”; (2) “[w]hether people who currently use any tobacco product would be more or less likely to stop using such products if the proposed new tobacco product were available”; and (3) “[w]hether people who currently do not use any tobacco products would be more or less likely to begin using tobacco products if the new product were available.”

    Because every vaping product, flavored or not, must already meet an extraordinarily high bar, there is no valid rationale for preempting the judgments of FDA scientists and, instead, letting politicians dictate them, as the Pallone bill would do.

    If current regulation, supplemented by unprecedented taxpayer-funded education campaigns, doesn’t prevent kids from vaping, there’s no reason to believe they won’t turn to even riskier products in a flourishing black market spawned by a flavor ban.

    Jeff Stier is a senior fellow at the Taxpayers Protection Alliance. Henry I. Miller, a physician and molecular biologist, is a senior fellow at the Pacific Research Institute. He was a research fellow at the National Institute of Child Health and Human Development and the founding director of the FDA’s Office of Biotechnology.

  • Fresh Farms E-liquid Confirms PMTA Submission to FDA

    Fresh Farms E-liquid Confirms PMTA Submission to FDA

    Fresh Farms E-Liquid has confirmed it submitted a premarket tobacco product application (PMTA) on Sept. 6 to the U.S. Food and Drug Administartion (FDA)

    Working with key scientific partners to ensure the highest standards of analysis as well as the world-class legal team at Keller and Heckman, Fresh Farms fully expects its submission to be accepted and move on to the substantive scientific review phase with the FDA, a press release states.

    “The Fresh Farms submission encompasses dozens of products as it seeks FDA approval to continue offering its extensive portfolio, which company leaders believe is perfectly suited to the needs of adults looking for alternatives to traditional, combustible tobacco products,” the release states. During the PMTA review, the FDA will evaluate whether there is sufficient scientific data demonstrating a net-positive public health result by allowing the product submissions to be sold as alternative options to traditional tobacco products.

    “From day one, we have sought to be the best,” said Fresh Farms CEO and co-Founder Tony Devincentis. “From our branding, our messaging, our team and the quality of our products – our commitment to the PMTA process has been no exception. We have spent years and countless hours evaluating our products, preparing for this moment, and the preliminary results have been phenomenal. Ultimately, our goal is to receive a marketing granted order from the FDA and begin postmarket reporting to them immediately. We plan on being a leader in our industry for years to come.”

    In addition to rigorous adherence to FDA regulations and filing PMTAs, Southern California-basedFresh Farms E-Liquid has proactively led the way for safer packaging with additional warning labels, launching a “No2Minors” campaign to build additional awareness and reduce underage sales to minors. Avail Vapor partnered with Fresh Farms E-liquids, the parent company of Fruitia, in July.

    “We could not be more pleased that Fresh Farms submitted PMTAs for their highly sought-after e-liquid products,” said James Xu, chairman of AVAIL.  “Our customers truly love the Fruitia brand, and we look forward to continuing our shared missions by providing adult smokers with high-quality alternatives to deadly cigarettes.” 

    As of September 9, only those products submitted to the FDA according to their PMTA guidelines will be permitted to remain on the market in the United States.

  • Canopy Growth to Launch CBD Brand With Martha Stewart

    Canopy Growth to Launch CBD Brand With Martha Stewart

    Photo: Kaylen Settles

    Canopy Growth has teamed with Martha Stewart on a CBD product line. The products that will be sold online via the Canopy website and will range in cost from $34.99 to $44.99. The brand isset for a release this week after more than a year in development, CNN reports. A line of pet products is set for later this year.

    David Klein, Canopy’s CEO, told CNN Stewart “brings that trusted voice” to the market.

    Stewart was closely involved with the development of the products, which include gummies that resemble pâte de fruits, and flavors such as Meyer lemon, kumquat, blood orange, and huckleberry. Stewart said that she is working on a separate CBD skincare project – called 86 Elm – with a dermatologist.

    The Martha Stewart brand is owned by Marquee Brands, which acquired it from Sequential Brands Group last year, along with the Emeril Lagasse brand, for $175 million. In 2018, Constellation Brands, which owns Corona and other beers, paid $4 billion for a major stake in Canopy Growth, a Canadian marijuana company.

    Stewart was reportedly introduced to Canopy by Snoop Dogg and his talent agency, Stampede Management. The duo has collaborated on several projects throughout the years. Snoop’s Leafs by Snoop brand is also produced in partnership with Canopy.

  • Opinion: Egypt’s Vapor Ban Driving Black Market

    Opinion: Egypt’s Vapor Ban Driving Black Market

    Credit: Bill Oxford

    Black market trade in e-cigarettes and associated products is being driven by smuggling. Regulating the category will protect consumers, secure much-needed tax revenues, and bolster Egypt’s free-market model.

    Restrictions concerning e-cigarettes, or ‘vapes’ as they are often referred to, have resulted in a myriad of illegal vape shops across the country that sell the product and its accessories, which are often smuggled into the country, according to an article on albawaba.com. Furthermore, they have been influential in online trading’s rise to prominence as people seek to acquire the products they require to quit cigarettes altogether.

    Egypt’s battle against counterfeit goods is an issue that is neither new nor recent. Unfortunately, no industry is safe from exploitation, and the Egyptian market is full of counterfeit products. Both local and international brands continue to be infringed, and the country is taking every measure possible to eradicate such activities.

    Last year, for instance, the Industry Committee of the House of Representatives in Egypt adopted a new legislation against fake branding and products, whether local or global, imposing severe punishments on producers, the article states. And more recently, Egyptian Prime Minister Mostafa Madbouly approved a draft presidential decree on “The Protocol to Eliminate Illicit Trade in Tobacco Products” to implement effective measures to control the supply chain.

    Now the popularity of vaping across the country has led to increased demand for products, these too have subsequently entered the realm of the country’s black market. E-cigarettes and associated products are smuggled into Egypt by air, sea, and land from the East and West, making their way into the country in containers, cars or trucks, hidden among other goods, and even concealed under clothing.

    The reasons for the restrictions on e-cigarettes being imposed were purportedly a lack of sufficient clinical studies to validate electronic cigarettes’ safety, the unknown long-term health consequences and effect of e-smoking when compared to regular smoking, and products containing toxic substances. However, many leading public health organizations have already acknowledged that these products are a healthier option for smokers who cannot or will not quit smoking, with e-cigarettes being been dubbed by renowned global public health institutions as better alternatives. Public Health England is a prominent example, maintaining its stance that vaping is 95% less harmful than smoking.

    The e-cigarette market in the Middle East and Africa alone is forecasted to reach USD 485 million by 2025[1], growing at a rate of 9.74 percent during this period. This is particularly relevant given that Egypt has consistently had one of the largest segments of tobacco smokers in the Arab world for years. As more and more people from this segment continue to adopt vaping, purchases through prohibited channels are also increasing substantially.

    Illicit trade of e-cigarettes has led to an underlying need for swift and appropriate regulation to counter black market activity. In addition to creating awareness concerning potential health risks and ingredients used in unregulated products, manufacturers, wholesalers, and retailers would be able to sell e-cigarettes and related products on the condition they meet set standards, undergo stringent quality checks, and carry relevant health warnings.

    The introduction of regulations in Egypt will not only boost efforts to combat smoking and the emergence of potentially related diseases; efforts to prevent the unpermitted circulation and distribution of these products without restrictions or controls will also be magnified.

    In other markets across the Middle East, including the GCC, suitable regulations for the entry of e-cigarettes into the market have been adopted, dispelling the need for consumers to acquire such products illegally.

    The UAE is a prominent regional example where new regulations and standards covering a wide range of electronic smoking products have been approved and brought into effect. The Emirates Authority for Standardization and Metrology (ESMA) announced early last year that the sales and use of e-cigarettes and similar smoking devices would be legalized, which came into effect in April 2019.

    Similarly, Saudi Arabia is another Gulf state where e-cigarette restrictions exist. According to Saudi legislation, vapes are classified as reduced-risk products (RRPs), those that have the potential to present less risk of harm to smokers who switch to these products as an alternative to smoking. Furthermore, vaping in the Kingdom is legal for citizens and tourists, although it is restricted in public places, including religious and cultural sites, among others.

    The regulations and restrictions enacted in the UAE and Saudi Arabia make a case for an Egyptian ban reversal. More importantly, regulations that would lower contraband trade levels in Egypt is a necessity to mitigate the ongoing tax revenue losses which the Egyptian treasury is incurring.

    Rather than smugglers, counterfeiters, and illicit traders pocketing money out of such illegal activities, the Egyptian government is urged to complement its previous decisions – adopting e-cigarette standards and a corresponding fiscal structure – by reversing the existing ban. Doing so will put an end to tax evasion schemes by placing this trade under the authorities’ umbrella, following suit with the majority of Arab, regional and international governments. At the same time, illegal activity and illicit trade, which is linked other forms of serious organized crime in several markets, will also be prevented.

  • Fliq Vapor Receives PMTA Acceptance Letter From FDA

    Fliq Vapor Receives PMTA Acceptance Letter From FDA

    Fliq Vapor has received and acceptance and filing letter for its premarket tobacco product application (PMTA). The company submitted the PMTA to the U.S. Food and Drug Administration (FDA) for its Fliq XL prefilled disposable system with PachaMama e-liquids.

    In an email to Vapor Voice, Fliq Vapor CEO Jimmy Arazi wrote that Fliq Vapor “has indeed submitted a compliant PMTA along with the associated Tobacco Master File (TPMF) files in a timely manner prior to the September 9, 2020 deadline.” The application was more than 75,000 pages.  

    “Fliq Vapor has retained an FDA registered analytical laboratory, who have performed a complete analysis on the Fliq XL product(s) and will secure the required laboratory testing, including for pharmacokinetics, harmful and potentially harmful constituents (HPHC), and product stability and provide the results to Fliq Vapor and the FDA,” he wrote.

    Fliq submitted the PMTAs for eight flavors of prefilled disposable devices with Pachamama e-liquid brand that is owned by Charlie’s Chalk Dust. Manufactured in the U.S., Charlies also submitted PMTAs for PachaMama e-liquids. The flavors include: Ice cherry limeade, Ice peach, Ice blue razz, Ice kool melon, ice pear apple, Grapple berry, tobacco And menthol.

  • China Cracks Down on Illicit Ads and E-cigarette Sales

    China Cracks Down on Illicit Ads and E-cigarette Sales

    China’s tobacco regulator has just concluded a two-month blitz on the e-cigarette market, which took aim at illicit online marketing and sales to minors.

    E-cigarettes have repeatedly come into the regulatory crosshairs in China, as authorities sought to restrict how they can be sold based on concerns over their potential health impact and use by under-18s. Eye-catching designs and flavors have been blamed for a spike in young nonsmokers taking up the devices, according to a story on caixinglobal.com.

    The State Tobacco Monopoly Administration (STMA) and the State Administration for Market Regulation jointly said Wednesday they had removed over 23,000 videos and links promoting the products from the internet and shuttered almost 5,000 sales platforms.

  • Illinois files lawsuit against California E-Liquid Company

    Illinois files lawsuit against California E-Liquid Company

    Illinois Attorney General Kwame Raoul has filed a lawsuit against e-cigarette maker Juice Man, alleging deceptive marketing practices aimed at enticing youth.

    The lawsuit was filed Thursday in Cook County against the California-based company, according to a story by the Associated Press (AP).

    The move follows a similar Illinois lawsuit in December against Juul, the nation’s biggest e-cigarette maker.

    The Juice Man lawsuit claims the company used child-friendly flavors like cotton candy and used social media platforms with cartoons and giveaway competitions to entice young people.

    E-cigarettes create an aerosol, commonly called vapor, made of particulate matter. The vapor typically contains propylene glycol, glycerin, nicotine, flavors, and traces of toxicants, carcinogens, heavy metals, and metal nanoparticles. Its exact composition varies, and depends on several factors including user behavior, according to wikipedia.

  • EAS Offers Free Webinar on PMTA Site Inspections

    EAS Offers Free Webinar on PMTA Site Inspections

    Tara Lin Couch and Andrew Mooney

    The EAS Consulting Group is offering a webinar on how to prepare for premarket tobacco product application pre-approval inspections of manufacturing facilities by the U.S. Food and Drug Administration (FDA).

    EAS Consulting Group’s senior director for dietary supplement and tobacco services, Tara Lin Couch, and LabStat’s Andrew Mooney will help participants understand the requirements.

    The webinar is free of charge and will take place Sept. 15, 2020, at 11 a.m. Eastern time. Participants can register here.

    On Nov. 9 2020, E-liquid manufacturer Purilum has entered into an exclusive, long-term supply agreement with E-Alternative Solutions (EAS), the manufacturer and supplier of Leap Vapor products.The Leap products containing e-liquids provided by Purilum have been on the market since prior to August 8, 2016, and are currently under review by the U.S. Food and Drug Administration (FDA).

     

  • U.S. FDA Sends 3 Enforcement Letters for Illegal Sales

    U.S. FDA Sends 3 Enforcement Letters for Illegal Sales

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    On the same day premarket tobacco applications (PMTAs) were due, the U.S. Food and Drug Administration (FDA) issued warning letters notifying three companies who sell or distribute unauthorized electronic nicotine delivery system (ENDS) products to remove those products from the market.

    The FDA issued a warning letter to XL Vape LLC (doing business as Stig Inc.) warning the company to remove their disposable e-cigarettes from the market because they do not have the required premarket authorization. Additional warning letters were issued to Flavour Warehouse LTD (doing business as Vampire Vape) and Pretty Women UK LTD (T/A Coil2oil and Mad Kingdom Liquids) for illegally marketing unauthorized menthol-flavored e-liquids.

    The labeling and/or advertising of these products also features cartoon images, such as vampires and kings, that are commonly marketed and/or appeal to youth.

    The FDA stated in a release that it will be prioritizing enforcement against any ENDS product that continues to be sold and for which the agency has not received a PMTA. “The warning letters issued today underscore our concern with the rise in youth use of disposable e-cigarettes and the notable use of menthol-flavored e-cigarettes,” thr release states. “As we have said many times, the FDA will take action against any ENDS product—regardless of whether it is cartridge-based, disposable, flavored, or otherwise—if it is targeted to kids, if its marketing is likely to promote use by minors, or if the manufacturer fails to take adequate measures to prevent youth access.”

  • Ukraine Latest Market for KT&G’s e-Cigarette ‘Lil SOLID’

    Ukraine Latest Market for KT&G’s e-Cigarette ‘Lil SOLID’

    Lil Solid device from KT&G

    KT&G’s cigarette-type e-cigarette, Lil SOLID, and its exclusive heatstick, Fiit, were launched in Ukraine on Sept. 7.

    This is the second achievement of collaboration between KT&G and Philip Morris International (PMI) following the launch of the product in Russia, according to an article in Business Korea.

    KT&G and PMI are stepping up their efforts to penetrate the global e-cigarette market as they expanded their presence to Ukraine in Eastern Europe about three weeks after the launch of Lil SOLID in Russia on Aug. 17. Ukraine has a population of about 42 million. Like Russia, Ukraine has many consumers who have interest in e-cigarettes.

    In Ukraine, Lil SOLID comes in three colors — dark navy, white and blue. Its exclusive stick also comes in three types — Fiit REGULAR, Fiit VIOLA, and Fiit CRISP. They are the same products as those launched in Russia.

    Under the deal with KT&G, PMI will fully manage product sales by utilizing its resources, knowledge and infrastructure in the Ukrainian market.