Category: Regulation

  • Fontem U.S. Submits PMTAs for Myblu

    Fontem U.S. Submits PMTAs for Myblu

    Imperial Brands subsidiary Fontem US has submitted Premarket Tobacco Product Applications (PMTAs) to the U.S. Food and Drug Administration (FDA) seeking authorization for the continued marketing of a wide range of its Myblu electronic vapor products.

    Fontem US’s Blu products play a fundamental role in the company’s goal of providing adult smokers with options that are potentially less harmful than combustible tobacco products. The PMTA submissions include data from a comprehensive range of laboratory and clinical scientific studies, including product analyses, behavioral data, nonclinical health risk information, and information on the impact to both users and non-users of tobacco products.

    Fontem US believes the evidence provided shows that Blu electronic vaping products could play a role in the protection of the public health, in line with the guidance issued by FDA.

    “We agree that the electronic vaping industry should be held to the highest product and marketing standards while providing adult smokers with alternative products that could serve the interest of the public health,” said Antoine Blonde, president of Fontem US.

    “Fontem US looks forward to working with the FDA as the agency develops and enforces an evidence-based regulatory policy.”

  • COP9 and MOP2 Postponed to November 2021

    COP9 and MOP2 Postponed to November 2021

    The World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) said it would postpone its major conferences for a year.

    “In light of the COVID-19 global pandemic and its impact on the conduct of international global conferences and travel, the Bureaus elected by COP8 and MOP1, after consulting the host country, have decided that convening the Ninth Session of the Conference of the Parties to the WHO FCTC (COP9) and the Second Session of the Meeting of the Parties to the Protocol to Eliminate Illicit Trade in Tobacco Products (MOP2), scheduled for November 2020, is no longer possible,” the organization states on its website.

    As a result, the Bureaus, in consultation with the host country and the Secretariat, decided during their Third Joint Meeting on 21 April 2020 to postpone the sessions of COP9 and MOP2 to the following dates:

    COP9: 8–13 November 2021; .

    MOP2: 15–17 November 2021.

    The meetings will convene on those dates in The Hague, Netherlands.

  • U.S. FDA Sends 10 Warning Letters for Targeting Youth

    U.S. FDA Sends 10 Warning Letters for Targeting Youth

    Today, the U.S. Food and Drug Administration (FDA) issued 10 warning letters to retailers and manufacturers who sell, manufacture and/or import unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth.

    The warning letters were sent to establishments marketing unauthorized products, such as a backpack and sweatshirt designed with stealth pockets to hold and conceal an e-cigarette, ENDS products that resemble smartwatches, or devices appearing as children’s toys such as a portable video game system or fidget spinner.

    Warning letters were also issued to companies marketing e-liquids that imitate packaging for food products that often are marketed and appeal to youth, such as candy, or feature cartoon characters like SpongeBob SquarePants.

    “The FDA is focused on manufacturers and retailers that make and sell ENDS products that are targeted to youth and increase their appeal. The public should really be outraged by these products. The FDA is especially disturbed by some of these new products being marketed to children and teens by promoting the ease with which they can be used to conceal product use, which appeals to kids because it allows them to conceal tobacco product use from parents, teachers, law enforcement or other adults,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “Even in the midst of the COVID-19 pandemic, we have not lost our focus on protecting youth against the dangers of e-cigarettes and will do everything we can to take action. These warning letters should send a clear message to all tobacco product manufacturers and retailers that the FDA is keeping a close watch on the marketplace. If you’re marketing or selling these products to youth, the FDA will not tolerate it.”

    The following retailers and/or manufacturers or importers received a warning letter:

    • Vaprwear Gear, LLC (manufacturer, online retailer)
    • Vapewear, LLC (manufacturer, online retailer)
    • Wizman Limited (manufacturer, online retailer)
    • EightCig, LLC (online retailer)
    • Ejuicepack, LLC (online retailer)
    • Vape Royalty, LLC (online retailer)
    • VapeCentric, Inc. (online retailer)
    • Dukhan Store (online retailer)
    • VapeSourcing (online retailer)
    • Shenzhen Uwell Technology Co., Ltd. d/b/a DTD Distribution Inc. (importer, retailer)

    The FDA has also issued warning letters to 73 brick-and-mortar retailers for selling unauthorized flavored, cartridge-based ENDS products. This follows 22 warning letters that FDA issued last month for similar violations to online and brick-and-mortar retailers and manufacturers across the country. These warning letters are part of a series of ongoing actions consistent with the FDA’s recently issued policy of enforcement priorities for e-cigarettes and other deemed products on the market.

  • France Bans Online Sales of Nicotine Products

    France Bans Online Sales of Nicotine Products

    Ded Mityay I Dreamstime.com

    France has banned the online sale of nicotine products and limited their sale in pharmacies, after researchers suggested that nicotine may play a role in protecting against coronavirus.

    The new rules cover products like nicotine gum and patches, designed to help people stop smoking. Last week, data from a Paris hospital indicated that smokers were statistically less likely to be admitted for treatment for Covid-19, according to an article on BBC.com.

    Trials are set to continue in France.

    France has reported nearly 22,000 coronavirus-related deaths since the start of the outbreak earlier this year. The authorities are planning to gradually lift the lockdown from 11 May.

    What are the new nicotine restrictions?
    The French government says people will only be allowed to buy one month’s supply of these products. The aim is to stop people putting too much nicotine into their bodies, in the hope of protecting themselves against coronavirus, and also to protect the supply for people who need it, says the BBC’s Lucy Williamson in Paris.

    What’s the background to this?
    The run on nicotine products was sparked this week after researchers noticed the low number of smokers among those hospitalised with Covid-19. The theory that nicotine could play a role in blocking the virus is due to be tested at a hospital in Paris, using nicotine patches.

    The government’s chief health official said the study was interesting but warned that smoking killed 75,000 people a year in France. The official also warned that smokers who did become infected with coronavirus tended to have more serious symptoms.

  • FDA Warns CBD Companies Over Illegal Claims

    FDA Warns CBD Companies Over Illegal Claims

    Cannabis plants

    The U.S. Food and Drug Administration has issued warning letters to two companies for illegally selling unapproved products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug and Cosmetic Act. This action is part of the FDA’s efforts to pursue companies that illegally market CBD products with claims that they can treat medical conditions, including opioid addiction or as an alternative to opioids.

    “The opioid crisis continues to be a serious problem in the United States, and we will continue to crack down on companies that attempt to benefit from selling products with unfounded treatment claims,” said FDA Principal Deputy Commissioner Amy Abernethy.

    “CBD has not been shown to treat opioid addiction. Opioid addiction is a real problem in our country, and those who are addicted need to seek out proper treatment from a health care provider. There are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD, and we will continue to work to protect the health and safety of American consumers from products that are being marketed in violation of the law.”

    The two warning letters were issued to Biota Biosciences of Washington state and Homero Corp DBA Natures CBD Oil Distribution of New Hampshire.

  • Court Extends Deadline for PMTA Applications to Sept. 9

    Court Extends Deadline for PMTA Applications to Sept. 9

    Tobacco and vapor companies have an extra four months to file their premarket tobacco applications (PMTAs) for newly deemed tobacco products with the Food and Drug Administration (FDA) following a U.S. court ruling.

    On July 12, 2019, the United States District Court for the District of Maryland ordered the FDA to require manufacturers of e-cigarettes, cigars and other deemed new tobacco products that were on the market as of Aug. 8, 2016 to submit applications for premarket review by May 12, 2020.

    However, the coronavirus pandemic has drastically impaired the FDA’s ability to adhere to this timeline. As a result of the pandemic and these exceptional and unforeseen circumstances, the agency requested on March 30 a 120-day extension of the May 12 deadline. This request has now been granted.

    The court order means applications for premarket review for many e-cigarettes, cigars and other new tobacco products are now required to be filed by Sept. 9, 2020. Consistent with the original court order, for companies that submit timely applications, the agency may continue to exercise enforcement discretion, meaning their products would generally continue to be marketed without being subject to FDA enforcement actions, for up to one year from the deadline (up to Sept. 9, 2021), unless a negative action is taken by the FDA on an application during that time.

    Following the Covid-19 outbreak, the agency received numerous inquiries from the tobacco industry expressing concern they would be unable to complete premarket applications by the original May 12 deadline due to disruptions at all stages of preparation, including preventions or disruptions to in-person laboratory work and clinical studies or necessary foreign travel, or from the shuttering of manufacturing facilities abroad.

    In a statement, the FDA said it believes the public health is better protected by not having these firms compromise their employees’ health or take actions that would risk spreading Covid-19 to others by trying to meet the previous May 12 deadline. In the more than a dozen requests for an extension that the FDA received, this public health concern was mentioned repeatedly.

    Another consideration, according to the agency, was that a number of the FDA’s Center for Tobacco Products (CTP) personnel have been deployed to work on Covid-19 pandemic issues for the U.S. Public Health Service (PHS), leaving fewer staff to process applications. Many of those deployed are among the staff that had been playing a critical role as CTP prepared for this deadline.

    “Ultimately, a Sept. 9 deadline will better serve the public health by allowing manufacturers to prepare for, and the agency to conduct, the thorough scientific review of these products that is required under law and vital to our mission of protecting Americans while reducing or eliminating physical contact during this critical period,” the FDA wrote in its statement.

    “Importantly, this new deadline does not detract from our efforts to prioritize enforcement of certain e-cigarette products currently on the market. Although the FDA’s in-person compliance checks and vape shop inspections are currently on hold due to the pandemic, review of previous inspections continues, and we continue to monitor the online marketplace and will take action as appropriate.

    “Accordingly, the January 2020 enforcement priorities guidance, which independently prioritizes earlier enforcement against certain e-cigarette products that are widely used by youth, remains in effect regardless of whether an application is submitted, although we intend to update it for products for which the Sept. 9 date now applies.”

  • Covid-19, Flavor Ban Could Crush New Jersey Vape Shops

    Covid-19, Flavor Ban Could Crush New Jersey Vape Shops

    Coronavirus cell
    Photo: mctic.gov.br | Flickr Creative Commons

    As people rushed to stock up on toilet paper and hand sanitizer in March, Debi Meinwieser dropped thousands of dollars on more than 400 bottles of vape juice for e-cigarettes, according to an article on NJ.com.

    The 56-year-old from Whiting Township said she sought out the supply not in anticipation of the coronavirus outbreak and stay-at-home order, but to avoid a drought when the state law banning flavored vaping products takes effect Monday.

    “I stocked up,” she said. “But I’m concerned for the new vapers and the smokers who haven’t had the chance to start vaping yet.”

    Meinwieser, like many others across the country, said she quit smoking cigarettes after three decades once she started vaping. She had tried nicotine gums and patches, but nothing helped to wean her off nicotine. Instead, she credits the flavored vaping products she has used for nearly five years for saving her life, according to the article.

    As New Jersey officials watch for the forecasted peak in coronavirus cases later this month, another date looms: April 20, the day when vape shops must stop selling flavored products. Gov. Phil Murphy signed the law banning the sale of of flavored vaping products, which include candy and fruity flavors that may attract teens, in January. It came with a 90-day waiting period before going into effect.

    The measure marked the nation’s first permanent flavor ban, going further than several emergency orders some states issued last year as a mysterious vaping health crisis took hold in the fall. Rhode Island has since made its temporary flavor ban permanent, too. The illness put 2,807 people into hospitals and killed 68, according to the U.S. Centers for Disease Control and Prevention, according to the article.

    Supporters of the law say it will keep the products out of the hands of teens, who have taken up vaping years after youth cigarette use fell. But opponents say it will force adult users, many of whom previously smoked cigarettes, either back to those products or to the black market. And vape shops, largely small businesses employing a few thousand people across the state, have promised the ban will thrust them into bankruptcy. It will also rob the state of tax revenue as people shift to the web or stores over state lines to buy the products.

    “They’re still easily accessible, ordering online, shipping in state,” said Sheryl Agro, owner of InnoVapes in Wrightstown. “You’ve effectively just given up your control over these products.” A former version of the flavored vaping bill included a ban on menthol cigarettes, but state Senate President Stephen Sweeney said lawmakers put that on hold, planning to bring it up again later this year during budget discussions. The change has vapor rights advocates accusing lawmakers of playing a political game, rather than looking out for the health of the state.

    The stress on the industry was exacerbated when Murphy ordered non-essential businesses to close in an effort to contain the coronavirus outbreak. In mid-March, the vape shops suddenly found themselves fighting a tighter deadline to unload the products, but had no customers walking through their doors. Now, they’re pleading for an extension on the ban, and for the state to allow them to operate with curbside pickup as essential businesses. Activists and shop owners say they haven’t heard back from officials, according to the article.

    “Cigarettes are still labeled to be sold. Cigarettes are proven to be killing,” said Shoaib Iqbal, CEO of Good Guy Vapes and a vice president of the New Jersey Vapor Rights Coalition. “We feel like an alternative should also be able to be sold.” Other countries under lockdown — including Spain, Italy and France — have kept vape shops open, and last week, Louisiana reversed a decision to close them.

    And for those like Meinwieser, who found relief in a legal and regulated product, the policy is a gut punch. “When I started vaping, I had no clue that vaping was being attacked,” she said. “I just thought, ‘Oh my god, I finally found something to help me quit smoking.’”

    She, too, wonders why vape shops have not been allowed to operate with curbside pickup as essential businesses, like takeout restaurants or stores that sell cigarettes. She bought some 400 bottles at $8 a piece, a wholesale price, but knows many others do not have the luxury to drop so much money at once.

    In early March, with about five week left until the ban took effect, vape shop owners said they had not seen customers stocking up yet, both because time remained, and because some customers knew they could order online. Now they’re facing even larger stockpiles of soon-to-be banned product than expected.

    “We’ve been kind of robbed of that time,” Iqbal said. “We’re hoping to get some sort of extension.” A spokeswoman for Murphy declined to comment on an extension of the enactment date. While they’ve started online ordering, Iqbal says many customers have reached out desperately — they do not know how to order products online, or do not have credit cards to pay for them.

    During the 90-day period, vape shop owners were meant to unload product and pivot their business models. Agro sells some CBD products for people and pets, but most of her revenue to support five employees with benefits comes from the flavored vaping products purchased by military personnel at nearby Fort Dix. She did not think her shop would survive the ban, and said the closure of nonessential businesses in March put her further behind, according to the article.

    For her, the inability to open during the stay-at-home order only builds on the idea that the government has something against vape shops. “To deem vape shops as nonessential is just more blatancy from the government that they just don’t want to accept that this works as a smoking cessation product,” Agro said. “I quit the day I started vaping. I would never go back. I had a dream that if I could do this myself, I could help so many other people.”

  • RAI Files 2 New PMTAs for Vuse Products

    RAI Files 2 New PMTAs for Vuse Products

    Reynolds American Inc. (RAI) has submitted two new premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration (FDA). RAI is seeking marketing orders for its Vuse Vibe and Vuse Ciro vapor products, which would allow these products to remain on the market after the FDA’s deadline for PMTAs for electronic nicotine-delivery systems.

    The applications include a range of scientific studies for Vuse Vibe and Vuse Ciro using well-known methodologies, including the comparative assessment of cigarettes and associated health risks. Though the PMTAs themselves are considered commercially proprietary and are thus confidential, the data and information submitted to the FDA include the results of product analyses, nonclinical health risk information and human health and population information, including the impact to both users and nonusers of tobacco products.

    According to RAI, the results of these studies demonstrate that the continued marketing of the Vuse Vibe and Vuse Ciro products is appropriate for the protection of the public health. The FDA s expected to extend the PMTA deadline to from May 12 to Sept. 9.

    “I am incredibly proud of our diverse team of scientists, researchers and regulatory experts, who have worked tirelessly together to complete these applications well ahead of the FDA’s May deadline for ENDS products,” noted Reynolds’ executive vice president and head of scientific and regulatory affairs, James Figlar.

    The PMTAs for Vuse Vibe and Vuse Ciro are the second and third complete grouped PMTA applications submitted by Reynolds to the FDA for review, following the initial PMTA applications for Vuse Solo submitted in October 2019.

  • U.S. FDA Shifts its Covid-19 Stance on Vaping

    U.S. FDA Shifts its Covid-19 Stance on Vaping

    Courtesy: US FDA

    The U.S. Food and Drug Administration modified its stance on Covid-19 and vaping, saying it has an unknown effect on the risk of the new coronavirus, while warning that smoking can create worse outcomes, according to Bloomberg News.

    “E-cigarette use can expose the lungs to toxic chemicals, but whether those exposures increase the risk of Covid-19 is not known,” the agency said Wednesday in an emailed response to a question from Bloomberg News.

    The agency had said late last month that vapers and smokers with underlying health conditions might be at higher risk from complications.

    Its description of cigarettes’ risks also differed from its earlier statements. “Cigarette smoking causes heart and lung diseases, suppresses the immune system, and increases the risk of respiratory infections,” FDA spokeswoman Alison Hunt said. “People who smoke cigarettes may be at increased risk from Covid-19, and may have worse outcomes from Covid-19.”

    The new statement comes as the disease afflicts young people in some countries at rates that are surprising, given initial data out of China, and some health experts speculate as to whether vaping could play a role, the article states.

    ‘Especially Serious’

    Other U.S. agencies have issued mixed warnings on both smoking and vaping. Nora Volkow, director of the National Institute on Drug Abuse, wrote a recent blog post warning that the coronavirus “could be an especially serious threat to those who smoke tobacco or marijuana or who vape.”

    The coronavirus presents a new challenge for the tobacco industry, which for years has faced lawsuits and higher taxes due to links between smoking and higher rates of lung disease. E-cigarette maker Juul Labs Inc. was already under fire for allegedly marketing its product to teenagers, and an amended complaint filed in San Francisco district court this month includes claims that vapers suffer a greater risk of more serious coronavirus complications.

    Before the outbreak of the coronavirus, the vaping industry had drawn scrutiny and restrictions from federal and state governments amid a series of deaths and illnesses that were linked to faulty cannabis products.

    Michael R. Bloomberg has campaigned and given money in support of a ban on flavored e-cigarettes and tobacco. He is the majority owner of Bloomberg LP, the parent company of Bloomberg News.

  • FDA Extends Comment Period  for Information on EVALI

    FDA Extends Comment Period for Information on EVALI

    Edgars Sermulis – Dreamstime.com

    In response to requests from the public, FDA is extending the comment period for a request for information (RFI) seeking data and information related to the use of vaping products that are associated with lung injuries

    The RFI, initially published in the Federal Register on Feb. 18, responds to direction from Congress to gather additional information that could help identify and evaluate additional steps that could be taken by the agency to “address the recent pulmonary illnesses reported to be associated with the use of e-cigarettes and vaping products.”