Tag: FDA

  • Motley Fool: Juul Removal Would Crown BAT King

    Motley Fool: Juul Removal Would Crown BAT King

    Photo: BAT

    The removal of Juul products would hand the U.S. market to BAT (formerly British American Tobacco), according to Motley Fool.

    Juul, which is partly owned by Altria Group, had been the undisputed e-cigarette leader, with a near-80 percent share of the market at the height of its success. The latest Nielsen data puts Vuse’s share at 35.1 percent compared to 33.1 percent for Juul. Third-place NJOY has a 3.1 percent share.

    Last year, the U.S. International Trade Commission ruled that Philip Morris International’s IQOS heated tobacco device infringed on BAT’s patents, and that device was prohibited from being imported and sold in the U.S. Altria had partnered with PMI to market and distribute IQOS in the U.S., but the ITC ruling disrupted those plans.

    Because Altria shelved its MarkTen e-cigarette brand in  favor of partnering with PMI, the ITC ruling leaves it without a vapor product. The FDA has all but wiped out the rest of its investment in Juul. In 2018, Altria paid $12.8 billion for a 35 percent in the vapor company. As of the end of the first quarter of 2022, Altria had reduced the fair value of its Juul position to just $1.6 billion.

    If the FDA is successful in eliminating Juul, BAT will essentially have no roadblocks in its way to market dominance.

    Vuse turned profitable in the U.S. for BAT in the second half of last year, and it’s been able to grow its share because it discounted the device and the consumables to attract users. Earlier this month, BAT said it was now ready to raise prices on both. With a major competitor removed from the market, this should provide the company with a big boost in profits.

    BAT’s vapor revenue grew 59 percent last year to £927 million ($1.14 billion), while its own heated tobacco products, marketed under the Glo brand, saw a 46 percent rise in sales to £853 million.

  • San Jose, California Flavor Ban Begins on July 1

    San Jose, California Flavor Ban Begins on July 1

    Credit: Andriano_cz

    The San José City Council’s unanimous action last fall to ban flavored vaping and other tobacco product sales will soon take effect. Starting July 1, 2022, the sale of flavored tobacco within the City of San José, California is prohibited, as outlined in the city’s Tobacco Retail Ordinance.

    “The ban applies to any tobacco products with an artificial flavor, natural flavor, aroma, herb or spice, including — but not limited to — cherry, chocolate, cinnamon, clove, cocoa, coconut, coffee, grape, licorice, menthol, mint, orange, pineapple, strawberry, vanilla, and other flavors,” according to press release. “This includes products where such flavors characterize the smoke or vapor produced by the tobacco product.”

    Certain products are exempted from the ban, including shisha, hookah, and premium cigars.

    The City’s Code Enforcement Division, which oversees tobacco retailers in San José, will enforce the ban. Sellers of the banned products, after June 30, 2022, could be fined up to $2,500 per day and/or have their tobacco license revoked.

    “The tobacco industry has targeted youth with these colorful, flavored tobacco products, leading to an alarming rise in tobacco use among youth. We are proud to put the health of our youth first with these prohibitions,” said Mayor Sam Liccardo.

    “Studies show that more than 80 percent of minors and young adults report that flavored tobacco was their first use of a tobacco product,” said Chris Burton, director of the Planning, Building and Code Enforcement Department. “This ordinance update to ban the sale of flavored tobacco and other steps can greatly help minimize access to tobacco by youth.”

    The City Council’s action and ordinance update in Fall 2021 included the steps of prohibiting the location of new tobacco retailers locating within 1,000 feet of facilities that serve youth and within 500 feet of an existing tobacco retailer. That requirement went into effect on November 18, 2021.

    The Code Enforcement Division facilitated the Tobacco Retail Ordinance update with a grant from the County of Santa Clara, which is coordinating with cities throughout the county on flavored tobacco prohibitions.

    San José and other cities proceeded with local bans after California Senate Bill 793, which banned the sale of flavored tobacco statewide in 2020, was placed on hold for a voter referendum in November 2022 that could potentially repeal the measure.

    The American Nonsmokers’ Rights Foundation reports that as of April 1, 2022, 235 municipalities (predominantly in California) have banned or restricted the sale of flavored tobacco.

    A trilingual brochure produced by the Code Enforcement Division explains the ban and other rules for tobacco retailers in English, Spanish and Vietnamese.

  • U.S. Appeals Court Delays FDA’s Ban on Juul

    U.S. Appeals Court Delays FDA’s Ban on Juul

    Credit: Tanasin

    A federal appeals court today granted Juul Labs Inc. a temporary stay of the U.S. Food and Drug Administration’s order for the vaping company to pull its e-cigarettes off the U.S. market.

    “The purpose of this administrative stay is to give the court sufficient opportunity to consider petitioner’s forthcoming emergency motion for stay pending court review and should not be construed in any way as a ruling on the merits of that motion,” the court wrote.

    The e-cigarette maker had earlier asked the court to pause what it calls an “extraordinary and unlawful action by the regulatory agency that would require it to immediately halt its business.

    The company filed an emergency motion with the U.S. Court of Appeals in Washington as it prepares to appeal the FDA´s decision.

    Juul said that the FDA cannot argue that there was a “critical and urgent public interest” in immediately removing its products from the market when the agency allowed them to be sold during its review.

    The company noted that the FDA denied its application while authorizing those submitted by competitors with similar products.

    The order sets a briefing schedule of June 27 for the petitioner’s emergency motion; July 7 for the respondent’s response, and July 12 for the reply.

    The request for an emergency stay while waiting to file an appeal was expected.

    “We respectfully disagree with the FDA’s findings … intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator,” said Joe Murillo, chief regulatory officer at Juul Labs, said in a statement. “We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide.”

    The marketing denial order, which concerns the FDA’s analysis of Juul products has not been released to the public. “Any portion of the record that was placed under seal . . . before an agency remains under seal in this court unless otherwise ordered,” the emergency motion states.

  • Juul Expected to be Pulled From Market Soon

    Juul Expected to be Pulled From Market Soon

    Let the shock settle in. The U.S. Food and Drug Administration is preparing to order Juul Labs to take its e-cigarettes off the market in the United States, the Wall Street Journal reported on Wednesday, citing people familiar with the matter.

    Todd Cecil, deputy director for the FDA’s Center for Tobacco Products’ Office of Science, told Vapor Voice during the Next Generation Nicotine Delivery seminar in Miami that he could not make a comment on the Juul decision until the FDA formerly issues a marketing denial order (MDO).

    The news sent Altria’s stock (MO) on a massive drop, falling more than 10 percent once the news broke.

    Wells Fargo analyst Bonnie Herzog wrote in an email that while the news comes as a bit of a surprise, she doesn’t believe all is lost for Altria and the company has several options it can pursue, adding that the sell-off today is overdone with the stock having lost an estimated $7 billion of market capital.

    “First, assuming the FDA does in fact issue an MDO for Juul, we believe the impact is far from certain given Juul’s likely options to appeal or challenge it (via a court decision similar to Kaival Brands’ approach for Bidi Vapor Sticks and IMB’s use of the appeals process for myblu), revise its [premarket tobacco product application] PMTA application, or sue the FDA altogether,” wrote Herzog. “Also, with no detail yet on the FDA’s rationale, it is tough to know how the agency is thinking about an MDO on Juul in the context of its broader efforts to encourage adult smokers to quit and/or move down the continuum of risk to less harmful alternatives (e.g., e-vapor, heat-not-burn, oral nicotine pouches, etc) especially given Juul’s critical leadership in e-cigs.

    “While it is unclear how the FDA is thinking about the remaining PMTAs that are pending (especially the popular VUSE Alto line), we have a hard time imagining the FDA would categorically remove highly popular e-cig brands without ensuring a suitable off-ramp for users (that isn’t back to combustible cigs).”

    It is expected that Juul will receive the MDO in a response to its PMTA because of its product’s potential to appeal to youth. The company has also seen a slump in sales recently, and has been taken over by RJ Reynolds Vapor Company’s Vuse brand e-cigarette in Nielsen rankings for the last two quarters.

    “We expect the company to appeal, with the products remaining on the market,” Vivien Azer, managing director for cannabis, consumer beverages and tobacco at Cowen Inc., New York, said in a research note.

    George Cassels-Smith, CEO of Tobacco Technologies, says Juul receiving an MDO is ridiculous. “For a company that has that has been a standard in this industry and has some of the highest quality products on the market, its shocking,” he said. “The company has tried hard to move past its early issues of appealing to youth. This isn’t appropriate for the protection of public health and it isn’t good for the industry. It hurts adult smokers because Juul is a product that is successful in helping smokers switch.”

    The decision is likely celebrated by some anti-nicotine groups who say Juul is the cause of the rise in teen vaping. That rise has also declined dramatically over the last 2-3 years. Recently, Juul Labs also settled several lawsuits related to youth marketing. Juul Labs — until recently the market leader in e-cigarette product sales — admitted to no wrongdoing in any of its settlements.

    Tony Abboud, executive director of the Vapor Technology Association (VTA) said that he was surprised by the news because Juul was always expected to get an approval order.

    “The reported denial of Juul’s PMTA application is stunning. While the company has certainly been at the epicenter of conflict, the amount of rigorous, peer reviewed science supporting their products’ ability to help smokers quit, raises serious questions about the FDA’s subjective balancing test, and whether public pressure campaigns will steer science policy,” said Abboud.

    Americans for Tax Reform (ATR) strongly condemned the decision. Tim Andrews, ATR’s director of consumer issues, said the Juul MDO will devastate public health across the country, and lead to easily preventable deaths.

    “Juul’s reduced risk tobacco alternatives are critical tools of smoking cessation that have been proven to help cigarette smokers across the U.S. save their lives through transitioning away from deadly combustible tobacco,” he said. ““This is a decision grounded in ideology, not science. It is a decision that will cause countless deaths that could have otherwise been prevented. For the sake of public health, it is a decision we hope will be overturned in the courts on appeal.”

    In 2018, Altria spent nearly $13 billion taking a 35 percent stake in Juul. The company has taken non-cash charges on the investment as regulatory scrutiny of Juul and its marketing practices have impacted sales. As of March 31, Altria said the estimated fair value of its investment in Juul was $1.6 billion.

    In 2019, Juul Labs announced it was suspending its print, broadcast and online advertising in the United States. That same year it halted the sale of its fruit and dessert flavors — including mango, creme brulee and cucumber — that were seen as a significant lure for teen users. The FDA also recently instituted a proposed rule to place a ban on menthol combustible cigarettes and flavored cigars. The menthol ban will not yet cover next-generation tobacco products, such as e-cigarettes, but the FDA has the authority to include them if it sees fit.

    Juul Labs submitted its PMTAs in July 2020. At the time, the company said its submission included comprehensive scientific evidence for the Juul device and Juul pods in Virginia Tobacco and Menthol flavors at nicotine concentrations of 5.0 percent and 3.0 percent, as well as information on its data-driven measures to address underage use of its products.

    Juul will not join NJOY as the only FDA-approved closed system, pod-style vaping device. The FDA is expected to make decisions on additional vaping brands that submitted timely PMTAs soon.

    Now that at the FDA has approved a quality vaping product in Njoy, many tobacco harm reduction groups are hoping the FDA publicly clarifies that vaping is a less risky alternative to smoking combustible. A recent Rutgers University study found that more than 60 percent of all doctors incorrectly believe all tobacco products are equally harmful, making them less likely to recommend e-cigarettes for people trying to quit smoking.

  • NIH, FDA Fund Study to Understand Effect of Flavors

    NIH, FDA Fund Study to Understand Effect of Flavors

    Credit: Feng Yu

    The National Institutes of Health and the U.S. Food and Drug Administration have given the University of Louisville a $3.6 million grant to study the effects of flavorings like mango and bubblegum used in vaping products.

    Researchers at UofL’s Christina Lee Brown Envirome Institute hope to better understand the short-and long-term impacts of flavorings -specifically on the heart- and catalog which are potentially harmful, according to Kentucky Today.

    “E-cigarettes are still relatively new, and we don’t yet fully understand what their health effects are,” said Alex Carll, an assistant professor in the Department of Physiology and co-lead on the project.  “Understanding this could help us make better purchasing and regulatory decisions.”

    The FDA banned flavors used in disposable e-cigarette and has not approved any flvors except tobacco through its premarket tobacco product application (PMTA) process. The agency contends that some flavors could appeal to kids and help fuel rising rates of youth vaping.

    Matthew Nystoriak, an associate professor of medicine and co-lead on the project, said some flavors may seem harmless because they taste like or use the same ingredients as in food. But while those ingredients are safe to eat, they may not be safe to inhale.

    “Our goal is to understand how individual flavoring chemicals impact the heart,” Nystoriak said. “There are many flavor chemicals used in e-cigarettes and if we know which are potentially more harmful than others, it’s possible for people to make more informed decisions about which products they use.”

    Identifying their biological effects also is likely to help the FDA in regulating flavoring additives in e-cigarettes in the future.

  • 31 Attorneys General Ask for FDA to Ban Synthetics

    31 Attorneys General Ask for FDA to Ban Synthetics

    Credit: Mongkolchon

    A bipartisan coalition of 31 attorneys general are calling on the U.S. Food and Drug Administration to reject marketing authorization for all non-tobacco nicotine products, which are currently being sold without regulation of their contents, manufacturing, health effects, required warning labels or marketing claims.

    In a letter to the agency, the coalition argues that these products currently don’t meet the FDA’s public health standard, and the regulatory agency should not gamble on the unknown effects of the products. The letter specifically calls for the FDA to reject a request by product manufacturers to grant marketing authorization for non-tobacco nicotine products.

    The letter also insists that if the agency does grant marketing authorizations for these products, it imposes the same restrictions required of tobacco-derived nicotine products including a ban on all products with a flavor other than tobacco and strict regulatory requirements regarding their contents, manufacturing, and effect on users’ health.

    Products should carry warnings concerning their addictiveness, and manufacturers should be required to validate health claims made about their products, including claims that a product is safer than tobacco.

    “E-cigarettes containing synthetic nicotine and other synthetic nicotine products are putting our kids’ health at risk,” said North Carolina Attorney General Josh Stein. “The FDA has the power to do more to protect them, and I hope it takes action to prohibit manufacturers and retailers from marketing and selling to young people, using youth-friendly flavors, and putting exorbitant amounts of nicotine in these products, especially because we don’t yet know how dangerous these products are. I appreciate that the FDA has started taking some steps, but it must do more to rein in this industry and keep our kids safe.”

  • NJoy Daily Disposable Gets FDA Marketing Approval

    NJoy Daily Disposable Gets FDA Marketing Approval

    Credit: NJOY

    NJOY now has two devices that have received marketing approval from the U.S. Food and Drug Administration. The regulatory agency today issued marketing granted orders (MGOs) under the premarket tobacco product application (PMTA) process for NJOY Daily Rich Tobacco 4.5% and NJOY Daily Extra Rich Tobacco 6%.

    “It should be noted that our determination that the marketing of these products is APPH [appropriate for the protection of public health] is based in part on the submitted microbial stability data,” the MGO states. “The issuance of these marketing granted orders confirms that you have met the requirements of section 910(c) of the FD&C Act and authorizes marketing of your new tobacco products.”

    The designation does not mean the products are safe and they are not “FDA approved,” the agency said, but the MGOs allows the company to legally market them in the United States.

    “Our finding that permitting the marketing of the new products is APPH does not mean FDA has ‘approved’ the new tobacco products specified in Appendix A,” the MGO states. “Therefore, you may not make any express or implied statement or representation in a label, labeling, or through the media or advertising, that the new tobacco products specified in Appendix A are approved by FDA.”

    The FDA also issued marketing denial orders (MDOs) to NJOY for multiple other Daily e-cigarette products. These are presumed to be for flavored products other than tobacco. Any of those products that remain on the market must be removed or risk FDA enforcement, the agency said. Applications for two menthol-flavored Daily products remain under FDA review.

    Additionally, this authorization imposes strict marketing restrictions on the company to greatly reduce the potential for youth exposure to tobacco advertising for these products. The FDA said it will closely monitor how these products are marketed and will act as necessary if the company fails to comply with any applicable statutory or regulatory requirements, or if there is a notable increase in the number of non-smokers—including youth—using these products.

  • US FDA Campaign to Focus on E-Cig Use by Native Youth

    US FDA Campaign to Focus on E-Cig Use by Native Youth

    The U.S. Food and Drug Administration announced the launch of its “Next Legends” youth vaping prevention campaign. The regulatory agency stated that the program is part of the FDA’s ongoing efforts to protect youth from the dangers of tobacco use.

    The campaign will educate American Indian/Alaska Native (AI/AN) youth, ages 12-17, about the harms of vaping through unique branding and tailored messaging created to inspire a new generation to live Native strong and vape-free, according to a statement.

    There are approximately 400,000 Native teens in the U.S., and more than half of them are at-risk of using tobacco products, including e-cigarettes, according to FDA. Studies show that Native youth are more susceptible to e-cigarette use than their non-Native peers, and they demonstrate disproportionately high experimentation and current use of e-cigarettes.

    “The Next Legends campaign is an important and creative way to educate Native youth about the harms of vaping,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products. “E-cigarettes are the most used tobacco product among youth, and they pose serious health risks if used during adolescence, when the brain is still developing. Next Legends builds on the success of previous youth e-cigarette prevention campaigns while also addressing health disparities among Native Americans and Alaska Natives associated with tobacco use. Communicating with Native youth through culturally-aligned messages will help these young people make informed decisions about healthy behavior, including being vape-free.”

  • US FDA Warns Four for Illegally Selling CBD Products

    US FDA Warns Four for Illegally Selling CBD Products

    Credit: Anankkml

    The U.S. Food and Drug Administration (FDA) yesterday issued warning letters to four companies illegally selling unapproved animal drugs containing cannabidiol (CBD) that are intended for use in food-producing animals. The companies include Haniel Concepts dba Free State Oils, Hope Botanicals, Plantacea LLC dba Kahm CBD and Kingdom Harvest.

    “While the FDA does not know the current extent of CBD use in food-producing animals, the agency is taking steps regarding these unapproved and potentially unsafe products now to help protect animals and the safety of the food supply,” a press release states. “After a food-producing animal is treated with a drug, residues of that drug may be present in the milk, eggs, or meat if the animal is milked, eggs are collected, or the animal is sent to slaughter before the drug is completely out of its system.”

    The FDA has not approved any human or animal products containing CBD other than one prescription drug product to treat rare, severe forms of epilepsy in children. The regulatory agency states all other CBD products intended for use as a drug (i.e. making medical claims) are considered unapproved drugs and are illegal to sell.

    Some of the claims made by the companies in the warning letters refer to helping “farm animals with stress, anxiety, pain, inflammation, injuries…” and providing “support to help manage normal stress, promote a calming effect, maintain a healthy gut, maintain a normal and balanced behavior, maintain healthy joints, maintain a normal inflammatory response….” These claims, among others, establish the intended use of the products as drugs, according to FDA.

    The FDA has requested responses from the companies within 15 working days stating how they will address these violations and prevent their recurrence. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.

  • U.S. FDA, NIH Release Latest PATH Study Data Files

    U.S. FDA, NIH Release Latest PATH Study Data Files

    Photo: Tobacco Reporter Archive

    The U.S. Food and Drug Administration’s Center for Tobacco Products and the National Institute of Health’s National Institute on Drug Abuse announced the availability and location of newly released and updated data files from the Population Assessment of Tobacco and Health (PATH) Study, including the following:

    New data sets:

    Updated datasets:

    The Wave 5.5 Special Collection data were collected from youth participants ages 13 to 19 between July and December 2020. Data in the PATH-ATS were collected between September and December 2020 from a subsample of adult participants ages 20 and older, complementing the Wave 5.5 Special Collection. Additionally, Restricted-Use Files have been updated to include Wave 5 Ever/Never Reference Data, and the Restricted-Use and Public-Use Master Linkage Files have been updated.

    Questions about the collection, content, weighting, documentation, or structure of PATH Study data (this excludes questions on statistical analysis or analytic guidance) may be submitted to PATHDataUserQuestions@Westat.com.