Category: Regulation

  • Georgia Moves to Ban Vaping in Public Spaces

    Georgia Moves to Ban Vaping in Public Spaces

    Credit: Sharafmaksumov

    Senators in the U.S. state of Georgia are moving to restrict vaping in public spaces.

    The state Senate voted 51-3 on Wednesday to pass Senate Bill 47, which would regulate vaping in the same way the state already regulates smoking. The measure moves to the House for further debate, reports Fox News.

    Georgia’s 2005 Smoke-Free Air Act says that people can’t smoke indoors in many public places, although it excludes some places including tobacco stores, bars that only admit patrons older than 18, and privately owned convention rooms.

    A person who violates the law commits a misdemeanor and can be fined $100 to $500.

    Last week, a bill was introduced in Georgia’s General Assembly that would raise the state tax on vaping and other tobacco products and use the proceeds to improve health care.

  • RJ Reynolds Wants Enforcement of Disposables

    RJ Reynolds Wants Enforcement of Disposables

    Credit: Casimiro

    RAI Services Company submitted a citizen petition asking the U.S. Food and Drug Administration to adopt a new enforcement policy directed at “illegally marketed disposable electronic nicotine delivery system” (ENDS) products.

    The petition was filed on Feb. 6 and posted by the FDA to Regulations.gov for public comment on Feb. 8.

    RAI Services and R.J. Reynolds Vapor Company, the maker of Vuse e-cigarettes, are owned by BAT. Vuse is the most popular brand in the c-store segment, according to Neilsen data.

    “As the Agency well knows, use of ENDS products in the United States has shifted to disposable products. And a new enforcement policy, one that is specifically directed at these disposables that are on the market illegally, is needed to better protect public health,” the petition states.

    Reynolds requested that the FDA prioritize enforcement for:

    • Any flavored disposable ENDS (except for tobacco- or menthol-flavored products);
    • Any disposable ENDS containing nicotine derived from any source other than tobacco that lacks premarket authorization;
    • Any disposable ENDS containing nicotine derived from tobacco that was not on the market as of August 8, 2016, or for which the manufacturer either failed to submit an application by September 9, 2020, or submitted a PMTA to FDA by that deadline, but received a negative action that is not being challenged in court;
    • Any disposable ENDS for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
    • Any disposable ENDS targeted to, or whose marketing is likely to promote use by, minors.

    Reynolds does not sell disposable vapes or vaping products in flavors other than tobacco or menthol. The U.S. Court of Appeals for the Fifth Circuit granted an administrative stay of an FDA marketing denial order (MDO) for two R.J. Reynolds Vapor Co. menthol flavored refill pods.

    “Such a policy,” writes Reynolds regarding its desired enforcement priorities, “will close an existing loophole in FDA’s current tobacco enforcement efforts, especially when it comes to youth.”

  • Status Report Confirms FDA Time Changes to PMTAs

    Status Report Confirms FDA Time Changes to PMTAs

    Credit: Fizkes

    The U.S. Food and Drug Administration has submitted a new timeline for its expected finish to the review of premarket tobacco product applications (PMTAs) in a court-mandated status report. As previously reported by Vapor Voice, the agency doesn’t expect to complete PMTAs for the most popular vaping products until the end of the year.

    In prior status reports, the FDA indicated that it expected to finalize actions on all covered applications by June 30, 2023. Filed with the Maryland Federal District Court on Jan. 24, 2023, the agency’s fourth report states that it now expects to have taken action on PMTAs as follows:

    • 52 percent of Covered Applications by March 31, 2023
    • 53 percent of Covered Applications by June 30, 2023
    • 55 percent of Covered Applications by Sept. 30, 2023
    • 100 percent of Covered Applications by Dec. 31, 2023

    The FDA is expected to give its next status update to the court on April 24.

    The FDA is under a Maryland Federal District Court order to file regular status reports on the agency’s review of PMTAs. The court case that ended in a court-imposed deadline for the FDA was filed by health groups seeking a timeline for the review of the PMTAs that were filed with the agency by Sept. 9, 2020.

    In the order requiring the FDA to submit status reports, the Maryland court stated that covered applications are limited to applications for products that are sold under the brand names JUUL, Vuse, NJOY, Logic, Blu, SMOK, Suorin or Puff Bar. Additionally, any product with a reach of 2 percent or more of total “Retail Dollar Sales” in Nielsen’s Total E-Cig Market & Players or Disposable E-Cig Market & Players’ reports.

    The original completion date was Sept. 9, 2021, however, the FDA was unable to meet it due to the extremely large number of PMTAs filed by manufacturers.

    The most recent delay is partially being caused by ongoing litigation and by the agency accepting some amendments to already filed PMTAs that the agency now needs to review, according to the report.

    Credit: JHVEPhoto
  • Australia Legalizes Medical Psilocybin and MDMA

    Australia Legalizes Medical Psilocybin and MDMA

    Credit: 24K Production

    The Australian government has rescheduled the psychedelics psilocybin and MDMA to provide access to people with post-traumatic stress disorder (PTSD) and treat-resistant depression.

    The substances aren’t being legalized for broad use, but by placing them in Schedule 8 for therapeutic use under the country’s drug code, psychiatrists who meet the required standards will be able to prescribe the psychedelics. The drugs will remain in the stricter Schedule 9 for unauthorized use.

    “The decision acknowledges the current lack of options for patients with specific treatment-resistant mental illnesses,” Australia’s Therapeutic Goods Administration (TGA) said in a notice on Friday, reports Marijuana Moment.

    The new rules mean that psilocybin and MDMA can be used therapeutically in a controlled medical setting starting on July 1, according to TGA. However, patients may be vulnerable during psychedelic-assisted psychotherapy, requiring controls to protect these patients.

    The decision follows applications made to the TGA to reclassify the substances in the Poisons Standard, extensive public consultation, a report from an expert panel, and advice received from the Advisory Committee on Medicines Scheduling.

    There are currently no approved products containing psilocybin or MDMA that the TGA has evaluated for quality, safety and efficacy. However, this amendment will allow authorized psychiatrists to access and legally supply a specified “unapproved medicine containing these substances to patients under their care for these specific uses.”

  • CTP to Release Reagan-Udall Response in February

    CTP to Release Reagan-Udall Response in February

    The Head of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) said in a perspective released today that the Center recently received the findings from the Reagan-Udall Foundation’s independent evaluation of its program and is in the process of closely reviewing the feedback. In February, the Center will provide an update on its planned actions in response to the evaluation.

    When the Reagan-Udall Foundation submitted its recommendations to Robert Califf, commissioner of the FDA, in December, the report concluded that vaping industry stakeholders observed a lack of “consistent implementation” of what the industry understood to be the policies of the CTP, particularly with respect to tobacco harm reduction and the requirements needed to navigate the PMTA process.

    CTP Director Brian King also announced the Center has accepted for review more than 8,600 marketing applications for synthetic products. In a recently released perspective, King said the center received more than 1 million premarket tobacco product applications (PMTAs) from 200 companies by May 14, 2022.

    “FDA has also issued refuse-to-accept (RTA) letters for more than 925,000 products in applications submitted by May 14 that do not meet the criteria for acceptance,” King wrote. “The RTA letters state that it is illegal to sell or distribute the product in the U.S. marketplace without a premarket authorization.”

    Brian King / Credit: FDA

    He also stated that in 2022, CTP participated in 52 meetings with stakeholders – averaging one per week – including 25 meetings since King became director. King also stated that starting when the FDA was given the authority by Congress to regulate non-tobacco nicotine products in April 2022, the CTP has issued more than 75 warning letters to manufacturers through Jan. 20, 2023, including manufacturers of brands popular among youth, such as Puff Bar.

    “We have also issued over 585 warning letters to retailers for the sale of non-tobacco nicotine products to underage purchasers as of December 2022. In October 2022, the U.S. Department of Justice (DOJ), on behalf of the FDA,” filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers that failed to submit PMTAs and continued to sell products,” wrote King.

    In a court filing last week, the FDA stated it will take until possibly December 31, 2023, before it completes the PMTA review process for some of the most popular vapes on the market.

    Much like an earlier op-ed this year, King does not address memos recently submitted to the U.S. Court of Appeals for the Third Circuit that show King reversed a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists, according to Logic’s lawyers. 

    King also failed to address the conclusion of a recent investigation conducted by the  U.S. Office of Special Counsel that found the CTP had relaxed its standards of review for certain tobacco products and stifled attempts by its scientists to raise concerns.

  • FDA Says PMTA Reviews to Take Until End of Year

    FDA Says PMTA Reviews to Take Until End of Year

    Credit: F Armstrong Photo

    In a court filing this week, the U.S. Food and Drug Administration stated it will take until possibly December 31, 2023, before it completes a premarket tobacco product application (PMTA) review process for some of the most popular vapes on the market.

    Upon being informed of the delay, Senator Dick Durbin of Illinois began demanding the FDA act immediately in removing e-cigarettes and vaping products from store shelves saying the agency has ignored a court order requiring them to take action by September 2021.

    “On Tuesday, in a stunning filing to the federal judge, the Food and Drug Administration disclosed that it will take another six-month delay in fulfilling the public health duty announced by the court years ago. That the Food and Drug Administration will not finish reviewing applications for the most popular e-cigarettes until the end of 2023, is another outrageous delay,” said Durbin. “How can this federal agency knowingly, willingly ignore this court order to protect America’s children?”

    Durbin, who has repeatedly urged FDA to complete the premarket review of e-cigarettes, called on FDA to use its authority to swiftly remove any and all unreviewed vaping products from store shelves for the safety of American consumers.

    “While the FDA has dithered, dallied and delayed, more than one million of America’s kids have started vaping,” Durbin stated this week calling on the agency to obey the court order. “Not next year. Not next month. Immediately. Today,” Durbin stated in a release.

  • FDA Authorizes Three New Heated Tobacco Products

    FDA Authorizes Three New Heated Tobacco Products

    The U.S. Food and Drug Administration today authorized the marketing of three new tobacco-flavored heated tobacco products included in Philip Morris Products S.A.’s supplemental premarket tobacco product applications (PMTAs).

    The products receiving marketing granted orders are Marlboro Sienna HeatSticks, Marlboro Bronze HeatSticks, and Marlboro Amber HeatSticks. 

    The three HeatSticks products are “heated tobacco products” (HTPs) used with the IQOS device.

    Based on FDA’s review of the supplemental PMTAs, the agency determined that the marketing of these products should be authorized because, among other things, the net population-level benefits to adult smokers outweigh the risks to youth. 

    In 2019, FDA authorized the marketing of IQOS and several other Marlboro HeatSticks products through the PMTA pathway. Philip Morris pursued marketing authorization for these new Marlboro HeatSticks by submitting supplemental PMTAs for modified versions and line extensions of the tobacco-flavored product for which the company had previously received a marketing granted order.

    A supplemental PMTA can be submitted in situations where an applicant is seeking authorization for a new tobacco product that is a modified version of a tobacco product for which they have already received a marketing granted order.  

    “Following FDA’s rigorous scientific evaluation of the applications, the agency determined that Marlboro Sienna HeatSticks, Marlboro Bronze HeatSticks, and Marlboro Amber HeatSticks are comparable to the previously authorized tobacco-flavored product,” according to FDA. “Like the previously authorized products, FDA has placed stringent marketing restrictions on the new products in an effort to prevent youth access and exposure.”

  • U.S. FDA to Seek Congress’ Help in CBD Regulations

    U.S. FDA to Seek Congress’ Help in CBD Regulations

    • “FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward”

    The U.S. Food and Drug Administration has concluded that a new regulatory pathway for cannabidiol (CBD) is needed. The regulatory agency states it will seek guidance from the U.S. Congress. The new rules would need to balance individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks, according to a press release.

    The FDA is also denying three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.

    “A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products,” the release states. “Some risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children. In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals.”

    FDA Principal Deputy Commissioner Janet Woodcock stated that a working group she chaired on the subject of CBD regulations closely examined studies related to the CBD-based drug Epidiolex, published scientific literature, information submitted to a public docket, as well as studies both conducted and commissioned by the agency.

    “Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives,” she stated. “For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods.

    “CBD also poses risks to animals, and people could be unknowingly exposed to CBD through meat, milk and eggs from animals fed CBD. Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food. A new regulatory pathway could provide access and oversight for certain CBD-containing products for animals.”

    Woodcock said the FDA will continue to take action against CBD and other cannabis-derived products to “protect the public, in coordination with state regulatory partners,” when appropriate.

    The U.S. House Oversight Committee plans to grill U.S. Food and Drug Administration Commissioner Robert Califf about why the agency still hasn’t developed CBD regulations.

    The FDA has said it is planning to release CBD guidance this year.

  • U.S. Court Grants Stay of Reynolds Menthol MDOs

    U.S. Court Grants Stay of Reynolds Menthol MDOs

    scales of justice
    Credit: Sang Hyun Cho

    The U.S. Court of Appeals for the Fifth Circuit has granted an administrative stay of a U.S. Food and Drug Administration marketing denial order (MDO) for two R.J. Reynolds Vapor Co. menthol flavored refill pods.

    The order was granted as a temporary stay pending a motion to file a stay with the court by Feb. 1, 2023.

    On Jan. 24, the FDA denied marketing applications for two menthol refills used in Vuse Vibe and Vuse Ciro vaporizers, which are sold in the U.S. by BAT subsidiary R.J. Reynolds. According to the agency, Reynolds’ applications presented insufficient evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.

    British American Tobacco said on Jan. 25 that it intended to appeal the MDO for its Vuse Vibe Tank Menthol 3.0% and Vuse Ciro Cartridge Menthol 1.5%, the company announced in a statement.

  • Reynolds to Appeal FDA’s Denial of Menthol PMTAs

    Reynolds to Appeal FDA’s Denial of Menthol PMTAs

    British American Tobacco will appeal the U.S. Food and Drug Administration’s marketing denial orders for its Vuse Vibe Tank Menthol 3.0% and Vuse Ciro Cartridge Menthol 1.5%, the company announced in a statement.

    On Jan. 24, the FDA denied marketing applications for two menthol refills used in Vuse Vibe and Vuse Ciro vaporizers, which are sold in the U.S. by BAT subsidiary R.J. Reynolds. According to the agency, Reynolds’ applications presented insufficient evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.

    “Reynolds intends to seek a stay of enforcement immediately and will pursue other appropriate avenues to allow Vuse to continue offering its innovative products to adult nicotine consumers age 21+ without interruption,” the company said.

    “We believe that menthol vapor products are critical to helping adult smokers migrate away from combustible cigarettes. FDA’s decision, if allowed to go into effect, will harm, not benefit, public health.

    “We remain confident in the quality of all of Reynolds’ applications, and we believe that there is ample evidence for FDA to determine that the marketing of these products is appropriate for the protection of public health.”

    Anti-tobacco campaigners countered that menthol e-cigarettes appeal to underage consumers. “Existing evidence demonstrates that non-tobacco-flavored e-cigarettes, including menthol flavored e-cigarettes, have a known and substantial risk with regard to youth appeal, uptake and use; in contrast, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk,” said  Matthew Myers, president of the Campaign for Tobacco-Free Kids in a statement.

    Morgan Stanley said it expected the rejected products to remain on the U.S. market for the duration of BAT’s appeal, with minimal impact on the company’s operations. “Longer term, should today’s denial order reflect a broader effort by the FDA to ban menthol e-cigarettes, BAT’s U.S. cigarette business could benefit given its menthol mix as it might discourage some smokers from quitting or switching to reduced risk products,” the bank wrote in a note to investors. Reynolds’ Newport brand represents about 40 percent  BAT’s U.S. cigarette dollar sales, according to Morgan Stanley.

    The Jan. 24  rejection of the Vuse refills underscores the FDA’s ongoing reluctance to approve menthol e-cigarette flavors. To date, the agency has approved only tobacco-flavored e-cigarettes.

    However, the FDA has granted both a premarket tobacco product application and modified risk tobacco product designation to IQOS’s menthol variant, which may eventually leave Philip Morris International’s heat-not-burn product as one of the few menthol reduced-risk alternatives on the market.

    The FDA is targeting publishing a final rule to ban menthol cigarettes in August 2023, but considering expected industry litigation, final implementation could be five to six years away, according to Morgan Stanley.