Tag: MDO

  • FDA Grants First Vapor Marketing Orders to RJR’s Vuse

    FDA Grants First Vapor Marketing Orders to RJR’s Vuse

    The U.S. Food and Drug Administration announced today it has authorized the marketing approval of three new vapor products to the RJ Reynolds (RJR) Vapor Company for its Vuse device and two tobacco-flavored pods It marks the first set of electronic nicotine-delivery system (ENDS) products ever to be authorized by the FDA through the premarket tobacco product application (PMTA) pathway. It also denied Vuse PMTAs for flavored products other than tobacco.

    The FDA issued marketing granted orders for RJR’s Vuse Solo closed ENDS device and accompanying tobacco-flavored e-liquid pods, specifically, Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1, and Vuse Replacement Cartridge Original 4.8% G2.

    The agency suggests the data submitted to the FDA by RJR demonstrated that marketing of these products is appropriate for the protection of public health. The authorization allows these products to be legally sold in the U.S.

    “Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation. The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption – by reducing their exposure to harmful chemicals,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “We must remain vigilant with this authorization and we will monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements or if credible evidence emerges of significant use by individuals who did not previously use a tobacco product, including youth. We will take action as appropriate, including withdrawing the authorization.”

    Under the PMTA pathway, manufacturers must demonstrate to the agency that, among other things, marketing of the new tobacco product would be appropriate for the protection of the public health. These products were found to meet this standard because, among several key considerations, the agency determined that study participants who used only the authorized products were exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols compared to users of combusted cigarettes, according to a release.

    “The toxicological assessment also found the authorized products’ aerosols are significantly less toxic than combusted cigarettes based on available data comparisons and results of nonclinical studies. Additionally, the FDA considered the risks and benefits to the population as a whole, including users and non-users of tobacco products, and importantly, youth,” the release states. “This included review of available data on the likelihood of use of the product by young people. For these products, the FDA determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth, provided the applicant follows post-marketing requirements aimed at reducing youth exposure and access to the products.

    The FDA also issued 10 marketing denial orders (MDOs) for flavored ENDS products submitted under the Vuse Solo brand by RJR. Due to potential confidential commercial information issues, the FDA is not publicly disclosing the specific flavored products.

    These products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. Should any of them already be on the market, they must be removed from the market or risk enforcement. Retailers should contact RJR with any questions about products in their inventory. The agency is still evaluating the company’s application for menthol-flavored products under the Vuse Solo brand.

    “Additionally, today’s authorization imposes strict marketing restrictions on the company, including digital advertising restrictions as well as radio and television advertising restrictions, to greatly reduce the potential for youth exposure to tobacco advertising for these products,” the release states. “RJR Vapor Company is also required to report regularly to the FDA with information regarding the products on the market, including, but not limited to, ongoing and completed consumer research studies, advertising, marketing plans, sales data, information on current and new users, manufacturing changes and adverse experiences.

    The FDA may suspend or withdraw a marketing order issued under the PMTA pathway for a variety of reasons if the agency determines the continued marketing of a product is no longer “appropriate for the protection of the public health,” such as if there is a significant increase in youth initiation. While today’s action permits the products to be sold in the U.S., it does not mean these products are safe or “FDA approved.”

    The agency will continue to issue decisions on applications, as appropriate, and is committed to working to transition the current marketplace to one in which all ENDS products available for sale have demonstrated that marketing of the product is “appropriate for the protection of the public

  • Triton Distro FDA Lawsuit Decision Expected This Week

    Triton Distro FDA Lawsuit Decision Expected This Week

    Triton Distribution filed a motion to stay the U.S. Food and Drug Administration’s decision to issue the company marketing denial orders (MDOs) for its premarket tobacco product applications (PMTAs). The company requested a decision from the judge by Oct. 15.

    “Black-letter rules of administrative law prevent an agency from retroactively changing legal requirements and from doing so without accounting for reliance interests. FDA failed to satisfy these requirements when it executed an about-face on the evidence it required to support a premarket tobacco product application (“PMTA”) for a marketing order for flavored electronic nicotine delivery system (“ENDS”) products almost a year after such applications were due,” the motion states. “FDA also acted arbitrarily and capriciously by ignoring relevant evidence found in Petitioner Wages and White Lion Investments, LLC d/b/a Triton Distributions (“Triton”) PMTA and applying a double standard to its consideration of that evidence when it issued Triton a marketing denial order (“MDO”). Further, by imposing a new, across-the-board requirement that flavored ENDS products be demonstrably more effective at promoting smoking cessation than otherwise identical tobacco-flavored products, FDA acted contrary to its authority under Section 910 of the Food, Drug and Cosmetic Act (“FDCA), 21 U.S.C. § 387j, and not in accordance with law.”

    Triton states that it has been irreparably harmed as a result of the FDA’s actions and faces an imminent shutdown of its business in approximately two weeks. This is why Triton entered an emergency stay of the “FDA’s MDO for Triton’s products by October 15, 2021, and order expedited merits briefing. Respondent FDA consents to the proposed expedited merits briefing schedule but opposes a stay.”

    At least six companies have filed lawsuits challenging the agency’s decision to make the companies remove their products from the market. Last week, the FDA rescinded the MDO issued to Turning Point Brands (TPB) and the company will be allowed to continue marketing its vapor products while the FDA re-reviews the company’s premarket tobacco product application (PMTA).

    The FDA admitted it made an error in TPB’s PMTA review and TPB did in fact submit studies that the agency decided during the PMTA process were needed, after saying for years the studies were not required. “Upon further review of the administrative record, FDA found relevant information that was not adequately assessed,” reads the FDA letter to TPB. “Specifically your applications did contain randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use, and perceptions in current smokers, current ENDS users, former tobacco users, and never users, which require further review.”

  • FDA Admits Error, Rescinds Turning Point Brands MDOs

    FDA Admits Error, Rescinds Turning Point Brands MDOs

    Turning Point Brands (TPB) has had its marketing denial orders (MDOs) rescinded by the U.S. Food and Drug Administration. The company will be allowed to continue marketing its vapor products while the FDA re-reviews the company’s premarket tobacco product application (PMTA).

    “We are encouraged by the FDA’s decision to reconsider our product applications and look forward to engaging the agency as our PMTAs are reviewed,” said Larry Wexler, president and CEO, Turning Point Brands. “It is important that the PMTA process is transparent, purposeful, and evidence-based. Our organization dedicated significant time and resources in filing our applications in accordance with agency guidance. We remain hopeful that the depth and range of our studies and data will persuade the FDA that the continued marketing of our vapor products is appropriate for the protection of the public health and that the agency will ultimately preserve a diverse vapor market for the more than 30 million American adult smokers who may wish to transition from combustible cigarettes to lower risk alternatives.”

    Credit: Momius

    The FDA admitted it made an error in TPB’s PMTA review and TPB did in fact submit studies that the agency decided during the PMTA process were needed, after saying for years the studies were not required. “Upon further review of the administrative record, FDA found relevant information that was not adequately assessed,” reads the FDA letter to TPB. “Specifically your applications did contain randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use, and perceptions in current smokers, current ENDS users, former tobacco users, and never users, which require further review.”

    The letter comes after TPB filed a petition with the court that forced the FDA to provide an administrative record for its decisions on PMTAs. TPB sells various flavored e-liquids marketed under the Solace, VaporFi and Vapor Shark brands. TPB then filed a stay motion asking the the court to review the FDA order “on the grounds that it is arbitrary and capricious, an abuse of discretion, contrary to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act of 2009, and otherwise not in accordance with law.”

    Avail Vapor and several other companies that received MDOs have also now filed petitions for information related to their PMTA reviews. After the FDA rescinded TPB’s MDOs, the company dropped its lawsuit against the regulatory agency.

    “In light of the unusual circumstances,” the FDA’s Center for Tobacco Products (CTP) Director Matt Holman stated in the letter. “FDA has no intention of initiating an enforcement action” against TPB’s products that had previously received an MDO.

  • Many Firms Received FDA Marketing Denial Overnight

    Many Firms Received FDA Marketing Denial Overnight

    According to sources, numerous companies received marketing denial orders (MDO) from the U.S. Food and Drug Administration overnight. A major white label manufacture confirmed that several of their clients received MDOs. The FDA is expected today to announce the fate of the vaping industry when it makes final decisions on premarket tobacco product applications submitted by Sept. 9. 2020.

    Credit: Zoran Milic

    The manufacturer can not be named because he had yet to speak with his clients about the denial order. The exact number of products that have received MDOs could not be confirmed, but some are suggesting its “hundreds of thousands” of products.

    Several companies have announced on Twitter having received them on Sept. 8, many late in the evening. Amanda Wheeler, president of the American Vapor Manufacturers Association (AVM) tweeted “Today was a tough day. Lots of very good people who I respect deeply and who helped thousands of smokers quit, got told by our government that their products were illegal. To all of you, I am so very sorry. To your customers, I am even more sorry. Our government is wrong on this.”

    The FDA has yet to update its list of companies that received MDOs. Recently, the agency announced it had sent in total 34 MDOs from Aug. 27 to Sept. 1, covering more than 300,000 products. At least one company has already filed a lawsuit against the FDA, according to Vape Radio.

    Many manufacturers have also said they would turn to synthetic nicotine because the FDA lacks the authority to regulate it. Vapor Salon will be switching to synthetic nicotine, the company wrote in a public Facebook post dated Aug. 26.

    The post was published on the same day that the U.S. Food and Drug Administration denied some 55,000 marketing applications by Vapor Salon and two other companies on the ground that they “lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by well-documented, alarming levels of youth use of such products,” according to an FDA press release.

    “VaporSalon is switching to TOBACCO FREE NICOTINE on Friday, 8/27/2021,” the Facebook post reads. “The main purpose of this is to be outside of the FDA’s regulations with their hefty PMTA requirement which takes full effect on Sept 9th 2021 with needing an approved PMTA, or your product can no longer be sold. There has been 0 approved PMTA’s for anything ENDS related to-date.”

  • FDA Sends PMTA Denial Orders to 3 More Companies

    FDA Sends PMTA Denial Orders to 3 More Companies

    All of the premarket tobacco product applications (PMTAs) that have received marketing denial orders (MDOs) from the U.S. Food and Drug Administration have been for flavored products other than tobacco. On Aug. 31, the agency issued MDOs to three companies for only their other-than-tobacco flavored e-liquids, bringing the total number of companies known to have received MDOs to six. According to Filter, approximately 800 PMTAs were denied in the recent round of denials.

    Credit: Veeranggull

    “Dimitris Agrafiotis, the self-described ‘Vapin’ Greek’ who runs International Vapor Solutions, a consultancy firm, told Filter that three e-liquid companies companies he represents—two of them large and one medium-sized—were sent marketing denial orders (MDOs) by the agency,” Alex Norcia writes. “None of the PMTAs Agrafiotis helped file were totally finished, and the companies’ intention was to send more data piecemeal to the agency as substantial product stability testing wrapped up. Agrafiotis said he could not reveal the names of the companies because of nondisclosure agreements.”

    Norcia was able to confirm that the FDA had issued additional MDOs, after it issued its first-ever MDOs for products from JD Nova Group, Great American Vapes and Vapor Salon for an estimated 55,000 products on Aug. 26. In its first MDO release, the agency stated that more marketing decisions would be forthcoming. The agency stated it would continue to review other premarket tobacco applications for non-tobacco flavored electronic nicotine-delivery systems (ENDS) to determine whether there is sufficient product-specific scientific evidence of a benefit to adult smokers to overcome the risk posed to youth.

    “If the applications contain evidence of this type, the FDA will conduct further in‐depth scientific evaluation as to whether the evidence satisfies that statutory standard for authorization,” the FDA spokesperson explained to Norcia. “But in the absence of this evidence, the agency intends to issue an MDO. We know that flavored tobacco products are very appealing to young people, therefore assessing the impact of potential or actual youth use is a critical factor in our decision-making about which products may be marketed.”

    Many in the vaping industry believe that the FDA will not approve a PMTA for a non-tobacco flavored product. A major e-liquid manufacturer recently told Vapor Voice that the agency may not immediately enforce the marketing of some flavored e-liquids for open systems that have submitted a PMTA, but the agency “will never give marketing approval for a flavor other than tobacco and menthol.”

    The FDA’s review of new tobacco products before they can be legally marketed ensures that they meet the standard Congress set in the law to protect the public health, according to the agency. The agency noted that “the evidence of benefits to adult smokers for such products would likely be in the form of a randomized controlled trial or longitudinal cohort study.” The FDA stated that there is the possibility that other types of evidence may exists that could be adequate if sufficiently robust and reliable. However, because the evidence was absent in these applications, the FDA issued MDOs.

    The FDA has received applications from over 500 companies covering more than 6.5 million tobacco products. The agency refused to file more than 4.5 million applications from the JD Nova Group. According to the FDA release, the products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. If the product is already on the market, the product must be removed from the market or risk enforcement.

    In June, the Agrafiotis’s three clients got a letter from the FDA that their PMTAs had been received and would be moving onto the review stage, according to the Filter story. Last week, his clients drafted letters to the FDA, stating that they would be sending further information. “They have done substantial scientific work and testing,” Agrafiotis said. “They invested some real money in this.” One company, which filed 45 product applications, spent close to $1 million. “Some of the PMTAs were not complete, and some of them were more complete than others.” Of all his clients’ applications, only those for tobacco or menthol flavors now remain pending.

    “It’s not clarified exactly why they were denied,” Agrafiotis said. “The FDA mentioned youth. The usual spiel. And I was honest with my clients that some of the product names might be considered appealing to youth by the FDA. I’m very honest with the industry.”

    Agrafiotis added that now each company he represents is moving into the synthetic nicotine space. One of the large companies is totally transitioning to synthetic nicotine, a legal gray area, because it does not want to spend any more money on the PMTA process. The other was beginning to explore synthetic nicotine as a stopgap solution while pursuing legal action against the FDA. Numerous companies that have received either a warning letter or MDA from the FDA have chosen to start using synthetic nicotine in order to attempt to avoid FDA regulation.

    The FDA has not stated whether or not it believes it has the authority to regulate synthetic nicotine.