Tag: FDA

  • 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.

  • Turning Point, 2 Other Firms Sue FDA Over Market Denials

    Turning Point, 2 Other Firms Sue FDA Over Market Denials

    At least three suits stemming from marketing denial orders (MDOs) issued by the U.S. Food and Drug Administration in response to premarket tobacco product applications (PMTAs) have been filed in the 2nd, 6th and 11th circuits courts of appeals (possibly more) against the FDA. Turning Point Brands (TPB) filed first a petition for review (a statutory review) with the United States Court of Appeals for the Sixth Circuit. TPB then filed an emergency motion to stay the FDAs order to remove TPB’s products from the market. Bidi Vapor and at least one other company have filed similar suits.

    Credit: Vitalii Vodolazskyi

    The TPB petition 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 is now asking 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.” The company requests the court “vacate or modify” the FDA order and asks that TPB be allowed to “continue to market the products subject to the challenged order.”

    In an explanation for its actions, the FDA’s director for its Center for Tobacco Products (CTP), Mitch Zeller, stated in a release that many of the accepted applications ultimately received an RTF letter at the filing stage of the review process because the application did not include required information. “For example, companies received RTF letters for not including required content such as ingredient listings, labels for each product to be marketed, or adequate environmental assessments,” he wrote.

    In a joint news release with Zeller and acting FDA commissioner Janet Woodcock, the FDA explained that the applications from many MDO recipients “lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the levels of youth use” of electronic nicotine-delivery systems (ENDS) products.

    The PMTAs submitted by TPB and denied by MDO included an in-depth toxicological review, a clinical study, and studies on patterns and likelihood of use, according to the motion to stay filed by TPB on Sept. 30. The stay contained responses from the FDA’s response to TPB’s petition for review. “TPB’s studies demonstrated that TPB’s products help adult smokers transition away from riskier traditional cigarettes. Those studies confirmed that youth users do not currently purchase TPB products and there is virtually zero likelihood that they will in the future,” the motion states.

    TPB accuses the FDA of moving the goalposts for data needed to receive a marketing order based on what the agency “learned” from the “review [of] PMTAs for flavored ENDS so far,” according to the stay. TPB noted that the “North Star of administrative law” is that agencies cannot induce regulated parties to rely on “agency representations about regulatory requirements,” then penalize them using the previously unannounced criteria after-the-fact.

    “But that is precisely what FDA did here,” the stay motion states. “[The] FDA reasoned that TPB failed to conduct ‘a randomized controlled trial and/or longitudinal cohort study’ or other studies performed ‘over time’ to show that TPB’s specific flavored products help adult users stop smoking more than tobacco-flavored products do. Yet FDA previously deemed these studies unnecessary.”

  • FDA has Issued 295 Marketing Denial Orders to Date

    FDA has Issued 295 Marketing Denial Orders to Date

    As of Sept. 17, the U.S. Food and Drug Administration has issued 295 marketing denial orders (MDOs) for more than 1,089,000 flavored e-liquid products. The move has sent shockwaves through the industry and crippled many vapor industry businesses ranging from prominent players to small business owners. All of the MDOs were for flavored e-liquids that were not either tobacco or menthol.

    Credit: Elnur

    Many of the most surprising denials were from company’s that many believed had the funds and experience to submit extensive and detailed premarket tobacco product applications (PMTAs). Turning Point Brands (TPB) International, Humble Juice Co., Beard Vape Co. and Avail Vapor were a few of the long-standing vapor industry companies whose flavored other-than-tobacco products were denied marketing approval.

    The letters are straightforward, according to James Xu, founder of Avail Vapor. “It just says you failed to demonstrate in your application for a flavored [electronic nicotine delivery system] ENDS product [that the benefits] outweigh the known risks of youth appeal,” Xu said, speaking only with Vapor Voice. “Then it goes on to say that it can be corrected with some form of a randomized controlled trial or longitudinal cohort studies that the FDA had previously stated weren’t required.”

    Many industry experts believe the FDA will only approve some tobacco and menthol flavors, most expected to be in closed-system formats. The FDA has yet to make a decision on any major tobacco company’s PMTA submissions for brands such as Juul, Logic, Vuse and Blu. The agency has not denied any synthetic product, although it’s difficult to know for sure since only brand names have been released and not actual flavor profiles.

    Many companies are moving towards using synthetic nicotine in their products in hopes to avoid current FDA regulations. The agency has stated that a synthetic product “may” be outside the agency’s jurisdiction.

    Eric Lindblom, a senior scholar at Georgetown’s O’Neill Institute for National and Global Health Law and a former director of the FDA’s Center for Tobacco Products Office of Policy, said that, in response to such moves by vapor companies, the FDA could either assert jurisdiction over synthetic nicotine as tobacco product or push for synthetic nicotine to be regulated like any other drug.

    The lawsuits are coming. At least two companies have already filed lawsuits against the FDA, although Vapor Voice could not confirm what companies had filed suit. The FDAs public list of companies released on Sept. 17 only includes 241 brands, the remaining 54 MDOs are believed to for brands that had not yet been on the market.

    “If smoking rates go up in 2022 and beyond, do not blame the tobacco industry. This predictable result will entirely be the fault of elected officials and regulators who have utterly failed to protect public health,” said Gregory Conley, president of the American Vaping Association. “The FDA’s opaque review process was intentionally designed to eliminate all but the largest players from the market. We look forward to lending our support to future court challenges.”

  • FDA Torches Vapor Industry With Latest Round of MDOs

    FDA Torches Vapor Industry With Latest Round of MDOs

    No company is safe. The U.S. Food and Drug Administration has now issued marketing denial orders (MDO) to some of the largest manufacturers in the vaping industry. Turning Point Brands announced today that on Sept. 14 it had received an MDO in response to TPB’s premarket tobacco product applications (PMTAs) covering many of the company’s vapor products. All MDOs were for flavored products other than tobacco.

    Credit: Cursed Senses

    “While we believe the FDA’s current conclusion is misguided, we will continue our dialogue with the agency in search of a path forward,” said Larry Wexler, president and CEO, Turning Point Brands. “As we explore options for appealing this decision, we are hopeful that the agency reaffirms its commitment to science-based decision making and to its announced Comprehensive Plan, which includes fully transitioning adult consumers down the continuum of risk in order to reduce the morbidity and mortality associated with combustible cigarette use by preserving the diverse vapor market.”

    Numerous other major e-liquid manufacturers, including Avail Vapor, have confirmed to Vapor Voice that they have also received MDOs from the regulatory agency for e-liquid flavors other than tobacco. Other major manufacturers say they are expecting an MDO any day now.

    TPB stated that its PMTA included an in-depth toxicological review, a clinical study, and studies on patterns and likelihood of use. The data demonstrated that TPB products “do not appeal to never users, youth, or former users and that a significant majority of users of TPB products had completely ceased use of combustible cigarettes. The scientific literature on lower-risk nicotine delivery systems shows that these products can significantly improve public health by providing alternatives that are much less harmful than combustible cigarettes.”

    TPB’s press release stated that the company believed it had established that the products’ it had continued marketing would be “appropriate for the protection of public health,” the standard established by the Family Smoking Prevention and Tobacco Control Act of 2009. “These products are crucial to improving public health by helping adult smokers migrate to less harmful products,” the statement reads. “TPB will continue to engage with the FDA and other stakeholders as we consider options moving forward, including a formal appeal of the decision and potential legal relief.”

    Many companies say they are readying lawsuits. TPB’s states that it continues to monitor regulatory developments and intends to take appropriate measures to manage and mitigate any risk exposure that may result from these and any future MDOs. “The FDA’s scorched earth policy towards the vaping industry will move on to the courts,” a source told Vapor Voice this morning. “This has become a political process instead of a scientific one and the FDA is only trying to save face.”

    Some companies, such as Bidi Vapor, stated they will continue to sell products even after receiving an MDO. Many other companies state that they will be switching to synthetic nicotine, an area where the FDA’s authority may be limited or even not exist.

    Bidi believes its particular decision to be a mistake on the FDA’s part, and is currently exploring next steps to address the situation, according to Filter.

    “It looks like FDA is making a mistake in many, many cases,” said Azim Chowdhury, a partner at the law firm Keller and Heckman, where he advises Bidi and other clients on nicotine regulations. “I have a number of companies that have received MDOs, but those MDOs are also identifying their menthol products. It seems like FDA, in their rush to get all these out, they’re not doing a very thorough job.”

    This story will be updated during the day.

  • FDA Seeks Nominations for Scientific Advisory Committee

    FDA Seeks Nominations for Scientific Advisory Committee

    Photo: Bill Gallery

    The Food and Drug Administration Center for Tobacco Products (CTP) is requesting nominations for individuals to serve as members on the Tobacco Products Scientific Advisory Committee (TPSAC). Nominees may be self-nominated or nominated by an organization.

    Nominations received on or before Nov. 8, 2021, will be given first consideration. Nominations received after Nov. 8, 2021, will be considered as later vacancies occur.

    TPSAC advises CTP in its responsibilities related to the regulation of tobacco products. The committee reviews and evaluates safety, dependence, and health issues relating to tobacco products and provides appropriate advice, information, and recommendations to the FDA commissioner.

    The committee shall consist of 12 members including the chair. Members and the chair are selected by the commissioner or designee from among individuals knowledgeable in the fields of medicine, medical ethics, science, or technology involving the manufacture, evaluation, or use of tobacco products. 

    Members will be invited to serve for overlapping terms of up to four years. 

    More information on the nomination process TPSAC members is available at the Federal Register notice

  • Tobacco Bill Would Tax Vapor Same as Combustibles

    Tobacco Bill Would Tax Vapor Same as Combustibles

    The proposed U.S. Tobacco Tax Equity (TTE) Act would tax vaping products the same as combustible cigarettes. According to research from the Tax Foundation, an independent tax policy nonprofit, the proposal would double the rates on combustible cigarettes and increase the rates on all other tobacco and nicotine products – including electronic nicotine-delivery systems (ENDS) – to achieve parity with the traditional tobacco tax rate.

    Credit: TS Donahue

    The proposed rule aims for the tax per 1,000 cigarettes to be increased to $100.66. Vaping products would be taxed at this same rate, with 1,000 cigarettes being equal to 1,810 milligrams of nicotine.

    “In addition to the one-time increase, the rates would be indexed to inflation, which means they would automatically increase every year,” the report states. “According to Tax Foundation estimates, the tax increases would raise $112 billion over 10 years. The bulk of the revenue, $74.8 billion, is from the doubling of cigarette taxes. The tax on vapor products would raise roughly $15 billion over 10 years.”

    According to Alex Norcia of Filter, the proposal would benefit large corporations and traditional tobacco products, while unfairly hurting people in lower socioeconomic classes as most smokers do not typically belong to the upper classes. Current cigarette smoking in the United States “is higher among people with low annual household income than those with higher annual household incomes,” according to the Centers for Disease Control and Prevention.

    “This means that a 30-milliliter bottle of e-liquid containing 3 milligrams of nicotine per milliliter would be subject a tax rate of $5 for the bottle. A 120-milliliter bottle of e-liquid that contains 6 milligrams of nicotine per milliliter would attract a tax rate of $40 for the bottle,” writes Norcia. “In comparison, critics and tax reformists have estimated that a four-pack of Juul pods would be taxed around $9—giving a clear advantage to a giant over the smaller player. More alarmingly, a pack of cigarettes would only be taxed around $2, creating an incentive for nicotine users to pick cigarettes over less-risky vapor products.”

    Credit: Tax Foundation

    The TTE Act as part a massive $3.5 trillion spending bill appear to be heading for a collision with President Joe Biden’s pledge not to raise taxes on America’s middle class. In an interview with C-Span on Sept. 15, White House Press Secretary Jen Psaki was asked if the White House believes that the proposed bill on taxing tobacco/vaping products would violate Biden’s promise to not raise taxes on those making under $400,000 per year. She replied, “No, we don’t,” adding that it was “just one of the ideas out there.”

    Vape Shop owners are saying that the proposed tax increase would “completely destroy” their businesses, saying it would be even worse than the U.S. Food and Drug Administration’s failure to approve any ENDS products by the Sept. 9 deadline and the issuing of nearly 200 marketing denial orders (MDOs).

    “This is going to more than double, and in some cases triple or quadruple, the price of liquids that I sell,” says Keith Gossett, the owner of Bucky’s Vape Shop in Columbus, Georgia, told Reason. “I’m going to sit there and try to tell a man with a $6 pack of cigarettes that my [$75] product is better. This tax will close my shop.”

    The last time the federal excise tax on tobacco was increased was in 2009. While the federal tax has not changed for 12 years, the average tax paid by consumers has increased drastically. Including the last federal increase, the average combined state and federal excise tax rate on tobacco products has jumped more than 80 percent (the average state excise tax rate increased 65 percent between 2009 and 2021), according to Tax Foundation.

  • Bidi Vapor Wants FDA to Ban Synthetic Nicotine Products

    Bidi Vapor Wants FDA to Ban Synthetic Nicotine Products

    Photo: Andrii

    Bidi Vapor is pushing for a ban on the marketing and distribution of synthetic nicotine in the United States, the company’s exclusive distributor, Kaival Brands Innovations Group, reported in a press release. The company, which manufactures a synthetic nicotine based smokeless pouch, insists synthetic nicotine should be classified as an unapproved drug and thus be subject to applicable Food and Drug Administration drug regulations.

    Bidi Vapor appears to be betting that a ban on synthetic nicotine pouches will benefit sales of its tobacco-derived nicotine pouch, which will be subject to the FDA premarket tobacco product application (PMTA) process before it can be distributed in the U.S. The reviewing process will further delay the launch of the tobacco-derived nicotine pouch, which had already been postponed due to Covid-19, according to Bidi Vapor.

    Following the FDA’s rejection of numerous PMTA’s earlier this month, many companies have set their sights on synthetic nicotine, a legal grey area. The FDA defines a “tobacco product” as anything “made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product”—a position suggesting that synthetic nicotine remains outside its remit.

    Bidi Vapor is now taking the opposite approach.

    “We believe that the delay in the distribution of the Bidi Pouch in the U.S. will lower revenues in the short term. However, we believe that in the longer term, the removal of all synthetic nicotine products in the U.S. market could prove to be a positive event for us,” the company wrote.

    “Based on the FDA’s PMTA decisions related to disposable ENDS products, we anticipate that Bidi Vapor’s naturally derived nicotine products will remain on the market following the completion of the FDA’s PMTA process. Conversely, we believe that many other ENDS manufacturers are utilizing synthetic nicotine as a loophole to avoid the rigorous PMTA process and that if synthetic nicotine is deemed to be an unapproved drug, the FDA will need to regulate synthetic nicotine products as unapproved drugs, or remove them from the market, in order to enforce and bolster compliance requirements.”

  • Charlie’s Holdings Confirms its PMTAs Still Under Review

    Charlie’s Holdings Confirms its PMTAs Still Under Review

    Charlie’s Holding’s, parent to e-liquid manufacturer Charlie’s Chalk Dust, confirmed that it premarket tobacco product applications (PMTA) remain under scientific review by the U.S. Food and Drug Administration. The company has not received a marketing denial orders (MDOs) or refuse-to-file letters for any of its submitted products.

    “Including product-specific scientific data, thorough perception studies, and detailed environmental assessments, Charlie’s PMTA’s cost more than $5 million and are among the most comprehensive PMTA’s in the entire industry,” a press release states. “The Company has publicly expressed its commitment to full regulatory compliance and youth access prevention and believes its submissions to the FDA will be recognized as both distinguished and suitable for approval.”

    Ryan Stump, Charlie’s COO, explained that in addition to human clinical trials that measured the nicotine delivery efficiency of the company’s products via pharmacokinetic studies, Charlie’s PMTA’s also included “product-specific, scientific evidence” that demonstrates the marketing of Charlie’s products meets the statutory standard of appropriate for the protection of the public health that is required for an FDA marketing order.

    “This is an important reason why we are highly confident that the FDA will recognize Charlie’s PMTA submissions as both distinguished and suitable for approval,” said Stump. “As a result of the painstaking efforts we invested in our PMTA’s, when others are forced to withdraw their products from the market, Charlie’s will be one of a very select group still legally allowed to operate in the flavored nicotine product space. We look forward to the competitive advantage – and to the corresponding increases in sales, profits, and market share – that will result from our steadfast commitment to providing Charlie’s customers with a trusted product portfolio in full regulatory compliance.”

    To date, the FDA has now issued 168 companies MDOs for an estimated 992,000 products. According to a press release, the regulatory agency released a revised listing of MDOs that includes 125 company names but not any specific products that were denied. There were no updates provided on several high-profile submissions, such as those submitted by Juul Labs, BAT and Japan Tobacco International. The agency also offered no response to any submitted open-system hardware products or tobacco-flavored e-liquids.