Tag: PMTA

  • U.S. FDA Issues Two Final Rules for PMTAs and SEs

    U.S. FDA Issues Two Final Rules for PMTAs and SEs

    The U.S. Food and Drug Administration has issued two final rules for the premarket review of new tobacco products. These foundational rules provide additional information on the requirements for the content, format and review of premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports—two of the most commonly used pathways through which a manufacturer can seek marketing authorization for a new tobacco product from the FDA.

    According to the agency, the finalization of these rules helps ensure that all future submissions contain the basic information needed to determine whether the new tobacco products meet the relevant premarket requirements to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. It also formalizes the general procedures the FDA follows when evaluating PMTAs, including application acceptance, application filing and inspections. 

    It also outlines, among other things, requirements for submitting application amendments, the time for review, withdrawal of applications, postmarket reporting requirements for applicants that receive marketing granted orders, the FDA’s communications with an applicant and the FDA’s disclosure procedures and electronic submission requirements. It also allows for a supplemental PMTA as opposed to a new submission in cases such as authorization for a modified version of a tobacco product for which they have already received a PMTA marketing granted order.

    “These final rules are important components of the FDA’s comprehensive approach to tobacco product regulation, which includes premarket application review, science-based use of the product standard authority and prioritized compliance and enforcement actions,” said acting FDA Commissioner Janet Woodcock, in a statement. “The FDA is committed to protecting Americans from tobacco-related disease and death by ensuring that new tobacco products undergo appropriate regulatory review to determine if they meet the public health standards set by law. If new tobacco products do not meet the standards for these pathways, they cannot be marketed or sold in the United States.”

    “Conducting review of new tobacco products before they can be legally marketed is a critical responsibility of the FDA,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “These final rules will provide greater clarity and efficiency in review of new tobacco products by describing information that any company must provide if they seek to market a new tobacco product in this country.”

    On Jan. 19, 2021, the PMTA and SE final rules were displayed in the Federal Register but did not publish. On Jan. 20, 2021, a memo from the White House Chief of Staff ordered the withdrawal of any rules that did not publish in the Federal Register by noon on that day. Therefore, these final rules were withdrawn at that time. The rules displaying today reflect clarifying changes made from the previous versions, but no significant substantive changes. Both final rules will publish on Oct. 5 and are effective Nov. 4. Beginning on the effective date, applications submitted through these pathways must meet the requirements described in these final rules.

  • 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 Urged to Deny Applications for All Flavored E-Cigarettes

    FDA Urged to Deny Applications for All Flavored E-Cigarettes

    Photo: Boki

    Seven leading public health, medical and parent organizations are urging the U.S. Food and Drug Administration to expedite decisions on remaining marketing applications for e-cigarettes and promptly deny applications for all flavored e-cigarettes, including menthol-flavored products.

    The organizations say they are concerned about these products’ appeal to youth and adverse impact on public health.

    In a letter to Acting FDA Commissioner Janet Woodcock, the groups also urged the FDA to prioritize enforcement against unauthorized flavored e-cigarettes with the largest market shares and products with the highest prevalence of youth use.

    The groups sending the letter are the American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, Parents Against Vaping e-cigarettes and Truth Initiative.

    Since Sept. 9, the FDA has denied marketing applications for more than 1,167,000 products, but it has yet to issue decisions on e-cigarette brands with the highest market shares, such as Juul, Vuse, NJOY and Blu, which make up over 78 percent of the market, according to Nielsen data.

    The health groups expressed particular concern that the FDA is still considering whether to authorize any menthol-flavored e-cigarettes and urged the FDA not to do so given the clear evidence that menthol is a flavor that appeals to and is widely used by kids.

    “Contrary to the FDA’s August 26 statement that menthol e-cigarette products raise ‘unique considerations’ for purposes of FDA review, we do not believe there is anything ‘unique’ about menthol flavoring that would justify issuance of a marketing order,” the groups wrote in their letter. “Indeed, there is no question that when FDA decided to prioritize enforcement against cartridge-based e-cigarettes in flavors other than menthol and tobacco, youth shifted to using menthol-flavored products.”

  • FDA Issues More Marketing Denial Orders for E-Liquids

    FDA Issues More Marketing Denial Orders for E-Liquids

    Photo: Jhvephotos | Dreamstime.com

    The U.S. Food and Drug Administration has issued additional marketing denial orders (MDOs) for electronic nicotine-delivery system (ENDS) products.

    As of Sept. 23, the agency has issued 323 MDOs accounting for more than 1,167,000 flavored ENDS.

    The list of MDOs is available here.

    The FDA issued the first MDOs in August.

    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.

    Companies receiving these MDOs may have submitted premarket applications for other products (such as ENDS devices, tobacco-flavored ENDS or menthol-flavored ENDS), and those products, if still pending, remain under review at FDA.

  • 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.”

  • Bidi Vapor to Market Menthol Sticks Despite MDO

    Bidi Vapor to Market Menthol Sticks Despite MDO

    Bidi Vapor will continue to manufacture and market its Artic (menthol) Bidi Stick in the United States despite receiving a marketing denial order (MDO) for the product, according to a trading update issued by Kaival Brands Innovations Group, the exclusive distributor of Bidi Vapor products.

    As of Sept. 10, the U.S. Food and Drug Administration has issued MDOs for some 992,000 electronic nicotine delivery system products from 168 companies. Bidi Vapor received an MDO for its non-tobacco flavored Bidi Sticks, including its Artic (menthol) Bidi Stick.

    The company, however, insists the FDA mischaracterized the Artic (menthol) Bidi Stick as flavored. Because its Arctic Bidi Stick is menthol, Bidi Vapor believes that this product is not subject to the MDO.

    “This position is aligned with the FDA’s public statements and press releases stating that tobacco and menthol ENDS are not deemed flavored products subject to the MDOs,” the company wrote in a press note. “Accordingly, along with the Classic (tobacco) Bid Stick, Bidi intends to continue to manufacture and market its Arctic (menthol) Bidi Stick for distribution by us.”

    The company, which has historically derived nearly all its revenues from sales of flavored Bidi Sticks, appears willing to accept the risk of enforcement.

    “If the FDA disagrees with Bidi Vapor’s position, issues a warning letter, or takes other action against Bidi Vapor resulting in us not being able to distribute the menthol (Arctic) Bidi Stick in the United States, or consumers do not purchase the tobacco (Classic) or menthol (Arctic) Bidi Sticks, our revenues and, thereby our financial results and condition, would be materially adversely affected, Kaival Innovations Group wrote in its news release.  

    For the three and nine months ended July 31, 2021, Arctic (menthol) Bidi Stick constituted approximately 15.2 percent and 18.5 percent, respectively, of the company’s total Bidi Sticks sales.

  • 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.

  • FDA Issues Another Round of PMTA Denial Orders

    FDA Issues Another Round of PMTA Denial Orders

    The U.S. Food and Drug Administration has now issued 168 companies marketing denial orders (MDOs) for an estimated 992,000 products. According to a press release, today the regulatory agency released a revised listing of MDOs that includes 125 company names but not any specific products that were denied.

    Credit: FDA

    The remaining 43 are expected to be for companies that did not currently have any electronic nicotine-delivery products on the market. “Several of the MDOs were issued to companies that are not confirmed to be currently marketing their products. To protect confidential commercial information (CCI), we cannot release additional information about those actions,” the agency stated.

    Yesterday, the FDA announced it had issued MDOs to more than 130 companies requiring them to pull an estimated 946,000 products from the market. 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.

     “We continue to work expeditiously on the remaining applications that were submitted by the court’s Sept. 9, 2020, deadline, many of which are in the final stages of review,” the agency wrote in its announcement. “For premarket tobacco product applications, our responsibility is to assess whether applicants meet the applicable statutory standard for marketing their new products. As we have said before, the burden is on the applicant to provide evidence to demonstrate that permitting the marketing of their product meets the applicable statutory standard.”

  • States Urged to Act in Absence of FDA Action on Majors

    States Urged to Act in Absence of FDA Action on Majors

    Photo: steheap

    The Campaign for Tobacco-Free Kids (CTFK) is urging U.S. states and cities to step up their efforts to eliminate all flavored nicotine products, including e-cigarettes, in the wake of the Food and Drug Administration’s failure to rule on the premarket tobacco product applications (PMTAs) of market leaders Juul, Vuse, NJOY, Blu, and Logic by yesterday’s deadline.

    On Sept. 9, the FDA announced it had denied market access to nearly 1 million electronic nicotine delivery devices owned primarily by smaller vapor companies. At the same time, the agency indicated it would require more time to process the remaining PMTAs, including those submitted by Juul Labs, BAT, NJOY, Imperial Brands and Japan Tobacco International, which account for the lion’s share of U.S. e-cigarette sales. Juul alone has a U.S. market share of more than 40 percent.

    “The FDA will leave our kids at risk unless it acts quickly on the remaining applications, including for products like Juul that have driven the youth e-cigarette epidemic, and eliminates all flavored e-cigarettes, including menthol-flavored products that are widely used by kids,” wrote CTFK President Matthew L. Myers in a statement. “Every day these products remain on the market, our kids remain in jeopardy.”

    The FDA’s failure to act on the market leaders is remarkable given that the agency had previously indicated it would prioritize those brands while processing marketing applications. Decisions on the bestselling brands would likely have the greatest impact on public health, the agency explained in earlier communications. The failure also raises legal questions, considering that the Sept. 9 deadline was ordered by a court following litigation from public health groups, including the CTFK.

    The CTFK indicated if the FDA does not decide on major application soon it would return to court to have the court enforce its order requiring the FDA to begin removing unauthorized products.

  • Report: FDA Seeking More Time for Some PMTA Decisions

    Report: FDA Seeking More Time for Some PMTA Decisions

    The U.S. Food and Drug Administration is expected to ask for more time before deciding whether some “e-cigarettes from market leader Juul Labs Inc” and others can be sold in the United States, the Wall Street Journal reported today, citing people familiar with the matter. The FDA is expected today to announce the fate of more than 2 million vaping products that had submitted a premarket tobacco product application (PMTA).

    Many businesses have already received marketing denial orders (MDO) from the FDA. Many companies have gone out of business, filed a lawsuit, or switched to synthetic nicotine after receiving MDOs.

    Concerning the FDA asking more time for a Juul Labs PMTA review, Greg Conley, president of the American Vaping Association, tweeted, “I want Juul’s five applications to be authorized. I want Reynolds’ two or three dozen applications to be authorized. But to see them likely get more time from FDATobacco after good small businesses spent the last month getting wrecked … Just wrong. Good job, FDA.”

    He also tweeted: “If I had the choice between 50,000 flavored vaping products being available or Juul surviving, I’d walk Juul over the plank myself. But that’s not the choice we have.”

    After news of the FDA request was reported, Guy Bentley, director of consumer freedom research at the Reason Foundation, tweeted, “The FDA couldn’t get it together to make a decision on one of the biggest companies in this space. Complete shambles.”

    No further information was provided. The FDA did not immediately respond to Reuters’ requests for comment.