Tag: U.S. Food and Drug Administration

  • FDA to Provide PMTA Updates Every Three Months

    FDA to Provide PMTA Updates Every Three Months

    Photo: Niroworld

    The U.S. Food and Drug Administration will be required to give premarket tobacco product application (PMTA) status reports every 90 days. The first reports are due on April 29, according to a revised order from District Judge Paul Grimm for the United States District Court for the District of Maryland.

    The revised order, signed on April 15, granted a motion filed by American Academy of Pediatrics (AAP) and other plaintiffs that requires the FDA to “forecast the percentages of such products for which it expects to have taken ‘action’ by June 2022 and quarterly thereafter.” Subsequent reports will also be required to state any revisions to prior estimates.

    The order states that “covered applications” means all applications for newly deemed tobacco products “sold under the brand names Juul, Vuse, NJoy, Logic, Blu, Smok, Suorin or Puff Bar.” Additionally, any product with a reach of 2 percent of more (vaping product brands deemed to have the greatest public health impact) in “Retail & Sales” in Nielsen’s “Total E-cig Market & Players” or “Disposable E-Cig Market & Players.”

    The FDA has approved some products from Vuse and Logic, while denying applications for Blu’s Myblu products.

    The decision was expected by the vaping industry. Speaking during Keller and Heckman (K&H) annual E-Vapor and Tobacco Law Symposium Feb. 2–3, K&H Partner Azim Chowdhury said the FDA had appeared to concede to the requested requirement to submit status reports on many of the remaining submissions under review, adding that the updated requirements requested by the anti-vaping groups appeared to be even broader than the original.

    It’s been more than eight months since the 12-month continued compliance policy for products subject to timely submitted PMTAs ended, but the agency is still sitting on some 88,000 reviews, including some of the vaping products with the highest market shares as measured by Nielsen.

    Requiring the FDA to provide the status reports comes with some controversy. Chowdhury says that it wouldn’t be appropriate for the protection of public health (APPH) or positive for the vaping industry if a requirement for status updates forced the regulatory agency to make PMTA decisions only to appease the anti-vaping groups or politicians.

    “These status reports could be used as a tool to pressure FDA to act—i.e., deny— applications quickly,” Chowdhury told Tobacco Reporter’s sister publication Vapor Voice. “Rather, we want FDA to review the science carefully and take the time it needs to determine whether a particular product is APPH.”

    In November 2021, the anti-vaping organizations whose lawsuit brought forward the deadline for filing PMTAs asked U.S. District Judge Paul Grimm to reopen the case. The plaintiffs asked him to require the U.S. Food and Drug Administration to regularly report on the status of the applications for the 10 bestselling vapor brands according to Nielsen rankings.

  • FDA Denies Market Access to Myblu

    FDA Denies Market Access to Myblu

    Photo: Alex Kalmbach

    The U.S. Food and Drug Administration issued marketing denial orders (MDOs) to Fontem US for several Myblu electronic nicotine delivery system (ENDS) products after determining their applications lacked sufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health.

    According to a notice published on the FDA’s website, the currently marketed products receiving MDOs include Myblu Device Kit, Myblu Intense Tobacco Chill 2.5% and Myblu Intense Tobacco Chill 4.0%.

    In reviewing premarket applications for tobacco products, the FDA evaluates the risks and benefits of those products to the population as a whole, including users and nonusers of the tobacco product, and considers, among other things, the likelihood that those who do not currently use tobacco products will start using those tobacco products.

    Based on the information submitted by Fontem US for these Myblu products and the available evidence, the applications lacked sufficient evidence regarding design features, manufacturing, and stability, according to the FDA. Additionally, the applications did not demonstrate that the potential benefit to smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth, the agency said.

    Tobacco products subject to an MDO may not be offered for sale, distributed or marketed in the U.S.

  • Michele Mital to lead FDA CTP

    Michele Mital to lead FDA CTP

    Illustration: Skypixel | Dreamstime.com

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) will name Michele Mital, the current deputy director of the CTP, as acting director when Mitch Zeller retires in April, reports Vaping360.

    The news was first reported Wednesday afternoon in a tweet by FDA Tracker and confirmed by Filter reporter Alex Norcia after speaking with FDA sources. No formal announcement has been made.

    Mital joined the FDA in 1996 and has held various positions in the agency, including in the Office of Legislation. Since the CTP was formed in 2009, Mital has worked there in various capacities. She was named deputy director in 2018.

    The FDA is still looking for a permanent director.

  • Health Groups Urge FDA Action on Top Vape Brands

    Health Groups Urge FDA Action on Top Vape Brands

    Photo: Dmytro

    Health groups are urging the U.S Food and Drug Administration to make haste in addressing the remaining premarket tobacco applications (PMTA) for leading e-cigarette brands such as Juul, Blu, Vuse (Alto) and NJOY, which make up 75 percent of the U.S. market and are among the most popular with youth.

    “We are grateful to see movement again by the FDA on the e-cigarette pre-market approval process under Dr. Califf’s leadership and the recognition of the risks these products pose to America’s youth while assessing the public health benefit for adult smokers,” wrote Robin Koval, president and CEO of the Truth Initiative, in a statement following the FDA’s authorization of Logic Technology Development’s tobacco-flavored e-cigarettes. Logic, however, makes up a small percentage of the U.S. e-cigarette market, with just over 1 percent according to retailer scanner data.

    The Truth Initiative also expressed concern about the FDA’s failure to deny marketing applications for Logic’s menthol e-cigarettes, which remain under review. “According to the latest NYTS data, nearly 30 percent of young people who use e-cigarettes reported using a menthol flavor,” wrote Koval. “As the FDA prepares to issue a proposed rule removing menthol cigarettes from the market, we continue to urge the FDA to remove all flavored tobacco products, including menthol to protect our nation’s youth.”

    Meanwhile, tobacco harm reduction advocates, took the approval of Logic, which is ultimately owned by Japan Tobacco International, as further evidence that the PMTA process favors deep-pocketed tobacco multinationals.

    “It’s mildly gratifying to hear FDA say out loud the obvious and simple truth that vaping is helping Americans quit smoking,” Amanda Wheeler, president of the American Vapor Manufacturers Association told Filter. “But meanwhile in the bureaucratic shadows, they are strangling the life out of our entire innovative, entrepreneurial industry.”

    “The FDA should be thoroughly embarrassed that the only vaping products with PMTAs are ones that have been rejected by adult consumers,” Greg Conley, the president of the American Vaping Association, told Filter. “If JTI did not have cigarette sales to subsidize their minimal effort offerings in next-gen products, market forces would have caused them to stop selling these products years ago.”

  • Reduced-Exposure Claim for IQOS 3

    Reduced-Exposure Claim for IQOS 3

    Photo: PMI

    The U.S. Food and Drug Administration has issued a modified-risk granted order authorizing Philip Morris Products to market the IQOS 3 system holder and charger with the following reduced-exposure information:

    • The IQOS system heats tobacco but does not burn it.
    • This significantly reduces the production of harmful and potentially harmful chemicals.
    • Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.
    • This reduced-exposure information is the same as the information previously authorized by FDA in July 2020 for an earlier version of the device.

    Today’s action follows the FDA’s review of a new modified-risk tobacco product (MRTP) application submitted by the company for the IQOS 3 system holder and charger. This MRTP application primarily cross-referenced the supplemental premarket tobacco product application for this device, which was authorized for legal sale and distribution in the United States in December 2020, as well as the MRTP application for the previous version of the device.

    The IQOS 3 device is similar in design to the previous version (with mainly aesthetic changes), uses the same tobacco source, and the company requested to use the same exposure reduction claim as authorized for the previous version of the device. Given these similarities, FDA largely relied on its past evaluations of the IQOS 3 device and previous version of the device in determining that the IQOS 3 device meets the authorization criteria to be marketed as an MRTP.

    Headquartered in Switzerland, Philip Morris is currently banned from importing the product into the United States following an adverse ruling in a patent dispute with BAT’s Reynolds American subsidiary.

    In an interview with Bloomberg, PMI CEO Jack Olczak said the company plans to manufacture IQOS in the U.S. to get around the import ban.

  • First FDA Warning for Vapor Hardware

    First FDA Warning for Vapor Hardware

    Photo: Sigelei

    The U.S. Food and Drug Administration posted its first warning letter for vaping hardware products on Tuesday. The letter was issued on Feb. 14.

    “Our review of the website http://sigelei.com revealed that you manufacture and offer for sale or distribution to customers in the United States ENDS [electronic nicotine-delivery system] products without a marketing authorization order including: Sigelei Humvee 80 and Sigelei 213 Fog Coil,” the agency wrote in its letter.

     On Feb. 5, 2021, the FDA sent Sigelei a “refuse to accept” letter regarding its premarket tobacco product application (PMTA) for six products. “New tobacco products that do not have the required FDA marketing authorization order in effect, including your ENDS products covered by PMTA STN PM0001221 that resulted in a refuse to accept determination, are adulterated and misbranded,” the agency warned.

    The move signals a shift in the FDA’s typical regulatory action against companies selling illegal vaping products. Thus far, the agency has issued letters for e-liquids, but now hardware manufacturers have been put on notice. One manufacturer, who asked to remain anonymous to avoid FDA scrutiny, said the recent action is worrisome.

    “The hardware segment has been operating almost at a near-normal, the same as before PMTAs were due,” the manufacturer said. “It hasn’t really hit home yet that FDA has the full intention to start enforcing hardware regulations too. This is going to hurt several companies, and we are going to start to see smaller businesses end their marketing in the U.S.”

    The letter also suggests that the warning is for all Sigelei products and not just the rejected PMTA products. “The violations discussed in this letter do not necessarily constitute an exhaustive list,” the letter states.

  • Graphic Health Warnings Postponed Again

    Graphic Health Warnings Postponed Again

    Image: FDA

    The U.S. Food and Drug Administration has postponed the effective date of its “Required Warnings for Cigarette Packages and Advertisements” final rule to April 9, 2023, following a Feb. 10, 2022, ruling by the U.S. District Court for the Eastern District of Texas.

    The move marks at least the fifth delay for graphic warning health warnings in the United States when counting previously set launch dates of June 18, 2021, Oct. 16, 2021, Jan. 14, 2022, April 14, 2022, and July 13, 2022.

    The FDA released its final rule requiring new graphic warnings for cigarettes in March 2020. The rule calls for labels that feature some of the lesser known health risks of smoking, such as diabetes. The graphic warnings must cover the top 50 percent of the front and rear panels of packages as well as at least 20 percent of the top of advertisements.

    In April and May 2020, cigarette manufacturers and retailers sued the FDA, arguing that the graphic warning requirements amount to governmental anti-smoking advocacy because the government has never forced makers of a legal product to use their own advertising to spread an emotionally charged message urging adults not to use their products.

    In a more recent challenge, tobacco companies argued that the deadline was too onerous due to the impact of the Covid-19 pandemic. They also pointed to the risk that they would lose their investments in new packaging if the graphic health warning requirement were to be thrown out in court.

    In March 2021, the Texas District Court granted a motion by the plaintiffs to postpone the effective date of the final rule to April 14, 2022. The move was followed by additional postponements.

    This is the FDA’s second attempt to enact graphic health warnings under the 2009 Family Smoking Prevention and Tobacco Control Act. The first rule was struck down by the federal court in the District of Columbia as a violation of the First Amendment.

    Pursuant to the Feb. 10, 2022, court order, any obligation to comply with a deadline tied to the effective date is similarly postponed. The FDA encourages entities to submit cigarette plans as soon as possible, and in any event by June 10, 2022.

  • Robert Califf Confirmed as FDA Commissioner

    Robert Califf Confirmed as FDA Commissioner

    Photo: FDA

    The U.S. Senate on Feb. 15 narrowly confirmed Robert Califf as commissioner of the Food and Drug Administration, reports The New York Times.

    The vote was 50-to-46, with six Republicans crossing the aisle to support him while five senators who caucus with Democrats opposed him. One senator voted present.

    A cardiologist who has served as the deputy commissioner of the FDA’s Office of Medical Products and Tobacco, as President Barack Obama’s FDA commissioner and as the head of medical strategy at Alphabet, Google’s parent company, Califf takes over the position from Janet Woodcock, the acting commissioner since President Joe Biden assumed office more than a year ago.

    According to Vaping360, Califf has been generally antagonistic toward vaping as a consumer product. He was at the FDA helm in 2016 when the agency rolled out the Deeming Rule, which gave the FDA authority over e-cigarettes and other tobacco-free nicotine products.

    Tellingly, the Campaign for Tobacco-Free Kids (CTFK) enthusiastically welcomed Califf’s appointment. “Dr. Califf is highly qualified and prepared on day one to address the enormous challenges facing the FDA, including the most significant decisions on tobacco in the agency’s history,” wrote CTFK President Matthew L. Myers in a statement.

    Califf is expected to be sworn in this week. He faces a looming flurry of decisions, including reviews of premarket tobacco applications from leading e-cigarette companies, such as Juul Labs. He will also have to contend with litigation from vapor companies over marketing denial orders (MDOs).

    After issuing MDOs to hundreds of manufacturers for hundreds of thousands flavored product, the agency has been challenged in court by more than 30 companies that claim their PMTAs were denied based on a standard that was not in place when the applications were submitted.

    One of the new commissioner’s first tasks will be working with Health and Human Services Secretary Xavier Becerra to find a replacement for Center for Tobacco Products Director Mitch Zeller, who plans to retire in April.

  • FDA Nominee Faces Stiff Senate Opposition

    FDA Nominee Faces Stiff Senate Opposition

    Robert Califf

    U.S. President Joe Biden’s nominee to lead the Food and Drug Administration is facing stiff opposition in the Senate.

    According to an article in The New York Times, abortion foes are urging Republican lawmakers to reject Robert Califf, who previously led the agency during the final year of the Obama administration. Meanwhile, key Democrats are withholding support over Califf’s opioid policies and industry ties.

    At least five Democrats are publicly opposing his nomination, so Califf needs at least five Republicans to support him in the evenly divided Senate, where Vice President Kamala Harris has a tie-breaking vote.

    The FDA commissioner role has been subject to Senate confirmation since 1988, unlike the director of the Centers for Disease Control and Prevention, who is a presidential appointee. The nominee tends to be subject to sharp questioning, but observers say the decision has never been so wrapped up in national politics unrelated to the nominee’s qualifications.

    With no confirmed leader, Janet Woodcock, the interim commissioner, can serve while the nomination is pending. If Califf’s nomination is voted down, she could lead the agency for 210 more days, according to the Government Accountability Office.

  • Court Stays Bidi Vapor Marketing Denial Order

    Court Stays Bidi Vapor Marketing Denial Order

    The U.S. Court of Appeals for the Eleventh Circuit has stayed the marketing denial order (MDO) issued by the U.S. Food and Drug Administration to Bidi Vapor in September 2021.

    The Feb. 1, 2022, ruling allows Bidi Vapor and Kaival Brands to market and sell all of its Bidi Stick electronic nicotine-delivery systems (ENDS), including its tobacco, menthol and flavored products, while Bidi Vapor continues with its merits lawsuit compelling the FDA to place Bidi Vapor’s premarket tobacco product application (PMTA) for the flavored ENDS back under scientific review.

    With the judicial stay decision going in favor of Bidi Vapor, the company expects many distribution partners to reestablish their previous sales volumes, with potentially new distribution chains added as well.

    “We expect this judicial stay will result in a rebounding of Bidi Stick sales,” said Niraj Patel, president and CEO of both Kaival Brands and Bidi Vapor, in a statement. “Many wholesale and retail partners had discontinued or slowed purchases of the Bidi Stick until we heard back from the courts on the likelihood of our merits case succeeding. This is what our wholesale and retail partners have been waiting for.”

    “We believe that Bidi Vapor has developed substantial, robust and reliable scientific evidence through, among other things, surveys, behavioral studies and clinical trials establishing support that the product is appropriate for the protection of the public health,” Patel said. “Following on FDA’s initial administrative stay of the MDO, we believe that this recent judicial stay is a good indication that the court finds some merit in Bidi Vapor’s arguments and puts Bidi Vapor’s PMTA one step closer to being properly and fully evaluated by FDA. We are extremely pleased with the court’s decision on this judicial stay order and continue to expect to be successful on the merits case as well.”

    “The company believes that this decision signals a new milestone in the path toward providing adult smokers 21 and older with a viable alternative to combustible cigarettes. Distributors, wholesalers, retailers and adult consumers are all anxious to see positive outcomes not just for Bidi Vapor, but for the vaping industry as a whole. We believe in science-based regulation of ENDS and hope the courts will require FDA to adhere to the law as it reviews Bidi Vapor’s PMTAs,” Patel said.