Tag: U.S. Food and Drug Administration

  • ‘FDA Took Unfair Shortcuts in Reviewing PMTAs’

    ‘FDA Took Unfair Shortcuts in Reviewing PMTAs’

    Image: smolaw11

    In establishing whether a nicotine product is appropriate for the protection of public health, the U.S. Food and Drug Administration held its Center for Tobacco Products (CTP) reviewers to a lower standard than the companies submitting premarket tobacco product applications, according to Alex Norcia writing in Filter.

    Citing documents obtained through the Freedom of Information Act, Filter describes procedures such as batching and bracketing, which allowed the CTP to apply conclusions to categories of products rather than evaluating them separately. “Despite imposing extremely onerous bureaucratic requirements on applicants, the agency was happy to find ways to cut through its own paperwork,” writes Norcia.

    “It’s clear that FDA allows itself efficient shortcuts that it has denied to applicants,” Clive Bates, director of The Counterfactual, told Filter.

    “The problem has always been that FDA’s extraordinarily burdensome process was obviously tremendously wasteful for applicants, but of course it was always going to be unmanageable for the assessors in FDA. Without this sort of shortcut, the PMTA process would have become a human resources nightmare. So FDA has allowed itself the kind of efficiencies it should have offered to the applicants—batching and bracketing thousands of near-identical products.”

  • It’s Official: FDA Denies Juul U.S. Market Access

    It’s Official: FDA Denies Juul U.S. Market Access

    Today, the U.S. Food and Drug Administration confirmed what many had already been anticipating: Juul Labs must remove all currently marketed Juul products from the U.S. market.

    “Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” said FDA Commissioner Robert M. Califf. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”

    These marketing denial orders (MDO) pertain only to the commercial distribution, importation and retail sales of these products, and do not restrict individual consumer possession or use—the FDA cannot and will not enforce against individual consumer possession or use of Juul products or any other tobacco products.

    “We respectfully disagree with the FDA’s findings … intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator,” said Joe Murillo, chief regulatory officer at Juul Labs, said in a statement. “We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide.”

    After reviewing the company’s premarket tobacco product applications, the FDA determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.

    In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data—including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods—that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications.

    Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, called the FDA decision “the most significant action the FDA has taken to reverse the youth e-cigarette epidemic. Juul, more than any other product or company, has been responsible for creating and fueling the youth e-cigarette epidemic.”

    The FDA says that, to date, it has not received clinical information to suggest an immediate hazard associated with the use of the Juul device or Juul pods. However, the MDOs issued today reflect FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using the Juul products.

    “There is also no way to know the potential harms from using other authorized or unauthorized third-party e-liquid pods with the Juul device or using Juul pods with a non-Juul device,” the agency wrote in a statement.

    “The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products. “As with all manufacturers, Juul had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”

    Gregory Conley, president of the American Vaping Association, asserted on Twitter that the Juul decisions were “manufactured” and “complete nonsense.”

    Andrew Bagley is the owner of the Illuminati Smoke Shop in Columbia, South Carolina, and says even with the popularity of Juul, he doesn’t have concerns about the ban’s effect on sales, reports News19.

    “I’m not concerned,” he said. “We have quite a few other vape products that are PMTA approved, which just means at this point we are legally allowed to sell them and Juuls were a very small percent of our sales, it’s not that big of a deal.”

  • 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.”

  • FDA Grants Reduced-Exposure Claim to PMI’s IQOS 3

    FDA Grants Reduced-Exposure Claim to PMI’s 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.

  • FDA Nominee, Califf Faces Stiff Senate Opposition

    FDA Nominee, Califf 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 of Appeals Stays Bidi Vapor Marketing Denial Order

    Court of Appeals 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 FDA had previously issued an administrative stay to Bidi Vapor, however, the agency rescinded that stay in December.

    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.

  • FDA Seeking Applicants for New CTP Director

    FDA Seeking Applicants for New CTP Director

    Credit: Sean Locke Photography

    The U.S. Food and Drug Administration is now accepting applications for the position of director, Center for Tobacco Products (CTP). The current director, Mitch Zeller, plans to retire in April.

    The CTP director is responsible for planning, managing, directing and coordinating major tobacco program objectives to implement the Tobacco Control Act and related regulations.

    This senior-level FDA position advises the FDA Commissioner, senior FDA officials and others on all matters involving tobacco product regulation that have an impact on policy development and execution and long-range program goals. The director develops and executes the strategies for compliance outreach, enforcement, regulations and guidance formulation, science-based application review and other product regulation activities.

    The individual selected for this position will represent the agency and establish/maintain relationships in meetings and conferences with top level FDA and Health and Human Services officials, national industry representatives, members of Congress, counterparts from federal, state, local and foreign governments.

    Candidates must complete their applications by 11:59 p.m. on Feb. 25, 2022.

  • FDA Urged to Act on Remaining PMTA Submissions

    FDA Urged to Act on Remaining PMTA Submissions

    Photo: New Africa

    Several anti-tobacco groups have sent a letter to the U.S. Food and Drug Administration urging the agency to act on the outstanding premarket tobacco product applications (PMTAs) and pushing for the denial of all flavored e-cigarette products.

    It’s been more than four months since the FDA was supposed to decide which e-cigarette products can remain on the market, but the agency still hasn’t completed some of the reviews, including some of the bestselling e-cigarettes.

    “We write to urge the U.S. Food and Drug Administration (FDA) to expedite decisions on the premarket tobacco product applications (PMTAs) still pending before the agency involving the flavored e-cigarette products, including those with menthol flavoring and, based on the best available scientific evidence, deny the pending applications for all non-tobacco flavored e-cigarettes in order to protect the nation’s young people from the health harms of these products,” the letter said.

    The letter was signed by the American Academy of Pediatrics, the American Heart Association and the Campaign for Tobacco-Free Kids, among others.

    “Every day that FDA delays action, more of our kids remain at risk,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids. “While the FDA has ruled on applications from a lot of small companies, it hasn’t ruled on the applications from the large companies whose products are being used by a majority of kids.”

    American Vaping Association President Gregory Conley pointed to data showing that youth vaping has been declining. According to the Centers for Disease Control and Prevention (CDC), use of e-cigarettes went down among middle and high school students from 2019 to 2020.

    But even with the drop, the CDC said it “estimated that more than 2 million U.S. middle and high school students reported currently using e-cigarettes in 2021.”

  • Biden Taps Ex-FDA Boss Califf To Lead Agency Again

    Biden Taps Ex-FDA Boss Califf To Lead Agency Again

    Robert Califf

    U.S. President Joe Biden today announced that he would nominate Robert M. Califf, a former commissioner of the Food and Drug Administration, to lead the agency again, reports The New York Times.

    A cardiologist and long-time consultant to drug companies, Califf ran the FDA during the last year of the Obama administration

    “Dr. Califf is one of the most experienced clinical trialists in the country, and has the experience and expertise to lead the Food and Drug Administration during a critical time in our nation’s fight to put an end to the coronavirus pandemic,” Biden said in a statement.

    Califf has been a forceful advocate for tobacco control; before he was the FDA commissioner, he was the agency’s deputy commissioner for medical products and tobacco. In an appearance with other former commissioners this year, he said, “I have never seen more capable or nastier lawyers than what I experienced in trying to deal with the tobacco industry. It was awesome and quite frightening for public health.”

    After stepping down as the vice chancellor for clinical and translational health at Duke University, Califf has worked as a senior adviser to Verily Life Sciences, a health technology firm, and its sister company Google Health. Califf, who remains an adjunct professor of medicine at both Duke and Stanford University, is on the corporate board of Cytokinetics, a biopharmaceutical company, according to its website.

    Califf said he was honored to be nominated for the position “at a critical time for our country,” adding, “There’s a lot of work to do, and if confirmed I look forward to rejoining the great team at the FDA to help in their inspiring mission to serve the public.”

    The FDA has had seven different commissioners, including Califf, since 2012, when Margaret Hamburg left the post.

  • FDA Stays Bidi Vapor MDO Pending Review

    FDA Stays Bidi Vapor MDO Pending Review

    The U.S. Food and Drug Administration has issued an administrative stay of its marketing denial order (MDO) for nontobacco flavored bidi sticks, pending the agency’s review of Bidi Vapor’s request that the MDO be rescinded based on product-specific scientific evidence in its premarket tobacco product applications (PMTAs).

    Bidi Vapor’s flavored Bidi Sticks may remain on the market without the threat of enforcement while the FDA reviews the company’s request.

    Bidi Vapor submitted PMTAs for all 11 flavor varieties of its Bidi Stick. The applications ran over 285,000 pages and contained information supporting the products as appropriate for the protection of the public health.

    On Sept. 29, 2021, Bidi Vapor filed a Petition for Review with the U.S. Court of Appeals for the 11th Circuit, seeking judicial review of the MDO under the Tobacco Control Act, the Administrative Procedure Act as well as the U.S. Constitution.

    “We appreciate FDA’s decision to stay, or put on hold, the MDO as it reconsiders its denial,” said Bidi Vapor Niraj Patel in a statement. “As we explained to the agency, Bidi Vapor submitted scientifically rigorous PMTAs that contained product-specific evidence demonstrating that the added benefit of our flavored Bidi Sticks to adult smokers outweighs any potential risks to youth, especially considering our stringent youth-access prevention measures and commitment to mature, adult-focused marketing.”

    “That said, we are still seeking a formal, judicial stay from the appellate court pending the outcome of the lawsuit,” Patel noted.

    The company has now filed a Motion for Stay Pending Review with the 11th Circuit Court of Appeals citing the “irreparable harm” it continues to suffer from the MDO.

    Multiple companies have challenges their MDOs in recent weeks. In early October, the FDA rescinded MDOs it has issued to Turning Point Brands and Fumizer, placing their products back under review.

    According to Filter, Triton, Bidi and Gripum recently received some temporary form of stay, and My Vape Order has demanded a recission due to the fact its PMTA includes some of the same data and studies that also appears in TPB’s applications.