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Tag: U.S. Food and Drug Administration

  • 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.

  • FDA Webinar on Pending Product Standards

    FDA Webinar on Pending Product Standards

    Photo: Postmodern Studio

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) will hold a live webinar, titled “FDA’s Rulemaking Process and Upcoming Tobacco Product Standards,” on Feb. 10 from 2 p.m. to 3 p.m. Eastern Time.

    The webinar will address the FDA’s planned tobacco product standards to prohibit menthol as a characterizing flavor in cigarettes and to prohibit characterizing nontobacco flavors in cigars; the FDA’s rulemaking process and how stakeholders can submit comments on proposed rules; and available cessation resources and tools.

    The webinar will feature a presentation from the FDA’s Office of Minority Health and Health Equity, the CTP’s Office of Health Communication and Education, and the CTP’s Office of Regulations. There will also be a question-and-answer session.

    The FDA will respond only to questions submitted by Feb. 4. To submit a question, please register for the webinar and complete the appropriate field on the registration form.

    The FDA stresses this webinar is not intended to communicate contents of the proposed rules or details about the timeline for their release.

    The webinar is live and free of charge, but prior registration is required by Feb. 9.

  • FDA Looking for New CTP Director

    FDA Looking for New CTP Director

    Photo: BreizhAtao

    The U.S. Food and Drug Administration is now accepting applications for the position of director of the 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, and 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 Applications

    FDA Urged to Act on Remaining Applications

    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 nontobacco 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 school 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 [school] and high school students reported currently using e-cigarettes in 2021.”