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Tag: FDA

  • Bidi Opens Latest Appeal Against FDA

    Bidi Opens Latest Appeal Against FDA

    Yesterday (April 2), Bidi Vapor LLC urged the Eleventh Circuit to reverse a U.S. Food and Drug Administration decision denying its application to market a disposable e-cigarette, saying the agency acted unlawfully. In oral arguments in Miami, attorney Eric Gotting told an appellate panel that the FDA’s decision was “arbitrary and capricious and unlawful,” and that the agency admitted adult smokers would likely switch to Bidi’s safer product—a disposable e-cigarette prefilled with tobacco-flavored e-liquid—but still denied the application.

    In January 2024, the FDA issued a marketing denial order (MDO) for the tobacco-flavored Bidi Stick-Classic disposable vape. The decision came while the agency was continuing a court-ordered second review of marketing applications for flavored Bidi Vapor products. The FDA said Bidi’s premarket tobacco application “did not demonstrate an overall net benefit to people who use tobacco products and lacked sufficient evidence to address health risks.”

    Bidi believes the FDA violated the Administrative Procedure Act and hopes to build on its record of successfully contesting adverse FDA decisions. In August 2022, the 11th Circuit set aside the original MDOs issued for its 10 non-tobacco-flavored products. That ruling put the 10 PMTAs back into scientific review and allowed those flavors to remain available for sale pursuant to the FDA’s compliance policy for deemed tobacco products.

  • Supreme Court Favors FDA in Flavor Battle

    Supreme Court Favors FDA in Flavor Battle

    Today (April 2), the Supreme Court unanimously overturned a lower court’s decision that the U.S. Food and Drug Administration incorrectly blocked flavored nicotine e-liquids, rejecting e-cigarette makers that were challenging regulatory hurdles on tobacco products.

    E-liquid companies Triton Distribution and Vapetasia LLC claimed the FDA unlawfully denied the marketing authorization for flavored vape products and disputed that the products appealed to children, arguing that the government was harming nicotine-addicted adults by keeping a cigarette alternative off the market.

    The vape companies argued the FDA failed to review the company’s own scientific evidence, which demonstrates its flavored products were crucial to getting smokers to switch from combustible cigarettes to e-cigarettes. The Fifth Circuit Court agreed with the e-cigarette maker, ruling that “the agency’s rejection was arbitrary and capricious because the FDA relied on conflicting evidence requirements.” The court also faulted the FDA for dismissing “out-of-hand companies’ strategies to keep their products away from minors.” The agency said such efforts haven’t proven to be effective.

    Public health groups had already sued the FDA for not moving fast enough to review the products after the agency, in 2016, finalized rules for regulating them under the 2009 Family Smoking Prevention and Tobacco Control Act. Under the Act, vape companies were forced to submit applications to the FDA in order to bring new vape flavors to market, and the FDA was to assess the public health effects of those products. A rift, however, emerged over the agency’s criteria for approving or denying those applications, which culminated in the Fifth Circuit.

    The fight was brought to the Supreme Court in November with the FDA contending it correctly applied the Tobacco Control Act, saying it considered both the “likelihood that existing users of tobacco products will stop using such products” and the “likelihood that those who do not use tobacco products will start using such products.”

    Oral arguments in front of the Supreme Court centered on whether the FDA standards are a policy position or a substantive rule imposed without notice and comment. The Biden administration argued the standards fell into the policy bucket, pushing the court to give the agency deference to interpret its role under the Tobacco Control Act. 

    Under the Biden administration, the FDA rejected more than a million flavored products, saying companies failed to show that flavored vapes will do more to benefit public health by helping smokers quit tobacco products than the harm they cause by appealing to young people.

    Vaping companies hope they’ll find a friendlier regulatory environment under the Trump administration, as the President previously promised to “save” flavored vaping.

  • Brian King, Dozens of Staffers Out at CTP

    Brian King, Dozens of Staffers Out at CTP

    The Associated Press is reporting that Brian King, the Food and Drug Administration’s chief tobacco regulator, was removed from his post this morning (April 1) amid sweeping cuts at the agency and across the federal health workforce. According to sources familiar with the situation, King sent an email to staff saying, “It is with a heavy heart and profound disappointment that I share I have been placed on administrative leave.”

    King was removed from his position and offered reassignment to the Indian Health Service, according to a person familiar with the matter who did not have permission to discuss the matter publicly and spoke on the condition of anonymity. Dozens of staffers in the FDA’s Center for Tobacco Products (CTP) also received notices of dismissal Tuesday morning, including the entire office responsible for enforcing tobacco regulations.

    In recent years, the CTP has been besieged by criticism from all sides, including politicians, anti-smoking advocates, and tobacco and vaping companies. Under King, the FDA rejected applications for millions of flavored e-cigarettes, citing insufficient data that the products would help adult smokers while not becoming popular with underage kids. Those rejections have resulted in multiple lawsuits against FDA from vape makers.

    “King, who joined the agency in 2022, has been vigorously criticized by vaping lobbyists for ordering thousands of companies to remove their fruit and candy-flavored e-cigarettes from the market,” the AP wrote. “During his time at FDA, teen vaping has fallen to a 10-year low.”

    The latest changes mean that nearly all of FDA’s top leaders overseeing drugs, food, vaccines, medical devices, and now tobacco products have resigned or retired in recent months. This comes after Robert F. Kennedy Jr.’s moves to fire 3,500 FDA staffers and push ahead with plans to scrutinize ultra-processed foods, childhood vaccines, antidepressants, and other long-established products.

  • Senate Confirms New FDA Commissioner

    Senate Confirms New FDA Commissioner

    Last week the U.S. Senate confirmed former Johns Hopkins surgeon and professor Dr. Marty Makary to lead the U.S. Food and Drug Administration by a 56-44 vote. During his confirmation hearing, Makary said his goals for the agency were “more cures and meaningful treatments for Americans,” and offered several insights as to how he would achieve those goals throughout the hearing.  

    In the past, Makary has been critical of the FDA, in 2021 calling for “fresh leadership at the FDA to change the culture at the agency and promote scientific advancement, not hinder it.” Reporting to Health and Human Services Secretary Robert F. Kennedy Jr., Makary’s leadership of the FDA also includes its Center for Tobacco Products (CTP). However, it’s not yet clear how he will approach CTP’s looming issues of reviewing premarket tobacco product applications (PMTAs), the illicit vape market, and other tobacco-related issues.

    Much of the confirmation hearing centered around past problems, including those with Covid-19 vaccines, the pharmaceutical industry, and various other issues that have often gained headlines of late, but he did not commit to specifics in that venue.

    “I have no preconceived plans on mifepristone policy except to take a hard look at the data and to meet with the professional career scientists at the FDA who have reviewed the data,” he said at his hearing. “We now have a generational opportunity in American healthcare. President Trump and Secretary Kennedy’s focus on healthy foods has galvanized a grassroots movement in America. Childhood obesity is not a willpower problem, and the rise of early-onset Alzheimer’s is not a genetic cause. We should be, and we will, be addressing food as it impacts our health.”

    When asked about the backlog of cases the FDA has across all departments, Makary did not rule out leveraging artificial intelligence and making other regulatory changes to streamline the drug review process. He suggested FDA reviewers could use AI “to help reviewers in the review process—not to replace human reviews, but to improve efficiency.”

    National Association of Tobacco Outlets (NATO) Executive Director David Spross told CSP on Friday that “NATO looks forward to working with Dr. Makary and the team at FDA on tobacco and nicotine product regulatory issues, including for the FDA is to support tobacco harm reduction policies by authorizing more PMTA vapor and nicotine pouch product applications that provide adult smokers with more choices.”

    Spross added that there is a “need for more transparency from the agency by providing retailers more information on illicit products, specifically in the vapor and nicotine pouch categories.”

    Makary is a surgical oncologist and health policy researcher who has spent more than 20 years at Johns Hopkins.

    “I am pleased to congratulate Dr. Makary on his new role as FDA commissioner,” said Johns Hopkins University President Ron Daniels. “We are fortunate to have one of our senior faculty members at the School of Medicine undertake this critical service to the nation.

    “An accomplished clinician and widely published health policy researcher, Dr. Makary has had a storied career at Johns Hopkins that reflects the research and clinical acumen and openness to different ideas and approaches undergirded by academic freedom that are the hallmark of our great institution,” said Daniels.

    Makary founded the Johns Hopkins Center for Surgical Trials and Outcomes Research and co-developed a surgical safety checklist used in operating rooms worldwide. He is a member of the National Academy of Medicine and has published more than 300 peer-reviewed articles and three New York Times bestselling books on healthcare.

    Senate also confirmed Jay Bhattacharya as the new director of the National Institutes on Health.

  • Bill Aims to Exempt Premium Cigars from FDA Control

    Bill Aims to Exempt Premium Cigars from FDA Control

    A bill introduced on the Congressional House floor Friday would exclude cigars from the broader “tobacco product” categorization defined by Federal Food, Drug and Cosmetic Act, thereby exempting premium, handmade cigars from FDA regulation.

    Under the new bill, premium cigars would follow the same definition Judge Amit P. Mehta recently established in the cigar industry’s lawsuit battle with the FDA. This definition of a premium cigar would include the following parameters:

    • Wrapped in whole tobacco leaf  
    • Contains a 100% leaf tobacco binder  
    • Contains at least 50% long-filler tobacco
    • Is handmade or hand-rolled
    • Has no filter, nontobacco tip, or nontobacco mouthpiece  
    • Does not have a characterizing flavor other than tobacco  
    • Contains only tobacco, water, and vegetable gum with no other ingredients or additives  
    • Weighs more than six pounds per 1,000 units.

    The Federal Food, Drug and Cosmetic Act essentially authorizes the FDA to regulate food, drugs, medical devices, and cosmetics. These broad categories ultimately include “tobacco products,” which are broadly defined in the Act as “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption…” H.R. 2111, being brought forth by Rep. Byron Donald, would amend this portion of the Act.

    “Back in January, the cigar industry notched yet another big victory against the FDA in the longstanding battle over regulating cigars,” Garrett Rutledge wrote for Cigar Aficionado. “The United States Court of Appeals for the District of Columbia shot down the FDA’s appeal, which sought to overturn the 2023 ruling by Judge Mehta that ruled against the FDA’s application of the Deeming Rule on the cigar industry. The ruling spared the industry from a number of draconian regulations, but it did not fully remove the FDA’s ability to regulate premium cigars. H.R. 2111 aims to take that next step in excluding premium cigars from FDA regulation.”

    “Congressman Donalds’ leadership in introducing this bill is a victory for premium cigar manufacturers, small businesses, and the countless American consumers who appreciate these handcrafted products,” says Mike Copperman, executive director of Cigar Rights of America. “This legislation is not just about regulation, it’s about preserving an industry and ensuring that premium cigars are treated fairly.”

    Donalds introduced similar legislation during the previous Congressional session, and while it gained 13 co-sponsors, it stalled in the committee stage largely due to the election.

  • FDA Says it Prevented 444,000 Youth from Using E-Cigs Last Year

    FDA Says it Prevented 444,000 Youth from Using E-Cigs Last Year

    Today, a study co-authored by U.S. Food and Drug Administration scientists was released showing the agency’s youth e-cigarette prevention campaign, “The Real Cost,” successfully reduced e-cigarette use among youth. The campaign, which launched in 2018 under the leadership of President Trump, was found to have prevented an estimated 444,252 American youth (age 11 to 17 at study recruitment) from starting to use e-cigarettes between 2023 and 2024.

    Published in the peer-reviewed scientific journal American Journal of Preventive Medicine, the study found evidence that the campaign contributed to the nearly 70% decline in e-cigarette use among American youth that has occurred since 2019. According to the National Youth Tobacco Survey, the number of U.S. middle and high school students who currently use e-cigarettes has declined from 5.38 million in 2019 to 1.63 million in 2024, the lowest level in a decade.

    “As part of our work to Make America Healthy Again, we must ensure that children have a healthy start in life,” said Acting FDA Commissioner Sara Brenner, M.D., M.P.H. “This includes taking evidence-based actions to prevent youth tobacco product use.”

    Data from the evaluation, which followed a nationally representative sample of U.S. youth over time, showed that viewing ads from “The Real Cost” lowered chances that youth who had never used an e-cigarette would later initiate use. The survey collected information on how frequently youth were exposed to “The Real Cost” campaign and which youth went on to try e-cigarettes, among other variables.

    “Adolescence is a critical period for prevention efforts because most adults who use tobacco products begin using them in their teenage years,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “Youth tobacco prevention campaigns not only work, but they are also a cost-effective approach to protecting young people from a lifetime of nicotine addiction.”  

    “The Real Cost” Youth E-cigarette Prevention Campaign uses a variety of marketing tactics and creative advertising to reach youth. Advertising and prevention materials are delivered across communication channels relevant to teens, including digital and streaming platforms, social media and gaming platforms. The agency’s activities also include compliance and enforcement actions across the supply chain – in coordination with federal partners using their unique authorities – to ensure that those that make, distribute or sell illegal tobacco products are held accountable to the law.

  • Vapers Bid to Block Iowa E-Cig Regulation

    Vapers Bid to Block Iowa E-Cig Regulation

    Yesterday (March 10), the state of Iowa urged a federal court to deny a motion from a group of vape interests seeking to block enforcement of a newly enacted law prohibiting the sale of e-cigarette products that lack federal authorization, according to Mike Curley for Law360.

    In December, a group called Alternatives to Smoking & Tobacco Inc. filed an injunction against the state of Iowa over HF 2677, which says products not authorized by the FDA are illegal and can’t be sold. The suit says the state violated the U.S. Constitution’s supremacy clause by usurping federal authority as only the FDA has the authority to govern what kinds of e-cigarettes are sold.

    The state argued that because the FDA has not authorized the plaintiffs’ products, those products are illegal and there is no judicial right to buy or sell an illegal product, “and while the FDA may be deferring enforcement, that does not create a binding effect or a legally cognizable right, the state argued, so the plaintiffs lack standing.”

    The state further argued that the plaintiffs haven’t shown they stand to suffer irreparable harm, as the sellers have not alleged they sell FDA-compliant vapes, and thus wouldn’t be able to sell them anyway, while the buyers have more options available than just these vape products if they wish to quit smoking, Curley wrote.

    In February, the parties filed a joint motion to drop the initial injunction as the plaintiffs later that week filed a new motion and supporting brief, arguing HF 2677 runs afoul of the Federal Food, Drug, and Cosmetic Act and also violates the Equal Protection clause by treating some vape makers and sellers differently than others.

    In Monday’s brief, the state argued that no such preemption exists, as it has long been the state’s purview to police the sale of tobacco and tobacco-related powers, and the FDCA contains explicit carveouts allowing states to create stricter regulations for their sale and use.

  • Charlie’s Holdings Receives PMTA Acceptance Filings for 11 Products

    Charlie’s Holdings Receives PMTA Acceptance Filings for 11 Products

    Charlie’s Holdings, Inc. announced today that it received acceptance filings for 11 of its best-selling flavored PACHA Disposables brands from the Center for Tobacco Products of the U.S. Food and Drug Administration. Charlie’s has received more than 700 acceptance filings for its PMTA submissions.

    The FDA has received PMTAs for nearly 27 million electronic nicotine delivery system products and has made determinations on more than 99% of the applications. However, the FDA has authorized fewer than three dozen tobacco- and menthol-flavored e-cigarette products and devices. To date, no company in the world has received an FDA marketing order for a flavored (non-tobacco or non-menthol) disposable vape product.

  • Judge Pauses FDA Menthol Ban Case to August

    Judge Pauses FDA Menthol Ban Case to August

    In a two-page order, U.S. District Judge Haywood S. Gilliam granted a request filed last week jointly by both the government defendants and the public health advocates who filed the lawsuit, seeking a stay on the proceedings until mid-August. The lawsuit filed by anti-tobacco groups seeking to challenge the Food and Drug Administration’s delay to ban menthol cigarettes was paused by a federal judge in response to moves made by the Trump administration.

    Judge Haywood S. Gilliam Jr. for the US District Court for the Northern District of California issued a stay  in the case between the African American Tobacco Control Leadership Council and the FDA over whether the agency lawfully delayed a Biden-era final rule that would ban menthol cigarettes from store shelves.

    Both parties in a joint submission proposed the stay on Feb. 18.

    In late January, the FDA withdrew its proposed rules to prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars.

    “The recent withdrawal of both proposed federal flavor bans is compelling evidence that the Trump administration is taking a less aggressive rulemaking posture compared to the Biden administration,” Troutman Pepper Locke wrote on its Tobacco Law Blog. “The Office of Information and Regulatory Affairs withdrawal filings do not detail the reasoning behind the decision. However, several comments submitted during each proposed rule’s comment period detail ample justifications for withdrawing the proposals.

    “With respect to the menthol cigarette ban, industry argued that illicit markets would proliferate, fed by consumer demand for menthol cigarettes despite the proposed prohibition.”

  • Trump Administration’s Cuts Reach FDA Tobacco Product Employees

    Trump Administration’s Cuts Reach FDA Tobacco Product Employees

    The Trump administration’s attempts to reduce the size of the federal workforce have reportedly extended to the Food and Drug Administration (FDA) this weekend, as recently hired employees who review the safety of food ingredients, medical devices, and other products were fired.

    On Friday, the U.S. Department of Health and Human Services announced plans to fire 5,200 probationary employees across its agencies, which include the FDA, National Institutes of Health, and the Centers for Disease Control and Prevention. Probationary employees across the FDA received notices Saturday evening that their jobs were being eliminated, according to three FDA staffers who spoke to The Associated Press on condition of anonymity.

    The total number of positions eliminated is still not clear, but the firings appeared to focus on employees in the agency’s centers for food, medical devices, and tobacco products — which includes oversight of electronic cigarettes.

    The FDA employs nearly 20,000 people but has been strained since a wave of departures during the COVID-19 pandemic, with a reported 2,000 uninspected drug facilities that haven’t been visited since before the pandemic. It has also been criticized for not moving faster to catch recent problems involving infant formula, baby food, and eyedrops. A former FDA official said cutting recent hires could backfire by eliminating staffers who tend to be younger and have more up-to-date technical skills, whereas the FDA’s current workforce skews toward older workers who have spent one or two decades at the agency.

    “You want to bring in new blood,” said Peter Pitts, a former FDA associate commissioner under President George W. Bush. “You want people with new ideas, greater enthusiasm, and the latest thinking in terms of technology.”