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  • 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.”

  • New Administration Withdraws FDA’s Menthol Ban Bid

    New Administration Withdraws FDA’s Menthol Ban Bid

    The Trump administration issued a setback to health regulators and anti-tobacco activists as it withdrew a plan to ban menthol cigarettes in the United States.

    In April 2022, the U.S. Food and Drug Administration (FDA) proposed to ban the sale of flavored cigars and menthol cigarettes after several health advocacy groups said they were highly addictive and attractive to young people. A January 21, 2025, filing by the Office of Information and Regulatory Affairs shows that the proposal has now been “withdrawn.”

    The FDA sent its final version of the regulation to the White House in October 2023, however, the administration allowed dozens of meetings with groups opposing the rule, including civil rights advocates, business owners, and law enforcement officials, according to Reuters, with the government missing deadlines in December 2023 and March 2024 to issue a final rule on the ban.

    An estimated 18.5 million smokers consume menthol cigarettes, comprising one-third of the U.S. market share, meaning a ban would have cost billions of dollars in annual revenue for the industry.

    With news of the proposal withdrawal, Tobacco companies saw their stocks rise today, with British American Tobacco gaining 1.3% and both Altria Group and Philip Morris International gaining 1%. The market’s response suggests investor relief at the removal of a significant regulatory risk for these companies.

  • Regulatory Freeze Pending Review

    Regulatory Freeze Pending Review

    As the Trump Administration digs in, it has called for a regulatory freeze pending review across all agencies, citing five points:

    (1)  Do not propose or issue any rule in any manner, including by sending a rule to the Office of the Federal Register (the “OFR”), until a department or agency head appointed or designated by the President after noon on January 20, 2025, reviews and approves the rule.  

    (2)  Immediately withdraw any rules that have been sent to the OFR but not published in the Federal Register, so that they can be reviewed and approved as described in paragraph 1, subject to the exceptions described in paragraph 1. 

    (3)  Consider postponing for 60 days from the date of this memorandum the effective date for any rules that have been published in the Federal Register, or any rules that have been issued in any manner but have not taken effect, for the purpose of reviewing any questions of fact, law, and policy that the rules may raise.  

    (4)  Following the postponement described in paragraph 3, no further action needs to be taken for those rules that raise no substantial questions of fact, law, or policy.  For those rules that raise substantial questions of fact, law, or policy, agencies should notify and take further appropriate action in consultation with the OMB Director.

    (5)  Comply in all circumstances with any applicable Executive Orders concerning regulatory management.

    Should actions be identified that were undertaken before noon on January 20, 2025, that frustrate the purpose underlying this memorandum, the administration modify or extend this memorandum, to require that department and agency heads consider taking steps to address those actions.

  • Trump Admin Pauses Federal Health Communications

    Trump Admin Pauses Federal Health Communications

    According to CNN, the Trump administration has directed federal health agencies to pause external communications, such as regular scientific reports, updates to websites, and health advisories, according to sources within the agencies.

    Contributors Brenda Goodman and Meg Tirrell wrote that the initial orders were delivered Tuesday to staff at agencies inside the U.S. Department of Health and Human Services, including to officials at the U.S. Food and Drug Administration, the U.S. Centers for Disease Control and Prevention and National Institutes of Health, according to the Washington Post, which first reported the story.

    The direction came without warning and with little guidance as to what exactly it covered, according to sources inside the affected agencies who asked not to be named because they were not authorized to share the information.

    In a follow-up memo obtained by CNN on Wednesday, Acting Health Secretary Dr. Dorothy Fink provided additional details, including that the directive would be in effect through February 1.

    CNN reported that “The memo told health agency employees to have all documents and communications – including regulations, guidance, notices, social media, websites and press releases – reviewed and approved by a presidential appointee before issuing them. It also directed employees not to participate in any public speaking engagements without approval, and to coordinate with presidential appointees before issuing official correspondence to members of Congress or governors.”

    “As the new Administration considers its plan for managing the federal policy and public communications processes, it is important that the President’s appointees and designees have the opportunity to review and approve any regulations, guidance documents, and other public documents and communications (including social media),” Fink said in the memo.

    The directive also told employees to notify higher-ups of any documents or communications that should be exempt either because they’re required by law or because they’re critical for health, safety or other reasons. Already Wednesday morning, the FDA sent out a communication about a safety warning added to the multiple sclerosis drug glatiramer acetate, which goes by brand names including Copaxone, for a “rare but serious allergic reaction.”

    According to the Washington Post, “The pause on communications includes scientific reports issued by the CDC, known as the Morbidity and Mortality Weekly Report (MMWR); advisories sent out to clinicians on CDC’s health alert network about public health incidents; data updates to the CDC website; and public health data releases from the National Center for Health Statistics, which tracks myriad health trends, including drugoverdose deaths.

    Several health officials said they are wary of any messaging halt after the first Trump administration pushed to tightly control the agencies’ communications during the coronavirus response in 2020. Others, however, suggestedthe move is aimed at helping the newly installed Trump health officials understand the vast flow of information coming out of the agencies. The pause, according to one official who spoke on the condition of anonymity to describe internal agency conversations, “seemed more about letting them catch their breath and know what is going on with regard to” communications.

  • SCOTUS Tapdancing Around Vape-Venue Dispute

    SCOTUS Tapdancing Around Vape-Venue Dispute

    Tobacco and vape manufacturers have had little success battling the Food and Drug Administration (FDA) in the majority of appeals courts around the country. However, one place where they have enjoyed modest success is the Fifth Circuit which is located in Louisiana and also governs Mississippi and Texas, and is widely considered the most conservative court in the country. That so many such cases are ending up in the Fifth Circuit is “forum shopping” and shouldn’t be allowed according to the government, an argument that was presented to the Supreme Court January 21.

    The case revolves around R.J. Reynolds Vapor (RJR), a subsidiary of British American Tobacco, a company based in North Carolina, which has found little success battling the FDA in its home Fourth Circuit. Under the Family Smoking Prevention and Tobacco Control Act, manufacturers must get marketing authorization from the FDA before introducing new tobacco products into interstate commerce, and any appeals must be made in either the plaintiff’s home circuit or the D.C. Circuit. The agency previously denied Reynolds’ authorization for flavored e-cigarette products out of concerns for public health. As such, RJR joined several retailers it supplies in Texas and Mississippi and filed its lawsuit in the friendlier Fifth Circuit, a court that has deviated from seven other circuits including the Fourth Circuit and the D.C. Circuit which upheld the FDA’s bans on flavored e-cigarettes. The FDA argued the venue should be based on the location of manufacturers, not the countless retailers.

    “They have circumvented that ability of a court to identify the most convenient forum,” the government said. “By allowing them to use the tactic that they have used, they can unilaterally send the cases to whichever court they prefer.” 

    Justice Clarence Thomas, a George H.W. Bush appointee, suggesting the government had a bias against the Fifth Circuit, asked, “Does it have anything to do with your not winning in the Fifth Circuit?” 

    The government said more than a dozen e-cigarette companies filed appeals in the Fifth Circuit last year. “In 2024, by our count … about 75% of e-cigarette cases were filed all in the Fifth Circuit, all of them by out-of-circuit applicants trying to use the tactic that was approved in the decision below,” said Vivek Suri, assistant to the solicitor general at the Justice Department. “What’s happening now is all of these applicants, whether they’re in California, Michigan, Ohio, or even China, are going to the Fifth Circuit to sue.”

    “Congress was trying to ensure that these kinds of cases go in certain forums or they’re being litigated all over the country and not just in one place chosen by the defendants,” Justice Ketanji Brown Jackson, a Joe Biden appointee, said, suggesting companies were using loopholes to undermine Congress’ venue limitations.

    Kelsey Reichman, writing for the Courthouse News Service, said, “The high court was skeptical that local retailers should be completely barred from challenging marketing denials keeping flavored vapes off store shelves, but their bigger concern stemmed from the potential ripple effects of the case … concerned that a broad venue ruling in this case could touch hundreds of other statutes.”

    “Some of the amici claim that there are as many as 650 review provisions that are similar to the one here,” Justice Samuel Alito, a George W. Bush appointee, said. “Can you tell us how many of those would be subject to the limitation that you just set out?” 

    The government suggested a narrow ruling limited to the Tobacco Control Act. By the end of the argument session, this seemed to be the most likely resolution to the dispute, Reichman said. 

    However, some of the justices questioned whether this was solving the government’s actual complaint. Justice Neil Gorsuch, a Donald Trump appointee, said even if the court prohibited companies from piggybacking on retailer lawsuits, manufacturers could use other tactics to put cases before their preferred court.  

    “What would stop manufacturers from simply funding retailer suits?” Gorsuch asked. “We’d end up in exactly the same place. Third-party funded litigation is not unknown in this country.” 

  • FDA Tobacco Case Heads to Supreme Court

    FDA Tobacco Case Heads to Supreme Court

    The Supreme Court will hear oral arguments on Tuesday in a clash between RJR Vapor and the U.S. Food and Drug Administration (FDA) centered around the rules in which the FDA can be challenged in court. The FDA argues that the Tobacco Control Act allows cases to be argued in one of three areas: in the D.C. Circuit, in the place where the plaintiff resides, or in the place where it has its principal place of business. RJR Vapor, a subsidiary of British American Tobacco based in North Carolina, however, is trying to challenge the FDA in the conservative U.S. Court of Appeals 5th Circuit based in Louisiana.

    RJR Vapor filed a petition for review along with Avail Vapor, a Texas retailer, and by a trade association for Mississippi gas stations and convenience stores that sell RJR Vapor’s products— states that reside in the 5th Circuit. RJR’s North Carolina home resides in the 4th Circuit, which had previously turned their appeal against the FDA denial of applications aside. The 5th Circuit, however, previously ruled against the FDA denials, saying the government agency was sending companies on “a wild goose chase.”

    RJR Vapor and the retailers argue the law states “any person adversely affected” can challenge the FDA, to include retailers within the 5th Circuit trying to sell RJR Vapor’s popular menthol-flavored Vuse brand e-cigarettes who could potentially go out of business. In 2016, the FDA rejected RJR Vapor’s application, saying the product would not be “appropriate for the protection of the public health.”

    The FDA argues that its rulings are “always or nearly always” regulating the manufacturer and that any effects on retailers are indirect and thus irrelevant, and that allowing this case in the 5th Circuit would allow “ready evasion” and create incentives for “forum-shopping.” The FDA contends the stakes are high in this case, as the 5th Circuit’s previous ruling would allow manufacturers to get around federal restrictions and cherry-pick the courts where its cases would be heard.

    The FDA approached the Supreme Court, and in October 2024, it agreed to hear the case. RJR Vapor argues the Supreme Court doesn’t have the authority to rule over “non-final” cases like this one to begin with, and wants the case dismissed without decision.