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  • 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.”

  • Markets Stand Behind Tobacco

    Markets Stand Behind Tobacco

    Seeking Alpha, a crowd-sourced content service that publishes news on financial markets, said the prices of tobacco and smoking products in the U.S. rose 6.8% in January compared to a year ago on an unadjusted basis. Overall, core inflation was up 3.3% year-over-year during the month, which was slightly higher than the pace in December and above the expectations of analysts.

    On a month-to-month comparison, tobacco and smoking products were up 0.4% in January to mark the fifth month in a row of higher pricing for the broad category.

    Analysts have not moved off their position that Philip Morris International, Altria, Imperial Brands, and British American Tobacco could all see benefits under the Trump Administration.

    Seeking Alpha said, “UBS sees the Republican control of Congress as a slight positive for tobacco stocks. Analyst Faham Baig reminded investors that Republican control has historically been seen as a positive for U.S. tobacco, due to the likelihood of reduced regulation. On that note, the Office of Information and Regulatory Affairs at the OMB withdrew in January the menthol cigarette ban and the U.S. has pulled back from the World Health Organization.”

  • 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.