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Regulatory Intelligence Insights for February 2

Deep Dive - PMTA Review Timeline Analysis

Week of January 26 Regulatory Intelligence Recap

Federal Regulatory Updates

  • NJOY v. FDA Litigation: Legal proceedings in the case involving flavored NJOY Daily products saw a status report filed and a subsequent dismissal, though the specific result - whether products remain denied or are back in review - was not immediately explained.

State Regulatory Updates

  • Florida: The "Florida Age-Gate Act" (SB 980) advanced through the Senate Industries Committee. The bill targets the marketing and display of non-FDA approved vapes and imposes escalating punishments for violators to prevent youth access.

  • Pennsylvania: The newly enacted Act 57, which requires manufacturers to register with the state and self-certify FDA authorization, is facing scrutiny. Experts suggest that while it mirrors laws in 11 other states, its effectiveness may be hampered by loopholes and enforcement funding issues.

  • Virginia: The state has requested a stay from the Fourth Circuit Court of Appeals on an order that blocked parts of its law restricting the sale of unauthorized vapes. Additionally, Virginia received an "F" grade in the American Lung Association’s (ALA) annual report for insufficient funding and a lack of flavored tobacco regulation.

  • Maryland: The ALA gave Maryland an "F" for its efforts to end the sale of flavored tobacco products, despite the state receiving high marks for smoke-free workplace laws.

  • West Virginia and Ohio: Both states received failing grades in the ALA’s "State of Tobacco Control" report due to shortfalls in tobacco prevention program funding and flavored product regulation.

  • Wisconsin: The ALA report highlighted failing grades for Wisconsin in prevention funding and cessation access, though it received a "B" for its smoke-free workplace laws.

  • Tennessee: The state received failing marks across almost all categories in the ALA report, including tobacco taxes, prevention funding, and access to quit services.

  • Colorado: Denver vape shop owners filed a lawsuit challenging the city's flavored tobacco ban that took effect January 1, arguing the ordinance is unconstitutional and selectively enforced.

Trade Press & Industry Trends

  • Pharmacy Retail Changes: Walgreens has resumed the sale of vapes for the first time since 2019, stocking FDA-authorized products like Juul in approximately 6,000 locations.

  • Illicit Vape Market: Convenience store retailers and industry groups continue to advocate for intensified enforcement against illegal e-cigarettes, which are estimated to account for 54% of products sold in the U.S.

  • Altria Q4 Performance: Altria Group reported missing Q4 profit estimates, with a 2.1% decline in net revenue and lower shipment volumes in its smokeable products segment.

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