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- Altria filed a lawsuit against the U.S. FDA seeking to force an overhaul of the tobacco product review process it says has blocked newer nicotine products from reaching market. - The company argues the FDA has never met its legal 180-day deadline for deciding applications, with some products under review for more than six years. - Altria claims the regulatory backlog has buried products such as its On! nicotine pouches in red tape while allowing foreign competitors that ignored the rules to gain market share. - The lawsuit, filed in Lubbock, Texas, asks the court to set aside the current system and require the FDA to develop a new one.
- FDA scientists are hesitating to authorize popular nicotine pouch products under a fast-track scheme due to potential risks to new users, particularly children and non-tobacco users. - Applications from major tobacco companies including Philip Morris International's Zyn and British American Tobacco's Velo remain pending despite expectations for decisions by end of 2025. - The delays represent a significant blow to the $22 billion U.S. smoking alternatives market, with PMI shares falling over 7% following the news. - Agency reviewers are taking a cautious approach as scientific evidence for fast-tracking these products is not as clear-cut as expected, particularly regarding youth addiction risks.
- Organigram Global finalized its acquisition of Sanity Group for €107.3 million, including €78 million in upfront cash and €29.3 million in shares, strengthening its international cannabis operations. - British American Tobacco invested C$65.2 million through a private placement at C$2.72 per share average, demonstrating institutional confidence in Organigram's global expansion strategy. - The transaction was partially funded through Organigram's Jupiter strategic investment pool and a C$60 million senior secured credit facility with ATB Financial. - BAT's ownership structure includes both common shares and non-voting preferred shares to maintain ownership below 30% threshold while preserving conversion rights with 7.5% annual increases.
