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Marlboro-maker Altria on Wednesday sued the U.S. Food and Drug Administration, seeking \u200cto force the agency to overhaul a product review process that tobacco companies say has stifled their growth in the key U.S. market, a legal filing showed.<\/strong><\/p>\n Under U.S. law, the FDA must review new tobacco products before they can be sold, assessing whether they provide a net public health benefit, \u200bsuch as helping smokers quit, without creating significant risk of new addiction among young people.<\/p>\n But the system has been plagued \u200bby a huge backlog of applications and a booming illegal market of products sold without FDA authorisation.<\/p>\n Altria\u2019s \u2060lawsuit marks the latest industry challenge to a regime that has become one of the biggest obstacles facing tobacco companies in \u200bthe $22 billion U.S. market. It follows an extensive lobbying campaign targeting President Donald Trump.<\/p>\n Filed in the federal court in Lubbock, Texas, Altria\u2019s complaint said \u200bthe FDA\u2019s approach had buried products such as its On! nicotine pouches in regulatory red tape, while allowing foreign competitors that ignored the rules to gain market share.<\/p>\n The plaintiffs, including two Altria subsidiaries and the Texas Food and Fuel Association, asked the court to set aside the current system and \u200brequire the FDA to develop a new one.<\/p>\n Their arguments included that the FDA\u2019s approach violates a legal requirement that the agency decide \u200bon applications within 180 days of receiving them, a deadline Altria\u2019s complaint said the FDA has never met.<\/p>\n An FDA official said the agency was \u200ccommitted to \u2060facilitating access to less harmful alternatives for adult smokers, while protecting young people from the dangers of nicotine addiction and toxic exposure.<\/p>\n \u201cFDA takes seriously this legal challenge \u2026 and will carefully review the issues raised,\u201d the official said.<\/p>\n SOME APPLICATIONS DELAYED FOR YEARS<\/strong><\/p>\n The agency has rejected tens of millions of applications for products such as vapes and nicotine pouches. Others have been under review for more than \u200bsix years, hurting sales and market \u200bshare at companies including Altria, \u2060Philip Morris International and British American Tobacco.<\/p>\n Tobacco companies have responded with lawsuits, threats to launch products without FDA permission and intensive lobbying of the Trump administration, aided by meetings, millions of dollars in donations to \u200bTrump\u2019s campaign, inauguration and White House ballroom project, and influential connections in Washington.<\/p>\n Those efforts have helped secure \u200bchanges including the \u2060first marketing authorisations for flavoured vapes, a fast-track pathway for nicotine pouches and a plan under which the FDA would not prioritise enforcement against companies launching certain vapes or nicotine pouches without agency approval.<\/p>\n Altria\u2019s complaint argued that some of the FDA\u2019s recent changes bolster its case. Applications for Altria nicotine \u2060pouches in \u200bthe fast-track programme, for example, remained under review despite the agency\u2019s target of \u200bdeciding them by December 2025, the complaint said.<\/p>\n A company spokesperson said it filed the complaint ahead of a statutory time limit, in order to fix a system \u200bthat has been \u201cbroken for a long time\u201d.<\/p>\n<\/div>\n