Altria Sues FDA to Overhaul Tobacco Product Review System
核心洞察
Altria (搜索) 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 (搜索) 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.
Marlboro-maker Altria (搜索) sued the U.S. Food and Drug Administration on Wednesday, seeking to force the agency to overhaul a product review process that tobacco companies say has stifled their growth in the key U.S. market, according to a legal filing. The lawsuit, filed in the federal court in Lubbock, Texas, marks the latest industry challenge to a regulatory regime that has become one of the biggest obstacles facing tobacco companies in the $22 billion U.S. market.
Under U.S. law, the FDA must review new tobacco products before they can be sold, assessing through an application process whether they provide a net public health benefit, such as helping smokers quit. However, the system has been plagued by a huge backlog of applications and a booming illegal market of products sold without FDA authorization.
Legal Arguments and Regulatory Deadlines
Altria (搜索) and fellow plaintiffs, including the Texas Food and Fuel Association (搜索), asked the court to set aside the current system and require the FDA to develop a new one. Among its arguments, the company said the FDA's approach violates a legal requirement that the agency decide on applications within 180 days of receiving them, a deadline Altria said the FDA has never met.
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 six years, hurting sales and market share at companies including Altria (搜索), Philip Morris International (搜索) and British American Tobacco.
Impact on Nicotine Products
In its complaint, Altria (搜索) argued the FDA's 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. The company contended that some of the FDA's recent changes bolster its case, noting that applications for Altria nicotine pouches in a fast-track programme remained under review despite the agency's target of deciding them by December 2025.
Industry Pressure and Recent Changes
The lawsuit follows an extensive lobbying campaign targeting President Donald Trump. Tobacco companies have responded to the regulatory environment 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 his campaign, inauguration and White House ballroom project, and influential connections in Washington.
Those efforts have helped secure changes including the first marketing authorizations for flavoured vapes, a fast-track pathway for nicotine pouches, and a plan under which the FDA would not prioritize enforcement against companies launching certain vapes or nicotine pouches without agency approval.
Campaigners, however, say the agency's process helps protect Americans, especially young people, from nicotine products. The FDA did not immediately respond to a request for comment.