By Emma Rumney and Jonathan Stempel
LONDON/NEW YORK, Sept 2 (Reuters) – Marlboro-maker Altria on Wednesday sued the U.S. Food and Drug Administration, 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, a legal filing showed.
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, such as helping smokers quit, without creating significant risk of new addiction among young people.
But the system has been plagued by a huge backlog of applications and a booming illegal market of products sold without FDA authorisation.
Altria’s lawsuit marks the latest industry challenge to a regime that has become one of the biggest obstacles facing tobacco companies in the $22 billion U.S. market. It follows an extensive lobbying campaign targeting President Donald Trump.
Filed in the federal court in Lubbock, Texas, Altria’s complaint said 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 plaintiffs, including two Altria subsidiaries and the Texas Food and Fuel Association, asked the court to set aside the current system and require the FDA to develop a new one.
Their arguments included that the FDA’s approach violates a legal requirement that the agency decide on applications within 180 days of receiving them, a deadline Altria’s complaint said the FDA has never met.
An FDA official said the agency was committed to facilitating access to less harmful alternatives for adult smokers, while protecting young people from the dangers of nicotine addiction and toxic exposure.
“FDA takes seriously this legal challenge … and will carefully review the issues raised,” the official said.
SOME APPLICATIONS DELAYED FOR YEARS
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, Philip Morris International and British American Tobacco.
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 Trump’s campaign, inauguration and White House ballroom project, and influential connections in Washington.
Those efforts have helped secure changes including the first 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.
Altria’s complaint argued that some of the FDA’s recent changes bolster its case. Applications for Altria nicotine pouches in the fast-track programme, for example, remained under review despite the agency’s target of deciding them by December 2025, the complaint said.
A company spokesperson said it filed the complaint ahead of a statutory time limit, in order to fix a system that has been “broken for a long time”.
(Reporting by Jonathan Stempel in New York and Emma Rumney in London. Editing by Mark Potter)
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