Altria sues FDA over tobacco product review system

Marlboro-maker Altria sued the U.S. Food and Drug Administration on Wednesday, seeking to force the agency to overhaul a review process it says has blocked newer nicotine products from reaching the market, a legal filing showed.

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.

In a complaint filed in the federal court in Lubbock, Texas, Altria 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.

Altria 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 FDA did not immediately respond to a request for comment.