Lawsuit Challenges FDA’s New E-Cigarette Policy

A coalition of public health groups has filed a lawsuit against the Food and Drug Administration (FDA), attempting to block a new policy that allows flavored e-cigarettes and nicotine pouches to enter the market without completing the necessary scientific review.

The lawsuit, filed on Tuesday, aims to overturn a policy announced in May and finalized shortly after executives from companies supporting it met with President Trump at his golf club in Florida. Records show that two days before this meeting, Reynolds American, which had top executives attend the gathering, donated $5 million to a super PAC supporting the president.

The new policy states that the FDA will not enforce its authority against manufacturers that have made considerable progress toward obtaining agency approval. This is expected to enable major tobacco companies to introduce new flavored e-cigarettes and tobacco pouches into the market within months.

Previously, the FDA allowed only menthol or plain tobacco-flavored vapes, as these are considered less attractive to young consumers. However, unauthorized products with high nicotine levels in flavors such as strawberry slushie have been entering the U.S. market illegally, mainly from China.

The lawsuit is led by the Campaign for Tobacco-Free Kids and includes plaintiffs like the American Lung Association, American Heart Association, American Cancer Society Cancer Action Network, and the American Academy of Pediatrics.

The plaintiffs argue that the new policy breaches the Tobacco Control Act, introduced during the Obama era. This act mandates each e-cigarette and tobacco pouch undergo a thorough FDA review before receiving a ‘marketing granted order,’ akin to an approval. The review assesses whether the product is suitable for protecting public health, often determined by studies on how effectively it helps adults quit smoking without appealing to young non-smokers.