Health Groups Sue FDA Over New E-Cigarette Policy

A group of public health organizations filed a lawsuit against the Food and Drug Administration (FDA) on Tuesday. The aim is to prevent a new policy that might lead to the introduction of new flavored e-cigarettes and nicotine pouches without a necessary scientific review. The lawsuit requests a judge to overturn a policy announced in May, finalized shortly after executive meetings with President Trump.

Two days before a meeting at President Trump’s golf club in Florida, Reynolds American donated $5 million to a super PAC supporting the president, according to campaign finance records. The new FDA policy suggests the agency will not enforce its authority against manufacturers making significant progress toward receiving agency approval. This approach could enable major tobacco companies to market new flavored tobacco pouches and e-cigarettes within months.

Previously, the FDA only allowed the sale of menthol or plain tobacco-flavored vapes, believed to be less attractive to young users. However, unauthorized products with high nicotine levels in flavors like strawberry slushie have been entering the U.S. illegally from China.

The lawsuit’s plaintiffs, led by the Campaign for Tobacco-Free Kids, include the American Lung Association, American Heart Association, American Cancer Society Cancer Action Network, and the American Academy of Pediatrics. They argue the new policy contravenes the Tobacco Control Act, established during the Obama administration. The act mandates each e-cigarette and tobacco pouch to undergo a rigorous FDA review before obtaining a ‘marketing granted order,’ akin to an approval.

The review evaluates whether a product is ‘appropriate for the protection of public health,’ typically using company studies on its effectiveness in helping adults quit smoking without enticing young users.