May 8 (Reuters) – The U.S. Food and Drug Administration (FDA) said on Friday it would not prioritize enforcement against certain unauthorized e-cigarettes and nicotine pouch products if the companies have marketing applications under review.
The new guideline applies to products with premarket applications that have been accepted for review or supplemental filings that have been pending for more than 180 days, the agency said.
Non-tobacco-flavored vape makers, who face heightened scrutiny due to youth usage concerns, must also provide sufficient scientific data to assess whether the products are “appropriate for the protection of the public health”.
The change means that manufacturers with products that meet the agency’s conditions are unlikely to face enforcement action even if they sell their products without the legally-required license.
It marks a boost for companies like Philip Morris International, which have held off on launching new products while waiting for an agency decision, sometimes at the expense of market share.
Tobacco companies have been lobbying President Donald Trump and other key officials in the administration for changes including a faster, clearer FDA authorization process.
Earlier this week, the agency approved the marketing of certain fruit-flavored e-cigarettes in a first authorization of non-tobacco-flavored vaping products.
The FDA also said on Friday that applications that include detailed data on product composition, health risks and device specifications are more likely to meet regulatory standards.
“By not prioritizing these tobacco products for enforcement, FDA will be able to better allocate its enforcement resources. FDA lacks the resources to pursue enforcement against every product that has not received authorization,” it said.
The FDA may still take action against products that have certain “presumptively underage-appealing elements such as depicting a cartoon-like fictional character, disguising its nature as a vaping product, or resembling a children’s toy, phone, or gaming platform.”
(Reporting by Aishwarya Venugopal in Bengaluru and additional reporting by Emma Rumney in London; Editing by Sriraj Kalluvila)
