The tobacco industry scored another victory Friday with a new policy announced by the Food and Drug Administration that would give some manufacturers of illegal e-cigarettes and nicotine pouches what one expert called a “get-out-of-jail-free card.”
The FDA has a large backlog of applications from manufacturers of e-cigarettes and nicotine pouches seeking permission to sell their products. Some people go ahead and sell their products while they wait to hear back from their distributors. In the new guidance, first reported by The New York Times, authorities said they would not prioritize cracking down on illegal sales under two conditions.
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First, the manufacturer’s application must be submitted to and accepted by the FDA. Second, in the case of flavored e-cigarettes, manufacturers must provide data that the agency determines is sufficient to assess whether the product is “appropriate to protect public health,” meaning whether the potential risks of consumption to youth outweigh the benefits it could provide to adult smokers trying to quit. (Notably, the FDA does not need to actually evaluate public health data for a company to receive a clean slate determination; this could happen later.)
Mitch Zeller, former director of the FDA’s Center for Tobacco Products, said the guidance is problematic for several reasons.
First, FDA skipped the process of first issuing a draft and allowing public comment before releasing the final draft. “This is concerning,” Zeller said, because the FDA typically moves directly to final guidance only when there is a public health emergency.
“The only thing I can understand is that this was a desperate attempt to save the commissioner’s job,” Zeller said, noting that his comments were pure speculation. President Trump reportedly plans to fire FDA Commissioner Marty McCulley, but no official announcement has been made. The agency last week also approved two fruit-flavored e-cigarette products from Los Angeles-based company Glass, reversing an earlier decision by McCurry, who told STAT he was “skeptical” about whether the device’s technology was sufficient to deter underage use.
Zeller said a second concern is that the FDA is effectively giving a “get-out-of-jail-free card” to companies that pre-paid for their products without authorization, which is “fundamentally unfair to companies that followed the rules and kept their products off the market.”
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He said it’s illegal for companies to market any product, whether it’s tobacco, drugs or medical devices, without FDA approval. “This is a terrible precedent that makes no legal sense.”
Meanwhile, the new policy does not address the problem of many illegal flavored e-cigarettes imported from China, which accounts for about 70% of the black market and which the Trump administration has frequently voiced opposition to. Implicit in the new guidance is the idea that FDA will focus its enforcement efforts in that area.
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