New FDA Guidance Gives the Tobacco Industry a Free Pass to Put Illegal Products on the Market

WASHINGTON, D.C. – The FDA’s recently issued guidance on Enforcement Priorities for new tobacco products is a gift to Big Tobacco that will allow illegal products – including e-cigarettes and nicotine pouches - to be on the market without full scientific review and authorization by the agency. It is further troubling that this guidance was announced without any opportunity for public comment, which is contrary to the agency’s longstanding approach and the Department of Health and Human Services’ commitment to transparency.

By allowing products with pending applications to be sold without the risk of enforcement action, the largest tobacco companies have been given a free pass to keep their products on the market without consequences – including flavored products with proven youth appeal. The federal Tobacco Control Act requires FDA to conduct rigorous scientific review of new tobacco products and provide an authorization before a product can be legally sold in the United States. Simply submitting an application does not give companies safe harbor from enforcement - if a product has not been authorized for sale by the FDA, it’s on the market illegally.

Concerns about this new guidance are compounded by the fact that the U.S. Government has taken no substantive enforcement actions against illegal tobacco products since last summer. If we are truly going to attack this problem head on, the FDA and other federal agencies, such as U.S. Customs and Border Protection and the Department of Justice, need to step up efforts to stop the sales of all unauthorized tobacco products. To maximize impact, such actions should be taken across the supply chain, including against manufacturers, distributors, importers, and retailers who are violating the law.

The failure to enforce the law against all unauthorized tobacco products has real, and significant public health consequences. While the United States has made significant progress reducing youth tobacco product use, more than 1.4 million middle and high school students currently use e-cigarettes and nicotine pouch use has increased among young people in recent years. Flavors play a key role in youth initiation and continued use of tobacco products. About 4 out of 5 youth who have ever used tobacco started with a flavored product and nearly 90 percent of youth who use e-cigarettes report using flavors.

This guidance comes amid media reports that the FDA has faced pressure from the White House to authorize more flavored e-cigarettes. It is deeply disappointing that the FDA has caved to political pressure rather than following the science and the law to best protect kids.