A ban on menthol cigarettes and flavored cigars will only exacerbate existing illicit trade of tobacco products, according to a letter from 20 U.S. representatives sent to Food and Drug Administration Commissioner Robert Califf.
The FDA expects to publish a final rule on these new tobacco standards in August; however, the ban wouldn’t take effect until at least a year later.
“When Congress enacted the Tobacco Control Act in 2009, the intent was for the FDA to use regulation to ensure proper oversight of the tobacco industry. When prohibition-based actions result in large illicit markets, it causes more risk for Americans, more crime, more burden on law enforcement and more opportunities for policy and community conflict,” the June 13 letter said. “We urge FDA to take illicit markets seriously. The FDA can do this by using regulation to safely meet adult consumer demand while also establishing controls on how those products are marketed to protect kids. We urge you to reconsider FDA’s proposed rules on menthol cigarettes and flavored cigars and refrain from any further prohibition-based actions that threaten to expand illicit markets.”
During the House Appropriations Subcommittee on Agriculture, Rural Development and Food and Drug Administration on March 29, Califf acknowledged the FDA’s inability to clear the market of illegal e-vapor products, the representatives said. The FDA has been regulating e-vapor products since 2016 but has failed to bring order to the category as it has denied authorization to all but a few products, leaving the vast majority of adult consumer demand unmet, the members of Congress said.
The FDA filed a status report in April on its progress on premarket tobacco product applications (PMTAs) saying it expects to be finished reviewing applications by the end of the year. As of that time, the agency had issued 45 marketing granted orders (MGOs) for tobacco products submitted through the PMTA process, and none for flavors other than tobacco.
The proposed rule to ban menthol cigarettes would move about one-third of all cigarettes sold in the U.S. today out of the legal, regulated distribution system, the letter said. The representatives are concerned that the ban will lead to a similar illicit market as vapor products, further burdening police to regulate the growing illicit tobacco markets.
The letter pointed to Massachusetts and California, both of which have enacted flavored tobacco sales bans, as examples of states that saw an expansion of the illicit tobacco market after flavors were prohibited.
“With this prohibition-based approach, we now see thriving illicit e-vapor markets all over the U.S.,” the letter stated. “These markets include illegal products with some of the highest incidence of underage use; products made in Chinese manufacturing facilities with no FDA oversight; products being illegally smuggled over U.S. borders and through U.S. ports; products being trafficked in violation of state and local criminal laws; and products being sold without age verification.”
The letter was signed by U.S. Reps. John Rutherford, Don Bacon, David Valadao, Ben Cline, C. Scott Franklin, Troy Nehls, Richard Hudson, John Rose, Jerry Carl, Eric “Rick” Crawford, Daniel Meuser, Andrew Garbarino, Debbie Lesko, Byron Donalds, Mike Ezell, David Rouzer, Anthony D’Esposito, Kat Cammack, Diana Harshbarger and Jeff Duncan.
The FDA has made recent efforts to curb the sales of illegal tobacco products. It warned 189 retailers for selling unauthorized products in a tobacco inspection blitz in June. The FDA in May also issued an import alert, authorizing U.S. Customs and Broder Protection to detain certain disposable e-cigarettes that do not have required marketing authorization, including Elf Bar, Esco Bar and Eon Smoke.
The FDA did not immediately respond to CSP’s request for comment.
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