In a letter dispatched to Food and Drug Administration (FDA) Acting Commissioner Stephen Hahn this week, House Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) pressed the agency not to change plans for setting a maximum nicotine level in cigarettes.
That plan had been gathering steam since March 2018, under former Commissioner Scott Gottlieb, with the intent to limit the addictiveness of what the FDA noted as the most toxic and widely used tobacco products. However, proposals linked to such a change were left out of the administration’s Fall 2019 Unified Agenda, raising alarm bells in the process.
“It is disappointing that FDA appears willing to shelve this critically important solution instead of working towards specific regulatory actions that could result in significant public health benefits,” Pallone wrote. “I strongly urge you in your new role as Commissioner to reconsider FDA’s decision to remove the nicotine level ANPRM from FDA’s 2019 Unified Regulatory Agenda and move forward with proposing and finalizing regulations on this issue as soon as possible.”
It’s not the only big tobacco-related pivot the FDA has taken recently. At the same time, the FDA has delayed compliance deadlines for premarket tobacco applications for newly regulated tobacco products such as existing e-cigarettes, allowing e-cigarette products from before Aug. 8, 2016, to remain on the market without extensive FDA review.
To back his stance on such issues, Pallone referenced a study in the New England Journal of Medicine from 2018, which found that lowering nicotine levels in cigarettes to minimum addictive levels could lead to major reductions in tobacco-related deaths within the United States.
As that study noted, “The age at which people begin smoking can greatly influence how much they smoke per day and how long they smoke, which ultimately influences their risks of tobacco-related disease and death. Addiction to nicotine in tobacco is critical in the transition of smokers from experimentation to sustained smoking and in the continuation of smoking for those who want to quit.”
Following his plea, Pallone asked that the FDA state why it removed the new tobacco product standard from its regulatory agenda, whether it plans to resume consideration of such regulatory action and if the FDA continues to believe such actions could still help limit addictiveness. He requested an answer by March 10.