FDA Eyes New Tobacco Regulations

The agency could require cigarettes with lower nicotine levels.

May 27, 2021

WASHINGTON—In April, the U.S. Food and Drug Administration announced it is working to ban menthol cigarettes, but industry insiders believe that may be the tip of the proverbial iceberg, according to the Washington Post. The agency also has discussed the possibility of reducing the level of nicotine in cigarettes, which would have a seismic impact on the tobacco industry and public health.

“Reducing nicotine in cigarettes to nonaddictive levels would bring about the most fundamental change in the tobacco market in history,” said Matt Myers, president, Campaign for Tobacco-Free Kids.

Those potential regulations are being discussed at a time when the world is seeing a push to end tobacco sales. More than 140 organizations have released a letter calling on governments to start phasing out the sale of all cigarettes. Signatories include the Association of American Cancer Institutes and schools such as the Johns Hopkins Bloomberg School of Public Health.

The FDA can’t ban cigarettes or nicotine, but the agency can require companies to lower nicotine levels to minimally addictive levels. Some experts think that alone would trigger a dramatic reduction in use, especially since nearly 70% of American smokers say they want to quit. 

“The aim of this is basically to reduce or eliminate addiction. What drives cigarette smoking is becoming addicted to smoking,” said Neal Benowitz, tobacco addiction researcher, University of California at San Francisco.

An FDA spokesperson confirmed that the agency continues to review comments it received in response to a 2018 nicotine-reduction proposal put forward under former FDA commissioner Scott Gottlieb. That proposal announced that the agency would explore reducing nicotine to minimally addictive levels, but it stalled after Gottlieb left the FDA in 2019.

One FDA-funded analysis published in the New England Journal of Medicine in 2018 predicted that lowering nicotine to minimally addictive levels would result in 5 million smokers quitting within a year and 13 million within five years. The U.S. smoking rate, which is currently at 14% in adults, would drop to 1.4% by 2060, according to this model. 

Eric Lindblom, former FDA executive focused on tobacco policy under the Obama Administration, said that officials at the agency’s Center for Tobacco Products probably favor nicotine reduction, but “without White House support, the nicotine rule will not happen, regardless of what FDA wants or tries to do.”

Critics of the “no cigarettes” idea are concerned that the policy would create a black market in smokes. Kaelan Hollon, spokeswoman for Reynolds American, warns of a “high potential for a dangerous illicit market” if the United States bans all but low nicotine cigarettes while the rest of the world allows higher nicotine content. She adds that lower-nicotine cigarettes would not, in themselves, be any safer than regular cigarettes.

In April, NACS Daily reported that the FDA plans to ban menthol cigarettes within the next year and prohibit all flavors—including menthol—in cigars.

Lyle Beckwith, NACS senior vice president of government relations, points out that “Menthol makes up more than 37% of the tobacco market, and that demand will not go away due to a ban,” he said. “NACS is on record opposing menthol bans as we believe illicit vendors will quickly source and begin selling foreign and counterfeit menthol cigarettes. Illicit vendors do not verify age, do not collect and remit taxes, and they sell other illegal products beyond just menthol cigarettes.”