The Food and Drug Administration said Friday it wants to reduce the nicotine in cigarettes to make them less addictive. The unexpected announcement sent shares of tobacco companies plummeting and sparked praise among some public health advocates.
If successful, the plan would be the first time the government has tried to get the Americans to quit cigarettes by reaching beyond warning labels or taxes and attacking the actual addictive substance inside.
The FDA rolled out a second major announcement at the same time: It is delaying for several years its regulation of cigars and e-cigarettes, including flavored vaping products that studies show are especially enticing to youth.
FDA’s commissioner Scott Gottlieb said both actions are part of a comprehensive plan to eventually wean smokers off conventional cigarettes and steer them toward less harmful alternative forms of nicotine like vaping.
“The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes — the only legal consumer product that, when used as intended, will kill half of all long-term users,” he said.
Some health proponents, however, expressed caution, pointing out that the nicotine-reduction proposal would take years to enact and could be derailed by major hurdles, including the significant lobbying power of tobacco industry.
The reason FDA is delaying new regulations on e-cigarettes, Gottlieb said, is because it needs time to set the proper foundation for supervising such products, which he believes give smokers the nicotine they crave without many of the dangerous chemicals in cigarettes smoke.
The surprising plan to force tobacco companies to lower nicotine in their cigarettes could have serious ramifications for the industry, which has seen a steady drop in American smokers for decades.
Smoking in the United States is now at an all-time low, with just 15 percent of adults still lighting up. And tobacco use among youth has fallen to similarly historic lows, sparking hope among public health officials that a smoke-free generation may finally be within reach.
Even before Gottlieb’s announcement, the tobacco industry has been trying to find new ways of maintaining its hold on remaining smokers in the United States by getting into the vaping business or with new tobacco products that deliver nicotine without smoke.
In their Friday announcement, FDA officials said other rules affecting e-cigarettes, such as a ways to prevent sales to minors, will remain in place. And the delay won’t affect future deadlines such as requirements that manufacturers provide FDA with lists of ingredients.
The moves came amid furious lobbying by the e-cigarette industry to roll back FDA regulations, issued last year, that require companies to submit to a rigorous approval process for products marketed after Feb. 15, 2007. That date meant that nearly all the e-cig products sold today would be required to go through the review, industry officials said. Some congressional Republicans have also been pressing for a change in the approval requirement.
The product-approval requirement for e-cigarettes and cigars was part of the so-called “deeming rule,” in which the agency decided that e-cigarettes would be subject to the same rules as conventional cigarettes. The rule gave manufacturers about two years — until sometime in 2018 — to get FDA approval for their products or risk having them pulled off the market.
Under the revised timelines applications for products such as cigars, pipe tobacco and hookah tobacco, would need to be submitted by Aug. 8, 2021 and applications for noncombustible products such as e-cigarettes would need to be submitted by Aug, 8, 2022. Manufacturers would be permitted to continue to sell their products during the FDA reviews.