WASHINGTON — The US Food and Drug Administration (FDA) announced on Friday that it will seek to lower nicotine in cigarettes to non-addictive levels as part of a “comprehensive regulatory plan” aimed at significantly reducing tobacco-related disease and death.
In a statement, the FDA also said it will “begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards.”
“Because almost 90 percent of adult smokers started smoking before the age of 18 and nearly 2,500 youth smoke their first cigarette every day in the US, lowering nicotine levels could decrease the likelihood that future generations become addicted to cigarettes and allow more currently addicted smokers to quit,” the US agency said.
According to the US FDA, cigarette smoking is responsible for more than 480,000 deaths per year in the United States, as well as an estimated USD 300 billion dollars in direct health care and lost productivity costs.
“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,” said FDA Commissioner Scott Gottlieb.
“Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use.”
The US agency also said it tries to reach “an appropriate balance” between regulation and encouraging development of “innovative tobacco products that may be less dangerous than cigarettes.”
As a result, it will give manufacturers of the controversial e-cigarettes and several other previously unregulated tobacco products more time to comply with a FDA final rule taking effect on August 8 last year that extended the agency’s authority to these tobacco products.
“Under expected revised timelines, applications for newly-regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, would be submitted by Aug. 8, 2021, and applications for non-combustible products such as… e-cigarettes would be submitted by Aug. 8, 2022,” the US FDA said.
Under the final rule issued last year, manufacturers were only given about three years to get FDA approval for their products.
Friday’s announcement will not affect other requirements, such as mandatory age and photo-ID checks to prevent illegal sales to minors.
In addition, the US agency said it will consider whether and how to exempt premium cigars from regulation and whether to ban menthol and other flavors in cigarettes, factors known as a leading driver of youth smoking.
Matthew Myers, president of Campaign for Tobacco-Free Kids, said in a statement the new tobacco regulatory agenda proposed by Gottlieb “represents a bold and comprehensive vision with the potential to accelerate progress in reducing tobacco use and the death and disease it causes in the United States.”
However, Myers criticized it as “a serious error” for the FDA to significantly delay critical deadlines for complying with the agency’s 2016 rule establishing oversight of electronic cigarettes, cigars and other previously unregulated tobacco products..
“This long delay will allow egregious, kid-friendly e-cigarettes and cigars, in flavors like gummy bear, cherry crush and banana smash, to stay on the market with little public health oversight,” Myers said.
“There is no reason to allow these products to stay on the market while developing and implementing the comprehensive strategy Dr. Gottlieb outlined today.”