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FDA Targets Nicotine Reduction Strategy to Reduce Addiction to Cigarettes

The Food and Drug Administration on Friday proposed cutting nicotine in cigarettes to “non-addictive” levels in a huge regulatory proposal that could increase use of e-cigarettes.

Although the 2009 Family Smoking Prevention and Tobacco Control Act gave the FDA “the authority to regulate the levels of tar, nicotine and other harmful components of tobacco products,” the agency had never used that power until now.

“A lot of people have been thinking about this for a long time, including experts in the agency, including myself,” FDA Commissioner Scott Gottlieb said Friday.

Gottlieb said the agency is planning to look at regulation to “render cigarettes minimally addictive.”

The FDA said it is seeking the right balance between regulation and encouraging new tobacco products that may be less dangerous than cigarettes.

“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,” Gottlieb said. “Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use.”

“Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts — and we believe it’s vital that we pursue this common ground,” he added.

Jeff Stier, director of the Risk Analysis Division at the National Center for Public Policy Research, praised the FDA for embracing what he called a “tobacco harm reduction” approach.

“Today begins a new era in the effort to reduce the harm caused by smoking. Whereas in the past, nicotine was primarily consumed through the most harmful delivery system — cigarettes — the federal government has now started to develop a regulatory approach that will harness private-sector innovation to advance public health,” he said.

Stier said it’s important the FDA recognize “there’s a continuum of risk among different nicotine products” and that the new FDA policy direction recognizes that reality.

He said the new FDA policy means it “will not impose onerous deadlines and ill-defined requirements for so-called pre-market tobacco applications. The FDA will first develop clear, science-based product standards before manufacturers would be required to submit applications. This approach, if implemented properly, will foster a robust market offering a range of options to smokers who wish to reduce the risk from smoking.”

Gottlieb said the goal is to give Americans informed choices.

“We were thinking about, or thought we could, potentially reduce levels of nicotine to create that inflection point in public health. Taking a new balanced approach to new product innovations could make a lot of sense and help people transfer off cigarettes in a world where cigarettes were no longer addictive,” Gottlieb said in the interview.

“I’ve pledged a deep commitment to taking aggressive steps to address the epidemic of addiction to opioids,” Gottlieb said earlier Friday. “I view our opportunity to confront addiction to nicotine with the same obligation. I’ll pursue efforts to reduce addiction to nicotine with the same vigor.”