On July 28, 2017, the FDA indicated that harm reduction would be strongly embraced—and even encouraged—with the announcement of a new regulatory program that seeks to lower smoking rates and encourage smokers toward alternatives.
“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,” Gottlieb said in the announcement. “We believe it’s vital that we pursue this common ground.”
The FDA dropped a number of regulatory announcements to support this new goal, including:
— Extending deeming application deadlines for noncombustible products.
— Exploring a requirement to lower nicotine levels in cigarettes.
— Exploring the role of flavors in tobacco and nicotine products.
— Intentions to issue product standards for electronic cigarette and vaping devices.
“We need to make sure we strike the right balance between FDA fulfilling its vital consumer protection role while also fostering innovation when it comes to potentially less harmful forms of nicotine delivery,” said Gottlieb.