The FDA's Roadmap for More Stringent Tobacco Regulation

In his first speech to the staff at FDA in July, newly confirmed FDA commissioner Scott Gottlieb, MD, had singled out smoking cessation as a mission that could have the most impact to prevent illness and mortality. He also spoke about harm reduction alternatives for smokers who cannot quit. Following up on that, the FDA has announced a regulatory plan that could shift the trajectory on tobacco-related disease and death.

The new plan aims to solidify the agency’s ability to implement the Family Smoking Prevention and Tobacco Control Act, which has been devised to ensure that the FDA can address issues including:

• Use of tobacco by young people
• Addiction to tobacco
• Setting national standards to control the manufacture of these products, including the quantity of the active ingredients
• Appropriate regulatory controls over the tobacco industry

With nearly 500,000 deaths attributed to tobacco use each year in the United States, the products are responsible for nearly $300 billion in lost productivity and direct healthcare 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 Gottlieb in a statement. “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.”

The FDA’s approach includes ensuring the development of innovative tobacco products that are less dangerous that cigarettes, in addition to seeking comments on the role of flavors in these products—a strategy used by tobacco product manufacturers to entice young children. The regulatory authority has also announced the need to initiate a public dialogue on reducing the levels of nicotine levels in combustible cigarette products to make them less addictive, which could significantly drop the number of individuals who start smoking before they turn 18 and, in turn, impact the number of smokers in generations to come.

Emphasizing the importance of a concerted effort, Gottlieb said that “addressing the addictive levels of nicotine in combustible cigarettes must be part of the FDA’s strategy for addressing the devastating, addiction crisis that is threatening American families.”

To give manufacturers additional time to ensure higher quality and a more complete application, the FDA has revised the timeline for applications for newly-regulated combustible products, including cigars, pipe tobacco and hookah tobacco, to August 8, 2021, and for non-combustible products such as electronic nicotine delivery systems to August 8, 2022. These policies will not, however, affect existing requirements for cigarettes and smokeless tobacco products.

Regulatory procedures are also being revised and made more transparent and predictable for manufacturers of these products.