FDA Calls for Lower Nicotine Levels

WASHINGTON -- In what appears to be the most revealing look thus far into how the U.S. Food and Drug Administration (FDA) will handle tobacco issues under the Trump administration, Dr. Scott Gottlieb, the newly appointed commissioner to head the FDA, issued an extended document focused on breaking nicotine addiction as a central strategy.

In addition, Gottlieb said alternatives to combustible cigarettes, such as electronic cigarettes, are in need of further public discussion and research, extending deadlines for manufacturers to submit their new-product applications to several years down the road.

“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. “And we believe it’s vital that we pursue this common ground.”

What follows are major elements within the document, made public July 28, 2017 …

The agency said it intends to issue an Advance Notice of Proposed Rulemaking (ANPRM) to seek input on the potential benefits and possible adverse effects of lowering nicotine in cigarettes. Tying lower levels of nicotine to when youth first try cigarettes, the FDA surmises that “lowering nicotine levels could decrease the likelihood that future generations become addicted to cigarettes and allow more currently addicted smokers to quit,” the document said.

“Because nicotine lives at the core of both the problem and the solution to the question of addiction, 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,” Gottlieb said in the document. “Our approach to nicotine must be accompanied by a firm foundation of rules and standards for newly regulated products. To be successful, all of these steps must be done in concert and not in isolation.”

Discussing the document in a recent newsletter, Thomas Briant, executive director of Minneapolis-based NATO, said part of the FDA’s goal is to develop a “product standard” that would regulate the properties of a lower-nicotine, combustible cigarette. He noted that Congress prohibited the FDA from lowering the nicotine level to zero.

Similar to the public-commentary period on lower-nicotine cigarettes, the FDA is also going to initiate a public comment period on the dangers of e-cigarette batteries, youth access to e-liquid and the potential of e-cigarettes to be a less harmful alternative to traditional cigarettes. “A key piece of the FDA’s approach is demonstrating a greater awareness that nicotine—while highly addictive—is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes,” Gottlieb said.

The agency said it intends to issue a new enforcement policy “shortly,” with new deadlines for when manufacturers must submit applications for new products. Instead of deadlines in 2018, products such as cigars, pipe tobacco and hookah tobacco have a deadline of Aug. 8, 2021, and e-cigarettes or vaping products have an Aug. 8, 2022, deadline.

Additionally, the FDA expects that manufacturers would continue to market products while the agency reviews product applications.

The FDA also is opening up a public-hearing period to look at what role flavors, including menthol, play in attracting youth to tobacco use and conversely, what role flavors play in getting smokers to use “less harmful” forms of nicotine delivery. The FDA will apply a similar public comment period to premium cigars and medicinal-nicotine products.