FDA Seeks the ‘Right Balance’ With New Tobacco Plan

Agency aims to reduce nicotine levels while shifting smokers toward e-cigarettes

WASHINGTON -- Scott Gottlieb, the U.S. Food and Drug Administration’s new commissioner, said he envisions “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.” That, he said, is the “cornerstone” of the FDA’s new effort to reduce cigarette use in the United States while consciously shifting smokers to electronic cigarettes.

As part of its new regulatory program announced July 28, the FDA will begin a public dialogue about lowering nicotine levels in combustible cigarettes to nonaddictive levels. It will issue an Advance Notice of Proposed Rulemaking (ANPRM) to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes.

Furthermore, the FDA has declared its commitment to innovations that could lead to less harmful products.

“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,” Gottlieb said.

To do this, the agency intends to extend timelines to submit tobacco product review applications for newly regulated tobacco products that were on the market as of Aug. 8, 2016. Under the expected revised timelines, applications to market newly regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, would be submitted by Aug. 8, 2021, and applications to market newly regulated noncombustible products, such as electronic nicotine delivery systems (ENDS) or e-cigarettes, would be submitted by Aug. 8, 2022.

All other compliance deadlines for manufacturers will remain the same, and the anticipated new enforcement policy does not affect any current requirements for cigarettes and smokeless tobacco—only the newly regulated tobacco products such as cigars and e-cigarettes.

In order to further explore how best to protect public health in the evolving tobacco marketplace, the FDA intends to issue ANPRMs to seek public comment on the role that flavors in tobacco products (including menthol) play in attracting youth, as well as the role they may play in helping some smokers switch to potentially less harmful forms of nicotine delivery; and solicit additional comments and scientific data related to the patterns of use and resulting public health impacts from premium cigars.

“Public input on these complex issues will help ensure the agency has the proper science-based policies in place to meaningfully reduce the harms caused by tobacco use,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.

To complement these larger policy considerations, the FDA plans to issue foundational rules to make the product review process more efficient, predictable and transparent for manufacturers. It will issue regulations outlining what information the agency expects to be included in premarket tobacco applications (PMTAs), modified risk tobacco product (MRTP) applications, and reports to demonstrate substantial equivalence (SE). The FDA also plans to finalize guidance on how it intends to review PMTAs for ENDS.

Gottlieb was confirmed as commissioner of the FDA on May 9.

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