Blog

Two US FDA contradictory announcements: Placing nicotine levels on the regulatory agenda, Agbaje, E. Public Health Law Center, Lead Senior Staff Attorney for Federal Regulation,

Commercial Tobacco Control Program. FDA’s New Announcements on Nicotine Reduction and Zyn Products. 21 Jan 2025.
https://www.publichealthlawcenter.org/commentary/250121/1/21/25-fdas-new-announcements-nicotine-reduction-zyn-products

”At the start of 2025, the U.S. Food and Drug Administration (FDA) released two announcements that appear to address smoking cessation and reducing nicotine addiction. The first was to announce a Notice of Proposed Rulemaking on January 16 for a rule to reduce nicotine in combustible tobacco products to non-addictive levels. Public health advocates have asked the FDA to develop such a rule since implementing the Family Smoking Prevention and Tobacco Control Act (TCA) in 2009. The TCA gives the FDA the authority to reduce nicotine to non-addictive levels in the tobacco product standard, although it prohibits the FDA from reducing nicotine levels to zero.”

“The second FDA announcement is a surprising authorization of 20 Zyn nicotine pouches in various flavors at 3 and 6mg nicotine content. The marketing granting order authorizes the sale of flavors such as Cinnamon, Citrus, Menthol, Peppermint, and other concept flavors like Chill and Smooth, among others. At a time when more research is coming out about the effects of nicotine on the brain and body and nicotine’s harmful effects on young people’s brain development, the authorization appears to contradict efforts to limit nicotine exposure in other tobacco products.

Both announcements seem slightly misaligned, but there is hope that through the nicotine reduction proposed rule comment period (until Sept 2025), public health advocates, attorneys, and scientists can submit documentation that will allow the FDA to reassess how it pursues nicotine prevention and cessation focused on stopping nicotine addiction. The market for nicotine products continues to change, and laws and regulations must keep up with it to protect the public health of the country. The Public Health Law Center will continue to engage with the FDA about its rules and regulations concerning commercial tobacco products to encourage a more comprehensive approach that will protect public health from nicotine addiction.”

Comment: The US regulatory process depends both on evidence and politics. With the new Trump presidency in 2025, reducing nicotine may not be realized for many years. It is vital that nicotine reduction is on the agenda and the process is moved along so all nicotine products are eventually nicotine-reduced. FDA promises that products like Zyn will not be available to youth are illusory, just as FDA regulation has not stopped e-cigarette use in the US. Stephen Hamann

What to Expect From a Low-Nicotine Product Standard for Cigarettes: A Response to “Denicotinized” Tobacco
Denlinger-Apte RL, et al. JAMA. Viewpoint. 9 Dec 2024. doi:10.1001/jama.2024.23371

https://jamanetwork.com/journals/jama/article-abstract/2827705

“Implementing regulatory measures to reduce nicotine content in cigarettes drastically now represents a pivotal opportunity to lessen the public health burden of tobacco.”

Comment: Nicotine addiction drives the profits of the tobacco industry. Regulatory public health measures have used demand-side methods to reduce cigarette use. Still, now supply-side considerations, including the manipulation of nicotine levels in combustible and alternative nicotine products, are beginning to bring attention to nicotine, which sustains the devastation of these products. Lowering nicotine to non-addictive levels in ‘Big Tobacco’ products must be a primary focus of preventive public health efforts. Stephen Hamann