FDA Set to Propose Maximum Nicotine Level in Cigarettes

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The US Food and Drug Administration (FDA) recently announced plans to publish a proposed rule that would establish a maximum nicotine level in cigarettes and certain “other combusted tobacco products.” At the moment, it is not clear what “other combusted products” FDA might have in mind. According to the Spring 2022 Unified Agenda of Regulatory and Deregulatory Actions, FDA is targeting May 2023 to issue the proposed rule, but that could always change. Even if FDA were to issue the proposed rule in May 2023, the public notice and comment and rule finalization process will take much longer.  Given the impact any final rule would have on the tobacco industry, it is likely many industry members will be very involved in the process and potentially challenge any final rule in court. Thus, it will be years before any rule takes effect, if ever.

To promulgate such a rule, FDA will rely on authority from the 2009 Family Smoking Prevention and Tobacco Control Act (TCA), which authorizes FDA to issue tobacco product standards that are appropriate for the protection of the public health, including provisions for nicotine yields of the product. 21 U.S.C. 387g(a)(4). Notably, however, the TCA prohibits FDA from “banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll-your-own tobacco products; or … requiring the reduction of nicotine yields of a tobacco product to zero….” 21 U.S.C. 387g(d)(3).  The law also requires FDA to consider technical achievability and the potential for contraband trade.

Stakeholders are likely to argue that there are numerous alternatives to the proposed standard. For example, some stakeholders may argue that FDA should instead support the growing list of noncombustible products, such as heat-not-burn products or e-cigarettes, as alternatives to combusted cigarettes. The industry is also likely to argue that the proposed standard would likely result in substantial illicit trade in cigarettes that do not meet the standard. Finally, the industry could assert that the standard is not technically achievable (particularly considering that FDA also must authorize any such changes), or at least economically prohibitive and thereby outweighing the stated benefits.

The idea of lowering nicotine levels in combustible cigarettes is not a new one for FDA. In 2018 FDA issued an advanced notice of public rulemaking (ANPRM) on this exact topic. Notably, that ANPRM sought comment on whether FDA should apply the same standard to combusted cigarettes (which FDA has previously interpreted to include kreteks and bidis), cigarette tobacco, roll-your-own (RYO) tobacco, some or all cigars, pipe tobacco, and waterpipe tobacco. Furthermore, in a 2018 statement by former FDA Commissioner Scott Gottlieb, he stated “what primarily causes death and disease from tobacco use isn’t the nicotine in these products. It’s the act of lighting tobacco on fire to free that drug for inhalation. While it’s the addiction to nicotine that keeps people smoking, it’s primarily the combustion, which releases thousands of harmful constituents into the body at dangerous levels, that kills people.” The rulemaking, however, was not completed during Commissioner Gottlieb’s tenure.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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