• Deanna Clark-Esposito

FDA Aims to Regulate Nicotine Levels of Combustible Cigarettes

Updated: Apr 13, 2018



The US Food and Drug Administration (FDA) announced that it is considering the issuance of a product standard to set a maximum nicotine level in cigarettes so that they are “minimally addictive or non-addictive.” This announcement was made in what is known as an "Advanced Notice of Proposed Rulemaking" (ANPRM), and is entitled, "Tobacco Product Standard For Nicotine Level Of Combusted Cigarettes," [Docket Number FDA-2017-N-6189].

FDA has hypothesized that making cigarettes minimally addictive or non-addictive would significantly reduce the morbidity and mortality caused by smoking. FDA further believes a reduction in nicotine levels could help to prevent experimentation by youth and young adults, and thereby circumvent their initiation of using cigarettes and becoming addicted to them. The result would therefore, lead to a decrease in the overall population’s risk of tobacco-related death and disease.

As the ANPRM has been published in order for the FDA to obtain information as it considers this new standard, there are seven specific areas in which comments from the public are sought, which generally speaking, are intended to help the FDA answer the following questions.


1. Should a tobacco product standard include some or all of the following products: combusted cigarettes, cigarette tobacco, roll-your-own tobacco, some or all cigars, pipe tobacco, and/or water pipe tobacco?

2. Is there merit to the argument that by reducing the addictiveness of cigarettes, children would be prevented from becoming addicted smokers, and those already smoking would have a greater sense of freedom to stop smoking?

3. How should any product standard be implemented? That is, should it be an incremental staging in of reduced nicotine levels, or should the approach be one of an immediate reduction?

4. Should a specific test method be provided to manufacturers and accredited test labs for the detection of nicotine levels in their products?

5. How feasible would it be to achieve compliance with any product standard issued by FDA?

6. What, if any, countervailing effects may exist that could diminish the envisioned population health benefits as a result of this nicotine tobacco product standard?

7. What other comments, data, research results, or other information regarding the economic impacts of a potential product standard should be considered by the FDA?

Notably, in relation to the vape industry, the entirety of this ANPRM focuses on combustible tobacco products - and not vape products - even where nicotine uptake through the purchase of other products is discussed.

If you have comments you believe would be beneficial for the FDA to consider, you may provide them in relation to this ANPRM until June 14th 2018. Submissions may be made electronically (www.regulations.gov) or via a paper submission, and where further information is sought, Gerie Voss from the Center For Tobacco Products at the FDA is available for further correspondence at gerie.voss@fda.hhs.gov


Keywords:


#tobacco

#FDA

#CTP

#Cigarettes

#vape

#nicotine

#law

#standard

#health

#addictive

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