FDA Advance Notice of Proposed Rulemaking Triggers ONS Response to Reduce Nicotine, Ban Flavors, and Regulate Premium Cigars

July 19, 2018 by Donna Sweeney ONS Director of Government Affairs

In response to the U.S. Food and Drug Administration’s (FDA’s) Advanced Notice of Proposed Rulemaking (ANPRM) on setting a tobacco standard for nicotine levels in combusted cigarettes, ONS submitted comments (https://www.ons.org/sites/default/files/ONS_FDA_Tobacco_Standard_Nicotine_Comments_July%202018_FINAL.pdf) urging the agency to lower nicotine levels in combusted cigarettes and all tobacco products.

Specifically, ONS recommended lowering the level of nicotine to a maximum of 0.4 mg or lower and that the ratio of tar to nicotine stay around 1 to reduce addiction. ONS pointed out that even lower levels of nicotine are harmful to health. ONS also cautioned the agency about the harm of additives in tobacco, including sugar, that counteract reduced nicotine levels.

Flavors: In a separate FDA ANPR asking for input on how tobacco flavors attract youth and whether flavors can help adult cigarette smokers to reduce use or switch to less harmful use, ONS urged FDA to ban all flavors (https://www.ons.org/sites/default/files/ONS_FDA%20Flavors_Comments_July_2018_0.pdf), including menthol, from tobacco products and stated unequivocally that flavors do not assist smokers in reducing use or quitting but rather have the opposite effect of increasing tobacco addiction.

ONS is particularly concerned for young people and minority groups that research shows are attracted to flavors, including menthol, which they may incorrectly perceive as being less harmful to health than non-flavored tobacco products. ONS expressed concern about the tobacco industry’s targeted marketing of menthol flavored tobacco products to certain minority groups, including African Americans, and the health disparities that have resulted.

Premium cigars: In a separate FDA ANPRM requesting input on patterns of use and public health impacts of premium cigars, ONS urged FDA to lift the current exemption and regulate premium cigars (https://www.ons.org/sites/default/files/ONS_FDA%20Premium_Cigars%20_Comments_July2018FINAL_0.pdf) in the same manner as all other tobacco products.

ONS pointed out that head and neck cancers can develop from smoking premium cigars and cited research showing that no safe level of tobacco use has been established. ONS expressed concern that young adults are using premium cigars and that the current regulatory exemption is sending the wrong and inaccurate message that cigars are not as harmful to health.

In all three sets of comments, ONS pointed out the important role nurses play in tobacco cessation and how oncology nurses have a unique imperative to help patients with cancer to quit tobacco products to improve their chances of survival and well-being.

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