FDA Issues Three Advanced Notices of Proposed Rulemaking 

Cigarettes, E-Cigarettes, FDA, Flavors (including Menthol), Large Cigars, Little cigars/Cigarillos, Smokeless Tobacco and SNUS
In July 2017, the FDA announced a new regulatory plan for tobacco and nicotine and announced their intention to issue a number of “Advanced Notices of Proposed Rulemaking.” Three ANPRMs were issued in March 2018:
1. Tobacco Product Standard for Nicotine Level of Combusted Cigarettes 
On March 15th, 2018, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced an ANPRM aimed at reducing nicotine in cigarettes to non-addictive levels. FDA-funded research published in the New England Journal of Medicine shows that this type of nicotine reduction could result 5 million more adults quitting within a year of implementation, and by 2100, could result in 33 fewer people becoming smokers, a drop in the smoking rate to as low as 1.4%, and could prevent 8 million tobacco-related deaths.See more here. However, advocacy groups like ACSCAN are also calling for a maximum nicotine level for all combustible products, not just for cigarettes. See the ANPRM summary and submit comments here

2. Regulation of Flavors in Tobacco Products 
menthol cigarettes On March 20th, the agency issued an ANPRM on the regulation of flavors in tobacco products. They are “calling upon all stakeholders to share data, research and information that can inform our process for examining the role that flavors – including menthol – play in initiation, use and cessation of tobacco products.” See the ANPRM summary and submit comments here.

This is not the first time that the FDA has called for recommendations on menthol. As part of the 2009 Family Smoking Prevention and Tobacco Control Act, the FDA created Center for Tobacco Products and the Tobacco Products Scientific Advisory Committee (TPSAC), and assigned TPSAC to make a recommendation to the FDA regarding menthol based upon scientific research and evidence. In 2011, TPSAC issued a report that concluded that removing menthol tobacco products from the market would be beneficial to public health, and in 2013, the FDA confirmed menthol tobacco’s negative health effects and asked for public comment on their preliminary findings. Learn more here.

Learn more about menthol and flavored tobacco products in our evidence summaries. Learn more about the FDA Tobacco Control Act and point-of-sale policies here

3. Regulation of Premium Cigars

On March 26th, the agency issued an ANPRM on the regulation of premium cigars. They are calling for information on the definition, use patterns, and public health considerations associated with these products. The 2016 deeming rule brought all cigars under FDA regulatory authority; however, it appears the agency may be re-considering exempting premium cigars from their regulation or modifying the extent to which they are regulated. While there have been previous legislative attempts to exempt premium cigars from FDA regulation, none have succeeded. In the past, the tobacco industry has also modified cigar products slightly to circumvent differential regulation. For example, when the 2009 Family Smoking Prevention and Tobacco Control Act banned flavored cigarettes,  it also instituted a tax on small cigars. To circumvent this tax, the tobacco industry subsequently slightly increased the weight of their cigars to be able to classify them as “large cigars” under Tobacco Control Act. However, these cigars are nearly identical to cigarettes, yet still allowed to be flavored. While cigarette sales have been declining, cigars have been on the rise in the US since 2000, driven in part by the proliferation of flavored LCCs. [1]

Read a statement from the Campaign for Tobacco Free Kids on the possibility of changing how premium cigars are regulated here and considerations from the Public Health Law Center on the topic as part of the FDA’s overall regulatory plan here. See the ANPRM summary and submit comments here.

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