US: FDA 2018 Year In Review: Tobacco

The deadline for implementing warning labels on cigars and pipe tobacco under 21 CFR §§ 1143.3 and 1143.5 originally was August 10, 2018, but it has been delayed until 60 days after the US Court of Appeals for the DC Circuit decides the Cigar Association of America, et al. v. U.S. Food and Drug Admin., et al., No. 1:16-cv-01460 (D.D.C. July 5, 2018). Cigar and pipe tobacco firms may choose to comply voluntarily with warning label requirements in the interim.  
 

While statements by Commissioner Scott Gottlieb in 2017 suggested that FDA would take a fresh approach to nicotine regulation and the potential impact of delivery mechanism on addiction—i.e., evaluation of products on a spectrum of risk—2018 represented a significant shift in agency policy regarding tobacco products.
 

FDA is expected to pursue the removal of ENDS products that are marketed to children or are appealing to youth.
 

In April, FDA issued more than 40 warning letters for violations related to youth sales of e-cigarettes. FDA also took steps to foreclose online sales of electronic nicotine delivery systems (ENDS) products to minors and examine youth appeal of ENDS products. In May, FDA and FTC jointly issued 13 warning letters to manufacturers, distributors and retailers for selling e-liquids “with labeling and/or advertising that cause them to resemble kid-friendly food products, such as juice boxes, candy, or cookies, some of them with cartoon-like imagery.” After a call for voluntary manufacturer action in September, and the release of the 2018 National Youth Tobacco Survey, which demonstrated a dramatic increase in youth use of ENDS products, Commissioner Gottlieb announced that FDA would be seeking to take the following actions and to provide more guidance around:
 

Limiting in-person sales of flavored ENDS products (other than tobacco, mint, menthol and non-flavored products) to age-restricted locations
 

Limiting internet sales of flavored ENDS products (other than tobacco, mint, menthol and non-flavored products) to online retailers with heightened age verifications
 

Banning marketing of ENDS products to children
 

Banning menthol in combustible tobacco products, including cigarettes and cigars  
 

Banning flavored cigars
 

Looking Ahead to 2019
 

FDA is expected to revise its compliance policy for ENDS products that are flavored, including by providing additional guidance on “age-restricted locations” and “heightened age verifications.” FDA is also expected to pursue the removal of ENDS products that are marketed to children or are appealing to youth, such as those using popular children’s cartoon or animated characters, or names of products favored by youth, such as brands of candy or soda.
 

Finally, FDA is expected to issue a Notice of Proposed Rulemaking that would seek to ban menthol in combustible tobacco products, including cigarettes and cigars, and to propose a product standard that would ban flavors in all cigars.