FDA Regulation of Tobacco
and Tobacco Products
In July 2107, the U.S. Food and Drug Administration (FDA) announced a comprehensive new regulatory plan regarding lowering nicotine in combustible cigarettes, and extended timelines for applications for newly-regulated combustible tobacco products (cigars, pipe tobacco and hookah) and newly-regulated non-combustible products (ENDS and e-cigarettes). The announcement also made references to the role of flavors.
This announcement contained some encouraging news for CDA members, as the timelines for applications for newly regulated tobacco products were extended significantly, and the FDA explicitly states that products can be marketed during the application process. This means that all newly deemed products on the market as of August 8, 2016, including cigars (premium and little cigars), pipe tobacco, hookah, and e-cigarettes, can be sold without any marketing authorization from the FDA until 2021 or 2022. As for currently regulated products such as cigarettes and smokeless tobacco, many of these products remain subject to pending provisional SE applications and may remain on the market unless the FDA issues a Not Substantially Equivalent (NSE) Order, which requires the manufacturer to cease manufacturing the tobacco product (FDA exercises enforcement discretion at the retail level for an additional 30 days to account for existing inventory of NSE products).
FDA issued three Advance Notices of Purposed Rulemaking (ANPRMs): one setting a maximum level of nicotine in cigarettes and possibly other tobacco products; one on the role of flavors in tobacco products; and one on the premium cigar category. This will be a very lengthy regulatory process. CDA has added our comments to FDA’s official docket on nicotine and flavors. We will continue to monitor and report on FDA activity on regulation of tobacco and nicotine products, and will advocate for thorough, science-based regulations that are beneficial to the convenience distribution industry and our industry partners.
CDA supports its members’ ability to sell these products responsibly. In November 2018, FDA commissioner Gottlieb announced additional measures that would restrict the ability of convenience stores to sell e-cigarettes. CDA is actively engaged with the FDA, allied trade associations and supplier partners to ensure that any action by FDA is fair and equitable for CDA members. CDA’s letter to the FDA Commissioner.
The We Card program is a national non-profit organization serving the nation's retailers of tobacco, alcohol, e-cigarettes, vapor products and other age-restricted products. Individual retail establishments as well as large retail chains utilize We Card's educational and training services for their compliance efforts with federal, state and local laws on preventing age-restricted product sales to minors.
National and state retail trade associations, government officials, community groups and others also support We Card's ongoing efforts to raise awareness of responsible retailing and age verification requirements and to educate and train retail employees to identify and prevent underage attempts to purchase age-restricted products. More information.