Public Policy Resources

This factsheet provides an overview of key activities by the FDA on menthol cigarettes and flavored cigars.

We write to urge you to respond to a new and growing threat to our nation’s youth: e-cigarette manufacturers’ use of synthetic nicotine to evade Food and Drug Administration (FDA) oversight. E-cigarette manufacturers, including the e-cigarette brand that is most popular with youth, are switching from using tobacco-derived nicotine in their products to synthetic nicotine in order to circumvent tobacco product regulations and to keep flavored e-cigarettes that are attracting and addicting youth on the market. We urge you to quickly address this serious public health situation by enacting legislation at the earliest possible opportunity that enables FDA’s Center for Tobacco Products to regulate synthetic nicotine products.

Whether Puff Bar is under the jurisdiction of the Center for Drug Evaluation and Research
(CDER) as a drug or the Center for Tobacco Products (CTP) as a tobacco product, it is critical that
FDA take action and not permit this company and this product to escape regulatory oversight.
Puff Bar has neither been approved as a drug nor received a premarket tobacco product order.
The agency should not allow any perceived regulatory “gap” to enable this company or any
other company to market new addictive nicotine products without going through the legally
required FDA review by either CDER or CTP.

Because JUUL’s products continue to have the largest share of the e-cigarette market, and therefore presumably are undergoing expedited review, we write at this time to express our conclusion that based on all of the publicly available evidence, no JUUL product currently on the market can meet the statutory public health standard. Therefore, they should not receive a marketing order.

The undersigned organizations submit this citizen petition supplement to update the administrative record for this citizen petition with the most recent information on the impact of menthol in cigarettes.

This joint statement from a consortium of public health organizations sets forth aspirational principles to help local and state health departments, decisionmakers, advocates, and other stakeholders advance equitable enforcement practices related to the purchase, possession, sale, and distribution of all tobacco products. These principles can also help address tobacco addiction and reduce tobacco-related harms while maintaining and improving the efficacy of enforcement of commercial tobacco laws and policies.

The undersigned public health and medical organizations write to urge the Food and Drug Administration (FDA) to grant the pending Citizen Petition referenced above and commence the requested rulemaking to prohibit menthol as a characterizing flavor in cigarettes.

This factsheet provides a summary of the premarket review requirements and status of FDA's enforcement of the requirements.