Public Policy Resources

The undersigned organizations write today to urge you to enforce the Congressionally-mandated deadlines for Premarket Tobacco Product Applications (PMTAs) for synthetic nicotine products and not allow any delays of those deadlines.

The undersigned organizations write today to urge you to enforce the Congressionally-mandated deadlines for Premarket Tobacco Product Applications (PMTAs) for synthetic nicotine products and not allow any delays of those deadlines.

High rates of menthol cigarette use is the result of deliberate actions by the tobacco industry to target certain populations. Decades of tobacco industry documents show how the tobacco industry targeted Black Americans, as well as LGBTQ+ and low-income communities with menthol cigarettes.

Cigars are tobacco wrapped in tobacco leaf or wrapped in a substance containing tobacco leaf. They can come in all shapes and sizes. One study found that the sales of cigarillos - which comprise most cigar sales - increased from 2016 to 2020 while their prices decreased. Lower prices can make tobacco products more attractive to youth because they are price sensitive. The study also found a significant increase in the sales of certain flavored cigarillos and large cigars.

Among adults who currently smoke cigars, those who used flavored products were more likely to be non-Hispanic Black individuals, younger, and have lower household incomes.

Flavors are a marketing ploy tobacco manufacturers use to target youth and young people to a lifetime of addiction. Adding flavors can improve the ease of use of a product by masking harsh effects, facilitating nicotine uptake, and increasing a product’s overall appeal.

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.