On March 13, 2019, the FDA announced that they were issuing a draft compliance policy for flavored e-cigarettes & flavored cigars. Under this new compliance policy, the FDA would prioritize enforcement for:
- Electronic Nicotine Delivery System (ENDS) products that are “offered for sale in ways that pose a greater risk for minors to access such products” including:
- ENDS products sold in flavors other than mint, menthol, or tobacco and offered for sale in establishments that minors (under age 18) can enter at any time, whether that is the entire establishment or an area within the establishment
- ENDS products sold online without limits on the quantity a customer can purchase during a set time period and/or without “third-party age- and identity-verification services that compare customer information against third-party data sources, such as public records.”
- ENDS products (other than mint, menthol, and tobacco flavors) that are on the market as of August 8, 2021, without the manufacturer submitting (and FDA receiving) a premarket application (or after action by FDA on that application). This means the FDA is moving the premarket review deadline up by one year – from August 2022 to August 2021, the same as the premarket review deadline for combustible products. However, this is still a delay from the original August 8, 2018 deadline set by the 2016 “Deeming Rule,” and this also means that ENDS products currently on the market can remain without FDA review for at least another two years. For more information on this, review the Public Health Law Center’s factsheet, “Extensions and Epidemics: The FDA’s Gatekeeping Authority for E-Cigarettes”
- All ENDS products that are targeted to minors or likely to promote use of ENDS by minors. The FDA has previously issued warning letters to e-liquid companies marketing products designed to resemble candy, sugary cereals and other kid-friendly food products.
- Flavored cigars (other than tobacco flavored) that were on the market as of August 8, 2016. However, this excludes any products that were on the market as of February 7, 2007, which by law are not considered “new tobacco products.”
This draft guidance is open for public comment until April 15th. You can submit comments here. Once comments are reviewed and the guidance is finalized, the rule will take effect in 30 days. However, we don’t know how long the rule will take to be finalized and approved and there is no deadline for the FDA to issue a final rule. The draft guidance also does not detail what actions are possible within their “prioritized” enforcement.
It is important to note that the draft guidance exempts mint and menthol flavored ENDS products, which are popular flavors among youth, with 51.2% of high school students who currently use ENDS reporting use of those specific flavors in 2018. For this reason among others, public health groups such as the Campaign for Tobacco Free Kids argue that the draft compliance does not go far enough to fight the epidemic of e-cigarette use among youth.
The draft compliance also does not include any updates on a potential menthol ban for cigarettes and other combustible products.
For more on the draft guidance, review the Public Health Law Center’s webinar, “Too Little Too Late? The FDA’s New Enforcement Guidance“