Today, FDA finalized an enforcement policy on unauthorized flavored cartridge-based e-cigarettes, including fruit and mint, that appeal to children. Companies that do not cease manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days risk FDA enforcement actions. Beginning 30 days from the publication of the notice of availability of this guidance in the Federal Register, FDA intends to prioritize enforcement against certain illegally marketed ENDS products that do not have premarket authorization.
FDA intends to prioritize enforcement of:
- Any flavored, cartridge-based ENDS products (other than tobacco- or menthol-flavored)
- All other ENDS products for which the manufacturer fails to take adequate measures to prevent minors’ access
- Any ENDS products targeted to minors
FDA’s policy attempts to balance the public health concerns related to youth use of ENDS with considerations regarding addicted adult cigarette smokers who may try to use ENDS products to transition completely away from combustible tobacco products. FDA is committed to preventing youth from using and becoming addicted to any tobacco product, including e-cigarettes. Today’s policy is an important step in FDA’s ongoing efforts to ensure these products are not marketed to, sold to, or used by kids. https://go.usa.gov/xpeDe