FDA Finalizes Enforcement Policy on Unauthorized Flavored Cartridge-based E-cigarettes
Amid the epidemic levels of youth use of e-cigarettes and the popularity of certain products among children, the U.S. Food and Drug Administration today issued a policy prioritizing enforcement against certain unauthorized flavored e-cigarette products that appeal to kids, including fruit and mint flavors. Under this policy, 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, the FDA intends to prioritize enforcement against these illegally marketed ENDS products by focusing on the following groups of products that do not have pre-market authorization:
- Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product);
- All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
- Any ENDS product that is targeted to minors or likely to promote use of ENDS by minors.
In other words, closed pod systems will be illegal within the United States within 30 days if they aren't in the flavors of tobacco or menthol. We assume this will greatly limit the access of Juul and other similar products to youth who have found the ease and discrete nature of those products easy to hide and use.
By not prioritizing enforcement against other flavored ENDS products in the same way as flavored cartridge-based ENDS products, the FDA has attempted to balance the public health concerns related to youth use of ENDS products with considerations regarding addicted adult cigarette smokers who may try to use ENDS products to transition away from combustible tobacco products.
At Cali Steam we do not see this recent action by the FDA impacting our ability to share our quality products with our customers. We have not sold or marketed a closed pod system and therefore should not be restricted in our initial sales. However, we continue to ensure our products to not appeal to children and are marketed in a way that restricts any sales to minors.