FDA Authorizes Flavored Vapes

The Food and Drug Administration (FDA) this week announced authorizations of additional nicotine vapor products, including its first authorization of fruit-flavored vapor products intended for adult customers through the premarket tobacco product application (PMTA) pathway. 

Each Glas product is an e-liquid pod containing 50mg/ml (or 5%) of tobacco-derived nicotine. The authorized pods flavors include Classic Menthol, Fresh Menthol, Gold and Sapphire. According to the Associated Press, the newly authorized Gold and Sapphire flavors are mango and blueberry. 

The FDA’s action permits these specific electronic nicotine delivery systems (ENDS) products to be legally marketed in the U.S. to adults 21 and older. The actions are specific to these four products only; the authorizations do not apply to any other Glas products, FDA said.  

The FDA has now authorized 45 ENDS products for marketing in the U.S. These 45 products are the only ENDS products that may currently be lawfully sold in the U.S. 

“We appreciate FDA moving forward with the process of deciding premarket applications,” said Margaret Mannion, NACS director of government relations. “All outstanding applications must also be decided so that the agency can focus on enforcement and clean up the illicit products coming in from China.”
 
The move by FDA follows quickly after Representative Richard Hudson (R-NC) and eighteen of his colleagues sent a letter to FDA on April 24 urging these approvals. NACS worked closely with the Members of Congress on the letter in order to promote reforms that would clean up the rapid expansion of illicit products. 

Tobacco E-Cigarettes