FDA Issues Warnings Over Vapor Products Resembling Smart Devices
The FDA said part of the reason the products are likely to appeal to youth is the way the designs potentially help conceal the nature of the products from parents, teachers, or other adults. All of the products lack authorization from FDA to be legally marketed in the United States.
In addition to the violations mentioned in the warning letters, the retailers and manufacturer were told to address any violations that are the same as, or similar to, those stated in the letter and promptly take any necessary actions to comply with the law.
Failure to promptly correct the violations can result in additional FDA actions, such as an injunction, seizure and/or civil money penalty.
"FDA is steadfast in our commitment to enforce the law," said John Verbeten, director of the CTP's Office of Compliance and Enforcement. "We will continue to take appropriate measures, working hand in hand with our federal enforcement partners, to address unauthorized tobacco products, especially those most appealing to youth.”"
To date, FDA has issued more than 700 warning letters and filed civil money penalty complaints against more than 75 manufacturers and more than 150 retailers for distribution and/or sale of unauthorized tobacco products.
The FDA has authorized 34 e-cigarette products and devices and maintains a one-page flyer of all such authorized products that retailers can consult to determine which products may be lawfully marketed and sold in the U.S.