FDA Begins Enforcing Tobacco Control Rules on Unauthorized ENDS Devices

The U.S. Food and Drug Administration (FDA) has sent the first batch of warning letters to manufacturers of electronic nicotine delivery systems (ENDS) that did not submit premarket tobacco applications by the September 9 deadline.
 
On January 15, the agency issued warning letters to 10 companies operating websites that manufacture and sell ENDS products (particularly e-liquids), notifying them that selling these products without premarket authorization is illegal and therefore cannot be sold or distributed.

In the U.S., under a court order, certain newly deemed tobacco products must have premarket review applications submitted to the FDA by September 9, 2020, including e-cigarette liquids. Before this deadline, the FDA generally intended to delay enforcement for up to a year until the FDA reviews, unless the FDA took negative action on the applications. The FDA plans to publish a list of products for which it has received applications. However, before providing such a list, the FDA is verifying certain information about these products to ensure the list's publication complies with the Freedom of Information Act.

Stephen M. Hahn

FDA Commissioner Stephen M. Hahn stated in a release: "The premarket application process ensures that many new tobacco products, including tobacco products, will undergo strong scientific evaluation by the FDA." "Conducting scientific reviews of new products is a key part of our mission to protect the public (especially children) from the harms of tobacco use. In addition to important premarket scientific reviews, we are also prioritizing enforcement against violators selling unauthorized products, which is our way of protecting public health."

The 10 companies that received warning letters are Little House Vapes; Castle Rock Vapor; Drip More Vapes; CLS Trading; Session Supply Co.; Coastal E-Liquid Labs/GC Vapor; Dr. Creamy; CMM Capital LLC; and E-Cig Warehouse.

Mitch Zeller

Mitch Zeller, Director of the FDA's Center for Tobacco Products, said: "These warning letters are the result of ongoing surveillance of tobacco law violations and internet monitoring." "We want to make it clear to all tobacco product manufacturers and retailers that the FDA will closely monitor the market and hold companies accountable for violations of the law."

The FDA has requested that each company respond within 15 business days of receiving the letter, detailing how each company intends to address the agency's concerns.