The U.S. Food and Drug Administration (FDA) has sent the first batch of warning letters to the manufacturer of the electronic nicotine delivery device (ENDS), which did not submit a pre-market tobacco application by the September 9 deadline.
On January 15, the agency issued a warning letter to 10 companies that manufacture and operate websites that sell ENDS products (especially e-liquids), informing them that it is illegal to sell these products without pre-sale authorization and therefore cannot be sold or distributed. .
In the United States, according to a court order, the pre-market review application for certain identified new tobacco products, including e-liquids, must be submitted to the FDA before September 9, 2020, as of August 8, 2016. Before this deadline, the FDA generally intends to postpone execution for up to one year until FDA review, unless the FDA takes negative action on the application. The FDA plans to publish a list of products for which the agency has received its application. However, before providing such a list, the FDA is verifying certain information about these products to make the release of the list comply with the Federal Open Act.
Stephen Hahn
FDA Commissioner Stephen M. Hahn said in a statement: “The pre-market application process ensures that many new tobacco products, including tobacco products, will be subject to strong scientific evaluation by the FDA.” “Yes. Scientific review of new products is a key part of our mission to protect the public (especially children) from the harm caused by tobacco use. In addition to important pre-sales scientific review, we are also committed to passing unauthorized sales Products to give priority to offenders. This is our way to protect public health."
The 10 companies that received the warning letter were Little House Vapes; Castle Rock Vapor; Drop Smoke Perfect Vapes; CLS Trading; Conversation Supply Company; Coastal E-Liquid Lab/GC Vapor; Dr. Crimei; CMM Capital LLC; and Electronic Cigarettes barn.
Mitch Zeller
Mitch Zeller, director of the FDA’s Tobacco Products Center, said: “These warning letters are the result of continuous surveillance and Internet surveillance for violations of tobacco laws and regulations.” “We want to show all tobacco product manufacturers and retailers that the FDA will pay close attention to the market and The company will be held responsible for violating the law."
The FDA has asked each company to respond within 15 working days of receiving this letter, detailing how each company intends to resolve the agency's problems.