In the first warning letters of their kind, the FDA wrote to the companies – Dr. K, Knoxville Vapor, and Vaperz – to tell them that they are violating section 301 of the U.S. Federal Food Drug & Cosmetic Act by suggesting to consumers that their products have been approved by the FDA.
“General examples of the violations include claims of FDA lab certification (Knoxville Vapor) and FDA registration/approval (Vaperz Ltd. and Dr. K),” the agency said today.
The firms now have 15 days to reply with details of the action they are taking in response, or could face civil penalties, injunction, or criminal prosecution.
The Websites of both Knoxville Vapor and Vaperz today included statements that their products had not been reviewed by the FDA.
What This Means: This is business as usual for the FDA, which was at pains to stress that it had taken action because the companies had made claims of federal approval for tobacco products – and that the warnings have nothing to do with the agency’s plans to regulate e-cigarettes through its deeming rules.
All the same, it underlines the importance for the industry as a whole of distancing itself – not least in the eyes of the FDA – from suppliers which put forward unsupportable or misleading ideas.
– Barnaby Page ECigIntelligence staff