LyfeUnit Selling Unapproved Ketamine Products: FDA

FDA says its 2/27 review of the Web site maintained by LyfeUnit found that the company is marketing in interstate commerce misbranded and adulterated ketamine products. A 6/23 Warning Letter says the agency has identified significant risks with unapproved ketamine products, especially in the absence of appropriate medical supervision. “Given the increased interest in the use of ketamine products,” it says, “the easy availability of unapproved and misbranded ketamine products via the Internet puts U.S. consumers at risk for serious adverse events.”

The letter says FDA is asking LyfeUnit to cease offering any unapproved and misbranded drugs for sale to U.S. consumers. “This is critical to shielding the U.S. public from harm,” it says.

LyfeUnit was told to respond with a list of specific steps it has taken to correct the violations, with documentation of each action.