FDA WARNING_LETTER - MyNicNaxs, Inc. - November 30, 2013

This FDA Warning Letter, FLA-15-18, dated February 20, 2015, addresses MyNicNaxs, Inc. for distributing unapproved new drugs and misbranded drugs. The letter details a history of non-compliance, beginning in July 2013 with the detention of "Reduce Weight Fruta Planta" containing sibutramine. Subsequent FDA sampling and a November 2013 inspection confirmed the presence of undeclared sibutramine, sibutramine analogues, and/or phenolphthalein in ten products, including "Fruta Planta," "Fat Loss Slimming Beauty," and "Meizi Evolution."

Despite a voluntary recall agreement in February 2014, the firm continued to import and distribute these products. The FDA classifies these products as unapproved new drugs because they contain sibutramine, which was authorized for investigation as a new drug before being marketed as a dietary supplement, thus excluding them from the dietary supplement definition. They are considered drugs due to their intended use for weight loss and are "new drugs" as they are not generally recognized as safe and effective. Their distribution violates sections 505(a) and 301(d) of the FD&C Act.

Furthermore, the products are misbranded under section 502(f)(1) for lacking adequate directions for use, as sibutramine requires professional supervision and was withdrawn due to serious safety risks