FDA WARNING_LETTER - Deseo Rebajar

The FDA issued a Warning Letter to Deseo Rebajar Inc. on March 7, 2014, following a November 2013 review of their websites (www.deseorebajar.com, www.adipotrim.com, www.facebook.com/Adipotrim.BajardePeso/info, and www.facebook.com/DeseoRebajarhtc). The letter identifies several products as unapproved new drugs and misbranded drugs, violating sections 505(a), 301(d), 502, and 301(a) of the FDCA.

Specifically, "Adipotrim XT," "Burn 7," and "Reductrol Fat Burner Formula" were found to contain undeclared active pharmaceutical ingredients: fluoxetine in Adipotrim XT; sibutramine and phenolphthalein in Burn 7; and acetaminophen and phenolphthalein in Reductrol Fat Burner Formula. These ingredients exclude the products from being classified as dietary supplements under section 201(ff)(3)(B) of the FDCA, as they contain approved new drugs or articles authorized for new drug investigation prior to being marketed as dietary supplements.

These products are deemed "new drugs" under section 201(p) of the FDCA due to their intended use for disease treatment/prevention and lack of general recognition as