FDA WARNING_LETTER - NanoBiotech Pharma, Inc. - December 31, 2014

The FDA issued a Warning Letter to NanoBiotech Pharma, Inc. in December 2014, following a review of their websites (nanobiotech.us, nanobiotech.squarespace.com, nanobiotechpharma.com). The FDA determined that the company was marketing NanobacTX and Urobac with therapeutic claims that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).

The violations include promoting NanobacTX for reversing atherosclerosis, dissolving calcified arterial plaque, and treating heart disease symptoms, and Urobac for eradicating Nanobacteria infection, dissolving kidney stones, and treating conditions like Polycystic Kidney Disease, BPH, and chronic prostatitis. These claims were found on their websites, in personal testimonials, and on their Facebook and LinkedIn pages. The company also cited scientific publications to support these unapproved drug uses.

The FDA cited that NanobacTX and Urobac are "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their promoted uses. Introducing new drugs into interstate commerce without prior FDA approval violates section 505(a) and 301(d) of the Act. Furthermore, these products are considered misbranded under section 502(f)(1) of the Act because they are intended for conditions not amenable to self