FDA WARNING_LETTER - NanoLiposomal Nutritionals - October 31, 2011

On November 22, 2011, the FDA issued a Warning Letter to Ms. Hilery Owens regarding products promoted on www.healthyitems.com and www.nanoliposomals.com. An October 2011 review found products like "Cactus Plus - Herbal Diabetic Formula," "Diatrol Plus," and various "Liposomal" products promoted with claims for curing, mitigating, treating, or preventing diseases, thus classifying them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)].

Examples of violative claims include "Cactus Plus - Herbal Diabetic Formula" for Type II diabetes support, "DIATROL PLUS" for normalizing blood-sugar levels in adult onset diabetes, "Liposomal CAN-HELP Complex" for preventing and stopping cancer cells, "Liposomal CoQ10" for Parkinson's Disease, Autism, heart disease, and cancer, and "Liposomal Synapse Plus" for alleviating Parkinson's symptoms.

These products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their claimed uses and lack FDA approval as required by section 505(a