Andes Natural – FDA Warning Letter, Aug 31, 2012

The FDA issued a Warning Letter to Andes Natural Skin Care LLC, specifically addressing Julio Bernabe, Managing Member, after reviewing their websites in August 2012. The FDA determined that products including BioSkinCare, Bio Skin Rejuvenation, BioSkinclear, Bio Acne Care, BioSkinforte, BioSkinexfol, and BioSkinrepair are promoted for uses that classify them as drugs under sections 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act).

The claims on the company's websites indicate that these products are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the human body. Numerous examples of these claims were cited for each product, such as "repairs sun damaged tissues at the cellular level," "takes away acne, rosacea, scars," "inhibits microbiological activity of dangerous, pathogenic skin bacteria," and "heals micro-tears in the skin." Personal testimonials also supported disease claims.

These products are not generally recognized as safe and effective for their promoted uses, making them "new drugs" as defined in section 201(p) of the Act. Under section 505(a) of the Act, new drugs cannot be legally marketed in the U.S. without prior FDA approval through