FDA WARNING_LETTER - Xtra Life Natural Systems, Inc. - June 05, 2013

On April 4, 2014, the FDA issued a Warning Letter to Xtra Life Natural Systems, Inc. following an inspection from May 30 to June 5, 2013. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering their products adulterated.

Additionally, the FDA determined that the company's Milk Thistle and Gingko Biloba products are unapproved new drugs due to therapeutic claims on their labels and websites (www.vtamins.net, www.xtralifemiami.com). Claims such as "treatment of diseases such as hepatitis C and B liver cirrhosis" for Milk Thistle and "used to treat Alzheimer's disease" for Gingko Biloba establish drug intent. These products are not recognized as safe and effective for these uses and lack adequate directions for layperson use, making them misbranded.

Key CGMP violations include: 1. Failure to establish and follow written procedures for quality control operations, including material review and disposition decisions (21 CFR 111.103, 111.140(b)(1)). 2. Failure to establish and follow written procedures for reviewing and investigating product complaints (21 CFR 111.553). 3. Failure to establish and follow written procedures for returned dietary supplements (21 CFR 11