FDA WARNING_LETTER - Body Systems Inc. - October 22, 2012

On April 8, 2013, the FDA issued a Warning Letter to Body Systems, Inc. following an inspection from October 18-22, 2012, at their Winter Springs, Florida facility. The inspection revealed serious violations of the Federal Food, Drug, and Cosmetic Act.

The FDA determined that Body Systems, Inc.'s "Joint-Ortho Care" and "Seven Flowers BP" products are unapproved new drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] due to therapeutic claims on their websites (www.bstcatalog.com and www.bodysystemsinc.com), such as "Arthritis Aid" and "help lower blood pressure." These products are not generally recognized as safe and effective and lack FDA approval, violating section 505(a) of the Act [21 U.S.C. § 355(a)]. "Seven Flowers BP" is also misbranded under section 502(f)(1) [21 U.S.C. § 352(f)(1)] for lacking adequate directions for layperson use.

Additionally, the inspection revealed multiple Current Good Manufacturing Practice (CGMP) violations for dietary supplements (21 CFR Part 111), causing "Liquid Colloidal Minerals" and potentially "Joint-Or