FDA WARNING_LETTER - AMS Health Sciences, LLC - December 17, 2013

The FDA inspected AMS Health Sciences, LLC from November 19 to December 17, 2013, and found serious violations of the Federal Food, Drug, and Cosmetic Act. Several products, including saba ACE, UROPOWER, UROSure, Digest-Eze, Shark Cartilage, Colloidal Silver, and Mobilite, were deemed unapproved new drugs due to therapeutic claims on their labeling and website (www.sabaforlife.com) for conditions like preventing tooth decay, lowering cholesterol, fighting cancer, treating diabetes, and infections. These products are not generally recognized as safe and effective for these uses and lack FDA approval. Additionally, saba ACE, UROPOWER, UROSure, and Colloidal Silver were misbranded because they lacked adequate directions for layperson use for conditions not amenable to self-diagnosis.

The inspection also revealed significant Current Good Manufacturing Practice (CGMP) violations for dietary supplements, rendering products adulterated. AMS Health Sciences, as a distributor, failed to establish finished product specifications for saba ACE and saba X-treme 5000, and quality control personnel did not approve manufacturing processes, master manufacturing records (MMRs), batch production records, and specifications from contract manufacturers. The firm also lacked procedures for reviewing and verifying MMRs, batch records, and test results, and failed to implement written procedures for reviewing and investigating product complaints. Furthermore, AMS Health Sciences did not collect and hold reserve samples of