FDA WARNING_LETTER - Sound Healing Arts, PC dba Sound Healing Arts Center - January 20, 2015

The FDA issued a Warning Letter to NaturalDoctor following an inspection from December 2014 to January 2015, and a subsequent review of product labeling and website. The letter identifies serious violations of the Federal Food, Drug, and Cosmetic Act.

Eight NaturalDoctor products (Vitamins C & K3 / 100:1, Goldenseal & Echinacea Plus, Centella Skin and Veins, Organic Artemisia Plus, Organic Dong Quai Plus, Organic Dandelion Plus, Vitex PMS, and St. John’s Mood Plus) are deemed "unapproved new drugs" because their labeling and website claims promote them for disease treatment, cure, mitigation, or prevention. These products are not generally recognized as safe and effective for these uses and lack FDA approval. Furthermore, these drugs are misbranded as they are intended for conditions not amenable to self-diagnosis, thus lacking adequate directions for layperson use.

Additionally, all dietary supplement products manufactured, repackaged, or distributed by NaturalDoctor are adulterated due to significant Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 111). Deficiencies include: 1. Failure to establish and follow written procedures for quality control operations, material review, and disposition decisions. 2. Failure to prepare and follow written Master Manufacturing Records (MMRs) for each unique dietary supplement formulation, specifically for packaging and labeling activities. 3. Failure to prepare batch production records for each