FDA WARNING_LETTER - Let's Talk Health, Inc. - February 11, 2019

On August 6, 2019, the FDA issued a Warning Letter to Let's Talk Health, following a February 2019 inspection of their Chula Vista, CA facility. The inspection, product labels, promotional literature, website, and blog revealed serious violations of the Federal Food, Drug, and Cosmetic Act.

The FDA determined that ten of the company's products (Cardio Advantage Plus, Urine-Eze, Re-Lev-It, Liposomal Symplex P, Liposomal Vitamin C, Melatonin, Liposomal B-Complex, Liposomal Curcumin, Liposomal Glutathione, and VariGone) are unapproved new drugs and/or misbranded drugs due to therapeutic claims made on their website, blog, labels, and brochures. These claims suggest the products are intended for disease cure, mitigation, treatment, or prevention, making them "new drugs" requiring FDA approval. Additionally, several products are misbranded because they lack adequate directions for use by a layperson, as they are intended for conditions requiring professional supervision.

Furthermore, all dietary supplement products are deemed adulterated under 21 CFR Part 111 (CGMP regulations). Repeated violations from a 2016 inspection include failure to establish and follow written procedures for quality control operations, master manufacturing records, reserve sample collection, product complaints, dietary supplement returns, receiving labels/products, holding/distributing operations, cleaning/pest control, and personnel. The