FDA WARNING_LETTER - Get the Tea, LLC.

On September 14-15, 2017, an FDA inspection of Get The Tea's facility revealed significant violations of dietary supplement Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering their products adulterated. A subsequent review of their website (www.getthetea.com) and product labels in March 2018 identified numerous products, including Allicin Advanced, Life Change Tea Super Strength, and Ceylon Cinnamon, as unapproved new drugs due to therapeutic claims for disease treatment, mitigation, or prevention, and/or affecting body structure/function. These products are also misbranded as they lack adequate directions for use, being intended for conditions not amenable to self-diagnosis/treatment.

Specific CGMP violations include failure to establish written procedures for quality control operations (21 CFR 111.103), product complaints (21 CFR 111.553), returned dietary supplements (21 CFR 111.503), and holding/distribution operations (21 CFR 111.453). The firm's provided Certificates of Analysis (COAs) were insufficient for quality control release decisions as they only covered microbiological testing, not identity, purity, strength, and composition.

Additionally, several dietary supplement products (e.g., Grapeseed Extract, Moringa Leaf capsules, Astaxanthin Max, Ceylon Cinnamon) are misbranded under