FDA WARNING_LETTER - Honest Globe, Inc. - October 08, 2019

On March 15, 2021, the FDA issued a Warning Letter to Honest Globe, Inc. following an inspection from October 4-8, 2019, at their Santa Ana facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211), rendering their drug products adulterated.

Additionally, the FDA determined that Honest Globe, Inc. markets "ELIXICURE PAIN RELIEF with CBD" products (roll-on and pump versions, original and lavender) on www.elixicure.com. These products, labeled to contain cannabidiol (CBD), are sold without a prescription and are deemed unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act. The FDA states that nonprescription CBD-containing drugs cannot be legally marketed without an approved new drug application, as they are not generally recognized as safe and effective (GRASE). Even if CBD were considered an inactive ingredient, the products would still require an approved application due to not meeting general requirements for nonprescription drugs, specifically regarding the safety and suitability of inactive ingredients (21 CFR 330.1(e)).

CGMP violations include: 1. **Inadequate Quality Control Unit (21 CFR 211.22(a) and 2