earthlab, inc., – FDA Warning Letter, Apr 14, 2022

The FDA issued a Warning Letter to EarthLab, Inc., DBA Wise Women Herbals, following an inspection from April 4-14, 2022, and a review of their websites. The letter identifies serious violations of the Federal Food, Drug, and Cosmetic Act.

Firstly, several products (Green Tea Solid Extract, Curcuma Spp. Organic Turmeric, PSA Capsules, Healthy Prostate, Turmeric Gold Capsules, Joint Support, Upper Respiratory Support, and Elderberry Plus Syrup) are deemed "unapproved new drugs" because website claims establish their intent for disease cure, mitigation, treatment, or prevention. These products lack FDA approval for such uses and are considered misbranded, particularly Green Tea Solid Extract, Curcuma Spp. Organic Turmeric, PSA Capsules, and Elderberry Plus Syrup, as they require professional supervision for safe use.

Secondly, the inspection revealed serious Current Good Manufacturing Practice (CGMP) violations for dietary supplements, rendering them adulterated. Key deficiencies include: 1. **Failure to establish specifications:** The firm lacked written specifications for components (e.g., Vitamin C, Zinc, Kava Kava Root, Echinacea purpurea Dry Root Powder) and finished products (e.g., Kava Capsules, Echinacea Glycerite, Elderberry Plus Syrup). Their identity specifications using Near-Infrared Spectroscopy (NIR) were inadequate without reference standards. 2. **Failure of quality control personnel to reject non-