Loading…
EarthLab, Inc., operating as Wise Woman Herbals, was cited for marketing unapproved new drugs including Green Tea Solid Extract, Turmeric products, PSA Capsules, and Elderberry Plus Syrup through their website and social media channels. The company violated the Federal Food, Drug, and Cosmetic Act by making disease claims on their websites (such as stroke prevention and prostate health support) that established these products as drugs requiring FDA approval, without obtaining such approval. The violations were identified during an FDA inspection of their Creswell, Oregon facility in April 2022, followed by review of their websites in September and November 2022, which confirmed the products were being marketed with therapeutic claims and orders were being taken for introduction into interstate commerce.