FDA WARNING_LETTER - Blue Poppy Enterprises Inc - September 28, 2021

The FDA issued a Warning Letter to Peoples Herbs, Inc. after reviewing their websites (www.peoplesherbs.com, www.bluepoppy.com) and social media pages (Facebook, Twitter, Instagram, Amazon Marketplace) in June and August 2021. The FDA determined that products sold, including Modified Perilla & Mentha, Empowered Cordyceps, Empowered Reishi, AllerEase, Empowered Eleuthro, Sui Bian Guo, Chinese Herbal Shampoo, Jade Dew Ointment, Stop Pain Tincture, Dr. Bob’s Medicated Oil, Cut & Sore Ointment, E-C-Z Ointment, Organic Cactus Seed (Prickly Pear) Oil Antioxidant Facial Serum, Skin Soothing Ointment, and Dragon’s Blood Liniment, are unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.

The products are deemed drugs because claims on the websites and social media establish their intent for use in the cure, mitigation, treatment, or prevention of disease. As "new drugs," they require prior FDA approval, which they lack, violating sections 201(p), 301(d), and 505(a) of the Act. Furthermore, Modified Perilla & Mentha, Empowered Cordyceps, Empowered Reishi, Sui Bian Guo, and Stop Pain Tincture are considered misbranded under section