FDA WARNING_LETTER - Rena's Organic - February 28, 2022

The FDA issued a Warning Letter to Rena's Organic (Ms. Greenberg) on May 3, 2022, following a February 2022 review of their website (www.renasorganic.com) and social media (Facebook, Instagram). The letter identifies multiple violations related to the marketing of CBD-containing products.

Eight human-use products ("300 mg CBD Full Spectrum Oil Cannabinoid Tincture," "600 mg CBD Full Spectrum Oil Cannabinoid Tincture," "1500 mg CBD Full Spectrum Oil Cannabinoid Tincture," "500 mg Pain Relief Cream," "1000 mg Pain Relief Cream," "1000 mg CBD Anti-Aging Beauty Cream," "CBD Super Cider," and "CBD Super Food") are cited as unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act, and misbranded drugs under section 502(f)(1). Claims on the company's websites, such as "Cancer-Fighting Capabilities," "Potential for Neurodegenerative Disorders," "Treat Opioid Dependency," "Help You Quit Smoking," "Help ADHD Patients," "Curing Insomnia," and "Relief from Fibromyalgia," establish their intended use as drugs. The pain relief creams are also cited for not conforming to the external analgesic TFM, as CBD is not a permitted active