CBD Concerns
The U.S. Food and Drug Administration (FDA) sent warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act) and published a revised Consumer Update regarding detailing CBD product safety concerns. The FDA says it cannot conclude that CBD is generally recognized as safe for use in human or animal food.
In exploring ways for CBD products to be lawfully marketed, the FDA is obtaining and evaluating information about the safety of the products, while maintaining the agency’s rigorous public health standards. According to the FDA, “In line with our mission to protect the public, foster innovation, and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate.”
There are unanswered questions and data gaps about CBD toxicity, and there are concerns about potential harm from CBD, the agency says. The revised Consumer Update provides specific safety concerns, including potential liver injury, interactions with other drugs, drowsiness, diarrhea and mood changes. Animal studies have shown that CBD can interfere with the development and function of testes and sperm, decrease testosterone levels and impair sexual behavior in males, and there are also concerns about cumulative use of CBD and CBD’s impacts on vulnerable populations including children and pregnant or breastfeeding women.
CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, food products such as chocolate bars and teas and topical lotions and creams. The warning letters explain that some companies are using product webpages, online stores and social media to market the products via interstate commerce in ways that violate the FD&C Act, including marketing CBD products to treat diseases or for other therapeutic uses for humans and/or animals, marketing them as dietary supplements and adding CBD to human and animal foods.
Letters went to: Koi CBD LLC, of Norwalk, California; Pink Collections Inc., of Beverly Hills, California; Noli Oil, of Southlake, Texas; Natural Native LLC, of Norman, Oklahoma; Whole Leaf Organics LLC, of Sherman Oaks, California; Infinite Product Company LLLP, doing business as Infinite CBD, of Lakewood, Colorado; Apex Hemp Oil LLC, of Redmond, Oregon; Bella Rose Labs, of Brooklyn, New York; Sunflora Inc., of Tampa, Florida/Your CBD Store, of Bradenton, Florida; Healthy Hemp Strategies LLC, doing business as Curapure, of Concord, California; Private I Salon LLC, of Charlotte, North Carolina; Organix Industries Inc., doing business as Plant Organix, of San Bernardino, California; Red Pill Medical Inc., of Phoenix, Arizona; Sabai Ventures Ltd., of Los Angeles, California; and Daddy Burt LLC, doing business as Daddy Burt Hemp Co., of Lexington, Kentucky. The FDA seeks responses in 15 days.
Previously, the FDA sent warning letters to other companies illegally selling CBD products that claimed to prevent, diagnose, mitigate, treat or cure serious diseases, such as cancer, or otherwise violated the FD&C Act in interstate commerce. Some products had additional violations, because CBD was added to food, and some of the products were also marketed as dietary supplements in spite of not meeting the definition of a dietary supplement.
