The U.S. Food and Drug Administration (FDA) said Tuesday it cannot conclude that cannabidiol, more widely known as CBD, is generally recognized as safe (GRAS) for its use in human or animal food.
The federal agency said CBD is marketed in a variety of food products such as chocolate bars and teas, as well as oil drops, capsules, syrups, topical lotions and creams.
The FDA also said there is no food additive regulation which authorizes the use of CBD as an ingredient in human food or animal food, and the agency is not aware of any other exemption from the food additive definition that would apply to CBD.
“CBD is therefore an unapproved food additive, and its use in human or animal food violates the FD&C Act for reasons that are independent of its status as a drug ingredient,” the FDA said.
In a revised Consumer Update, the agency said that there exist “data gaps” regarding CBD toxicity as well as “only limited data about CBD safety and these data point to real risks that need to be considered before taking CBD for any reason.”
“CBD can cause liver injury,” the FDA said. “CBD has the potential to harm you, and harm can happen even before you become aware of it.”
The agency said CBD can cause the following side effects:
- Changes in alertness, most commonly experienced as somnolence (drowsiness or sleepiness)
- Gastrointestinal distress, most commonly experienced as diarrhea and/or decreased appetite
- Changes in mood, most commonly experienced as irritability and agitation
“We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt,’” said Dr. Amy Abernathy, FDA principal deputy commissioner. “Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA and we want to be clear that a number of questions remain regarding CBD’s safety, including reports of products containing contaminants, such as pesticides and heavy metals, and there are real risks that need to be considered.”
The FDA also issued warning letters to 15 companies for illegally selling products containing CBD in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The following warning letters were issued Tuesday: , these particular companies are using product webpages, online stores and social media to market CBD products in 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. Other violations include marketing CBD products as dietary supplements and adding CBD to human and animal foods.
The companies receiving warning letters are:
- 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
- Daddy Burt LLC, doing business as Daddy Burt Hemp Co., of Lexington, Kentucky
The companies have 15 days to respond to the FDA or face possible seizure of their products.