On November 25, the U.S. Food and Drug Administration issued 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). The FDA also published a revised Consumer Update detailing safety concerns about CBD products more broadly.
Questions also remain about the cumulative use of CBD and about CBD’s impacts on vulnerable populations such as children and pregnant or breastfeeding women.
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
Under the FD&C Act, any product intended to treat a disease or otherwise have a therapeutic or medical use, and any product (other than food) that is intended to affect the structure or function of the body of humans or animals, is a drug. The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy.
Additionally, some of the products outlined in the warning letters issued today raise other legal and public health concerns:
Some of the products are marketed for infants and children – a vulnerable population that may be at greater risk for adverse reactions due to differences in the ability to absorb, metabolize, distribute or excrete a substance such as CBD.
Some of the products are foods to which CBD has been added. Under the FD&C Act, it is illegal to introduce into interstate commerce any human or animal food to which certain drug ingredients, such as CBD, have been added. In addition, the FDA is not aware of any basis to conclude that CBD is GRAS among qualified experts for its use in human or animal food. There also is no food additive regulation that 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.
Some of the products are marketed as dietary supplements. However, CBD products cannot be dietary supplements because they do not meet the definition of a dietary supplement under the FD&C Act.
One product outlined in a warning letter to Apex Hemp Oil LLC is intended for food-producing animals. The agency remains concerned about the safety of human food products (e.g. meat, milk, and eggs) from animals that consume CBD, as there is a lack of data establishing safe CBD residue levels.
The FDA has requested responses from the companies within 15 working days stating how the companies will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction.
The FDA encourages human and animal health care professionals and consumers to report adverse reactions associated with these or similar products to the agency’s MedWatch program.