The US Food and Drug Administration (FDA) issued a warning to 15 companies that have illegally sold cannabidiol products, also known as CBD.
FDA is apprehending the companies for adding cannabidiol products to food or marketing them as a dietary supplement.
The agency also published a consumer update about CBD. CBD refers to the non-psychoactive ingredient in marijuana. People use it to cure pain and anxiety.
FDA has yet to learn more about the effectiveness and safety of cannabidiol products. Meanwhile, it cannot generally consider the ingredient as safe or approve products that contain it.
"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,'" FDA Principal Deputy Commissioner Amy Abernethy said.
With this, FDA sent letters to the following 15 companies for distributing cannabidiol products. The agency warns them about violating the Food, Drug and Cosmetic Act for marketing CBD as a means to treat illnesses or for therapeutic use.
The companies should not claim that CBD is a dietary supplement or allowed to add to food for humans and animals.
-Red Pill Medical Inc. of Phoenix, Arizona
-Pink Collections Inc. of Beverly Hills, California
-Healthy Hemp Strategies LLC (does business as Curapure) of Concord, California
-Koi CBD LLC of Norwalk, California
-Sabai Ventures Ltd. of Los Angeles, California
-Organix Industries Inc. (does business as Plant Organix) of San Bernardino, California
-Whole Leaf Organics LLC of Sherman Oaks, California
-Infinite Product Company LLLP (does business as Infinite CBD) of Lakewood, Colorado
-Sunflora Inc. of Tampa Florida/Your CBD Store of Bradenton, Florida
-Daddy Burt LLC (does business as Daddy Burt Hemp Co.) of Lexington, Kentucky
-Bella Rose Labs of Brooklyn, New York
-Private I Salon LLC of Charlotte, North Carolina
-Natural Native LLC of Norman, Oklahoma
-Apex Hemp Oil LLC of Redmond, Oregon
-Noli Oil of Southlake, Texas
-Pink Collections Inc. of Beverly Hills, California
-Healthy Hemp Strategies LLC (does business as Curapure) of Concord, California
-Koi CBD LLC of Norwalk, California
-Sabai Ventures Ltd. of Los Angeles, California
-Organix Industries Inc. (does business as Plant Organix) of San Bernardino, California
-Whole Leaf Organics LLC of Sherman Oaks, California
-Infinite Product Company LLLP (does business as Infinite CBD) of Lakewood, Colorado
-Sunflora Inc. of Tampa Florida/Your CBD Store of Bradenton, Florida
-Daddy Burt LLC (does business as Daddy Burt Hemp Co.) of Lexington, Kentucky
-Bella Rose Labs of Brooklyn, New York
-Private I Salon LLC of Charlotte, North Carolina
-Natural Native LLC of Norman, Oklahoma
-Apex Hemp Oil LLC of Redmond, Oregon
-Noli Oil of Southlake, Texas
While it is not illegal to sell products that are not approved yet by the FDA, it is considered illegal to add certain drug ingredients to products unless they are approved food additives.
Not an approved additive
The agency emphasized that CBD is not an approved additive. It is also not categorized as a dietary supplement under the Food, Drug and Cosmetic Act.
The FDA noted that some of the companies marketed products to infants and children. These children may be exposed to higher risk for negative side effects of CBD due to their metabolism and ability to consume and excrete the ingredient.
Abernethy said reports of the presence of pesticides and heavy metals in CBD sparked questions about its safety and toxicity.
Moreover, the FDA has never studied the effectiveness of CBD products as well as the amount in a "proper" dosage. No data on the potential side effects of consuming the products and the manufacturing process is available yet.
The agency allows one prescription drug that contains CBD, Epidiolex, which is used to treat two forms of childhood epilepsy.
Other marketed CBD products carry different amounts of the ingredient, which the FDA has not evaluated.
