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The Federal Drug Administration (FDA) has issued warnings to 15 companies that sell products containing cannabiodol (CBD), telling them to stop marketing and selling their unapproved products illegally.
CBD, a chemical compound from the cannabis plant, is used by some as an alternative or supplement to medical treatment. Products containing CBD for human or animal consumption or absorption, include oil drops, capsules, syrups, food products such as chocolate bars and teas, and topical lotions and creams.
While the FDA says it is exploring ways that the products can be marketed, the agency says for now, “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,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D.
“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.’ Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA…”
Some data, the FDA says, raises “serious concerns about potential harm from CBD… including potential liver injury, interactions with other drugs, drowsiness, diarrhea, and changes in mood. In addition, studies in animals have shown that CBD can interfere with the development and function of testes and sperm, decrease testosterone levels and impair sexual behavior in males. Questions also remain about cumulative use of CBD and about CBD’s impacts on vulnerable populations such as children and pregnant or breastfeeding women.”
The FDA also said, “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.”
The FDA sent letters to the 15 companies for violating the FD&C Act which says that any product intended to treat disease, or is intended for therapeutic or medical use, is considered a drug.
The agency said that the companies violated the Act by marketing their CBD products as treating disease for humans and/or animals. Other violations, the FDA said, include the marketing of CBD products as dietary supplements and adding CBD to human and animal foods.
“As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we’ll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns,” the FDA said.
The interstate commerce companies who received the 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 FDA said it has previously sent warning letters to other interstate commerce companies for illegally selling CBD products which claimed to “prevent, diagnose, mitigate, treat or cure serious diseases, such as cancer, or otherwise violated the FD&C Act.”
The FDA has not approved any CBD products other than one prescription human drug product which is used to treat rare, severe forms of epilepsy. In June 2018, the FDA approved Epidiolex, a liquid drug containing CBD which the agency found reduces seizures in patients with Lennox-Gastaut Syndrome and Dravet Syndrome.
But unlike drugs approved by the FDA, the agency said there has been no FDA evaluation of whether the products sold by the 15 companies are “effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns.”
In addition, the FDA, said, “The manufacturing process of unapproved CBD drug products has not been subject to FDA review as part of the human or animal drug approval processes. Consumers may also put off getting important medical care, such as proper diagnosis, treatment and supportive care due to unsubstantiated claims associated with CBD products. For that reason, it’s important that consumers talk to a health care professional about the best way to treat diseases or conditions with existing, approved treatment options.”
The FDA has requested responses from the companies within 15 working days stating how each will correct the violations. The agency said that the companies’ failure to address the violations promptly may result in legal action, including product seizure and/or injunction.