At first cannabis and cannabidiol (CBD) were all the rage.
But now, the bloom appears to have come off the rose as the U.S. Food and Drug Administration has issued new guidance on CBD that included a stark warning that it can cause liver injury and other damage to the human body.
Say it ain’t so, Joe.
In a statement on its website, the FDA specifically warned 15 companies for illegally selling various products containing CBD. The violations include marketing unapproved new human and animal drugs, selling CBD products as dietary supplements, and adding CBD to human, animal foods. The agency goes on to publish a revised Consumer Update detailing safety concerns about CBD products more broadly. Based on the lack of scientific information supporting the safety of CBD in food, the FDA also indicated that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.
“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. 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 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. We recognize the significant public interest in CBD and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products.”
Many unanswered questions and data gaps about CBD toxicity exist, and some of the available data raise serious concerns about potential harm from CBD. The revised Consumer Update outlines specific safety concerns related to CBD products, 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.
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 and readily available almost anywhere. Some have touted its homeopathic properties as relieving pain, anxiety and even promoting hair growth. As outlined in the warning letters issued by the FDA, 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 were:
- 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 has previously sent warning letters to other companies illegally selling CBD products in interstate commerce that claimed to prevent, diagnose, mitigate, treat or cure serious diseases, such as cancer, or otherwise violated the FD&C Act. Some of these products were in further violation because CBD was added to food, and some of the products were also marketed as dietary supplements despite products which contain CBD not meeting the definition of a dietary supplement.
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 a 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. There is very limited information for other marketed CBD products, which likely differ in composition from the FDA-approved product and have not been evaluated for potential adverse effects on the body.
Unlike drugs approved by the FDA, there has been no FDA evaluation of whether these unapproved products 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 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 the companies will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction.
While the popularity of CBD is higher than ever amid the FDA scrutiny and the potential spectre of it being outlawed is on some minds, the industry is not standing pat. Some companies are turning to other cannabinoids and cannabinoid-like alternatives such as patented proprietary olecules and cannabigerol (CBG) to help provide a safe, effective way to seek the benefits of cannabis.
One such company, Kannalife, Inc. has created a patented CBD-like molecule called KLS-13019, which researchers at the Lewis Katz School of Medicine at Temple University have proven to be five times safer and 1,000x more effective than CBD. Kannalife was awarded a grant from the National Institute on Drug Abuse (NIDA) to research the effects of KLS-13019 for chemotherapy-induced peripheral neuropathy (CIPN) and drug dependency and preliminary results from this research have been published in the Journal of Molecular Neuroscience.
Precision Plant Molecules is also researching CBG and other subsititutes. The firm announced that its scientists are currently working on proprietary techniques to process, isolate and purify the acidic and varin versions of cannabinoids recognized to have therapeutic properties. CBC, THC-V, and other cannabinoid-based products are PPM R&D priorities.
