CBD—hype vs. reality
Consumption of cannabidiol, or CBD, a nonintoxicating component of marijuana is a new wildly popular fad being touted as a miracle cure for a broad variety of ailments. CBD is one of more than 100 biologically active components called cannabinoids that are in the cannabis plant. THC is the psychoactive ingredient in marijuana. It binds with your brain’s cannabinoid 1 (CB1) receptors to create a high. CBD, is not psychoactive, it does not bind with CB1 receptors in the brain, so people can’t get high from it.
Even though it is promoted as a way to relieve pain, anxiety, insomnia, depression, and even as treatments for serious diseases like diabetes, cancer, schizophrenia, and multiple sclerosis, scientists know only that it has a variety of neurological and anti-inflammatory effects, but little evidence that it improves human health.
Advocates for the use of CBD suggest that it might treat autism, sensory processing problems, anxiety, attention deficit hyperactivity disorder (ADHD), depression, and other health problems. But there is little documented research to support the use of CBD for these purposes. There is, however, enough anecdotal evidence that CBD may provide some benefits to suggests that further research is warranted.
The legality of cannabis products and CBD is still unclear. CBD derived from hemp is federally legal, while CBD derived from marijuana plants is subject to the legal status in each state — and remains federally illegal. The Food and Drug Administration (FDA) properly considers CBD to be a drug so it can’t be marketed as a medical therapy in food or in drinks or as a supplement. In spite of lack of data and a plethora of unproven claims, as of April 2019, 47 states, Puerto Rico and the District of Columbia had passed laws making CBD legal for medical and other uses.
The FDA approved form of CBD
The FDA has approved use of one specific formulation of CBD for children with rare intractable seizure disorders, the Lennox-Gastaut syndrome or the Dravet syndrome. The drug Epidiolex is a 99% pure form of CBD that contains less than 1% THC. Administered in a daily dosage range of 5 to 20 mg per kilogram of body weight, it reduced the frequency of seizures by 36% to 41% compared with a reduction of 14% to 16% in patients receiving a placebo. Adverse effects include elevated liver enzymes indicative of possible liver damage in 13% of patients and other side effects in about 10% of patients included, somnolence, decreased appetite, diarrhea, fatigue, weakness, rash, sleep problems, and malaise. Epidiolex also caused blood abnormalities and an increase in suicidal ideation.
The FDA approved guidance for use of Epidiolex cautions that bilirubin levels and liver function tests should be obtained prior to starting treatment, and at 1 month, 3 months, and 6 months, as well as at 1 month following a dosage change. In summary, Epidiolex’s adverse effect profile is significant, and the long-term effects of Epidiolex are not known.
Claims about various uses of CBD
A 2017 systematic review of medical cannabinoids in children and adolescents found sufficient evidence that THC-derived products are effective for chemotherapy-induced nausea as well as CBD for epilepsy.  The study also reported insufficient evidence for cannabinoids for spasticity, Tourette syndrome, neuropathic pain, and posttraumatic stress disorder. It noted that recreational use of marijuana has potential psychiatric and cognitive adverse effects, including lower intelligence quotient scores, deficits in memory, psychomotor performance, and attention.
CBD for anxiety
A review of 49 studies in adults, found promising results about CBD’s short-term efficacy in reducing the anxiety associated with multiple disorders, including generalized anxiety disorder (GAD), panic disorder (PD), post-traumatic stress disorder (PTSD), social anxiety disorder (SAD), and obsessive–compulsive disorder (OCD). Research also suggest minimal sedative effects, and a good safety profile. Further studies are required to establish whether chronic dosing of CBD has similar effects for those who struggle with chronic anxiety, as well as what the impact of extended CBD use may be.
CBD for autism
A study of the use of CBD over 3 months to reduce problem behaviors in children with Autism Spectrum Disorder (ASD) found substantial improvement in behavioral problems as well as stress levels reported by parents. Behavioral outbreaks were much improved or very much improved in 61% of patients. Anxiety and communication problems were much or very much improved in 39% and 47% respectively. Disruptive behaviors, were improved by 29% from baseline. Adverse events included sleep disturbances (14%) irritability (9%) and loss of appetite (9%).
A similar study among 53 children with ASD found behavioral improvements after an average of two months of taking CBD. Self-injury and rage attacks improved in 67.6% and worsened in 8.8%. Hyperactivity symptoms improved in 68.4%, did not change in 28.9% and worsened in 2.6%. Sleep problems improved in 71.4% and worsened in 4.7%. Anxiety improved in 47.1% and worsened in 23.5%. Adverse effects, mostly somnolence and change in appetite were mild. The study authors concluded that parents’ reports suggest that cannabidiol may improve ASD symptoms; however, the long-term effects should be evaluated in larger studies.
CBD for attention deficit hyperactivity disorder (ADHD)
Consumer’s Report collected anecdotal reports of the effectiveness of CBD for ADHD as well as the opinions of researchers and medical practitioners.  One parents found that about 15 mg of a CBD oil helped a child with inability to focus and pay attention in school and keep up with schoolwork, “improve by leaps and bounds.” But other parents found that CBD made no difference.
Some researchers and medical professionals dealing with ADHD say that children with an anxious variety of ADHD may get some benefit. Others say they are not surprised by the current interest in CBD oil for ADHD symptoms, but they are not impressed by arguments in favor of it. They feel that the research on CBD oil and other cannabis products as a possible intervention for ADHD does not show effectiveness for managing symptoms, and actually shows increased mental and physical health risks. Furthermore, there haven’t been adequate studies on the use of CBD oil in children; nor have there been studies on long-term effects.
CBD for Pain
Consumer Reports notes that there have been no clinical human trials evaluating CBD and migraines specifically. But research suggests it may treat pain (possibly including migraine pain) by interacting with pain receptors throughout the body, through pathways called the endocannabinoid system. Other research shows that CBD can decrease inflammation, which may also relieve pain.
CBD regulation and quality control problems
While anecdotal evidence of the benefits of CBD is common, there are risks associated with using these products, especially in children.
Prescription drugs have labels, package inserts, advertising and health claims that must be approved by the FDA as scientifically sound, accurate and balanced, with risks as well as benefits described. But the advertising and information provided to consumers about dietary supplements does not require premarket review or approval by the FDA and the result has been the frequent development and introduction of unsafe products.   In contrast, he FDA has issued a statement making clear that products that contain CBD — even if they are derived from legal, commercial hemp — cannot claim to have therapeutic benefits or be sold as supplements unless they have been approved by the FDA for that use. The FDA maintains a webpage to help the public understand CBD at: https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd
In spite of the FDA requirements, almost all CBD products other than Epidiolex remain largely unregulated and are unreliable in delivering a consistent amount of CBD. They could have less, or more, than claimed, and most do not offer independent verification of active contents. Usually sold suspended in oil, alcohol (as a tincture), or vaporization liquid, analysis of products for sale show that many do not have the amount of CBD that they advertise and are often contaminated with THC and other active ingredients. One study found that 70% of 84 CBD products purchased online were mislabeled with regard to the amount of CBD and 20% of them contained THC.
Mislabeled or counterfeit products can be dangerous. There were 52 cases of serious adverse health effects including seizures, loss of consciousness, vomiting, nausea and altered mental status, in Utah from 2017 to 2018 after people ingested a CBD product. No CBD was found in blood samples of the sick patients, only 4-cyano CUMYL-BUTINACA (4-CCB), a dangerous fake CBD oil. Over the past several years, FDA has issued warning letters to firms that market unapproved new drugs that allegedly contain cannabidiol (CBD).
A few supplements have obtained an independent evaluation and come with a written guarantee that the product is made under the FDA’s good manufacturing practices (GMP) conditions, as well as a Certificate of Analysis (COA) that assures that the label accurately describes what the customer is buying. However, many supplement manufacturers just lie and claim their products are made with GMP when they are not. Consumers can also gain assurance from labeling that shows that the product has been “U.S.P. Verified.” This proves the supplement has been inspected and approved under the United States Pharmacopeial Convention. Unfortunately, fewer than 1% of supplements on the market have been U.S.P. Verified.
Various delivery systems — vaping, taking it orally, eating it in baked goods, etc. — have different rates of delivery. The oils that the CBD is dissolved in can result in varying effects. CBD may interact in harmful ways with other medications an adult or child is taking, especially those that are also metabolized in the liver. Since CBD use for children is still so new and poorly studied, proper dosing for children is poorly established and uncertain.
The FDA site for consumer education lists the following risks of CBD:
CBD has the potential to harm you, and harm can happen even before you become aware of it.
- CBD can cause liver injury.
- CBD can affect how other drugs you are taking work, potentially causing serious side effects.
- Use of CBD with alcohol or other drugs that slow brain activity, such as those used to treat anxiety, panic, stress, or sleep disorders, increases the risk of sedation and drowsiness, which can lead to injuries.
- Male reproductive toxicity, or damage to fertility in males or male offspring of women who have been exposed, has been reported in studies of animals exposed to CBD.
CBD can cause side effects that you might notice. These side effects should improve when CBD is stopped or when the amount used is reduced.
- 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.
There are many important aspects about CBD that we just don’t know, such as:
- What happens if you take CBD daily for sustained periods of time?
- What level of intake triggers the known risks associated with CBD?
- How do different methods of consumption affect intake (e.g., oral consumption, topical , smoking or vaping)?
- What is the effect of CBD on the developing brain (such as on children who take CBD)?
- What are the effects of CBD on the developing fetus or breastfed newborn?
- How does CBD interact with herbs and other plant materials?
- Does CBD cause male reproductive toxicity in humans, as has been reported in studies of animals?
Although is known that CBD it can cause adverse side effects, widespread use does not appear to have loosed a flood of trips to emergency rooms.
Summary and recommendations
CBD has only been scientifically shown to be an effective therapy for refractory seizures associated with two uncommon medical conditions. For the duration of the trials, CBD was well tolerated but adverse effects were frequent. Cannabidiol has not been studied adequately via randomized clinical trials for medical problems for which CBD distributors claim significant benefit, including anxiety, attention-deficit/hyperactivity disorder (ADHD), pain, inflammation, and sleep disorders. Although many individuals report symptomatic improvement from CBD, only randomized controlled trials can exclude the placebo effect as being responsible for the results observed by consumers.12
If you’re considering CBD for yourself or your child, it is essential to consult and work with your doctor or pediatrician so that he or she can manage overall care, monitor and test for possible side effects, especially liver damage, and help you to avoid medication interactions. If you decide to try CBD it seems wise to choose to use only the pure prescription CBD oil Epidiolex, rather than an over-the-counter product of unknown strength, composition, or quality.
Recommendations based on their study of dietary supplements by Offit and Erush probably apply equally to CBD “…until the day comes when medical studies prove that these supplements have legitimate benefits, and until the FDA has the political backing and resources to regulate them like drugs, individuals should simply steer clear. For too long, too many people have believed that dietary supplements can only help and never hurt. Increasingly, it’s clear that this belief is a false one.” 
CBD may harm health either because of known and unknown direct effects of the drug or, because as is the situation with unproven claims for other supplements, turning to CBD for medical therapy may keep some patients from accessing appropriate, proven therapies to treat serious diseases. Research now underway may demonstrate the utility of CBD for prevention of disease and improvement of health and provide better data on its safety profile. For now, it is best to avoid CBD until more studies are available, particularly regarding its long-term safety, and it is endorsed for specific conditions by the FDA
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