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Medical Fraud, Mislabeling, Contamination: All Common in CBD Products
Graduate of Westminster College in Fulton, Missouri, and Rutgers Law School. He is Senior Counsel for the Cannabis Industry Victims Educating Litigators (CIVEL). CIVEL educates lawyers on the legal rights of the victims of the marijuana industry. He was formerly a Research Scientist in the New Jersey Department of Health
Cannabidiol (CBD) is an oil derived from the cannabis plant. It is touted as a “wonder drug.” Advertisements claim it is perfectly safe and legal and can be used for all that ails you or makes you uncomfortable mentally or physically. People are consuming it under the misapprehension that it is safe, however, CBD has negative side effects and may interfere with the functioning of other medications and may be contaminated.
Consumer demand for CBD has increased due to aggressive marketing and fraudulent health claims. In the rush to market CBD, there has been little consideration of the concerns that must be addressed before CBD is given full acceptance. This article will explore those concerns.
Is CBD Legal?
There are claims that CBD from hemp used as a medicine or food is always legal. This is not accurate. The Agriculture Improvement Act of 2018 changed federal law regarding the production and marketing of hemp. Hemp is defined as cannabis and its derivatives with extremely low (less than 0.3% a dry weight basis) concentration of the THC. These changes removed hemp from the federal Controlled Substances Act, which means that it will no longer be an illegal substance under federal law. However, Congress explicitly preserved the FDA’s authority to regulate these products under the Federal Food, Drug, and Cosmetic Act and section 351 of the Public Health Service Act. These compounds are subject to the same requirements as FDA-regulated products containing any other substance regardless of the source of the substance. Cannabis products claiming in their marketing materials that they’re intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases must go through the FDA drug approval process for human or animal use before they are legally marketed. 1
As stated by the FDA Commissioner:
“Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments raises significant public health concerns, as it may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.” 2
CBD products that are not approved by the FDA and are sold as medicines, or as food, or cosmetics are “black-market” and are illegally trafficked and sold. This includes those sold in reputable stores, restaurants, and other places that don’t have FDA approval to do so. Black-market CBD products have not been evaluated by the FDA to determine if they are safe as foods or effective or safe for any medical use, and if safe, what the proper dosage would be. In addition, they are not administered with any federally approved medical protocols as are prescription drugs and there may be no warnings for how they interact with other drugs, or whether they have dangerous side effects. 3
A pure form of CBD is approved by the FDA as a medicine for two rare seizure disorders. Its approval was based on well-controlled FDA clinical trials. This is a purified form of CBD in a reliable dosage form and a reproducible route of delivery. Since it is manufactured according to FDA standards by a reliable company that has followed the rules, we can assume it is free from adulterants and contaminants. Its side effects and other clinical data are publicly available. This type of data is not provided by the black-market CBD products. 4
There are a number of papers discussing the pros and cons of CBD as a medicine that can be viewed on the National Library of Medicine website at www.nlm.nih.gov. Some studies, notwithstanding their many deficiencies, provide some support for the hypothesis that CBD may exert some beneficial effects, but is has yet to be proven to be both effective and safe. FDA quality studies with purified CBD are warranted. However, clinical data does not support some claimed uses of CBD for Parkinson’s disease, schizophrenia, cancer palliation and treatment, chronic pain and spasticity, depression, anxiety disorder, insomnia, and inflammation. There is insufficient evidence to rate effectiveness of CBD for Bipolar disorder, Crohn’s disease, diabetes, dystonia, Huntington’s disease, multiple sclerosis (and its muscle spasms, tiredness, bladder control, the ability to move around, or well-being and quality of life), schizophrenia, nerve damage in the hands and feet (peripheral neuropathy) and other conditions. 5
CBD Mislabeling and Contamination
Studies suggest that black-market CBD is not very reliable or safe. In 2020, the FDA did a study on products that claimed to have a specific amount of CBD and those claimed amounts were compared to the FDA testing results. Of the 102 products that indicated a specific amount of CBD, 18 products (18%) contained less than 80% of the amount of CBD indicated, 46 products (45%) contained CBD within 20 percent of the amount indicated, and 38 products (37%) contained more than 120 percent of the amount of CBD indicated. Of great concern is that 49% of the products tested contained THC. 6
The Journal of the American Medical Association published a letter demonstrating the results of “undercover” purchases of CBD. Of 84 samples tested, THC was detected in 21%. There were other defects in the mislabeled products. Only 30.95% were accurately labeled. Accuracy of labeling depended on product type, with vaporization liquid most frequently mislabeled (87.50%) and oil most frequently labeled accurately (45.0 %). THC was detected (up to 6.43 mg/mL) in 18 of the 84 samples tested (21.43%). 7
A Johns Hopkins researcher tested CBD products. Testing showed 44 products (59%) had detectible levels of CBD, but the average ratio of THC to CBD was 36-to-1. Only one product had a 1-to-1 ratio, which some research suggests is associated with fewer side effects and improved clinical benefit compared with higher ratios of THC to CBD. The testing indicated the edible cannabis products may have very little CBD. 8
A study published by the National Institute of Health showed that products were mislabeled with 26% containing less CBD than labeled and 43% containing more, indicating a high degree of variability and poor standardization of online products. Notably, the oil-based products were more likely to be accurate (45% compared to 25% for tincture and 12.5% for vaporization liquid) and had a smaller percentage of deviation. Oil based products also had a higher range of concentration. In addition to CBD mislabeling, THC was detected in 21% of samples. This study also notes that products containing THC could have sufficient enough concentrations to produce intoxication in children. 9
In a recent federal lawsuit, the plaintiff bought CBD products relying on advertising that the products had “No Heavy Metals or Insecticides.” The products failed laboratory testing for heavy metals, including copper, nickel, and lead and also for total yeast and mold. Lead can cause poisoning, speech, and language problems, neurologic toxicity, and reproductive problems. Mold can cause allergic and respiratory problems, and yeasts can cause infection in people with compromised immune systems. 10 On July 28, 2020, another CBD product was recalled due to lead contamination. The recall noted that acute lead poisoning could cause pain, muscle weakness, paresthesia, abdominal pain, nausea, vomiting, diarrhea, constipation, poor appetite, weight loss, symptoms associated with encephalitis, metallic taste in the mouth, shock, hemolysis, and kidney damage. 11
False Medical Claims
Examples of false claims for CBD can be taken from FDA and Federal Trade Commission (FTC) warning letters to CBD companies. In order to make claims of treatment or medical use, products must obtain approval from the FDA after submitting their data. False claims include using CBD to treat: alcoholism, Alzheimer’s disease, arthritis, autism, blood pressure and heart rate, cancer, chronic traumatic encephalopathy, cardiovascular disease, chemotherapy-induced hearing loss, colitis, concussions, depression, diabetes, leukemia, liver inflammation, lupus, Lyme disease, neurological damage, Parkinson’s disease, stroke, schizophrenia, traumatic brain injury (TBI), and tumors. 12
CBD Negative Side Effects and Drug Contraindications
There may be interactions between CBD and immunosuppressive drugs used in transplants or chemotherapy and with warfarin as there may be the potentiation of anticoagulant effects with marijuana, including CBD. CBD may interact with other medicines, including prescription and over-the-counter medicines, vitamins, herbal supplements, and any cannabis-based products. CBD may affect the way other medicines work, and other medicines may affect how CBD works.
CBD may decrease how fast the liver metabolizes the drug. This may possibly increase the effects and side effects. CBD may potentially interact in a negative way with anti-epileptic drugs such as: carbamazepine (Tegretol), phenytoin (Dilantin), phenobarbital (Luminal, Solfoton, Tedral), primidone (anti-seizure). Users should be cautious before taking CBD with: sedatives, herbs, and supplements that cause drowsiness, seizure medications, drugs that are broken down and changed by the liver. People should be cautious with using Brivaracetam (Briviact), Eslicarbazepine (Aptiom), and Everolimus (Zostress). 13 Consumers should not take CBD with Clobazam for seizures. 14 The use of CBD along with these drugs might increase the effects and side effects of the drugs.
The adverse reactions to CBD include: hepatocellular injury, somnolence and sedation, suicidal behavior and ideation, hypersensitivity reactions–allergic reactions, negative interaction with anti-epilepsy drugs (such as Tegretol, Dilantin, luminal, Solfoton, Tedral, primidone), interactions with immunosuppressive drugs used in transplants or chemotherapy and with warfarin. CBD use can impair kidney function and cause anemia. 15 Black market CBD is generally sold without warnings about adverse reactions.
The side effects of CBD can include: drowsiness, decreased appetite, diarrhea, transaminase elevations, fatigue, feeling unwell (malaise), rash, difficulty sleeping (insomnia, disordered sleep, and poor-quality sleep), infections, somnolence, decreased appetite, diarrhea, and asthenia. 16
Research shows that more than 40% of children with epilepsy who were given CBD orally had adverse events that included THC like symptoms. The research challenged the widely accepted premise that CBD is not intoxicating. 17
A recent study suggests that CBD doesn’t lower eye pressure but instead raises it. High eye pressure is the primary risk factor for glaucoma, a leading cause of blindness. 18 [Editor’s Note: see sidebar.]