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 CBD oil is a new option for those who are looking for relief from pain and other symptoms without the mind-altering effects of marijuana or prescription drugs.
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.]
What are the Benefits of CBD Oil
Chances are, even if you have not yet tried a cannabidiol (CBD) product, you might have at least been recommended one by a friend or family member. Unfortunately, these kinds of suggestions are often dismissed because many still consider CBD to be just another passing health fad — or at worst, a snake oil pitch.
However, the increasing prevalence of CBD products has made many would-be skeptics take a second look at this unique compound. After studying the already considerable research that has been done regarding its potential properties, some have decided that CBD might be worth trying out after all.
Currently, CBD products come in many different forms, including tinctures, capsules, drinks, gummies, and even cbd oil for dogs. This is all despite the fact that the FDA has yet to definitively conclude that CBD, in addition to the other compounds in cannabis, has any true type of medicinal purpose. As such, most CBD companies are not allowed to specifically state that their products have efficacy in terms of treating any particular disease or condition.
CBD is a phytocannabinoid, which means it is one of hundreds of cannabis compounds that are specifically designed to interact with internal cannabinoid (CB) receptors that function as part of our endocannabinoid system (ECS). Out of the many varieties of cannabis, hemp is known for containing the highest amounts of CBD, which is why most CBD companies use extract that has been derived from hemp.
Recently, scientists have been conducting a multitude of studies in order to determine the various properties and characteristics of individual phytocannabinoids, with a particular emphasis on CBD. So, what are the benefits and uses of CBD?
Treatment of Epileptic Seizures
At present, the only type of CBD medication that has been granted approval by the FDA is Epidiolex, which utilizes an isolated form of the compound. The studies showed that CBD can have considerable efficacy in the treatment and prevention of epileptic seizures that are associated with certain forms of the disease, including Lennox-Gastaut syndrome and Dravet syndrome.
The testing was performed through double-blind studies where patients were given varying doses of 10 and 20 mg/kg of CBD, twice per day. Its researchers concluded that CBD was safe and effective, which the FDA confirmed through commissioner Scott Gottlieb, who stated:
“Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.”
The approval of Epidiolex has also brought up an interesting quandary regarding the legal status of CBD, which is considered a somewhat grey area because of the FDA’s reluctance at allowing full spectrum hemp extract products that contain CBD to make any sort of medical claims.
Relieve Aches and Pain
A few studies have looked into the potential pain relieving properties of CBD and other cannabinoids, as some research has indicated that CBD could possibly assist with helping to thin the synovial membrane, which is what provides a buffer between our joints. When the synovial layer thickens, it can cause pain and stiffness, and this is often associated with arthritis pain.
The research was conducted to see how CBD might be able to affect other systems that regulate pain. The ECS works through the potentiation of other sub systems, including the opioid system. This is significant because the opioid system is involved with the regulation of pain receptors, as well as playing an essential part in mood modulation.
Sooth Nerves and Calm Feelings of Stress or Anxiety
While everyone has to deal with the common, everyday pressures of life, some may find them overwhelming. Many people are curious as to whether CBD can help sooth nerves and calm feelings of stress or anxiety. Part of this concerns the involvement of other body systems and receptors that work to improve your state of mind. For instance, serotonin is one of many neurotransmitters that assist with mood regulation, and a myriad of conditions are specifically associated with serotonin deficiency.
A lot of studies have been directed at finding out the mechanisms that are utilized by the ECS when it comes to modulating other systems. For instance, some research has shown how CBD may possibly help with attenuating behavior associated with acute stress reactions in rats, through the activation of 5-HT1A serotonin receptors, as serotonin is particularly associated with anxiogenic properties.
Alleviate Side Effects of Chemotherapy
Cannabinoids, including CBD, are often used as palliative care in patients with terminal cancer, partly because they are thought to have a potential to alleviate the side effects of chemotherapy, which include lack of appetite, nausea, and exhaustion.
This makes sense as some of the key side effects associated with CBD include an increase in appetite as well as sleepiness. A combination of THC and CBD has also been studied in order to determine their efficacy for helping pain associated with cancer.
Could Help with Substance Abuse Disorder
As mentioned before, scientists have worked towards learning about what abilities the ECS has with regard to modulating other body systems — and this is important for many reasons. A big question remains as to whether CBD can help with substance abuse disorders. According to the Centers for Disease Control, drug overdose deaths numbered at 67,367 in 2018. This number has steadily crept up in the last few decades, something which has been partially attributed to the overprescription of opioid painkillers. So, how does CBD factor into that?
Although all of the compounds in cannabis are psychoactive, including CBD, the only cannabinoid that has psychotropic properties is delta-9-tetrahydrocannabinol, or delta-9-THC. This also means that THC is the only cannabinoid to facilitate addiction, as repeated use can lead to tolerance as well as emotional and physical reliances to be formed. Interestingly, CBD is able to mitigate these effects in THC, by inhibiting the mechanisms that allow THC to bind with specific CB receptors in the brain.
Similarly, researchers have speculated whether the ECS is able to modulate the processes of the opioid system, because a potential for allaying the addictive properties of opioids could be essential in defeating the current epidemic that has already killed thousands of people.
Support Sleep and Relaxation
Scientists are also working to determine whether CBD can help to support sleep and relaxation in patients who suffer from insomnia as well as other sleep disorders. One study in particular speculated that “evidence points toward a calming effect for CBD in the central nervous system.”
Chronic insomnia afflicts around 10-15% of the population, and it can have a significant impact on energy levels, as well as the ability to perform everyday tasks. This is another reason why people are eager to discover the full capabilities of CBD, because lack of sleep can affect almost every aspect of your life.
Whatever the reasons a person has for wanting to try a new CBD supplement, it is important to examine the quality of the CBD and trustworthiness with the brand that is being considered. This is why it is vital to choose companies that utilize third party laboratory testing. In addition, verified testimonials can be a great way of gauging the potential quality of a particular product. Ultimately, you should always consult your physician to determine whether trying CBD is something you may want to consider.
The information shared within this article was gathered from trusted medical journals online, and the sources are linked within this article. Our intention is to share this information with our viewers in a structured layout which might help answer some common questions. We are not making any medical claims about our products or providing medical advise in any way. Always consult your physician to verify information.
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.