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 affects everyone differently- but most people take CBD oil without having any negative side effects. Here, we address some potential side effects of CBD oil, and offer advice on how to avoid them.
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 Side Effects of CBD Oil?
For the many health problem you might be facing, there is often a helpful solution that involves the use of CBD.
At Rosebud, we’re obviously advocates of hemp, and cannabis in general, so we’re not going to deny the health benefits of CBD. However, we would be remiss if we didn’t also mention the potential side effects of CBD oil.
Of course, the side effects of CBD are incredibly mild, especially when you compare them to common over-the-counter or prescription drugs. But there are some reported side effects you should be aware of as you incorporate CBD into your wellness routine.
Scroll down to read about the most common side effects of CBD, and learn what you can do to potentially prevent them altogether.
What is CBD?
Cannabidiol (CBD) is one of the many active compounds found in the cannabis plant. On its own, CBD isn’t psychoactive; meaning it won’t give you a high. It does, however, have the power to help you feel better since CBD may help with many different kinds of ailments.
The Scoop on CBD Side Effects:
Here’s the thing: there isn’t much clinical data available when it comes to cannabis.
Until Congress passed the Farm Bill in 2014, cannabis (even the kind without any THC present) was classified by Drug Enforcement as a Schedule 1 Drug. This meant that, under no circumstances, could CBD be sold. This ban made it extremely difficult for anyone in the medical field to observe the side effects of CBD, which is why there is such a lack of information.
However, since the legalization of CBD- the World Health Organization has stated, “To date, there is no evidence of recreational use of CBD or any public health-related problems associated with the use of pure CBD.”
Lots of CBD oil available online contain additional ingredients to improve their effects. These ingredients might increase the chances of experiencing side-effects.
Rosebud is proud of the fact that our CBD oil contains only two ingredients: CBD and MCT (which is simply coconut oil). This not only is healthier for you, but it also cuts down the chances of experiencing any potential side effects.
Most customers don’t have any problems whatsoever when taking CBD oil; but, it is important to note that in rare cases, the following side effects have been reported:
Diarrhea: This reaction is probably caused by the other ingredients in your CBD oil, as CBD itself actually has gastroprotective qualities.
If you are experiencing this side effect, stop taking your CBD oil for 24 hours, to determine whether it was caused by the CBD, or something else entirely.
Dry mouth: Frequent cannabis users are probably familiar with this common THC-induced side effect. According to a 2006 study, the sensation of a dry mouth is mostly due to the inhibition of cannabinoid receptors present in our salivary glands. While dry mouth has been listed as a potential side effect of CBD, most studies examining these side effects use a mixture of CBD and THC. This implies that any THC present in your CBD oil is probably responsible for your dry mouth.
To help avoid experiencing dry mouth, make sure that you drink lots of water before, and after, you consume your CBD oil.
Fatigue: Taking small doses of CBD can be stimulating, help improve focus, and have an amazingly positive effect on your mood. Higher doses of CBD oil, however, can occasionally induce fatigue or drowsiness. This is why some people choose to incorporate CBD into their bedtime routine.
This factor aside, there are a surprising amount of studies that actually report decreased fatigue in patients using CBD oil.
While cannabinoids affects everyone differently, the majority of CBD users can consume CBD oil without experiencing any side effects.
A great way to avoid the potential side effects of CBD oil, is to check the sellers credibility. If the third-party lab testing results for their CBD products show less than 0.3% THC, you have nothing to worry about.
At Rosebud, we make our third-party lab tests readily-available to our customers. This not only ensure that you avoid experiencing any side effects of CBD oil, but also guarantees your experience with CBD oil is completely safe.
FDA DISCLOSURE Representations regarding the efficacy and safety of Rosebud CBD have not been evaluated by the Food and Drug Administration. The FDA only evaluates foods and drugs, not supplements like these products. These products are not intended to diagnose, prevent, treat, or cure any disease. Click HERE and HERE to find evidence of a test, analysis, research, or study describing the benefits, performance or efficacy of CBD Oil based on the expertise of relevant professionals. These statements have not been evaluated by the FDA and are not intended to diagnose, treat, or cure any disease. Always check with your physician before starting a new dietary supplement program. The Cannabidiol (CBD) in Rosebud CBD is a natural constituent of industrial hemp plant and grown in the United States of America. Rosebud CBD does not sell or distribute any products that are in violation of the United States Controlled Substances Act (US CSA). All products contain less than 0.3% THC. All products are legal in all 50 states.
Since I’ve started taking this oil I’m getting headaches. I wonder why this is a side effect.
Hi Amy! This is commonly due to dehydration. We recommend drinking a full glass of water before taking your CBD and maintaining water intake throughout the day to keep your body hydrated. Hope this helps!