Labeling of Cannabidiol Products: A Public Health Perspective 1 The Center for Medical Cannabis Education, Del Mar, California, USA. 2 Helfgott Research Institute, National University of 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 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
Labeling of Cannabidiol Products: A Public Health Perspective
1 The Center for Medical Cannabis Education, Del Mar, California, USA.
2 Helfgott Research Institute, National University of Natural Medicine (NUNM), Portland, Oregon, USA.
3 Scientific and Regulatory Affairs, CV Sciences, Inc., San Diego, California, USA.
4 Communications Department, Americans for Safe Access, Washington, District of Columbia, USA.
5 Graduate School of Education and College of Arts and Sciences, University of Redlands, Redlands, California, USA.
2 Helfgott Research Institute, National University of Natural Medicine (NUNM), Portland, Oregon, USA.
5 Graduate School of Education and College of Arts and Sciences, University of Redlands, Redlands, California, USA.
* Address correspondence to: Jamie Corroon, ND, MPH, The Center for Medical Cannabis Education, 428 8th Street, Del Mar, CA 92014, USA [email protected]
Introduction: Interest in the therapeutic use of cannabidiol (CBD) has reached a fever-pitch in recent months, as CBD-containing products appear everywhere from online retailers to grocery stores and gas stations. The widespread availability of hemp-derived CBD products is confounding given that CBD is a U.S. Food and Drug Administration (FDA)-approved drug, and thus precluded from being added to food and beverages, or included in dietary supplements. The use by manufacturers of disease-related claims on marketing materials and product labels, along with the federal legalization of hemp in December 2018, has created political pressure on FDA to promulgate regulations.
Conclusions: Accurate and informative labeling of hemp and hemp-derived CBD products is an important public health issue. FDA-regulated product labels are considered an essential tool for protecting consumers and enabling informed decision-making. Untruthful or unsubstantiated health-related claims, and unallowed Drug Claims, in marketing materials and on labels of CBD products may create harm by enticing consumers to forgo more evidence-based medical interventions. Furthermore, missing or inaccurate labeling of the amount of CBD, delta-9 tetrahydrocannabinol (THC), and potentially harmful contaminants such as pesticides, naturally-occurring yeast and mold or heavy metals may result in harm and/or lack of efficacy. Manufacturers of these products may reasonably be expected to understand and adhere to FDA regulations for labeling and marketing of food, dietary supplements and drugs, both over-the-counter (OTC) and prescription, even though FDA has interpreted federal law as excluding them from these categories. As manufacturers prepare for forthcoming regulations, a better understanding of the basic framework for FDA labeling and marketing regulations for food, dietary supplements and drugs is warranted.
Cannabidiol (CBD) is one of more than a hundred cannabinoids found in Cannabis sativa L., a plant more well-known colloquially as marijuana or hemp. 1 CBD was first isolated in 1940 and characterized structurally in 1963. 2,3 Interest in the therapeutic use of CBD has reached a fever-pitch in recent months, as CBD-containing products appear everywhere, from online retailers to grocery stores and gas stations.
Widespread availability of hemp and hemp-derived CBD products is confounding, given the position of the U.S. Food and Drug Administration (FDA), which maintains that CBD is an approved drug, 4 and thus precluded from being added to food and beverages, or included in dietary supplements. 5 To date, FDA enforcement has been limited to sending warning letters to manufacturers, largely for mislabeling or misbranding their products as unapproved new drugs, or for making claims that a product is indented to treat a disease condition on labels and marketing materials (FDA considers all sales materials, including consumer testimonials used in marketing, to be extensions of the label). 6–8 Political pressure on FDA is mounting. The agency had initially indicated it would expedite its deliberations regarding regulation of hemp-derived CBD products, 9 however, a late 2019 update promised only to inform stakeholders “as quickly as possible.” 10
The public health imperative
Accurate and informative labeling of CBD products is an important public health issue. Product labels, and associated marketing materials, provide vital information about that product’s composition and ingredients, as well as the potential risks and benefits of use. Unsubstantiated health-related claims, and unallowed drug claims, on labels of CBD products may create harm by enticing consumers to forgo more evidence-based medical interventions. In addition, absence of disclosure of major food allergens or solvents or excipients, if present, would constitute misbranding; and inaccurate labeling of the amount of CBD, delta-9-tetrahydrocannabinol (THC), or potentially harmful contaminants such as pesticides, naturally occurring yeast and mold, or heavy metals may result in harm and/or lack of efficacy.
Manufacturers of hemp and hemp-derived CBD products intended to be sold and marketed as food or dietary supplements may reasonably be expected to understand and adhere to FDA regulations for labeling and marketing of such products, even though FDA has interpreted federal law as excluding them from these categories. Similarly, manufacturers of products intended to be sold and marketed as drugs must comply with a different, more rigorous, set of FDA regulations that are specific to that category.
What’s in a Label?
In the United States, the label of FDA-regulated products, which include food, beverages, dietary supplements, drugs, and more, represents the product’s identity card. Product labels provide important information about that product’s composition and ingredients, as well as the potential risks and benefits of use. FDA-regulated product labels are considered an important tool for protecting consumers and enabling informed decision-making. 11
Widespread mislabeling of hemp and Cannabis products has been documented by both independent researchers and the FDA and other organizations. 12,13 Underlabeling and overlabeling of both CBD and THC content have been reported. The actual contents of available products can vary considerably from what are disclosed on the label; sometimes no CBD is present at all. Inadequate label information also poses risks of unintended, unwitting, or overconsumption of THC, the primary intoxicating compound in Cannabis, as well as potentially harmful contaminants.
Identity and Composition
FDA regulations mandate that food, dietary supplements, and drugs prominently display a “statement of identity” as one of the dominant features of the principal display panel of the label. This descriptive statement is used to identify the product (e.g., “Crackers,” “Cereal,” “Herbal Supplement”) and allow consumers to easily interpret its intended use (e.g., food for nourishment, a dietary supplement to supplement the diet, or a drug for therapeutic purposes). A “statement of identity” is also important for hemp-derived CBD products. While the statement “Dietary Supplement” is required for products intended to supplement the diet, statements that identify other forms of CBD products, such as “Vape cartridge,” or “Ointment,” may help consumers more easily identify products that are not intended to supplement the diet.
Declarations related to the principal constituents of a food, dietary supplement, or drug are made within FDA-regulated Fact Panels. Most FDA product category requires a Fact Panel (i.e., Nutrition Facts, Supplement Facts, and Drug Facts) on the label to convey the information required for the safe, informed use of the product. For food and dietary supplements, the “Serving Size” and the “Servings Per Container” must also be stated within the Fact Panel. For prescription and over-the-counter (OTC) drugs, the active ingredients per dosing unit (e.g., tablet, capsule, and packet) and adequate directions for use are stated in the Drug Fact panel. The presence of Fact Panels on labels implies the product is in compliance with all FDA requirements for the corresponding category (i.e., food, dietary supplement, or drug).
CBD and THC content per serving is often intentionally absent from the label of hemp-derived CBD products marketed as dietary supplements. In the case of CBD, this omission is often intended to reduce the risk of enforcement actions by FDA or other federal agencies. In the case of THC, it may be due to the presumption that levels are low enough to be nonpsychoactive.
The presence of trace amounts of THC in hemp-derived CBD products is not unlike the presence of trace amounts of alcohol in certain beverages. For example, Kombucha products (i.e., fermented tea beverages) containing 0.5% or less alcohol by volume are not deemed alcohol beverages and not subject to Alcohol and Tobacco Tax and Trade Bureau regulations ( Table 1 ). 14
Allowable Amounts of Selected Ingredients
|Labeling claim||Legal threshold|
|Hemp||0.3% dry weight THC|
|Kombucha and N/A beer||0.5% ABV|
|No calorie||5 calories per serving|
|Fat free||0.5 g per serving|
|Sodium free, salt free||5 mg per serving|
|Sugar free||1.0 g per serving|
The 2018 Farm Bill defines hemp as the plant Cannabis with a THC concentration of not more than 0.3% by dry weight. The Farm Bill does not define a level that applies to finished consumer products. However, the Farm Bill explicitly maintains FDA’s authority to determine a safe level for consumer products that it regulates such as foods, dietary supplements, cosmetics, and drugs.
ABV, alcohol by volume; THC, delta-9-tetrahydrocannabinol; FDA, Food and Drug Administration.
FDA allows “free from” claims for food products that contain trace amounts of sodium, fat, and sugar. However, hemp-derived CBD products should not carry a “THC-free” or similar claim until a specific legal threshold has been established. At least one consumer lawsuit has been filed based on a presumably faulty “THC-free” claim. 15 Similarly, if manufacturers use the term “Broad Spectrum” to suggest that a product is free of THC, then that needs to be defined in terms of an exact quantity and a specific analytical method.
Health-Related Claims on the Label
Health-related label claims are important because they communicate to consumers a given product’s intended use, potential benefits and harms, and anticipated effects. FDA guidelines describe four categories of allowable health-related claims on labels of food, dietary supplements, and drugs. These include the following: (1) Nutrient Content claims; (2) Structure/Function claims; (3) Health claims; and (4) Disease claims. Each category of claims requires a certain level of evidence for substantiation of the claim that is in accordance with FDA regulations.
FDA Nutrient Content Claims
Nutrient Content claims simply characterize the level of a nutrient in a food, food component, or dietary ingredient, using terms such as free, high, and low (e.g., “low-calorie,” “high-fiber,” “fat-free”). Claims that use these terms are only allowed for nutrients with established Daily Values (i.e., Reference Daily Intakes or Dietary Reference Value). Nutrient Content claims can also compare the level of a nutrient in a food to that of another food, using terms such as more, reduced, and light (e.g., “reduced-sodium,” “more fiber,” “light” [referring to reduced fat]). 16 The use of Nutrient Content claims is grounded in nutrition science to avoid arbitrary use of these terms and to help consumers accurately identify and compare the nutritional value of foods.
The use of terms such as free, high, and low, while currently prohibited, may be helpful for hemp-derived CBD products when referring to biologically active compounds such as phytocannabinoids (e.g., “high in CBD,” “THC free”). Standardized label terminology will reduce misuse of descriptive terms on labels and facilitate consistent communication to consumers. Industry stakeholders would benefit from engaging in an open process to reach consensus on harmonized constituent thresholds, as well as terminology for characterizing the composition of these products. Ultimately, appropriate terminology and thresholds should be negotiated with FDA and adopted by industry before being used in marketing.
FDA Structure/Function Claims
Structure/Function claims describe the role of a food or dietary ingredient in terms of its effect on the normal structure or function of the human body (e.g., “calcium builds strong bones,” “fiber maintains bowel regularity”). Labels of foods and dietary supplements, as well as drugs, can display Structure/Function claims. Structure/Function claims for conventional foods are limited to physical attributes such as taste, aroma, or nutritive value (e.g., beef provides iron to support hemoglobin levels). For dietary supplements, Structure/Function claims may include non-nutritive support (e.g., supports memory and focus), general well-being, and claims related to nutrient deficiencies (e.g., vitamin C prevents scurvy). Structure/Function claims do not require premarket approval by FDA; however, the manufacturer must have substantiation that the claim is truthful and not misleading. A notification with the text of the claim must be submitted to FDA no later than 30 days after marketing the product. 17
Claims related to a product’s effect on normal function may help set expectations for consumers of hemp-derived CBD products. Nondisease-oriented claims (e.g., promotes a restful sleep or fosters stress resilience) can be supported with the appropriate scientific evidence, if available. Manufacturers should avoid referring to specific disease states (e.g., insomnia or anxiety), and instead use appropriate terminology that describes the anticipated effect for most users. This framework for claims making would encourage marketers to conduct research on unique cultivars, formulations, and delivery technologies to determine if, in fact, different products lead to different effects.
It should be noted that the use of Structure/Function-type claims presents a risk of misinterpretation by consumers and misuse by manufacturers. The current use of Structure/Function claims for food and dietary supplements has been criticized because consumers may be confused and interpret a nondisease-oriented claim such as “promotes a restful sleep” as a therapeutic claim for a sleep disorder. 18
FDA Health Claims and Drug Claims
Health claims and Qualified Health claims (Health claims) describe the relationship between a food or dietary ingredient and reduced risk of a disease or health-related condition (e.g., “adequate calcium throughout life may reduce the risk of osteoporosis”). Health claims pronounce disease risk reduction and therefore require FDA preauthorization and a higher level of substantiation. Alternatively, they may be based on an authoritative statement of the National Academy of Sciences, or a similar scientific body within the U.S. government that has responsibility for public health protection or nutrition research. When a product bears a label claim that states or implies the product is useful in diagnosing, curing, mitigating, treating, or preventing a disease, that claim is considered a drug claim and designates that product as a drug according to the FDA. 19
Drug claims for prescription and OTC drugs are roughly analogous to Health claims for nondrugs but allow for statements beyond risk reduction (i.e., diagnosing, curing, mitigating, treating, or preventing). These claims are product-specific and subject to the most rigorous FDA premarket approval process, requiring both preclinical and clinical trials, including multiple phase 1–4 clinical trials. Results of these trials lead to clearly established indications and contraindications for use of the drug in specific diseased populations. 19
FDA regulations prohibit any product that has not received premarket approval as a drug from making a Drug claim on its label or in marketing materials. Epidiolex TM , an FDA-approved prescription form of CBD, can be marketed with Drug claims. Hemp-derived CBD products cannot.
Multiple manufacturers in the emerging CBD industry have made marketing statements that qualify as Health or Drug claims ( Table 2 ). FDA has delivered cease-and-desist letters to more than 40 companies since 2015—the number more than tripled to 22 in 2019—for making such claims about their CBD products in labeling, including claims that they treat, or even cure, Alzheimer’s disease, opioid withdrawal, pain, and anxiety. 20
Selected Examples of Labeling Claims Cited by Food and Drug Administration in Warning Letters
|Company||Location of claim||Claim|
|Curale af, Inc.||Webpage||“CBD can successfully reduce anxiety symptoms, both alone and in conjunction with other treatments.”|
|Advanced Spine and Pain, LLC (d/b/a Relievus)||“Cannabidiol Fights Against Cancer CBD and other chemicals found in Cannabis have an anti-tumor effect and could be used to improve standard treatments. Please visit our website for more information!|
|Nutra Pure, LLC||Webpage||“Cannabidiol (CBD) Treats Neuropsychiatric Disorders”|
|PotNetwork Holdings, Inc.||Webpage||“Interestingly, however, in some lab studies, CBD has also shown the ability to kill cancer cells directly without the help of our immune system.”|
|Green Roads of Florida, LLC||Webpage||“[CBD] has antipsychotic properties, which makes it very useful for treating bipolar disorder.”|
|Natural Alchemist Alurent, Inc.||Webpage||“I was pleasantly surprised to find that CBD helped my arthritis…I have shared with my son and he states he is a big believer in CBD for. .. TBI [traumatic brain injury] after being acquainted with military personnel who have tried it.”|
|Dose of nature||“CBD May Reverse Brain Deficits in Parkinson’s, Alzheimer’s”|
To underscore the importance of FDA preapproval of all Drug claims, FDA requires labels of dietary supplements that make any claims to include a disclaimer which states that the FDA has not evaluated the claim(s) and that the product “is not intended to diagnose, treat, cure, or prevent any disease.” 21
Accurate and informative labeling of hemp and hemp-derived CBD products is an important public health issue. Untruthful or unsubstantiated health-related claims, and unallowed Drug claims, in marketing materials and labels of CBD products may create harm by enticing consumers to forgo more evidence-based medical interventions. Furthermore, missing or inaccurate labeling of the amount of CBD, THC, and potentially harmful contaminants such as pesticides, naturally occurring yeast and mold, or heavy metals may result in harm and/or lack of efficacy. Manufacturers of these products may reasonably be expected to understand and adhere to FDA regulations for labeling and marketing of food, dietary supplements, and drugs, both OTC and prescription, even though FDA has interpreted federal law as excluding them from those categories. As manufacturers prepare for forthcoming regulations, a better understanding of the basic framework for FDA labeling and marketing regulations for food, dietary supplements, and drugs is warranted.
Design, research, and article writing, oversight—J.C. Design, research, and article writing—D.M. Research and article writing—W.D.
|ABV||alcohol by volume|
|FDA||Food and Drug Administration|
Author Disclosure Statement
J.C., ND, MPH, is the Medical Director at The Center for Medical Cannabis Education, a for-profit clinical and consulting entity. D.M., ND, has no conflicts to disclose. W.D., MA, is a paid consultant for Americans for Safe Access Foundation, a 501(c)3 nonprofit educational organization.
No funding was provided for this article.
Cite this article as: Corroon J, MacKay D, Dolphin W (2020) Labeling of cannabidiol products: a public health perspective, Cannabis and Cannabinoid Research 5:4, 274–278, DOI: 10.1089/can.2019.0101.
1. RU (ed). Cannabis inflorescence monograph: a monograph . American Herbal Pharmacopoeia: Scotts Valley, CA, 2014:66 [Google Scholar]
2. Adams R, Hunt M, Clark JH. Structure of cannabidiol, a product isolated from the marihuana extract of Minnesota wild hemp . I. J Am Chem Soc . 1940; 62 :196–200 [Google Scholar]
3. Michoulam R, Shvo Y. Hashish . I. The structure of cannabidiol. Tetrahedron . 1963; 19 :2073–2078 [PubMed] [Google Scholar]
4. Press Announcements. FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy [press release]. Office of the Commissioner, 2018
5. Commissioner Oot. Public health focus—FDA and marijuana: questions and answers . 2018. Available at: https://fda.gov/NewsEvents/PublicHealthFocus/ucm421168.htm Accessed January9, 2020
6. U.S. Food and Drug Administration. FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety | FDA [press release], July 23, 2019. U.S. Food and Drug Administration
7. Commissioner Oot. Press announcements—FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer. 2018
8. U.S. Food and Drug Administration. FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer | FDA [press release], November 1, 2017. U.S. Food and Drug Administration
9. @US_FDA. Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for Cannabis-containing and Cannabis-derived products | FDA. 2019. Available at: https://fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-steps-advance-agencys-continued-evaluation Accessed January9, 2020
10. U.S. Food and Drug Administration. What you need to know (and what we’re working to find out) about products containing Cannabis or Cannabis-derived compounds, including CBD. 2019. Available at: https://fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-Cannabis-or-Cannabis Accessed January8, 2020
11. Viola GCV, Bianchi F, Croce E, et al.. Are food labels effective as a means of health prevention? J Public Health Res . 2016;5 [PMC free article] [PubMed] [Google Scholar]
12. Bonn-Miller MO, Loflin MJE, Thomas BF, et al.. Labeling accuracy of cannabidiol extracts sold online . JAMA . 2017; 318 :1708–1709 [PMC free article] [PubMed] [Google Scholar]
13. U.S. Food and Drug Administration. FaDAFo. Warning letters and test results for cannabidiol-related products. 2018 . Available at: https://fda.gov/news-events/public-health-focus/warning-letters-and-test-results-cannabidiol-related-products Accessed January9, 2020
14. RRD. TTB | Kombucha | Kombucha information and resources. [Overviews and factsheets, PG]. 2015 . Available at: https://ttb.gov/kombucha/kombucha-general.shtml#labeling Accessed January9, 2020
16. Nutrition CfFSaA. Guidance documents and regulatory information by topic—guidance for industry: food labeling guide . 2018. Available at: https://fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm2006828.htm Accessed January9, 2020
17. Nutrition CfFSaA. Labeling and nutrition—structure/function claims. 2018 . Available at: https://fda.gov/Food/LabelingNutrition/ucm2006881.htm Accessed January9, 2020
18. Hasler CM. Health claims in the United States: an aid to the public or a source of confusion? J Nutr . 2008; 138 :1216s–1220s [PubMed] [Google Scholar]
19. Avery RJ, Eisenberg MD, Cantor JH. An examination of structure-function claims in dietary supplement advertising in the U.S.: 2003–2009 . Prev Med . 2017; 97 :86–92 [PubMed] [Google Scholar]
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.
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.]