The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD. Curious about how CBD affects the body? CBD has many promising uses. See how it may be able to help with your condition.
What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD
The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD.
- Cannabis is a plant of the Cannabaceae family and contains more than eighty biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). THC is the component that produces the “high” associated with marijuana use. Much interest has been seen around CBD and its potential related to health benefits.
- Marijuana is different from CBD. CBD is a single compound in the cannabis plant, and marijuana is a type of cannabis plant or plant material that contains many naturally occurring compounds, including CBD and THC.
- The FDA has approved only one CBD product, a prescription drug product to treat seizures associated with Lennox Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in people one year of age and older.
- It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.
- The FDA has seen only limited data about CBD safety and these data point to real risks that need to be considered before taking CBD for any reason.
- Some CBD products are being marketed with unproven medical claims and are of unknown quality.
- The FDA will continue to update the public as it learns more about CBD.
Potential harm, side effects and unknowns
- 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?
Unanswered questions about the science, safety, and quality
You may have noticed that cannabidiol (CBD) seems to be available almost everywhere, and marketed as a variety of products including drugs, food, dietary supplements, cosmetics, and animal health products. Other than one prescription drug product to treat seizures associated with Lennox Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in people one year of age and older, the U.S. Food and Drug Administration (FDA) has not approved any other CBD products, and there is very limited available information about CBD, including about its effects on the body.
The FDA recognizes the significant public interest in cannabis and cannabis-derived compounds, particularly CBD. However, there are many unanswered questions about the science, safety, and quality of products containing CBD. The agency is working on answering these questions through ongoing efforts including feedback from a recent FDA hearing and information and data gathering through a public docket.
Despite the 2018 Farm Bill removing hemp — defined as cannabis and cannabis derivatives with very low concentrations (no more than 0.3% on a dry weight basis) of THC — from the definition of marijuana in the Controlled Substances Act, CBD products are still subject to the same laws and requirements as FDA-regulated products that contain any other substance.
The FDA is concerned that people may mistakenly believe that using CBD “can’t hurt.” The agency wants to be clear that we have seen only limited data about CBD’s safety and these data point to real risks that need to be considered. As part of the drug review and approval process for the prescription drug containing CBD, it was determined that the risks are outweighed by the benefits of the approved drug for the particular population for which it was intended. Consumer use of any CBD products should always be discussed with a healthcare provider. Consumers should be aware of the potential risks associated with using CBD products. Some of these can occur without your awareness, such as:
- Liver Injury: During its review of the marketing application for Epidiolex — a purified form of CBD that the FDA approved in 2018 for use in the treatment of two rare and severe seizure disorders — the FDA identified certain safety risks, including the potential for liver injury. This serious risk can be managed when an FDA-approved CBD drug product is taken under medical supervision, but it is less clear how it might be managed when CBD is used far more widely, without medical supervision, and not in accordance with FDA-approved labeling. Although this risk was increased when taken with other drugs that impact the liver, signs of liver injury were seen also in patients not on those drugs. The occurrence of this liver injury was identified through blood tests, as is often the case with early problems with the liver. Liver injury was also seen in other studies of CBD in published literature. We are concerned about potential liver injury associated with CBD use that could go undetected if not monitored by a healthcare provider.
- Drug Interactions: Information from studies of the FDA-approved CBD drug Epidiolex show that there is a risk of CBD impacting other medicines you take – or that other medicines you take could impact the dose of CBD that can safely be used. Taking CBD with other medications may increase or decrease the effects of the other medications. This may lead to an increased chance of adverse effects from, or decreased effectiveness of, the other medications. Drug interactions were also seen in other studies of CBD in published literature. We are concerned about the potential safety of taking other medicines with CBD when not being monitored by a healthcare provider. In addition, there is limited research on the interactions between CBD products and herbs or other plant-based products in dietary supplements. Consumers should use caution when combining CBD products with herbs or dietary supplements.
- Male Reproductive Toxicity: Studies in laboratory animals showed male reproductive toxicity, including in the male offspring of CBD-treated pregnant females. The changes seen include decrease in testicular size, inhibition of sperm growth and development, and decreased circulating testosterone, among others. Because these findings were only seen in animals, it is not yet clear what these findings mean for human patients and the impact it could have on men (or the male children of pregnant women) who take CBD. For instance, these findings raise the concern that CBD could negatively affect a man’s fertility. Further testing and evaluation are needed to better understand this potential risk.
In addition, CBD can be the cause of side effects that you might notice. These side effects should improve when CBD is stopped or when the amount used is reduced. This could include changes in alertness, most commonly experienced as somnolence (sleepiness), but this could also include insomnia; gastrointestinal distress, most commonly experienced as diarrhea and/or decreased appetite but could also include abdominal pain or upset stomach; and changes in mood, most commonly experienced as irritability and agitation.
The FDA is actively working to learn more about the safety of CBD and CBD products, including the risks identified above and other topics, such as:
- Cumulative Exposure: The cumulative exposure to CBD if people access it across a broad range of consumer products. For example, what happens if you eat food with CBD in it, use CBD-infused skin cream and take other CBD-based products on the same day? How much CBD is absorbed from your skin cream? What if you use these products daily for a week or a month?
- Special Populations: The effects of CBD on other special populations (e.g., the elderly, children, adolescents, pregnant and lactating women).
- CBD and Animals: The safety of CBD use in pets and other animals, including considerations of species, breed, or class and the safety of the resulting human food products (e.g., meat milk, or eggs) from food-producing species.
Unproven medical claims, unsafe manufacturing practices
Some CBD Products are Being Marketed with Unproven Medical Claims and Could be Produced with Unsafe Manufacturing Practices
Unlike the FDA-approved CBD drug product, unapproved CBD products, which could include cosmetics, foods, products marketed as dietary supplements, and any other product (other than Epidiolex) making therapeutic claims, have not been subject to FDA evaluation regarding whether they are effective to treat a particular disease or have other effects that may be claimed. In addition, they have not been evaluated by the FDA to determine what the proper dosage is, how they could interact with other drugs or foods, or whether they have dangerous side effects or other safety concerns.
Misleading, unproven, or false claims associated with CBD products may lead consumers to put off getting important medical care, such as proper diagnosis, treatment, and supportive care. For that reason, it’s important to talk to your doctor about the best way to treat diseases or conditions with available FDA-approved treatment options.
In addition to safety risks and unproven claims, the quality of many CBD products may also be in question. The FDA is also concerned that a lack of appropriate processing controls and practices can put consumers at additional risks. For example, the agency has tested the chemical content of cannabinoid compounds in some of the products, and many were found to not contain the levels of CBD they claimed. We are also investigating reports of CBD potentially containing unsafe levels of contaminants (e.g., pesticides, heavy metals, THC).
CBD products are also being marketed for pets and other animals. The FDA has not approved CBD for any use in animals and the concerns regarding CBD products with unproven medical claims and of unknown quality equally apply to CBD products marketed for animals. The FDA recommends pet owners talk with their veterinarians about appropriate treatment options for their pets.
The FDA’s top priority is to protect the public health. This priority includes making sure consumers know about products that put their health and safety at greatest risk, such as those claiming to prevent, diagnose, treat, mitigate, or cure serious diseases. For example, the agency has warned companies to stop selling CBD products they claim are intended to prevent, diagnose, treat, mitigate, or cure serious diseases such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes. While we have focused on these types of products, we will continue to monitor the marketplace for any product that poses a risk to public health, including those with dangerous contaminants, those marketed to vulnerable populations, and products that otherwise put the public health at risk.
Evaluation of the regulatory frameworks
The FDA is Continuing to Evaluate the Regulatory Frameworks for Products Containing Cannabis and Cannabis-Derived Compounds
The FDA continues to believe the drug approval process represents the best way to ensure that safe and effective new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy. The agency is committed to supporting the development of new drugs, including cannabis and cannabis-derived drugs, through the investigational new drug and drug approval process.
We are aware that there may be some products on the market that add CBD to a food or label CBD as a dietary supplement. Under federal law, it is illegal to market CBD this way.
The FDA is evaluating the regulatory frameworks that apply to certain cannabis-derived products that are intended for non-drug uses, including whether and/or how the FDA might consider updating its regulations, as well as whether potential legislation might be appropriate. The information we have underscores the need for further study and high quality, scientific information about the safety and potential uses of CBD.
The FDA is committed to setting sound, science-based policy. The FDA is raising these safety, marketing, and labeling concerns because we want you to know what we know. We encourage consumers to think carefully before exposing themselves, their family, or their pets, to any product, especially products like CBD, which may have potential risks, be of unknown quality, and have unproven benefits.
Our Consumer Update includes a practical summary of what we know to date. As we learn more, our goal is to update you with the information you need to make informed choices about CBD products. Also, as the regulatory pathways are clarified we will take care to inform all stakeholders as quickly as possible.
CBD: Benefits, Types, & Side Effects
CBD, or cannabidiol, is recommended for everything from anxiety and stress to indigestion and depression. And, a lot of people are using it. A recent Gallup poll found 1 in 7 adults in the U.S. has used CBD.
So, does it help? Studies of CBD are ongoing, but some benefits have been found.
What is CBD?
CBD is an herbal remedy – a treatment that comes from a plant, in this case, it is the cannabis sativa plant. Cannabis sativa has been used for thousands of years for both its healing and mind-altering effects.
There are two types of cannabis sativa: hemp and marijuana. The hemp plant is the source of CBD used in most products.
Hemp and marijuana plants
CBD is one of a group of substances called cannabinoids derived from the cannabis sativa plant.
There are dozens of cannabinoids, as well as other substances, in cannabis sativa.
CBD is the primary cannabinoid in hemp. It has various healing properties. For example, it seems to lessen inflammation, the body’s response to illness or injury. In this way, it may help treat many different diseases.
CBD is not psychoactive; it does not have a mind-altering effect.
CBD vs. THC
To better understand CBD, it helps to contrast it with tetrahydrocannabinol (THC). Many people are familiar with THC. It is the best known of the cannabinoids. THC was identified long before CBD. THC is the substance in marijuana that causes the high.
Marijuana contains more THC than CBD. Hemp has a very small amount of THC, less than 0.3 percent, and not enough to cause a high. As of 2018, CBD from hemp became legal in the U.S. with the Food and Drug Administration (FDA) maintaining control.
CBD’s main property is healing and it’s derived from the hemp plant. On the other hand, THC’s main property is mind-altering and it’s derived from the marijuana plant.
Excessive and continued use of CBD may lead to side effects, including memory loss, slow reaction time, and changes in mood such as irritability.
How CBD Works
As stated above, CBD is in a class of chemicals called cannabinoids. Because it comes from a plant, it is further classified as a phytocannabinoid.
The human body also produces natural cannabinoids, called endocannabinoids.
Both variations of cannabinoids act on cannabinoid receptors. These receptors are part of the complex endocannabinoid system (ECS). The system regulates the release of neurotransmitters (chemicals that communicate between nerve cells) in the brain, as well as in other parts of the nervous system. The ECS responds to both types of cannabinoids, phyto- and endo-.
By acting on the ECS, CBD may have many different effects on the body. Examples include: balancing the body’s overall physical functions (homeostasis), reducing pain sensation, and lessening the body’s reaction to injury or inflammation.
Medical Uses of CBD
CBD has been recommended for many different purposes, some of them tested, and some not. The prescription drug Epidiolex is the only CBD product approved by the FDA. It may be prescribed to treat two rare seizure disorders, or types of epilepsy, in children and adults.
Studies are ongoing, but some results show that CBD may be effective in reducing anxiety/stress and chronic (long-term) pain like back pain. It may also be effective for insomnia, or trouble sleeping.
There are studies of oral, topical, and inhaled CBD products for use in many other conditions, including dystonia (movement disorder), Fragile X syndrome (rare genetic disorder), graft-versus-host disease (bone marrow transplant rejection), multiple sclerosis (MS), opioid withdrawal, schizophrenia, and smoking cessation. CBD is also used to alleviate symptoms associated with Parkinson’s disease, but some study results advise against it.
Types of CBD Products
CBD products can be used by mouth (oral/edible) or applied to the skin (topical). These products have different concentrations of CBD.
CBD oil may be used both ways.
Other oral products include edible gummies and capsules. Topical CBD products may also be found in lotions, creams, or balms. Again, they are available in various concentrations.
The proper dosing of CBD for different conditions is still being studied, so new information is continuing to become available.
CBD should be used according to the manufacturer’s instructions. Make sure you read and follow the label carefully. Only use the amount instructed. Using more may increase the chance of side effects, interactions, or other problems.
The dose of a CBD product depends on the form and strength, as well as the concentration of CBD in it. It’s also based on whether or not it has other active ingredients.
Side Effects and Interactions of CBD
Common CBD side effects include: drowsiness, dry mouth, vomiting, decreased appetite, weight loss, and abnormal liver function blood tests.
INTERACTIONS: Check with your doctor or pharmacist before taking CBD with other medications. CBD may interact with some commonly prescribed medications including warfarin, lithium, sertraline, tramadol, codeine, captopril, and valproic acid and carbamazepine (both are anti-seizure medications).Fatty foods may increase the absorption of CBD.
CAUTIONS: People with liver problems or Parkinson’s disease should not take CBD.
Do not use CBD with medicines that are prescribed to control seizures or epilepsy (e.g. valproic acid or carbamazepine).
CBD may increase drowsiness when taken with other sedating medicines or herbal products.
Oral CBD for Pain
Research on the safety and effectiveness of oral CBD for pain is ongoing. Some of the research includes:
The National Academies of Sciences (NAS) found significant evidence that cannabis was an effective treatment for long-term (chronic) pain. However, much of the research was done outside of the U.S. And the forms of cannabis studied in the U.S. were not the same as those commonly used.
Reviews and meta-analyses of cannabinoids found the following:
Studies looked at the use of cannabinoids (THC alone and CBD combined with THC) in people with chronic pain. In general, results showed improvements in pain measures, but they were not statistically significant.
Studies found evidence, although not high-quality, that cannabis-based medicines reduced long-term nerve (chronic neuropathic) pain. All but two studies used plant-based THC/CBD mouth spray products (the other two used synthetic oral THC products).
Results of observational studies and randomized controlled trials (RCTs) of the effectiveness of cannabinoids in chronic non-cancer pain showed a 30% reduction in pain in 1 out of 3 of those using cannabinoids. These results were considered significant.
Topical CBD for Pain
There is also continuing research on the safety and effectiveness of topical CBD. Some of the research includes the following:
Although not in humans, an animal study found transdermal CBD had the ability to lessen the pain and inflammation of arthritis.
Topical cannabidiol oil was studied in 29 people with lower limb peripheral neuropathy. After using the oil for 4 weeks, results showed less intense and sharp pain and fewer other uncomfortable sensations.
Applications of transdermal cannabidiol were studied in people with temporomandibular (joint of the jaw) disorders (TMD) that caused myofascial (coverings of muscle) pain. Those studied had less muscle tension and pain after applying the topical CBD for 2 weeks.
Oral CBD to Help with Sleep
Oral CBD products may be used to help with sleep. This research includes the following:
Early results of research suggest that a 160mg dose of cannabidiol before bed significantly improves sleep duration compared to a placebo in patients with insomnia. Smaller doses did not have this effect. Also, patients did not feel drowsy the next morning.
Early research on CBD for the treatment of insomnia suggests that it may be effective. Additional studies are needed.
Animal studies of CBD found increased total sleep and improved sleep quality when sleep issues were associated with anxiety/stress.
Medical cannabis users reported they used cannabis with higher CBD and lower THC concentrations for their insomnia. They also reported a decrease in the time required to fall asleep.
A review and meta-analysis of 8 studies with low-quality evidence of cannabis-based medicines found that they were better at reducing sleep problems compared to inactive medicines (placebo).
A review of clinical trials of the effect of cannabinoids on sleep suggested that cannabinoids could improve sleep quality, decrease sleep disturbances, and decrease the time it takes to fall asleep. However, there were limiting factors, such as the small size of the studies.
An app was used to measure changes in insomnia in over 400 people taking medical cannabis. Results showed an average symptom severity reduction of 4.5 points on a 10-point scale, a significant improvement in insomnia.
Another review with meta-analysis of 104 studies evaluated cannabinoids for the treatment of chronic non-cancer pain. Within this review and analysis, the effect of cannabinoids on sleep was also examined. There was low-quality evidence of improved sleep.
The takeaway is that the initial research of CBD is promising but there is still much to learn. It may help with some conditions like long-term pain and sleep.
Because it is so widely available and recommended for so many problems, it must be used carefully and purchased from reliable sources.
CBD is just one of many supplements that can alleviate back pain or insomnia. Take a Goodpath assessment for an integrative program that incorporates supplements, nutrition, mind-body therapies, and exercise.