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
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.
The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD.
Frequently asked questions about CBD
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- Can CBD make you sick?
- Can CBD oil kill you?
- Can a dog overdose on CBD oil?
- Can CBD oil lower your blood pressure?
- What is the right amount of CBD?
Cannabidiol (CBD) has become one of the most popular products in the entire cannabis industry, showing up in local coffee shops, pharmacies, and legal marijuana dispensaries. Despite the explosive popularity of CBD, there is still a lot of confusion about what CBD is and how it affects humans. For example, some may wonder: Can you overdose on CBD?
CBD stands for cannabidiol, a non-intoxicating substance found in cannabis. Photo by: Gina Coleman/Weedmaps
In short, probably not, but there are associated risks. CBD is recognized as having a number of anti-inflammatory, anti-anxiety, and neuroprotective qualities, many of which can have positive effects on a broad range of health conditions. However, it’s still important to fully grasp not only the positive ways CBD can affect you, but also any of the potential side effects that may accompany the cannabinoid.
Can CBD make you sick?
If you consume pure CBD, you are unlikely to get sick or experience unpleasant side effects. A 2017 World Health Organization (W.H.O.) report concluded that CBD is “generally well-tolerated with a good safety profile,” and further stated that “in humans, CBD exhibits no effects indicative of any abuse or dependence potential.”
However, people participating in CBD-related studies have at times reported several side effects, including extreme sleepiness, decreased appetite, diarrhea, fatigue, convulsions, vomiting, and some abnormal results on liver function tests.
One such study was published in 2013 in the journal Current Drug Abuse Review as researchers reported on a phenomenon called Cannabinoid Hyperemesis Syndrome. This newly identified clinical syndrome coincides with chronic cannabis abuse and frequent episodes of nausea and vomiting, according to the authors of the study, all of whom are physicians. The researchers classified the prevalence of the syndrome as unknown, so further studies are needed to understand if such side effects are rare.
Of course, other factors could complicate the effects of CBD and could be responsible for adverse reactions. For example, adverse effects could stem from an interaction between CBD and the patient’s existing medications.
Other factors, such as an interaction between CBD and the patient’s existing medications, could complicate the effects of CBD and could be responsible for adverse reactions. Photo by: Gina Coleman/Weedmaps
On a similar note, the Harvard Health Blog published a post in 2018 regarding adverse effects caused by impurities or contaminants in the CBD, which could exist given the largely unregulated status of cannabis products. Following the passage of the 2018 Farm Bill, hemp-derived CBD products were legalized and placed under the jurisdiction of the United States Food and Drug Administration (FDA).
Can CBD oil kill you?
A 2017 review of clinical research published in Cannabis and Cannabinoid Research confirmed that CBD is generally very safe, particularly when compared to other drugs. In general, the biggest risk you likely run if taking a huge dose of CBD may be getting sleepy as the cannabinoid can have tranquilizing effects in large doses.
However, the journal Case Reports in Ophthalmological Medicine reported a CBD-linked fatality in 2019. According to the report, a 56-year-old woman presented with Stevens-Johnson Syndrome, a rare but serious disorder of the skin and mucous membranes. The patient had begun using a CBD extract spray one week prior to being admitted to a hospital emergency room, where she later died of septic shock.
The woman had reported consistent use of other CBD products over a 5-year period prior to this incident and it is unclear whether the new spray caused her to develop Stevens-Johnson Syndrome, though the authors of the report suspect that it did. The patient, however, had a complex medical history including coronary artery disease and hypertension, so linking her death directly to CBD may not illustrate the full picture.
The bottom line is that CBD appears unlikely to be fatal, but exceptions may exist and collaboration with your physician is essential before starting a regimen.
Can you overdose on CBD gummies?
Regardless of the CBD product you’re taking, the answer is still the same. If you’re wondering, “Can you overdose on CBD gummies?”, the answer is no. When you eat a CBD gummy, your body will metabolize the CBD differently than it will if you smoke or vape CBD. While this could change how long it takes the CBD to go into effect or how long the effects last, it won’t change the toxicity of CBD.
Can a dog overdose on CBD oil?
Interestingly, CBD has made significant headway into pet products. According to a PR Newswire report that circulated in early 2019, pet and animal product sales are expected to reach $125 million by 2022, making the sector one of the fastest-growing in the CBD market.
Within the rapidly growing pet CBD market, products for our furry friends are especially popular, which has led many pet owners to wonder, can a dog overdose on CBD oil? According to the American Kennel Club, there is not a lot of definitive evidence on how CBD affects dogs.
CBD may help improve appetite and promote heart health in dogs, and many CBD-infused dog treats and CBD oil for dogs are readily available on the market. Photo by: Gina Coleman/Weedmaps
Anecdotal evidence suggests that CBD oil can help treat pain and seizures in dogs, and that it has beneficial anti-inflammatory, anti-nausea, anti-anxiety, and anti-cancer properties, just as has been observed in humans. CBD may also help improve appetite and promote heart health in dogs, and many CBD-infused dog treats and CBD oil for dogs are readily available on the market.
So far, anecdotal evidence suggests that side effects of CBD overconsumption by dogs include dry mouth, lower blood pressure, and drowsiness. Without definitive evidence, it’s hard to say whether dogs can overdose on CBD. Recognizing that “we do not know what size dosage would be toxic,” the American Kennel Club suggests “to start out with small amounts and then closely monitor the effects” to make sure you don’t inadvertently give your dog too much CBD.
Can CBD oil lower your blood pressure?
Scientific studies to date have shown that CBD can help lower blood pressure. In a 2017 study conducted by the American Society for Clinical Investigation and published in the journal JCI Insight, researchers gave a group of subjects a dose of either 600 milligrams of CBD or a placebo. They then put subjects through a number of tests, analyzing blood pressure and other related body processes. Ultimately, they found that CBD reduced blood pressure levels compared with the placebo.
This could have some important implications on health, as a 2014 study published in the journal Current Hypertension Reports found that “high blood pressure is linked to higher risks of a number of health conditions, including stroke, heart attack and metabolic syndrome.”
What is the right amount of CBD?
So far, scientific research has not pinpointed any clear limits to how much CBD is too much. Dosages in studies cover a very broad range, from as little as 1 milligram to as much as 1,500 milligrams per day. Currently, no dosage has been identified as hazardous, but it is possible to abuse cannabis and you should seek medical intervention if CBD is interfering with how you function in daily life.
The key to dosing is figuring out how it affects your unique body. Every person is different, and since researchers have not identified any precise doses, the best thing to do is start slowly and pay attention to how your body reacts.
Fortunately, you can experiment with CBD confidently knowing you are unlikely to overdose or get sick from taking too much. Instead, you can focus on figuring out how much CBD will give you the type of experience and health benefits you seek.
CBD oil usually comes with a dropper to allow consumers and patients to measure out their dose. Photo by: Gina Coleman/Weedmaps
First-time users should start with a minimal dose of CBD (as small as one drop of oil or 5 milligrams per day) and gradually increase the dosage over time, while paying attention to the effects of different amounts. This process should be continued until the most effective dosage for your specific condition or ailment is achieved.
If you reach a point where you don’t feel significantly better by adding to your dosage, or you feel worse, then scale back the CBD and discuss your dosing options with your physician.
Frequently asked questions about CBD Copy article link to clipboard. Link copied to clipboard. Contents Can CBD make you sick? Can CBD oil kill you? Can a dog overdose on