Find out the benefits of CBD, what it is, and the associated risks. Does it get you high? Is it safe to use? We asked the experts about what happens to your body on CBD, including the benefits and the risks. The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD.
Health Benefits of CBD
CBD is an abbreviation for cannabinoid. Cannabinoid is a natural substance found in cannabis, also known as marijuana, and also in hemp plants. Today, you can find CBD oil in capsules, oil bases for vaporizers, tinctures, food items, and beauty products such as bath bombs or lotions.
Unlike its cousin THC, CBD is not intoxicating or psychoactive. Proponents of CBD oil claim that it can be used to treat conditions such as chronic pain, inflammation, migraines, epilepsy, autoimmune diseases, depression, and anxiety.
Research into some of these claims is ongoing, and there is still a lot about CBD that we don’t know but researchers are trying to find out.
Researchers are looking for answers when it comes to the full potential of CBD. What have they discovered in the meantime? So far, we know that CBD is a proven treatment when it comes to epilepsy, and early research is showing promise in regards to various anxiety disorders.
Approved to Treat Epilepsy
In 2018, the first FDA-approved drug, cannabidiol (Epidiolex), containing CBD was released on the market to treat two different kinds of epilepsy — Dravet syndrome and Lennox-Gastaut syndrome.
The FDA approved the treatment for patients as young as two years old. Studies showed it was effective in comparison to a placebo in reducing the frequency of seizures.
Though we need more research, a 2015 medical journal review article looked at CBD and its effect on multiple anxiety disorders, including generalized anxiety disorder, seasonal affective disorder, panic disorder, and post-traumatic stress disorder.
The results showed that there was “strong preclinical evidence” to support the treatment of anxiety disorders with CBD, though more research is needed on long-term dosing.
Research surrounding CBD is ongoing, and there are many questions that researchers do not have the answers to yet, such as whether or not the means of taking CBD impacts the risks or efficacy. Some common means of taking CBD include inhaling through a vaporizer, ingesting in food, or taking orally as a pill.
Here is a list of a few potential risks and side effects that come with CBD. Some of these risks are controllable if taking CBD under the guidance of your doctor.
During drug trials for Epidiolex, the FDA determined liver injury to be a side effect of CBD. Signs of liver injury showed up on blood work used to detect early problems with the liver. You can manage this risk by only taking CBD under the supervision of your doctor.
Interaction with Other Medications
If you are taking other medications, CBD can impact their efficacy, and the dose you are taking may need to be re-evaluated by your doctor. CBD can potentially interact with other medications to cause side effects.
Because there is limited research on how CBD interacts with prescription drugs and with standard over-the-counter supplements, it is best to talk to your doctor before taking CBD if you are taking other medications.
Though not much research has looked specifically at CBD, it seems that there is a negative relationship between cannabis use and sperm count, as well as other measures of male fertility, including sperm viability and motility.
Most of these studies have focused on animal participants, and further research is needed. Experts recommend awareness around these potential side effects when prescribing cannabis to patients who are of reproductive age.
Amounts and Dosage
Because the FDA currently does not regulate CBD, there are not specific recommended doses. Doses in most clinical trials have ranged from 100 to 800 milligrams a day.
Before using any CBD product, you should speak to your doctor to come up with a safe dosage plan that works for you. This plan should also take into account your symptoms and any other medications or supplements that you may be taking.
Neurotherapeutics: “Cannabidiol as a Potential Treatment for Anxiety Disorders.”
The Journal of Urology: “Cannabis and Male Fertility: A Systematic Review.“
U.S. Food and Drug Administration: “FDA Approves First Drug Comprised of an Active Ingredient Derived from Marijuana to Treat Rare, Severe Forms of Epilepsy.”
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.”
What Happens to Your Body on CBD
There are a lot of people talking about CBD these days. CBD (cannabidiol) is a cannabinoid that is found in cannabis and hemp and is known for having numerous health benefits. However, while these health benefits look promising, it does create a lot of questions from the general public on what happens to your body on CBD. Does it really work? Can you use too much of it? And will it make one high just like normal marijuana would?
In order to fully understand the health benefits and risks of CBD, we spoke with Triniti Gawthrop, Founder and CEO of Ami Wellness, to fully understand what happens to your body on CBD.
It can help with numerous physical and mental struggles.
Between any type of physical pain or mental struggles (like built-up anxiety), CBD can actually be a way to help calm your body and make you feel better.
“Your endocannabinoid system also has receptors and the way that CBD works with your body is that it helps your endocannabinoid system pick those up, so it essentially creates better communication,” says Gawthrop. “So if you take it regularly, then you’re supporting the communication of that system better and your endocannabinoid system supports the nervous system. It’s just helping your body what your body needs to do. So your body may need help with pain, but my body may need help with dealing with anxiety. Whatever it is you need, it’s helping your body be in the action state.”
Gawthrop also mentions that some studies show how CBD can also help your neuroprotective properties, meaning it can help protect your neurological system.
It won’t fix a health problem.
“CBD doesn’t actually heal you, it just helps your body know to do something to heal itself,” says Gawthrop. “So for instance, if you were dealing with chronic inflammation or chronic pain or if you’re dealing with anxiety or even if you are dealing with any other lifestyle health-focused wellness barrier, it’s going to help your body help you move through that.”
It doesn’t get you high.
For those who aren’t familiar, CBD is a compound found within the cannabis plant. Cannabis also famously has THC, which is the compound that makes people feel high. However, a CBD oil—such as the one sold at Ami’s Wellness—does not have enough THC in it in order for one person to feel any kind of high effects. While Ami’s Wellness does focus on creating products that are full-spectrum (leaving all of the natural compounds of the cannabis plant within the oil), it does not play a main role in the oils that they sell. Simply a “friend” to the many other plants used for the different types of oils.
“The science right now tells us that your body will pick up the CBD better if it does have some THC,” says Gawhtrop. She points out the oil only has 0.3% THC, and based on the science, feels it creates the most effective product for her customers. She points out that even in history from a healer’s perspective, CBD was never meant to “own the table,” but merely be a small part of the entire product.
It is best applied topically.
As of now, the FDA has not approved any kind of dietary supplement for CBD. Meaning that it cannot be ingested like you could with any pill or vitamin. Gawthrop and the team at Ami Wellness make sure to follow all FDA guidelines and only provide products that are topical, meaning they are applied through the skin. 6254a4d1642c605c54bf1cab17d50f1e
“For our products, we only make topical products because we feel it’s the more responsible route to work with the FDA and make sure we know what they know and if there’s education to be done, to be working with them to continue to educate ourselves and educate them,” says Gawhtrop.
Plus, with topical use, you don’t have to worry about overdoing it, because your skin can actually handle a lot of it (it’s a big organ, after all). For those topically applying CBD for the first time, Gawhtrop says 16 milligrams per topical use is enough for you to feel an effect.
It can ease pain and inflammation.
By using it topically, Gawthrop points out that the user can acutely choose where they apply the CBD on their skin. This, of course, can help with anyone experiencing pain or inflammation in particular parts of their body.
“If you’re using it for stress and you find it you’re holding that stress in your neck or in your shoulder, being able to apply it there and kind of rub it in can also create a calming ritual,” says Gawhtrop. “If you’re feeling pain, being able to direct;ly apply it where you are experiencing pain and inflammation usually creates a really positive response for people.”
Make sure to read the labels
Not all CBD products are as transparent. Gawhtrop points out that some CBD products are sold without having almost no CBD in them, and others that market products that include chemicals, pesticides, and heavy metals. She highly encourages all users to take a look at the labels of their products before using them.
“I tell people to think about it as having the same level of education as you would about your vitamins or about anything else you put on your body,” says Gawhtrop. “So treat it with that same level of respect. Read a label and understand where it comes from.”
At Ami Wellness, two of the most popular products are Soothe and Dream. Soothe is an herbal tincture that helps relax muscle tension, and Dream helps to quiet the body and mind for restful sleep. All made with certified organic ingredients or farmed organic ingredients that you don’t have to worry about.
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.