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 and CBD Oil: What Is It and Does It Really Work?
The popularity of medical marijuana is soaring, and among the numerous products consumers are seeking are CBD, or cannabis oils.
A wealth of marketing material, blogs and anecdotes claim that CBD oils can cure whatever ails you, even cancer. But the limited research doesn’t suggest that cannabis oil should take the place of conventional medication, except for in two very rare forms of epilepsy (and even then, it’s recommended only as a last-resort treatment). And, experts caution that because CBD oil and other cannabis-based products are not regulated or tested for safety by the government or any third-party agency, it’s difficult for consumers to know exactly what they’re getting.
What is CBD?
Simply put, cannabis oil is the concentrated liquid extract of the marijuana plant, Cannabis sativa.
Similar to other herbal extracts, the chemicals in cannabis oils vary depending on how the extract is made and what chemicals were in the plant to begin with.
Cannabis plants produce thousands of compounds but the most well recognized belong to a class called cannabinoids. There are several cannabinoids but the two that are most well-known among consumers are THC (tetrahydrocannabinol) and CBD (cannabidiol).
THC is the primary psychoactive compound in marijuana and it is what people are searching for when they want a product that gives them a “high.” Unlike THC, CBD isn’t known to cause psychoactive effects, and is therefore attractive to those who want to avoid the high but who believe there are other benefits of CBD, said Sara Ward, a pharmacologist at Temple University in Philadelphia. [Healing Herb? Marijuana Could Treat These 5 Conditions]
CBD products that don’t contain THC fall outside the scope of the U.S. Drug Enforcement Agency’s (DEA) Controlled Substances Act, which means CBD products are legal to sell and consume as long as they don’t have THC. That’s likely one of the reasons why CBD products, including CBD oil, are becoming more socially acceptable and increasingly popular. In 2016, Forbes reported that CBD products are expected to be a $2.2 billion industry by 2020.
How are CBD oils consumed?
The physiological effects of cannabinoids can vary widely from person to person, and also depend on how they’re consumed. That lack of predictability is one of the reasons why cannabis oil is a challenging candidate for developing into a medicine, Ward told Live Science.
“Two people may eat a brownie [made with cannabis oil] and one may absorb massive amounts of cannabinoids and the other may not,” Ward said. “How long it takes to work and how long it stays in the system differs greatly.”
It’s a little more uniform when the product is absorbed by smoking or vaping the oil, Ward said. But, “there are obvious concerns about smoking something.” A 2007 review published in the journal JAMA Internal Medicine found that smoking marijuana resulted in similar declines in respiratory system health as smoking tobacco. A similar review published in 2014 in The American Journal of Cardiology found that marijuana smoke inhalation can increase the chances of heart attack or stroke. Neither review analyzed the effects of vaping cannabis oil alone, so it’s unclear if it has the same health risks as smoking other marijuana products.
Why do people use cannabis oil?
People claim that cannabis oil can be used to treat a wide range of conditions, though evidence to back up these claims is often lacking. For example, according to Medical News Today, people use cannabis oil for conditions ranging from pain to acne; some even claim the oil can cure diseases like Alzheimer’s and cancer. (But again, there is no clinical evidence to support these claims.)
A review published in 2017 in the journal Frontiers in Pharmacology described how CBD may work to protect the hippocampus — the part of the brain responsible for several important functions, such as learning, memory and navigation — during times of stress, and may also help prevent brain-cell destruction that results from schizophrenia. Another 2017 review published in the journal Annals of Palliative Medicine summarized a handful of studies that suggest cannabis oils containing THC or CBD, or both, may help with chronic pain management, but the mechanism is unclear.
Cannabis treatment in people with certain forms of epilepsy has been more promising. The only FDA-approved cannabis-based drug is Epidiolex, a CBD oral solution for treating two rare and severe forms of epilepsy. A recent clinical trial found that Epidiolex reduced convulsive seizures by 50% in children with Dravet syndrome, a type of epilepsy, MedPage Today reported.
Why medical experts are hesitant about CBD
It’s important to know that the research in this area is in its infancy, partly because we haven’t really understood much about CBD until relatively recently,” said Marcel Bonn-Miller, an adjunct assistant professor at the University of Pennsylvania Perelman School of Medicine. He pointed out that the classification of marijuana as a Schedule 1 drug by the DEA makes it difficult to get material to use in laboratory studies. Schedule 1 drugs have a high potential for abuse, according to the DEA, and are illegal under federal law.
Because of this classification, it’s not easy for researchers to get their hands on the drug. “That’s not to say you can’t do it, but there are hoops you need to jump through that can be a pain, which may deter researchers from going into this space,” Bonn-Miller said. “Relatively speaking, it’s a small group of people in the U.S. that do research on cannabinoids in humans.”
However, Bonn-Miller told Live Science that he thinks cannabis research is on the upswing. “If we flash forward five years I think you’ll see more studies,” he said. Those studies could reveal more conditions that CBD may be helpful for and may also reveal that some of the reasons why people say they use CBD oil are not supported by the science but are instead a placebo effect. “And that’s why we need to do the studies,” he said.
The side effects and risks involved with consuming marijuana-based products aren’t clear, either, Bonn-Miller said. It’s important to “determine cannabinoids that are useful therapeutically while understanding and using cannabinoids that are associated with less risk,” he said. At least with CBD, he said, it doesn’t appear to have the potential for addiction. That’s different from THC, which has been associated with addiction, he said, and negative side effects, including acute anxiety.
What consumers should know
Both Bonn-Miller and Ward stress that it’s up to the consumer to be well-educated about the material they’re purchasing and the research that’s out there. “The companies that are creating [cannabis oils] are offering lots of claims about its use that are not necessarily substantiated by any research,” Bonn-Miller said. So “I think there needs to be, from a consumer standpoint, a lot of vigilance,” he added.
And the products on the shelf aren’t all the same, Ward said. “There can be many, many different varieties, and if you’re thinking about doing this for medical reasons, you want to find a trusted source and do your research,” she said. “Where does that oil come from, and how confident can you be that you know the exact percentages of the different cannabinoids in the product?”
Bonn-Miller also explained that it’s imperative to exhaust the traditional and established front-line treatments that are available before seeking out these products. “CBD is not really a first-line treatment for anything,” he said. “You don’t want situations where somebody says, ‘I have cancer I’m going to forgo chemotherapy because I read something about CBD or THC helping with cancer.'” That’s not a good idea, Bonn-Miller said. “Not only is the science not there, but you may end up worse off.”
Kimberly has a bachelor’s degree in marine biology from Texas A&M University, a master’s degree in biology from Southeastern Louisiana University and a graduate certificate in science communication from the University of California, Santa Cruz. She is a former reference editor for Live Science and Space.com. Her work has appeared in Inside Science, News from Science, the San Jose Mercury and others. Her favorite stories include those about animals and obscurities. A Texas native, Kim now lives in a California redwood forest.
How to Make CBD Oil
Posted: May 12, 2020 · Updated: May 12, 2020 by Jenny McGruther · This site earns income from ads, affiliate links, and sponsorships.
Many people use CBD oil to reduce inflammation, soothe pain, or improve their body’s response to stress. And it’s super easy to make at home, too. Plus you can use healthy fats and you’ll know exactly what you’re putting into your bottle, avoiding the refined oils and additives that commercial producers sometimes add.
If you’re looking to make CBD oil, you’ll need just two ingredients: hemp and a carrier oil like olive oil. The result is a vibrantly herbaceous infused oil with soothing anti-inflammatory properties.
What is CBD oil?
CBD oil is a non-intoxicating herbal remedy made from hemp flower, another is cannabis honey. It is rich in cannabidiol, a type of compound found in cannabis that has strong anti-inflammatory properties. One of CBD’s benefits is that it conveys the beneficial properties of cannabis without the high since it contains little to no THC.
Many people take CBD to help combat inflammation, anxiety, or restless sleep. Some research suggests it helps protect and support nervous system health (1) and may reduce pain (2), while other research suggests it supports gut health and proper immune system function (3).
To make CBD oil at home, you’ll need to follow a simple two-step process: decarboxylation and infusion. While it sounds complex, decarboxylation is a simple process of precision heating that activates beneficial compounds in cannabis. The second step, infusion, releases those compounds into a carrier oil. Infused oils are easy to take, and oil makes these compounds easier for your body to absorb, too.
Activating the CBD
In order to make CBD oil, you need to extract cannabidiol from hemp first. Further, you need to activate through a process called decarboxylation. The compounds in cannabis plants aren’t active or bioavailable on their own; rather, they’re activated through heat which is why the plant is traditionally smoked.
Rather than smoking, you can activate these compounds through other means of heating. Some people bake hemp flowers in a slow oven for about an hour or use a slow cooker. These methods are inexpensive, but they’re also imprecise and may not activate all the CBD.
To activate CBD efficiently and to get the most from your plant material, you’ll need a precision cooker (also known as a decarboxylator) that can maintain the exact temperatures needed for the full activation of CBD and other cannabinoids. With precision heating, decarboxylators extract a higher percentage of beneficial plant compounds than cruder methods and are a worthwhile investment for anyone who takes CBD oil regularly or wants to make a consistently good product.
Where to Find a Decarboxylator. Commercial CBD oil producers use huge decarboxylators capable of activating the cannabinoids in several pounds of cannabis; however, if you’re making it at home, you’ll need a smaller version.
We used the Ardent Flex for making this CBD oil. With multiple settings, you can use it to activate CBD as well as similar compounds. And, you can also use it to make herbal infusions. Save $30 with code NOURISHED.
What you’ll need to make CBD oil
To make CBD oil you only need two primary ingredients: hemp and a carrier oil. Hemp flowers that are high in CBD will yield the best results, and if you can’t find them locally, you can order them online. After decarboxylating the hemp flowers, you can then use them to make a CBD-infused oil.
High-CBD hemp flower
Depending on their strain, cannabis may contain large or relatively low amounts of CBD. When you make CBD oil, choose a strain with a high CBD content so that you can extract the most beneficial compounds into your homemade oil.
Where to Find High-CBD hemp flower. Since hemp flower is non-intoxicating with negligible to no-detectable THC content, it is legal on a federal level. You may be able to find it locally; however, your best bet is to purchase it online from Botany Farms.
Finding the right carrier oil
A carrier oil is an oil that you use for herbal infusions. Coconut oil and MCT oil (which is derived from coconut) are popular carrier oils both in commercial and homemade CBD products. Avoid highly refined, inflammatory oils such as vegetable oil, soybean oil, grapeseed oil, and corn oil.