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.
Is hemp the same thing as marijuana?
There’s been a lot of discussion about hemp recently, since the 2018 Farm Bill made it legal for farmers to grow industrial hemp for the first time since the passage of the 1970 Controlled Substances Act (or, practically speaking, since the 1937 Marihuana Tax Act).
There are still quite a few restrictions and regulations associated with growing hemp, but the fact that hemp is now legal – while marijuana is not – has raised a lot of questions.
NC State’s College of Agriculture and Life Sciences, and NC State Extension, are engaged in a variety of research and educational programs related to hemp. That puts us in a position to help answer some of the most common hemp questions.
What’s the difference between hemp and marijuana?
Hemp and marijuana are, taxonomically speaking, the same plant; they are different names for the same genus (Cannabis) and species.
“Hemp and marijuana even look and smell the same,” says Tom Melton, deputy director of NC State Extension. “The difference is that hemp plants contain no more than 0.3 percent (by dry weight) of THC (tetrahydrocannabinol), the psychoactive substance found in marijuana. By comparison, marijuana typically contains 5 to 20 percent THC. You can’t get high on hemp.”
In other words, Cannabis plants with 0.3 percent or less of THC are hemp. Cannabis plants with more than 0.3 percent THC are marijuana.
Is it now legal to grow hemp in North Carolina?
It is legal to grow hemp, but you must be licensed.
In North Carolina, licenses must be approved by the state’s Industrial Hemp Commission, which is affiliated with the N.C. Department of Agriculture & Consumer Services. Licensed growers must abide by stringent regulations, including tests to ensure that the THC levels in any hemp remain at or below the limit of 0.3 percent.
Why is there interest in growing hemp?
In short, the answer is that farmers grow things for which there is a market – and there appears to be a market for industrial hemp.
“Many see industrial hemp as a rapidly growing industry and a way to replace losses in acreage or value in other commodities,” Melton says.
What are some benefits and uses of hemp?
Industrial hemp has many potential uses. Hemp fibers can be used in textiles or industrial processes. Hemp can also be used for grain, and the flowers are often used as a source for cannabidiol, a hemp extract also known as CBD.
“Ninety-five percent of North Carolina hemp crops are grown for their flowers,” Melton says. “CBD is widely acclaimed for use in addressing many aches, pains and mental disorders. However, there is little data supporting many of the claims.”
And the regulatory requirements related to CBD can be confusing.
Is growing hemp for CBD legal?
“Growing hemp for its flowers was already legal, prior to the 2018 Farm Bill, under the 2014 Farm Bill,” Melton says. “The 2014 Farm Bill allowed states to have Industrial Hemp Pilot Research Programs, under which any part of the hemp plant could be produced by a licensed grower.
“Prior to the 2018 Farm Bill, extraction of CBD from the flower would have been considered illegal by the U.S. Drug Enforcement Administration (DEA). The laws pertaining to CBD were, and are, complicated and not mutually agreed upon even by states or cannabis lawyers,” Melton says.
“However, it is clear that, even prior to the 2018 Farm Bill, North Carolina was producing hemp flowers legally by licensed growers. The 2018 Farm Bill effectively moved oversight from the DEA to the U.S. Department of Agriculture for hemp and all its derivatives and extracts. At the same time, the law removed CBD that is produced by licensed growers of industrial hemp from the controlled substance list. The USDA has not developed its program yet – the Farm Bill was only signed in December 2018 – so we are still operating our NC Pilot program and licensing farmers under that.”
According to a Feb. 8 announcement from the N.C. Department of Agriculture & Consumer Services, CBD is considered a drug by the U.S. Food and Drug Administration and cannot legally be added to food or animal feed that is for sale – nor can companies make health claims about products containing CBD.
Citation: Is hemp the same thing as marijuana? (2019, February 15) retrieved 28 May 2022 from https://phys.org/news/2019-02-hemp-marijuana.html
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What Is Hemp?
Nutritional Advantages of Eating Hemp Seeds and Hempseed Oil
Sherry Christiansen is a medical writer with a healthcare background. She has worked in the hospital setting and collaborated on Alzheimer’s research.
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Hemp (Cannabis sativa L.) is grown for use in many different products. Hemp is made into foods, health products, fabric, rope, natural remedies, and much more. Different parts of the hemp plant are used to make different products.
Hemp seeds are edible and highly nutritious. They have a high concentration of fiber. They also contain omega-3 and omega-6 fatty acids. These fatty acids are nutrients that are important for heart and skin health.
Hemp is sometimes confused with marijuana. Hemp, however, contains only trace amounts of THC, the main chemical in the marijuana plant that makes people get “high.” Because hemp contains little THC, it is grown for non-drug use.
This article discusses some of the health benefits of hemp, its uses, and its potential side effects. It also answers some common questions about hemp and how it should be used and stored.
Also Known As
- Narrow-leaf hemp
- Bitter root
- Indian hemp
- Wild cotton
Does Hemp Offer Any Benefits?
There are three different plants in the Cannabis genus, also called the Cannabaceae family. These include Cannabis sativa, Cannabis indica, and Cannabis ruderalis. Hemp varieties of Cannabis contain 0.3% or less THC. Marijuana varieties have more than 0.3%. Higher amounts of THC can produce a high.
The seeds are the main edible part of the hemp plant. The leaves can be used to make tea, but most of the nutrients are in the seeds. In fact, hemp seeds are over 30% fat, including essential fatty acids. The potential health benefits of hemp, therefore, come mainly from its seeds.
Hemp seeds are, as the name implies, the seeds of the hemp plant. Hemp hearts are seeds that have had the shell removed.
Hemp seeds are high in soluble and insoluble fiber. Soluble fiber dissolves in water, while insoluble fiber does not. Both types of fiber are important for digestion. Because hemp hearts lack the fibrous shell, they are lower in fiber and other nutrients than whole hemp seeds.
Hemp seeds are also rich in gamma-linolenic acid (GLA). GLA is an omega-6 fatty acid that has been shown to have many health benefits. A 2016 study found that GLA has strong anti-inflammatory properties.
Hemp seeds contain a 3-to-1 ratio of omega-3 to omega-6 fatty acids. This is considered an optimal ratio for heart and brain health.
This ratio is difficult to get in the Western diet. Western diets tend to be too heavy in omega-6 fatty acids, which can be found in foods like vegetable oil. Many Western diets don’t contain enough omega-3 fatty acids. These are found in foods like salmon and other wild-caught, cold-water fish.
Hemp seeds contain many nutrients, including protein, minerals (such as magnesium, calcium, iron, and zinc), and vitamins.
Whole hemp seeds contain 20% soluble and 80% insoluble fiber. The fiber in hemp seeds may help digestion. It may also help lower bad cholesterol and improve heart health. The insoluble fiber in hemp seeds has also been linked to a lower risk of diabetes.
Hemp Oil vs. CBD Oil
Hemp oil is also called hempseed oil. It is made by cold-pressing hemp seeds. Hempseed oil is different from CBD oil. CBD oil is extracted from the cannabis plant and then combined with a base oil. Examples of base oils include coconut or olive oil.
Hempseed oil comes from hemp seeds only. It is not derived from the Cannabis plant itself. Hempseed oil does not contain any psychoactive properties. You can not use it to get high. Hemp oil has unique properties and health benefits.
Hemp oil contains healthy nutrients such as:
- Essential fatty acids (EFAs), which are important for good health
- Minerals like zinc, magnesium, calcium, iron, and more
- Antioxidants like vitamin E
Hemp oil can be used as a cooking oil. Just like any other type of healthy oil, it can be added to foods such as salads, dips, and spreads.
Animal studies have suggested that hempseed oil may lower blood pressure. It may also reduce the risk of stroke and heart attack. This hasn’t been proven in human studies, though.
Hemp oil is often used as a hair conditioner or a skin moisturizer. Some studies found that hemp seed oil may improve dry, itchy skin and help symptoms of eczema, a common skin condition. When used for eczema symptoms, it may reduce the need for prescription medication.
Hemp oil is not the same as CBD oil. Hemp oil comes from the seed of the hemp plant. It can be used for cooking or as a hair conditioner or skin moisturizer.
Hemp protein is a powder made from the seeds of the hemp plant. Hemp protein contains all nine essential amino acids. Amino acids are the building blocks of protein. Some studies, though, have shown that hemp protein isn’t as good a source of one amino acid, lysine, compared to soy protein.
Hemp protein is a good choice for vegetarians or vegans because it contains essential fatty acids. Whole hemp seeds contain about 25% protein. This is higher than flax or chia seeds, which contain only around 20% and 18% protein, respectively.
Other Health Benefits
There is not enough clinical research data to back up claims that hemp is a safe or effective treatment for any condition. People still use it as a remedy for many illnesses, though, including:
- Heart problems
- Urinary conditions (increasing urine flow)
- Warts (when applied to the skin)
How It Works
Hemp contains chemicals that may affect the heart and might help reduce blood pressure. Hemp also contains terpenes. Terpenes are the compounds that give plants their distinctive odors.
Some studies suggest that terpenes may have health benefits. These benefits may include:
- Neuroprotective or brain-protective benefits
- Anti-inflammatory benefits
- Anti-tumor properties
Hemp contains more protein than seeds like chia and flaxseed. It also contains other substances that may have health effects. Some people claim it can help with certain illnesses, though this has not been proven through clinical research.
Possible Side Effects of Hemp Seed
Taking whole hemp seed by mouth can cause many side effects, including:
- Throat irritation
- Nausea and vomiting
- Bradycardia, or slow heart rate
- Hypertension, or high blood pressure
There is not enough clinical research data to prove that hemp is safe for use in people who are pregnant or breastfeeding. There is also not enough research to show it is safe to use topically on the skin.
Eating hemp seeds is not considered as unsafe as is eating hemp leaves or other parts of the plant. But because of the high fat content, the seeds can cause mild diarrhea.
Interaction with Medications
Do not ingest hemp when taking cardiac glycosides or diuretics.
Cardiac glycosides, such as Lanoxin (digoxin), help the heart beat strongly and can slow down the heart rate. They are used for treating heart failure (in which the heart can’t pump blood well enough to meet the body’s needs) and irregular heartbeats.
Hemp is also known to slow the heart rate. Taking hemp with cardiac glycosides could slow the heart rate too much. Ask your doctor before taking hemp with Lanoxin.
Diuretics are drugs that increase the amount of urine. They are used to reduce the amount of fluid in the body and lower blood pressure. Diuretics include:
- Diuril (chlorothiazide)
- Thalitone (chlorthalidone)
- Lasix (furosemide)
- Microzide (hydrochlorothiazide)
An increase in the amount of urine may lead to a loss of potassium. Hemp can also decrease potassium. Taking diuretics and hemp together may result in dangerously low potassium levels. This might cause problems with heart function.
Selection, Preparation, and Storage of Hemp Seed
Hemp seeds can be eaten raw, roasted, or cooked with other foods. In China, hemp seed oil has been used as food or made into medicine for thousands of years.
There are many ways to eat hemp protein, oil, and seeds, including:
- In a smoothie
- On oatmeal or cereal
- Sprinkled over salads
- As a nut butter
- As a form of milk called hemp milk
- On yogurt
- In meal bars or granola bars
- In salad dressing
- On casserole dishes
- Added to baked goods
- In recipes
- As a cooking oil
Hemp seeds need to be stored properly. The healthy fats in hemp seeds can degrade if they are exposed to air for long periods. Storing hemp seeds at high temperatures can have a similar effect. Hemp seeds stored this way could contain unhealthy trans fats, a type of fat especially linked to heart disease.
Store hemp seeds and hemp oil in an airtight container. Keep these products in a cool, dark place. It is best to refrigerate hemp products after opening.
Many hemp products come in different forms, including:
- Hemp oil
- Hemp milk
- Hemp protein powder
Many of these products can be purchased in health food stores or online.
Cooking hemp seeds or heating the oil to temperatures above 350 degrees F can destroy the healthy fatty acids. Hemp seeds and oil are best eaten raw. If cooking with hemp oil, use low heat.
The dosage of any herbal or natural supplement, including hemp, depends on several factors. Age and health condition are two important considerations. Never take more than the recommended dosage on the package insert.
Always ask your doctor before taking hemp or any other herb. The recommended dosage may not be right for you.
If you are going to eat hemp seeds, experts suggest starting slow. This is especially true if you have digestive problems. Start with 1 teaspoon and work up to more as tolerated.
Ask your doctor before taking hemp. Your safe dosage may be different than what is on the packaging.
Hemp seeds are grown in many different countries. Some people prefer hemp from Canada for its taste and the strict government restrictions aimed to improve quality. Look for products that have been tested in the lab for purity and potency. Consult the manufacturer if you have questions.
Regulations on hemp grown in U.S., Europe, and Canada are stricter than in other countries, such as China.
Are hemp seed hearts the same as hemp seed?
No. Hemp hearts have had the fibrous shell removed. This makes them lower in fiber and other nutrients than whole hemp seeds. Hemp hearts are not as nutritious as whole hemp seeds. However, hemp hearts are very high in healthy polyunsaturated fats.
Are hemp seeds legal to ingest in the U.S.?
Yes, hemp seeds are legal in the United States. Hemp seeds in the U.S. must contain a minimal amount of THC. THC is the psychoactive part of the cannabis plant.
According to the FDA, some hemp products are safe for food, including:
- Hemp seeds
- Hemp seed protein powder
- Hempseed oil
Can eating hemp cause a person to fail a drug test?
No. Eating moderate amounts of hempseed oil, protein powder made of hemp, or hemp seeds will not cause you to fail a drug test. Hemp contains only trace amounts of THC. Unless you are using other varieties of the Cannabis plant, such as marijuana, or you are eating large amounts of hemp, you are unlikely to fail a drug test.
Hemp hearts do not contain any THC. The shells of whole hemp seed do have trace amounts below 0.3% THC. If you are recovering from cannabis addiction or just want to avoid exposure to THC in any amount, avoid eating whole hemp seeds.
What does hemp taste like?
Hemp seeds have a mild, nutty flavor. They are similar to unsalted sunflower seeds, but the texture is not as hard.
Hemp seeds are a good source of protein and fiber. Hemp seeds may also have other health benefits, though there is not enough clinical research to say for sure. Because hemp may interact with some drugs and cause certain side effects, it is a good idea to consult your doctor before adding hemp seeds to your diet.