cbd oil information

December 15, 2021 By admin Off

The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly 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.

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).

Potential harm, side effects and unknowns.

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.

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:

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.

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:

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.

Evaluation of the regulatory frameworks.

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.

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.

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.

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.

Unproven medical claims, unsafe manufacturing practices.

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.

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.

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.

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.

Meanwhile, at least one study in mice revealed CBD had effects similar to the antidepressant imipramine. Human trials are needed, though, to confirm whether CBD can induce this same antidepressant reaction in our bodies.

Amyotrophic lateral sclerosis (ALS) is a disease that causes nerve cells in the brain and spinal cord to deteriorate, resulting in loss of muscle control that worsens over time. It’s not yet understood exactly why ALS occurs, although it can be hereditary in some cases. There’s no known cure, and there are only two FDA-approved medications to help treat ALS symptoms.

For starters, tests on human cells found that CBD helps reduce the effects of high glucose levels on other cells in the body, which typically precedes the development of diabetes and various complications. Researchers concluded that with further studies, CBD could have significant benefits when used in patients with diabetes, diabetic complications and plaque buildup in artery walls.

1. Offset Anxiety and Depression.

A 2006 study found that Sativex—a CBD-based botanical drug approved in the United Kingdom in 2010—promoted statistically significant improvements in quality of sleep, pain during movement and pain at rest in patients with rheumatoid arthritis when compared to a placebo. It was the first controlled trial of Sativex as a treatment for rheumatoid arthritis, involving 58 patients. CBD was found to have a pain-relieving effect, as well as an ability to suppress disease activity.

In 2018, the Food and Drug Administration (FDA) approved the use of CBD under the brand name Epidiolex to treat seizures resulting from Lennox-Gastaut syndrome and Dravet syndrome—two rare forms of epilepsy—in patients at least 2 years old.

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Preclinical and clinical studies show that CBD has antioxidant and anti-inflammatory properties. Researchers deduce these characteristics can provide significant neuroprotection, or protection against numerous pathological disorders.

CBD research is growing, too. Here are nine ways studies suggest CBD oil could benefit your health.

Meanwhile, continued studies in the U.S. indicate CBD is effective in treating chronic, non-cancer pain. In one 2020 study, researchers administered CBD topically to a group of patients with symptomatic peripheral neuropathy (a result of brain nerve and spinal cord nerve damage) while another group with the same condition received a placebo. Results showed a significant reduction in intense, sharp pains and cold, itchy sensations in those who used the topical CBD compared to those who used the placebo. No participants reported adverse side effects.

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5. Alleviate ALS Symptoms.

Several preclinical studies suggest CBD can produce beneficial effects against Parkinson’s disease, Alzheimer’s disease and multiple sclerosis. Huntington’s disease and cerebral ischemia were also tested, although significant positive results were not recorded. Further clinical studies are needed to confirm CBD’s benefits when used as a treatment for these disorders.

In one such study, researchers administered CBD to people with heroin use disorder. Over the course of a week, CBD significantly reduced heroin users’ cue-induced cravings, withdrawal anxiety, resting heart rate and salivary cortisol levels. No serious adverse effects were found.

Cannabidiol, or CBD, is a chemical compound found in the cannabis sativa plant. When applied topically or consumed through smoke inhalation or edible consumption, CBD interacts with neuroreceptors in your endocannabinoid system, which sends signals between your cells to help regulate your movement, mood, homeostasis and immune system.

When introduced topically, CBD oil doesn’t affect the systemic issue as it might if it were introduced directly into the bloodstream. Instead, topical CBD is more localized and treats pain in a certain area. Since it’s more direct, it may have a more pronounced effect.

The results were interesting, although not entirely conclusive. On one hand, those treated with CBD did not experience much change in pain when compared with placebo patients. On the other hand, there were statistically significant differences between the group receiving the 250-milligram dose and the placebo group when measuring the average weekly improvement of their worst pain levels and their WOMAC (Western Ontario and McMaster Universities Arthritis Index) physical function rating. Additionally, men seemed to benefit from CBD more significantly than women in this test.

7. Ease Diabetic Complications.

CBD’s ability to calm is perhaps its most popular effect and the reason its use is so widespread. A 2017 study in the Brazilian Journal of Psychiatry tested the anxiety levels of 57 men in a simulated public speaking test. Some received a placebo while others received either 150 milligrams, 300 milligrams or 600 milligrams of CBD before their speeches. Those who received 300 milligrams of CBD experienced significantly reduced anxiety during the test compared to those who received the placebo. Interestingly, participants who received either 150 or 600 milligrams of CBD experienced more anxiety during the test than the 300 milligrams group.

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Research suggests people with ALS can benefit from the entourage effect created by the combination of THC and CBD, similar to people with PTSD. In a 2019 study, patients received a combination of THC and CBD in varying doses depending on their needs and preferences. Those with mild, moderate or severe spasticity (muscle tightness and stiffness) due to ALS reported high levels of satisfaction with the treatment, and those with moderate to severe spasticity reported higher satisfaction rates than those with mild spasticity.

Four other human trials from 2012 to 2016 suggest CBD reduces PTSD symptoms, although some include THC, or tetrahydrocannabinol, the main mind-altering element in cannabis. When THC and CBD work together, they create what’s called an “entourage effect,” complementing each other’s benefits and potency. For example, taking the same dose of THC and CBD together tempers the “high” from THC, while just a little THC paired with more CBD enhances the effects of the CBD.

In some instances, CBD can be used to treat epileptic seizures.

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CBD and THC can affect how other medicines work. Always discuss possible interactions with a specialist.

Nabiximols (Sativex) is a cannabis-based medicine that is sprayed into the mouth.

The government has no intention of legalising the use of cannabis for recreational (non-medical) use.

Nabilone is a medicine, taken as a capsule, that has been developed to act in a similar way to THC (the chemical in cannabis that makes you high). You may have heard it described as a “manmade form of cannabis”.

Cannabis bought illegally off the street, where the quality, ingredients and strength are not known, is the most dangerous form to use.

What are the side effects?

CBD is a chemical substance found in cannabis that has medical benefits.

Many cannabis-based products are available to buy online, but their quality and content is not known. They may be illegal and potentially dangerous.

Some cannabis-based products are available to buy over the internet without a prescription.

You cannot get cannabis-based medicine from a GP – it can only be prescribed by a specialist hospital doctor.

If the above does not apply to you, do not ask a GP for a referral for medical cannabis.

The main risks of THC cannabis products are:

It would only be considered when other treatments were not suitable or had not helped.

Some products that might claim to be medical cannabis, such as “CBD oil” or hemp oil, are available to buy legally as food supplements from health stores. But there’s no guarantee these are of good quality or provide any health benefits.

Epidyolex is a highly purified liquid containing CBD (cannabidiol).

Epidyolex can be prescribed for patients with Lennox-Gastaut syndrome and Dravet syndrome (both rare forms of epilepsy).

Nabiximols (Sativex) for MS.

Health stores sell certain types of “pure CBD”. However, there’s no guarantee these products will be of good quality.

It’s expected this would only apply to a very small number of people in England.

After taking medical cannabis, it’s possible to develop any of the following side effects:

Currently, it is only likely to be prescribed for the following conditions:

Generally, the more THC the product contains, the greater these risks are.

It’s likely most of these products – even those called “CBD oils” – will be illegal to possess or supply. There’s a good chance they will contain THC, and may not be safe to use.

It will not get you high, because it does not contain THC (tetrahydrocannabinol), the chemical in cannabis that makes you high.

Will the laws on cannabis be relaxed?

CBD can also affect how your liver works, so doctors would need to monitor you regularly.

But in reality, most products will contain a certain amount of THC.

A hospital specialist might consider prescribing medical cannabis if:

Nabilone can be prescribed by a specialist to help relieve these symptoms, but only when other treatments have not helped or are not suitable.

It is licensed in the UK for people with MS-related muscle spasticity that has not got better with other treatments.

If you experience any side effects from medical cannabis, report these to your medical team. You can also report them through the Yellow Card Scheme.

And it is only likely to be prescribed for a small number of patients.

There is some evidence medical cannabis can help certain types of pain, though this evidence is not yet strong enough to recommend it for pain relief.