As CBD Oils Become More Popular, The FDA Considers Whether To Set New Rules
Cannabidiol, or CBD, is a compound that can be extracted from marijuana or from hemp. It doesn’t get people high because it doesn’t contain THC, the psychoactive component of the cannabis plant. Getty Images hide caption
Cannabidiol, or CBD, is a compound that can be extracted from marijuana or from hemp. It doesn’t get people high because it doesn’t contain THC, the psychoactive component of the cannabis plant.
The Food and Drug Administration is holding its first public hearing on CBD, the cannabis extract that has quickly grown into a billion-dollar industry. Today’s hearing will help officials determine how to regulate CBD products.
The compound can be extracted from marijuana or from hemp. It’s promoted as a way to ease anxiety and inflammation – and it doesn’t get people high because it doesn’t contain THC, the psychoactive component of the cannabis plant.
People are using oils with cannabidiol, or CBD, to help with everything from menstrual cramps to insomnia. While the hype around CBD has gotten ahead of the science, there are a growing number of small studies that do point to some health benefits. But the FDA has concerns over how these products are marketed, and is seeking more data about their safety.
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“Questions remain regarding the safety considerations raised by the widespread use of these products,” FDA officials wrote in a Federal Register notice about today’s hearing. “These questions could impact the approaches we consider taking in regulating the development and marketing of products.”
Regulators are expected to hear from many players in the CBD industry eager for the agency to step in and set some clear rules, because there’s been a cloud of uncertainty over the legality of marketing and selling CBD products.
The 2018 farm bill lifted longtime restrictions on hemp, meaning that hemp would no longer be regulated as a controlled substance. The hemp industry saw this as a green-light to move ahead in promoting CBD products.
“When the farm bill passed last year, we were beyond thrilled. This ended a multi-decade prohibition on hemp,” says Jonathan Miller who serves as general counsel to the U.S. Hemp Roundtable, a coalition of dozens of hemp companies. “It was a historic moment.”
But the FDA quickly stepped in to make it clear that it has regulatory authority over CBD. The agency has said, for example, that cannabidiol products cannot be sold as dietary supplements.
So the industry is asking for a more definitive set of rules, and the FDA hearing is a first step.
“We really need the FDA to join in and help us lay a path toward a regulated legal product,” Miller says. This is the main message he says he’ll deliver during today’s hearing.
But the FDA has a lot of questions for his industry, and researchers who study cannabis say there’s still a lot to learn about cannabidiol.
“We’re really in the infancy of understanding the physiological effects of cannabadiol right now,” says Ziva Cooper, research director for the UCLA Cannabis Research Initiative.
Cooper says there are important questions to answer, such as: What doses are safe? And what happens when people use it for long periods of time?
The FDA has already approved one drug made of purified CBD, called Epidiolex, which is used to treat two rare and serious forms of epilepsy.
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You need a doctor’s prescription to get this medication, and it contains a much higher dose of CBD than what people typically get from the oils sold online or in dispensaries or markets.
Clinical trials of Epidiolex found that the high dose of CBD was generally safe but that it did cause side effects in some people, including lethargy and gastrointestinal distress. The FDA also pointed to concerns about possible liver injury.
“This is a potentially serious risk that can be managed when the product is taken under medical supervision in accordance with the FDA approved labeling for the product,” agency regulators wrote in the Federal Register notice. “But it is less clear how this risk might be managed if this substance is used far more widely, without medical supervision.”
One potential strategy to regulate CBD may be to set a threshold. High-dose products could be restricted and require a prescription, while low-dose products similar to many of the CBD oils currently on the market would be widely available.
The hemp industry has signaled its support for this approach. The lower dose products could be sold “over-the-counter in natural food stores, drug stores and grocery stores,” says Miller of the U.S. Hemp Roundtable.
The FDA has set no timeline to regulate CBD products, and its evaluation is likely to continue over the coming months.
A Complete Guide to CBD Oil in 2020
As CBD oil explodes onto the market, a lot of people find themselves asking some important questions about its use. There are many personal reports out there about the effects of CBD on the human body. Even so, many of these accounts are not backed by actual research. This is mostly due to the lack of backing from the Food and Drug Administration (FDA). But a need for physical testing does not mean CBD oil isn’t safe to consume. Consumers have reported an array of health benefits they have experienced from regular use.
This comprehensive look at CBD will answer some of the most critical questions out there—things like side effects, the legality of the substance, how high quality CBD oil is made and what to use it on. Everyone should understand where a product comes from and how it’s made before consuming it. Know what it is you are putting into your body before moving ahead.
What Is CBD Oil?
To understand what CBD oil is, you need to know where it comes from. Some have asked if CBD is made from hemp or marijuana. The answer to that is both; the marijuana plant and the hemp plant can be used to produce CBD. The difference between a marijuana and hemp plant is the amount of THC present in each plant. There have been reports that hemp and CBD oil are the same product, but that is incorrect. They may both come from the Cannabis Sativa plant, but they are two completely different products.
The Cannabis Sativa plant is used in the manufacturing of CBD oil. Although there are different ways to extract cannabidiol, the final product should be strictly CBD. This substance is then combined with other oils, such as coconut or hemp seed, to allow for easy absorption by the human body.
CBD can be added to edibles, topical treatment, oils and even drinks. CBD oil is said to be more concentrated and, therefore, reputedly works better than hemp oil when it comes to effectively treating anxiety disorders, arthritis and sleep deprivation. CBD has been credited with being able to relieve many physical and mental ailments. Even so, little research has been done to back up such claims.
Also known as hemp seed oil, hemp oil is extracted from industrial hemp. Some marijuana plants are bred to have fewer flowers, significantly lowering the amount of THC present in the plant. As long as the THC count is not over 0.3%, the plant is labeled hemp. It has been reported that hemp seed oil has some great health benefits, but it should not be confused with CBD oil. It is said that hemp oil can promote healthy hair, skin and nails.
Make sure you check the ingredients on the bottles when purchasing CBD oil. Due to a lack of FDA involvement, some companies will water down their oils. Find a reputable company to buy from, so you are sure to get what you’re paying for. Avoid vendors who tell you hemp oil has the same health benefits as CBD. This just is not true.
What Are the Effects of CBD on the Body?
As with any substance, each body is going to respond to CBD in its own way. Everyone has something called an endocannabinoid system made up of receptors (CB1 and CB2), which are located all over the body. When studies started on cannabinoids, it was found that the body makes a similar substance called endogenous cannabinoids (endocannabinoids). These neurotransmitters affect the body in many different ways; they can regulate pain and even reduce anxiety. The role of endocannabinoids is to promote balance when it comes to mental, physical and emotional health.
There is a condition called clinical endocannabinoid deficiency (CECD) that some individuals suffer from. When the body does not create enough endocannabinoids, it can cause serious health problems. A few conditions scientists believe to be associated with CECD are:
- Multiple sclerosis (MS);
- Irritable bowel syndrome (IBS);
- Post-traumatic stress disorder (PTSD);
- Parkinson’s disease;
- Huntington’s disease;
- And even autism.
Consumers report that using CBD oil has helped reduce the effects of some disorders and diseases. It is speculated that they experience relief because of how the body uses CBD. Once introduced, CBD oil triggers the CB1 and CB2 receptors to produce more endocannabinoids. With an uptake in production, the body balances out and begins healing. Studies have been done to show that CBD helps reduce inflammation and treat pain caused by swelling.
A form of childhood epilepsy, those with Dravet syndrome have found CBD oil can treat symptoms in children as young as 2 years old. The FDA has recently approved a drug, Epidiolex, to be used as a treatment for epilepsy in children. Although the FDA has not said they back all CBD-related products, they do recognize a few cannabis-derived drugs. This means testing has been done on these treatments, and the CBD was found to be safe enough for children to ingest. It also shows there were positive results from using said product.
Does CBD Oil Make You High?
Having touched on where CBD oil comes from, there is always the question of whether or not it will make a user high. The answer is no—CBD oils should not make you high. While there can be slight amounts of THC found in some oils, it is not enough to cause a high.
The endogenous cannabinoids in the body are also found in the brain. The chemical THC works with these neurotransmitters just as CBD oils do. The difference is found in how the body recognizes these different substances. THC is similar to anandamide which controls brain function. Once THC enters the body, it can attach to molecules and activate receptors in the brain. This causes a disruption to different mental and physical features, resulting in a high. Because CBD oils have little to no THC, the body will not treat it like anandamide.
It is possible to find CBD products with added THC, but not all oils contain it. The oils that do offer THC should be labeled as such, because THC was likely added during production. CBD and hemp oils should not produce a high when ingested. If such effects are occurring, check the ingredients on the bottle of your product before taking more.
Side Effects Reported While Using CBD Oil
As with most supplements, there are reported side effects that go along with using CBD. Most of the secondary effects are not life-threatening, but some patients have had signs of liver injury while using CBD. The common side effects are:
- Lower blood pressure;
- And dry mouth.
Some consumers report taking CBD oil to acquire better sleep and to lower their blood pressure. For this reason, it may not have been reported as a side effect by some individuals while they were taking it. Not everyone is going to experience the same side effects, and some individuals have reported no side effects at all. Researchers have stated that this could be due to how frequent a person is using CBD or how much they are using at one time. Because each person is going to process CBD oil differently, side effects may vary.
If you are already taking prescribed medication, it is advised you speak with your doctor before moving forward with taking CBD oil. Some studies do show that CBD oil can interfere with other drugs, over-the-counter medicine and blood thinners. With no FDA backing, there is little known about how much CBD should be taken to treat an affliction. It is recommended that a person starts with the lowest dose possible and gradually move up until getting the desired effect.
Is CBD Oil Legal?
It is easy to obtain CBD through the use of the internet, but just because you can buy it, doesn’t make it legal. Thus, the questions regarding the legality of this product. All 50 states have different laws when it comes to possession of CBD. The government still places CBD in the same class as marijuana, but there are no laws enforced against the use of CBD. As the FDA has begun backing the use of CBD in some newer seizure medications, some researchers believe there may be a change in the legality of CBD soon.
When it comes to state and national government, they do not always agree on how these products should be handled. While some states have made the move to legalize marijuana, others have not. In some states, medical marijuana is accepted, but recreational use is still illegal. If you live in a state where all forms of cannabis are legal, there should be no issues when it comes to possessing CBD products.
When thinking about purchasing CBD oil, it is best to check your local laws first.
Where Can CBD Be Purchased?
CBD oil can be found everywhere. Major retailers are carrying it, gas stations, corner shops and even liquor stores. Everyone is looking to get in on the CBD movement. Recent news reports have issued warnings about purchasing CBD products online. With an influx in the market, there are many great CBD-related offers on the internet; but, according to a study cited by Consumer Reports, only a fraction of CBD oil purchased online actually contained CBD. Out of the bottles tested, some were found to have no CBD at all, while others contained unreported THC.
The safest way to purchase CBD would be to shop around. Find people who have used CBD products and ask them what company they recommend. Research vendors before you buy from them. Are they reputable? The cheapest product is not the best in this situation. The cost of reliable CBD oil may be a little high, but at least there is an understanding of what you’re putting in your cart.
Where Do We Go From Here?
Researchers agree that there is still a lot we have to learn about CBD oil. Until the FDA agrees to back the research, there is no funding available to move forward with more extensive studies. Small groups involved with the analysis of CBD have reported mostly positive results. Although there have been liver injuries, those have been rare cases, and it has not be proven that CBD was the cause of the damage.
Safety is critical when it comes to trying any new product. It is especially vital with CBD products due to little knowledge of long-term use. There is good evidence showing that CBD can help with pain management and inflammation, and there have also been studies by the FDA on how well drugs, like Epidiolex, work for treating epilepsy. With so many positive steps, it is difficult to understand why the FDA will not back more studies.
If you or someone you know is looking to try CBD for the first time, know your product. CBD has been reported to provide relief for some ailments, but little is known about things like long-term side effects or proper dosing. As with any supplement, check with your doctor before proceeding. This is especially important if you are already taking medications for other diagnoses.