Tag: SCIENCE

Benefits of Cannabidiol (CBD)

Posted on by @edualexis_Se in SCIENCE

Over the last few months we’ve given you an overview of hemp, the endocannabinoid system (ECS) and the beneficial cannabinoids found in Cannabis sativa L. In last week’s post The Benefits of Cannabinoids there was one significant cannabinoid missing, cannabidiol (CBD). In this week’s post we will discuss the wildly popular cannabinoid cannabidiol (canna-bi-diahl) and help you begin to understand the distinctions between various CBD product forms.

Nowadays, CBD is everywhere and is constantly being talked about— and for good reason! With so many options, product types, and forms, it has become increasingly difficult to make an educated decision about which form of CBD to choose. One of the most important things to understand is how to determine the differences between CBD products. One topic we will discuss further, following the benefits of CBD, is how to understand the differences in forms of CBD, including full spectrum, broad spectrum, or isolate products.

As we shared in our earlier post Hemp vs. Marijuana, CBD was discovered in the 1940s and is one the most abundant cannabinoids in the hemp plant. It does not produce the psychotropic effects commonly associated with THC. When CBD was discovered, researchers recognized the potential of the plant, but due to legality reasons, which have unfortunately continued until very recently, and other obstacles it took over 20 years to begin really exploring and understanding how to best expand on some of the original findings. Throughout 1963-64, Dr.Raphael Mechoulam, an organic chemist at the Weizman Institute in Israel, and his team worked to identify the chemical structure of CBD, isolate it, and then synthetically recreate it in his lab. They found that, although CBD is one of the most abundant cannabinoids, it could be given at increased amounts with little to no side effects. It was Dr. Mechoulam and his team that first recognized that CBD had antiepileptic properties, research that would later be used to develop FDA approved pharmaceuticals; one for use in rare childhood seizure disorders. [1]

What is Cannabidiol (CBD)?

CBD is a phytocannabinoid found in various concentrations through most parts of the hemp plant, but the highest levels are found in the flowers and trichomes. Phytocannabinoids accumulate in the sticky cavity of trichomes, which are small hairs that largely occur in female flowers and can be found in lower concentrations in other aerial parts of the plant.[2]

Benefits of CBD
In our last post titled The Benefits of Cannabinoids, we learned that CBD does not just start as CBD. It is created through a series of chemical conversions which occur in nature mostly through changes in temperature and time. This begins when Cannabigerolic acid (CBGa), the mother of cannabinoids, is broken down into its non-acidic form Cannabigerol (CBG), which then breaks down into Cannabidiolic acid (CBDa) and Tetrahydrocannabinolic acid (THCa). CBDa is then further broken down into CBD.

Interestingly it is estimated that by 2025 CBD will be close to a $25 billion-dollar industry.[3] Clearly CBD has gained some incredible popularity with consumers, but we are also seeing an increase in research and clinical studies of the compound and are starting to discover new and exciting benefits. There is increasing evidence that CBD has numerous therapeutic potentials and is essential to supporting inner balance and the overall health and wellness of many of our body’s systems. If you read our previous posts on the ECS, you know that CBD binds to the network of receptors throughout the body that make up the ECS and play an important part in regulating pain perception, balanced emotions, and other autonomic functions. Several studies demonstrate the reduction of pain perception following intake of CBD,[4] and when combined with other phytocannabinoids, it can cause an even greater reduction in pain perception. This research also supports the importance of the entourage effect to benefit health, using the synergistic effects of all the compounds found in hemp versus using isolated compounds.

What is not commonly known about CBD and its potential benefits is that, in 1999, the U.S. Government, under the Department of Health and Human Services, filed a patent on non-psychoactive cannabinoids, including CBD, as a treatment for specific illnesses. The U.S. Government was awarded that patent in 2003; “Cannabinoids as antioxidants and neuroprotectants, Unites States Patent 6,630,507”. Click here to see the full patent.

As popularity has grown over this compound both medical and regulatory agencies have begun to weigh-in with their opinions about the benefits and safety profiles of CBD. For example, the World Health Organization (WHO) published their Cannabidiol (CBD) Critical Review Report[5] where the WHO discussed the available research in regard to medical and recreational uses, safety profiles, and outcomes following CBD usage. Following this report, the WHO recommended that pure CBD and CBD preparations containing no more than 0.2% THC should no longer be included in the international drug control conventions, after noting in their report that CBD had been found to be “generally well tolerated with a good safety profile”.

Interestingly, in addition to the WHO’s recommendation to remove CBD from international drug control conventions, the World Anti-Doping Agency (WADA), an international organization that “was founded with the aim of bringing consistency to anti-doping policies and regulations within sport organizations and governments right across the world”[6], removed CBD from their list of prohibited substances. However, it is important to note that although CBD is no longer prohibited, athletes should be aware that many CBD products contain low levels of THC, which is still a prohibited substance under WADA.

Product Formulation of CBD
For the majority of CBD supplements on the market it appears the products are mostly sold in three different overarching forms, or categories—full spectrum extract, broad spectrum extract, and isolate, but what is the difference?
The following definitions of these products have come from the U.S. Hemp Authority Glossary, developed to promote standardized labeling for the hemp industry.

  • Full Spectrum Extract “is hemp extract including THC and other cannabinoids, terpenes, and other naturally occurring compounds, that has been processed without intentional complete removal of any compounds and has a final THC quantification of not greater than 0.3%.”
  • Broad Spectrum Extract “is hemp extract that has been intentionally processed to remove THC such that the quantified THC has been deemed non-detectable by a compliant laboratory using a fit-for-purpose method with a limit of quantification of less than 0.01%.”
  • Isolate “is the confined molecule and most pure form of the cannabinoid such as CBD.”

Ultimately, the difference between a full spectrum, broad spectrum, and isolate products seems to come down to efficacy; the degree of product processing; and number of compounds in the final product. The most important thing you can do as a consumer is to first research the different forms and then choose a product to best fit your needs and desired outcomes.

Because each form of CBD is specific to a consumer’s need, the conversation around full spectrum versus broad spectrum versus isolate CBD is a much bigger one. We will go into more detail about the specific differences about each of these forms of CBD and how they contribute to the entourage effect in a future post.

[1] Bialer, M. (2019) Raphael Mechoulam adn the history of cannabis research. Epigraph. Vol 21 (1) https://www.ilae.org/journals/epigraph/epigraph-vol-21-issue-1-winter-2019/raphael-mechoulam-and-the-history-of-cannabis-research
[2] Andre, C. M., Hausman, J. F., & Guerriero, G. (2016). Cannabis sativa: The Plant of the Thousand and One Molecules. Frontiers in plant science, 7, 19. https://doi.org/10.3389/fpls.2016.00019
[3] 2019 CBD Market Report (Rep.). (2019). Retrieved June 26, 2020, from Brightfield Group website: https://content.brightfieldgroup.com/2019-us-cbd-market
[4] Cannabidiol (CBD): Critical Review Report (Rep.). (2018, June 4). Retrieved June 26, 2020, from World Health Organization website: https://www.who.int/medicines/access/controlled-substances/CannabidiolCriticalReview.pdf
[5] What We Do. (2017, December 01). Retrieved June 26, 2020, from https://www.wada-ama.org/en/what-we-do
[6] 2019 CBD Market Report (Rep.). (2019). Retrieved June 26, 2020, from Brightfield Group website: https://content.brightfieldgroup.com/2019-us-cbd-market

CBD VS CBG

Posted on by @edualexis_Se in SCIENCE

In the past few years, products containing CBD (cannabidiol) have taken over the market. Not only does this substance boast of anti-inflammatory properties, but it is also known for its antioxidant effect. As a result, it’s become a trendy and beneficial ingredient in many wellness products. But now, people are starting to take notice of CBG as well. The new spotlight is causing consumers to wonder what are the differences between CBG vs CBD? We will look at both independently and compare them side-by-side to give you the answers you need.

What is CBG?

CBG is one of over 100 cannabinoids found in the cannabis plant. These cannabinoids contain active chemical compounds that cause reactions in our cells. Cannabigerol (CBG) can be found in both marijuana and hemp plants. However, the concentration is relatively small, with less than one percent in marijuana and two percent in hemp.

While CBG might sound new to you, it was actually discovered in 1964 by two Israeli scientists. It wasn’t that long ago that some Japanese researchers figured out that CBG actually starts as CBGA (cannabigerolic acid) and is synthesized by heat or over time.

This non-intoxicating cannabinoid doesn’t cause the same euphoric effects that THC does. It might even help to suppress the THC intoxication that creates the notorious “high” feeling. 

Because it is difficult to harvest CBG, cannabis breeders have begun experimenting with plant cross-breeding and genetic manipulation to create higher yields. It’s also been discovered that higher levels of CBG are found when the budding plants are six weeks into the flowering cycle. 

We recommend dosing with water soluble CBG only as the absorption rates are around 94% greater than oil based products. Very few companies know how to formulate this process correctly. We recommend trying Zilis Ultra CBG Oil over other brands. By using a water soluble product, you’ll lower your daily dosing needs and maximize your monthly investment. Although their product is a bit higher in price, in the long run, it’s significantly less than others due to this key feature.

What is CBD?

As you evaluate the differences between CBD vs CBG, you want to look at what the more popular substance has to offer. CBD (cannabidiol) is another chemical compound that comes from the Cannabis sativa plant. It is a naturally occurring substance that can be found in wellness oils and edibles. While people use CBD products to create a calming effect and relaxation, it is not the same thing as THC. Instead, delta-9-tetrahydrocannabinol is found in marijuana and is psychoactive.

While there are very few studies regarding the effectiveness of CBD products, many people claim that it has helped them relive several health conditions. It could be related to the anti-inflammatory properties or the antioxidant effect, but more research is needed to know for sure.

For CBD, we go back to the focus on water solubility. It’s very hard to find super high grade full spectrum CBD and also have it come in a water soluble formula. Absorption rates are everything in this space. Learn more about Zilis Ultra Cell Topical formula today.

CBD vs. CBG: What are the Differences?

So, what is CBG vs CBD and what differences do you need to know about? CBG actually helps to create CBD. In fact, both of these substances are considered cannabinoids, but they are different compounds from the cannabis plant. They also tend to serve different purposes and target different ailments, although there tends to be a lot of overlap between the two. 

While there are some differences between CBD and CBG, there are also many similarities. Both of these substances are considered non-psychotropic. This term means that you won’t receive an altered state of mind from using it. You can use either CBD or CBG every day and your functions won’t be limited. Plus, there is no reduction in your mental clarity as a result of taking these products. The only benefit that has been shown to occur to the state of mind is in a positive effect, especially when it comes to relaxation and calming. 

CBD and CBG are nothing like THC, which can have intoxicating effects on the body. In fact, both CBG and CBD are shown to counteract THC’s intoxicating properties. However, most people consuming marijuana don’t deal with these counter-active effects because there are very limited amounts of CBG found in cannabis. 

In addition, CBG might increase the appetite, which is opposite what most people notice with CBD. In fact, CBD has been promoted as a substance that could inhibit appetites and lead to some weight loss. 

While looking at these differences, you have to carefully select which one is going to work best for you.

CBG Oil vs CBD Oil: Which One Do You Want?

Now that we’ve discussed the differences between the two, it’s time to decide whether you want CBG oil vs CBD oil. CBD oil has become more recognized around the world as a popular supplement, but that shouldn’t discount the benefits of CBG oil. CBG might not be heard of as much, but it is considered to be the first cannabinoid compound. Essentially, it makes up CBD

CBG is currently being studied, but many people find that it can promote well-being. It has already shown some anti-inflammatory, antibacterial and antioxidant properties. Initial reports suggest that both CBD and CBG can:

  • Help support cartilage and joint functions
  • Help relieve muscle pain following exercise
  • Help promote healthy sleep patterns
  • Help reduce frustration and stress

It’s best to try both products to determine which one suits your needs the best. Without more research, it’s difficult to determine which one will respond better to your particular need. In fact, some customers have suggested that using both oils is the best way to promote overall well-being. 

Is CBG or CBD Oil Legal?

When Congress passed the Marijuana Tax Act in 1937, industrial hemp was legal. It wasn’t until the 2014 Farm Bill passed that states were allowed to regulate the production of hemp and CBD. Even more recently, President Trump enacted a new Farm Bill that makes it federally legal to grow hemp. This means that as long as you are compliant with your state laws, you can grow and use hemp products. 

While state policies vary greatly, it’s important to do your research before using any hemp products. We suggest looking into your hemp state laws first. 

Where to Find CBG Oil

While it’s a good thing that CBD and CBG oils are growing in popularity, it also means you have to watch out for scam artists. When you are shopping for these products, there are some ways to ensure you get the best quality available. Here are a few things to consider while shopping.

Label Representation

Take a good look at the label. The label might look nice and pretty, but does it have the valuable information you need? Reputable companies attach an FDA disclaimer and warning section to all dietary supplements. 

You also want to check the label for any identifying information. Just as your groceries and other wellness products contain identification in case of a recall, there should be something on the label of your CBD or CBG products that mark the batch. Good manufacturing practices are followed when the company can tell what batch you received. If the company should need to communicate with users in the future, they will know who to contact. 

Third-Party Lab Testing

Any CBD or CBG product you consume should undergo third-party testing to confirm the accuracy of the label. Otherwise, you could be paying for a product that doesn’t contain what it claims. In 2017, the Journal of the American Medical Association found that 26% of CBD products tested had lower doses than stated on the bottle. 

You want to see a quality assurance stamp or some type of certificate from the third party to ensure accuracy. It also helps if you can see the test results. If a company isn’t willing to share this information with you, they might have something to hide. 

Added Ingredients

In conjunction with the testing, you want to make sure you know everything that is inside your formula. After all, this product is going into your body, so it doesn’t make sense to ingest things you don’t have knowledge about. Some companies go as far as putting melatonin in their CBD products, which is fine if that’s what you want to pay for. By knowing what’s in a product, you can decide if it is the right way to spend your money.

Dosage

Your next step is to look at the dosing. Many products don’t clearly instruct the consumer what the dosing is, leaving people confused. Start by examining whether the product is full-spectrum or an isolate. Full-spectrum formulas can contain other cannabinoids, which together create the entourage effect. In some cases, these are more effective than using one product alone. In comparison, isolate is considered to be 100% CBD. So, if a consumer is taking 10 mg of full-spectrum CBD and switches to isolate, they might find that they need a much higher dose, such as 100 mg instead. 

Fake Claims

If the product you are looking at claims to cure diseases and ailments, run the other way. You don’t want to work with any company that claims to cure disease. Either this company is breaking valuable marketing rules or they simply don’t care. Whatever the case is, you don’t want to spend money with them. 

Other Customer Reviews

If you are trying out a new product, you want to research what other customers think. A reputable company should provide access to customer testimonials. You can also do a quick Google search on just about any company to make sure there aren’t negative reviews plaguing them. By spending a little extra time performing due diligence, you make sure you get the CBD or CBG products you need.

Source: https://elitehealthproducts.org/cbg-vs-cbd/

Benefits of Cannabinoids

Posted on by @edualexis_Se in SCIENCE

After such invaluable insight into the U.S. hemp regulations and the 2018 Farm Bill by our very own Joy Beckerman, we return to science in this week’s post. Let’s take a look at some of the different cannabinoids that are found in Cannabis sativa L. and what benefits research on these cannabinoids has revealed.

Now that we are more familiar with the endocannabinoid system, let’s focus on some of the compounds that activate this system and, as of late, have gained a lot of attention—cannabinoids. Becoming familiar with some of the more abundant cannabinoids found in the hemp plant, and the research that has been conducted to further analyze these compounds may help us better understand the effects cannabinoids can have on our systems.

As we have discussed in previous posts, phytocannabinoids are cannabinoids that have been produced in a plant. In this case we are discussing the hemp plant, which as defined by federal regulation cannot contain greater than 0.3% tetrahydrocannabinol (tetra-hydro-cannab-in-al), referred to as THC. THC is just one of over 100 phytocannabinoids1researchers have discovered within this plant.

“Mother of Cannabinoids”

The highest percentage of phytocannabinoids are found in the unseeded flower buds of female plants.2

The most abundant of the phytocannabinoids begin as “parent” cannabinoids called Cannabigerolic (canna-bi-ger-o-lic) acid or CBGa, also known as the “mother of cannabinoids,” and Cannabigerovarinic acid or CBGVa. The formation of some of the most abundant cannabinoids occurs when CBGa is converted into:

  • Cannabigerol (canna-bi-ger-al), commonly called CBG;
  • Cannabidiolic (canna-bi-di-ah-lic) acid—CBDa;
  • Tetrahydrocannabinolic (tetra-hydro-cannabin-alic) acid—THCa; and
  • Cannabichromenic (cannabi-chrom-ee-nic) acid—CBCa.

As further break down of these compounds occur other cannabinoids are revealed. In the image below, the parent cannabinoids CBGa and CBGVa, are converted to other compounds.

These chemical conversions typically occur in nature mostly through changes in temperature and time. In the laboratory or manufacturing facility however, these conversions can be achieved in an expedited fashion through a multitude of manufacturing processes such as time, temperature, and pressure. One common example of this process—called decarboxylation (de-carboxil-ation)—involves exposing the plant, or an extract from the plant, to high temperatures over an extended period of time. In a fresh hemp flower or a fresh extract, CBDa exists at a very high level, which can be converted to CBD through the process of decarboxylation, in order to produce products formulated with consistent levels of CBD.

Cannabinoid Benefits

Although discussed less often than CBD, CBG is an important cannabinoid, and like CBD, has been shown to be non-psychotropic (mind-altering).3 In a recent study, CBG was shown to have some aseptic-like properties and activity, and appeared to support the destruction of “drug-resistant MRSA by destroying preformed biofilms and resistant organisms in cell culture and non-human studies.”4CBG has also been studied as a possible way to support healthy levels of inflammatory compounds and support normal bone growth and healing.5

The acidified compounds of THC and CBD, Tetrahydrocannabinolic acid (THCa) and Cannabidiolic acid (CBDa) are believed to have their own supporting attributes. Like CBG, both THCa and CBDa are non-psychotropic, as they do not produce intoxicating effects.  THCa has been researched as a possible way to support healthy cell function and healthy muscle function while CBDa and THCa also have been studied as a way to help support appropriate levels of inflammatory-compounds.6 Additionally, in one study, CBDa was correlated with increased serotonin receptor level activation, a receptor associated with the serotonin neurotransmitter, known for its participation in overall well being, emotional balance, and other autonomic system-related functions.7

THC, primarily recognized for its psychotropic effects, is used in both medicinal and adult-use forms across the world. The Food and Drug Administration (FDA) has approved three drugs, Marinol®, Cesamet®, and Syndros®, as synthetic versions of THC for therapeutic uses in the United States. As of June 2020, in the U.S., there are over 10 states with adult use regulations and over 30 states with regulations regarding medical use of THC.

CBC, like CBD and CBG, is non-psychotropic, and interestingly,  is thought to work through non-cannabinoid receptors that can communicate with the endocannabinoid system (ECS) to help balance emotional fluctuations, support healthy bone growth and support healthy cell function.8 Although CBC is structurally similar to THC and CBD, it has been shown to affect the production of our endocannabinoids, leading to an increase in the level of Anandamide. CBC binding appears to take place on capsaicin receptors, called TRPV1, which are responsible for nociception, heat sensation, body temperature, and detection of harmful toxins we ingest or absorb from our external environment.9 CBC also binds to sensory receptors, called TRPA1, that stimulate our senses and protective responses10. Interestingly, studies of CBC use on the skin have shown its support of overall skin health and has shown its ability to maintain normal oil levels.11

Future Cannabinoid Potential

As the science evolves over time, and the variations in the hemp plant continue to change through breeding techniques and genetic research, we will see the potential of many more cannabinoids like Tetrahydryocannabivarin (THCV) and Cannabidivarin (CBDV), which have already begun to show therapeutic potential across multiple body systems. Studies have demonstrated the potential of THCV to support emotional balance, support healthy appetite level and also supports healthy bone growth as studies revealed it binds with both CB1 and CB2 receptors throughout our ECS. 12 Likewise, CBDV has shown promise in supporting healthy brain development and healthy cellular function by binding with the non-cannabinoid receptor, TRPV1,13 previously mentioned as a binding site for CBC. In addition, a few companies have started looking into cultivation of pharma grade, algae-based cannabinoids for medical therapies. With the potentially massive grow ability, algae-based cannabinoids could eliminate the need for synthetic cannabinoids.14 As many believe the 2018 Farm Bill was passed to create a new stream of income for U.S. farmers, synthetic cannabis and non-hemp derived cannabinoids may become obsolete (i.e. under the guidelines of the U.S. Hemp Authority Certification, synthetic cannabinoids and non-hemp derived cannabinoids are not allowed). We will discuss the ins and outs of the U.S. Hemp Authority in a future post.

For the continued benefit to our bodies and in order to support inner balance, it is important for us to learn more about cannabinoids and to support the research being conducted on these compounds. Although this post discussed the benefits of major cannabinoids in the hemp plant, we did not discuss the most popular one—CBD.  Never fear! We didn’t forget it. This cannabinoid is so important, it deserves its own post. In our next post we will take an in-depth look at CBD and the benefits that have been uncovered by past and current research.

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State Regulatory Overview & Federal Factors

Posted on by @edualexis_Se in LAWS & REGULATIONS
Our post this week is brought to you by guest blogger Joy Beckerman, an expert in hemp law and regulations and the new Director of Regulatory and Legal Affairs at Zilis. Joy’s overview of the different States’ regulatory guidelines and contributing Federal factors helps shed light upon how the industry is moving forward and what the industry leaders are doing to ensure access across the country.The dome of the United States capitol with an American flag and dramatic clouds behind

As a preliminary matter, it’s key to understand that just because a Federal law is passed to either partially or fully legalize something, it doesn’t mean that it automatically becomes legal in all 50 States. Under the U.S. Constitution, each of our 50 states wield and maintain political powers held for its own State government rather than Federal government. This is why we see a patchwork of laws and their corresponding regulations across the 50 States on a spectrum of issues.

2014 Farm Bill

After decades of advocacy by dedicated grassroots activists and heroic professionals and legislators who later joined the hemp revolution, a short but significant provision titled, “Legitimacy of Industrial Hemp Research” within the Agricultural Act of 2014 (2014 Farm Bill) was passed; and the amazing hemp crop began to re-establish itself under agricultural pilot programs to study the growth, cultivation, and marketing of industrial hemp in States that enacted laws allowing the cultivation of hemp. The 2014 Farm Bill also defined industrial hemp for the first time in U.S. history, thereby distinguishing it from its Cannabis cousin commonly known as marijuana.

While the 2014 Farm Bill’s introductory words clearly stated, “In General–notwithstanding the Controlled Substances Act…” 1 —meaning not subject to the Controlled Substances Act—the U.S. Drug Enforcement Administration (DEA) held and publicized the erroneous position for the next four years that hemp extract and cannabinoids derived from hemp were still controlled substances.

The hemp industry was ultimately forced to file a lawsuit against the DEA in the Ninth Circuit Court of Appeals to prove that no part of the hemp plant sown under the provisions of the 2014 Farm Bill, including hemp’s derivatives, extracts, and cannabinoids, were controlled substances. Yet, due to the DEA’s messaging, many States were hesitant to embrace the safe and legal opportunities provided by the agricultural pilot program pathway.

2018 Farm Bill

Learning from all this confusion, hemp industry advocacy organizations and Federal legislators began to carefully and strategically draft expanded hemp provisions in the Agriculture Improvement Act of 2018 (2018 Farm Bill), which was enacted on January 1, 2019. The three most relevant provisions of what we’re seeing among the 50 States’ permissions and regulation—or lack thereof, as the case may be—are as follows:2

  • Hemp and tetrahydrocannabinols derived from hemp were unequivocally removed from the Controlled Substances Act;
  • The definition of “hemp” was expanded for total clarity by specifically stating, “The term ‘hemp’ means the plant Cannabis sativa and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” (Emphasis added.); and
  • Nothing in the Bill affects or modifies the Federal Food, Drug, and Cosmetic Act.
Image source Florida Farm Bureau.

The final point about the Federal Food, Drug and Cosmetic Act is important for the hemp industry with regard to dietary supplements and food additives. Within the Federal Food, Drug, and Cosmetic Act, a provision commonly referred to as the “Investigational New Drug (IND) Preclusion,” states that if an article has been authorized for investigation for which substantial clinical investigations have been instituted, and made public, then products containing that substance are precluded from the definition of a “dietary supplement” unless it was marketed as a dietary supplement or as a conventional food before new drug investigations were authorized.3

What does this mean? A great example is the use of cannabidiol (CBD) in the approved drug EPIDIOLEX®. Cannabidiol was submitted as an IND, with substantial clinical investigations made public, and it is currently being debated as to whether CBD can be considered a dietary supplement because no evidence has thus far been identified to demonstrate that CBD  was marketed as a dietary supplement before being used in clinical trials to treat specific childhood epilepsy disorders. Regardless of such evidence, this same statute also grants authority to the U.S. Food & Drug Administration (FDA) to override this restriction and simply issue a regulation allowing a substance to be marketed as a dietary supplement that would otherwise be prohibited under the IND Preclusion. The IND Preclusion only applies to dietary supplements and foods and does not apply to cosmetics, thus cosmetics containing CBD are not affected.

The Market

Despite the ongoing debate, the CBD dietary supplement and food markets have grown to such an extent that the Gallup Poll reported in August of 2019 that one in seven [or 14% of] Americans is using a CBD product of some kind.4 This has occurred because the FDA’s statements concerning the debate amount only to a guidance position at this point. The FDA’s guidance position has never been determined by the courts to be valid, and is neither final, nor legally binding since no final agency actions or determinations have been issued on the subject. In fact, FDA Commissioner Stephen Hahn recently stated during his address at the National Association of State Departments of Agriculture’s 2020 Winter Policy Conference, “People are using these [CBD] products. We’re not going to be able to say, ‘You can’t use these products,’ because…even if you did, it’s a fool’s game to even try to approach that.”5

The hemp industry coalition has been lobbying the FDA to use its overriding authority to allow CBD products to be marketed as dietary supplements and added to food. It has also been providing guidance and safety data to assist the FDA in creating a regulatory framework for quality assurance oversight of hemp processing. The coalition has also been lobbying Congress to mandate these actions, and there is much encouraging movement in these regards.

Challenges Today

In the meantime, and until the FDA formally acts, a mishmash of State laws and regulations govern CBD, with some States only allowing cosmetic CBD products to be sold, and others still not allowing any CBD products to be sold. Conversely, certain States allow all CBD products to be sold with virtually no oversight, while yet others are taking quality assurance into their own hands by creating laws and regulations allowing the sale of all or certain CBD products that are produced in accordance with various testing, labeling, and good manufacturing practices. Some States even have onerous product registration requirements that apply to both in-State and out-of-State manufacturers and distributors.

For the States that do have labeling requirements, these requirements often differ from State to State, making it impossible for national CBD industry leaders to print a single label that complies with all of the various State labeling mandates. One State even requires language that is very similar to, but differs from, FDA-required labeling language, making it impossible to print a label for that State that complies with both State and Federal law.

Yet hemp and its cannabinoids are legal again because we put one foot in front of the other and continue marching this plant down the field. Most State authorities greatly support the CBD industry and do not enforce excessively burdensome requirements. All will eventually come around right and one day we’ll look back on how this critical body of law and regulation unfolded with humor. Stay the course and engage in the process!

[1] Agricultural Act of 2014; H.R. 2642; Pub.L. 113–79, also known as the 2014 Farm Bill

[2]  Agriculture Improvement Act of 2018; S. 3042; Pub.L 115-334, also known as the 2018 Farm Bill

[3] §201(ff)(3)(B) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 321(ff)(3)(B)]

[4] Jones, J., Saad, L. (2019) Gallup Poll, June 19-July 12, 2019 CBD Consumption Habits [data set] Random sample—2,543—American adults in all 50 states and the District of Columbia. Retrieved from news.gallup.com

[5] YouTube, “FDA Commissioner Hahn makes first public comments on CBD”

Source: https://blog.zilis.com/hemp-vs-marijuana/