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FDA and CBD

Will the FDA finally authorize the use of CBD products?

Will the FDA finally authorize the use of CBD products?

For those who are not already in the know when it comes to cannabidiol, also known as CBD, it is one of over 100 identified cannabinoids found in the cannabis Sativa plant. It is also the second-most active ingredient in marijuana behind tetrahydrocannabinol (THC), which is the chemical compound in marijuana that triggers a euphoric high when it is either smoked or consumed as an edible. Because these two cannabinoids are native to the same cannabis Sativa plant, many people falsely believe that they both affect the body in the same way. And this couldn’t be any further from the truth. In short, CBD and THC interact differently with the CB1 and CB2 receptors in the body’s endocannabinoid system, a cell-signaling system that works to promote and maintain bodily homeostasis.

The Endocannabinoid System: Cannabidiol vs. Tetrahydrocannabinol

To understand how CBD and THC affect the endocannabinoid system and the body as a whole, it helps to know a little more about CB1 and CB2 receptors. Firstly, CB1 receptors, while also found in other parts of the body, are located primarily in the brain. CB2 receptors, on the other hand, are located in the immune and gastrointestinal system. When an individual smokes or otherwise consumes marijuana, the THC cannabinoid in the plant binds to CB1 receptors and triggers a euphoric high. Of course, this is not entirely surprising considering the role of CB1 receptors in the brain.

According to data published by the National Institutes of Health, these specific receptors are responsible for regulating the release of multiple neurotransmitters in the brain, including serotonin, dopamine, and glutamate. Therefore, it stands to reason that anything that interferes with these naturally-occurring processes would trigger emotional and psychological changes.

By comparison, when individuals consume CBD-infused edibles, for example, the cannabinoids in them bind to both CB1 and CB2 receptors. This response results in an agonist-antagonist effect whereby CBD-related cannabinoids block THC-related cannabinoids that ordinarily interact with CB1 receptors. However, the CBD-based cannabinoids can still interact with CB2 receptors, which produces numerous health benefits while minimizing the euphoric effects of THC. According to a study published by Harvard Health Publishing, the CBD-based cannabinoids found in tinctures, gummies, and oils, for example, based on the interaction with CB2 receptors, can benefit individuals struggling with any of the following:

  • Anxiety
  • Insomnia
  • Epileptic seizures
  • Chronic pain

What You Might Not Have Known About the Legalization of CBD-Infused Products

Now that we have a better understanding of the differences between CBD and THC, let’s shift our attention to why more people are choosing to buy high grade CBD products rather than prescription and over-the-counter medications to treat various health problems. Firstly, CBD-based cannabinoids are becoming more understood and also embrace by medical and scientific communities all across America. They are also gaining support from the federal government. In 2018, cannabis-derived products, such as CBD-infused oil, edibles, and the like, became legal with the passing of the Farm Bill. However, there was a caveat in that these products had to be derived from hemp and could contain no more than 0.3 percent THC. And this is not the only example of the federal government showing their support for CBD-based products.

In the same year that the Farm Bill passed, the Food and Drug Administration (FDA) approved Epidiolex, a CBD-infused medication, aimed at treating seizures resulting from either Dravet syndrome or Lennox-Gastaut syndrome, two rare forms of epilepsy in children. According to a study published by the University of California San Francisco, 1 in 15,000 children struggles with severe seizures that stem from Darvet syndrome. And a separate study published by the National Organization of Rare Diseases (NORD) revealed that 2 in 100,000 children struggle with seizures related to Lennox-Gastaut syndrome. All in all, there is a large body of evidence that shows CBD-infused medications and other products are viable alternatives to traditional medicine when it comes to treating a wide range of health problems.

FDA Seeks Approval From Congress to Legalize the Use of Even More CBD-Infused Products

When President Trump signed the Farm bill into law in 2018, it only legalized CBD-infused products derived from hemp. It excluded CBD-infused products derived from cannabis, also known as marijuana, which often contains THC levels of 25 percent or more. And before the bill was signed into law, there were only a few credible studies that addressed safety and efficacy when it came to the use of products that contained the cannabinoid. Fast-forward just a couple of years, and it is clear that things have changed significantly. There are now multiple studies that substantiate many of the claims previously made about CBD-based products. Plus, we now have a CBD-infused prescription medication on the market that is improving the lives of many children struggling with seizures caused by Dravet syndrome or Lennox-Gastaut syndrome. All of these facts have motivated the Food and Drug Administration to seek approval from Congress to legalize the use of even more CBD-infused products.

What You Should Know About the Report That the FDA Submitted to Congress

In short, if everything goes according to plan, the CBD-infused market will see significant changes that will benefit CBD-based dispensaries as well as consumers looking to buy high grade CBD products. In the report submitted to Congress in March 2020, the FDA goes over the regulatory pathways they are pursuing to make it legal for the following products to be CBD-infused and made available to consumers:

  • Dietary supplements
  • Foods
  • Cosmetics
  • New CBD-infused drugs

It is worth noting that the steps involved in accomplishing this goal will vary slightly from one product to the next, but here is a small glimpse of what was mentioned in the FDA’s report as it pertains to each of the products mentioned in this article:

Dietary supplements – Currently, CBD-infused products cannot be sold legally as dietary supplements. However, that may soon change. According to the FDA, moving forward, companies that submit dietary ingredient notifications to the agency to obtain premarket for CBD-containing supplements must include CBD-specific information about their product. This measure will help pave the way for reputable companies to be able to sell CBD-containing dietary supplements legally. It will also ensure consumers looking to buy high grade CBD supplements get what they are paying for, according to the FDA’s report to Congress.

Food – According to the FDA, it is currently illegal to add CBD-based cannabinoids to any food consumed by humans or animals. To make doing so legal, the FDA is encouraging researchers and scientists to conduct even more studies to determine if it is safe to consume food that contains such cannabinoids.

Cosmetics – While cosmetic products don’t require premarket approval like dietary supplements or food products, the FDA, in the report to Congress, stated that the agency still urges cosmetic manufactures to ensure the safety of their products before they ever reach consumers.

New CBD-infused drugs – Not surprisingly, the FDA is hoping to have the same success with a new CBD-infused drug as they did with Epolidex. For this reason, the agency is working to ensure that incentive programs exist to help promote clinical research and, more importantly, reward drug manufacturers who can develop and ultimately introduce new CBD-infused drugs to the pharmaceutical industry.

Bottom Line

In summary, the FDA is making great strides in their efforts to legalize more CBD-based products. However, multiple factors will determine if and when this will all happen. The agency noted that there are several steps involved in the process, including collaborating with other government bodies, reopening the public hearing docket to allow for the exchange of public information, and analyzing additional CBD-containing products currently on the market. But as it stands, the CBD-based market will probably look a lot different to consumers in the market to buy high grade CBD-based products.

Image Source:(Nastasic, maystra, channarongsds/iStock)

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