Cannabis-containing products have finally taken off in the international market. As consumption is growing overall the industry is growing rapidly. 

The legalisation of cannabis in several states in the USA has made it much more accessible and acceptable in society. The stigma which surrounded cannabis users is slowly waning, as are the negative connotations associated with its use. However, the controversy around medical use is yet to be overcome.

In this article, we will talk about cannabis containing products, its type, and differences. We will also discuss how the FDA approves cannabis based products.

What do you need to know about Cannabis containing products?

Cannabis is a member of the Cannabaceae family of plants and contains over eighty chemical compounds with biological activity. Delta-9-tetrahydrocannabinol (THC) and cannabidiol are the most well-known chemicals (CBD). THC is the active ingredient in marijuana that generates the “high” associated with its consumption. There has been a surge of interest in CBD and its possible health advantages.

Marijuana is not the same as CBD. CBD is a single component found in the cannabis plant, whereas marijuana is a type of cannabis plants or plant material containing a variety of naturally occurring compounds, including CBD and THC. [1]

Cannabis vs. hemp

Hemp and marijuana  are considered cannabis plants. The distinction is that hemp plants contain less than 0.3 percent THC, but marijuana plants contain significantly more.

CBD is extracted from hemp or marijuana. Depending on your location and the rules in your state or nation, you may be allowed to purchase CBD products made from marijuana or hemp. Alternatively, you may have access to solely hemp-derived CBD products – or none at all. 

It is critical to understand the difference between marijuana and hemp because marijuana-derived CBD products may have psychoactive effects and the THC contained in these products will show up on a drug test.

CBD derived from hemp contains trace levels of THC — often insufficient to cause a high or register on a drug test, though this is conceivable. CBD and THC function synergistically rather than independently. This phenomenon is referred to as the entourage effect. [1]

What is the difference between compounds, isolates, full-spectrum, and broad-spectrum?

Your choice of CBD isolate, full-spectrum CBD, or broad-spectrum CBD will dictate what other ingredients are included in your product in addition to the CBD. 

• Full-spectrum CBD contains all of the cannabis plant’s naturally occurring components, including THC. THC, on the other hand, will not exceed 0.3 percent by dry weight in hemp-derived full-spectrum CBD. When the flowers are processed into oil, the THC content increases. 
• Broad-spectrum CBD contains all of the naturally occurring chemicals, with the exception of THC, which is normally eliminated entirely or with the exception of a trace amount. 
• CBD isolate is the purest form of CBD, having been extracted from the hemp plant’s other chemicals. CBD isolates should be THC-free.

Some people choose full-spectrum cannabis because they want all of the cannabis plant’s benefits — with all of the cannabinoids and other components acting in harmony. Others opt for broad-spectrum strains in order to obtain all of the terpenes and flavonoids without the THC. Certain individuals choose CBD isolation because it is flavourless and odourless and they do not want any other ingredients.

Cannabis-derived cannabinoids, terpenes, and flavonoids

Apart from CBD and THC, the cannabis plant includes over 100 other cannabinoids, as well as a variety of additional substances called terpenes and flavonoids. Cannabinoids act on the endocannabinoid system in your body. The endocannabinoid system contributes to the stability of the neurological system and immunological function.

Terpenes, like cannabinoids, are another plant chemical that has been claimed to have medicinal and health-promoting properties. Additionally, flavonoids, which are found in green tea and certain fruits, have been demonstrated to have anti-inflammatory properties.  [1]

Role Of CDSA and FDA

Prior to the Cannabis Act taking effect on October 17, 2018, cannabis was classified as a controlled substance under the Controlled Drugs and Substances Act (CDSA) and a drug under the Food and Drug Act (FDA). Activities involving cannabis are generally prohibited under this legislative framework, unless specifically authorised by certain regulations (e.g., the Access to Cannabis for Medical Purposes Regulations (ACMPR), the Narcotic Control Regulations (NCR), the Food and Drug Regulations, and the Industrial Hemp Regulations (IHR)).

Together, the CDSA and the FDA impose strict guidelines on the manufacture, possession, distribution, and sale of cannabis-infused health goods. Cannabis may be incorporated in prescription medications under the same conditions as other narcotics. Additionally, under certain circumstances, certain portions of the cannabis plant that do not contain psychoactive cannabinoids may be included in Natural Health Products (NHPs) or Veterinary Health Products (VHPs). [2]

Has the FDA authorized any medical products that contain cannabis or cannabinoids produced from cannabis, such as CBD?

The agency has not yet approved a cannabis marketing application for the treatment of any disease or condition. However, the FDA has approved one cannabis-derived product and three cannabis-related items. These FDA-approved medications are accessible only with a prescription from a licensed healthcare physician.

• Epidiolex, which contains a purified form of the chemical CBD, has been approved by the FDA for the treatment of seizures associated with Lennox-Gastaut or Dravet syndrome in individuals aged 1 year and older. Additionally, the FDA approved Epidiolex for the treatment of seizures associated with tuberous sclerosis complex in patients aged one year and older. This indicates that the FDA has determined that the medicine is safe and effective for its intended use.
• Marinol and Syndros have also been approved by the FDA for therapeutic applications in the United States, including the treatment of anorexia linked with weight loss in HIV patients. Marinol and Syndros both include dronabinol, a synthetic delta-9-tetrahydrocannabinol (THC) that is regarded to be the psychoactive component of cannabis. Cesamet, another FDA-approved medicine, contains the active component nabilone, which is synthetically manufactured and has a molecular structure similar to THC. [3]

Why hasn’t the FDA authorized more goods for medical purposes that contain cannabis or cannabis-derived compounds?

The FDA is aware that unapproved cannabis or cannabis-derived products are being used to treat a variety of medical illnesses, including AIDS-related wasting, epilepsy, neuropathic pain, multiple sclerosis-associated spasticity, and cancer- and chemotherapy-induced nausea.

Currently, the FDA has not authorized a marketing application for cannabis for the treatment of any disease or condition, and hence has not determined that cannabis is safe and effective for any specific disease or condition. However, the agency has approved one cannabis-derived medication and three cannabis-related medications as mentioned above.

The FDA conducts research with the assistance of applicants and scientific investigators. The agency’s role, as defined by the FD&C Act, is to analyze data submitted to the FDA as part of an application for approval to ensure that the drug product complies with applicable statutory standards.

Cannabis and cannabis-derived chemicals must be studied in clinical trials to determine their safety and efficacy in the treatment of any disease or condition. 

The FDA’s December 2016 Guidance for Industry: Botanical Drug Development makes precise suggestions for the submission of investigational new drug applications (INDs) for botanical drug products, such as those derived from cannabis, in support of future marketing applications. 

Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry, published in July 2020, addresses quality considerations for anybody conducting clinical research in this field, particularly those unfamiliar with the FDA.

The FDA will continue to assist companies in bringing safe, effective, and high-quality products to market, including scientifically-based studies on cannabis’ therapeutic benefits. [3]

Conclusion

The cannabis industry is growing and having to deal with the government structure for approval. As a consumer, be aware of the imposter products on the market that claim to be what they are not and associate negative connotations with the use of cannabis containing products.

In the end, it will be easy for you to understand the benefits of cannabis containing products. Its use in the medical field is astounding but there has been significant progress made in recent years to allow its use as a recreational drug.

References:

[1]- https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis

[2]- https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/guidance-cannabis-act-food-and-drugs-act-related-regulations/document.html

[3]- https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd