Where Does The FDA Stand on CBD and CBD Products?

Cannabis has come a long way from being the taboo herb of decades past. Lately, CBD has warranted a huge share of public and media attention for its perceived benefits to health and well-being.

CBD is everywhere these days. Do a quick Google search, and you’ll find thousands of websites selling CBD products online, as well as the locations of brick and mortar CBD stores near you.

Given the stress that many of us experience on a daily basis, plus the socio-economic uncertainties brought forth by the current pandemic, more and more people are looking to CBD as potential sources of calm and relaxation, among other things.

But while the ongoing buzz around cannabis-derived products isn’t too surprising, a lot of people can’t help wondering how the market is being regulated and what the FDA has to say about it.

A Closer Look at CBD

Cannabidiol, which also goes by the now-popular term CBD, is just one of the more than 100 natural compounds found in the cannabis plant. Out of all the cannabinoids, CBD from hemp is the most widely used for manufacturing cannabis-derived products such as oils, tinctures, candies, and even cosmetics because it carries almost no THC – the compound that gives marijuana its mind-altering properties.

CBD is found to be generally safe when consumed in prescribed portions. The absence of THC means that using or consuming CBD products will not change your spatial or sensory perceptions. In short, it won’t get you high.

Several countries across the globe have legalized the use of CBD for industrial applications over the last couple of years. In the United States, the passage of the 2018 Farm Bill, which de-scheduled hemp plants from the “controlled substance” list, broke the glass ceiling for the CBD industry.

The Unprecedented Growth of the CBD Market

Today, CBD has become a consumer trend. The reported healing benefits of CBD, combined with the marketing efforts of the manufacturers, sellers, and social media influencers advertising the benefits of cannabidiol, have driven the unprecedented growth of the CBD market. A lot of people who have never heard or were once afraid to try have now jumped in and joined the CBD train.

The CBD market has exploded and became a multi-billion-dollar industry in such a short time. It has been predicted that the U.S hemp-CBD market alone could hit $22 billion by 2020, which is a mind-blowing figure given that the estimated worth of the entire U.S organic food market by 2025 is at $70.4 billion.


CBD Products and the FDA

The U.S. FDA is the government agency that ensures the safety and quality of foods, drugs, cosmetics, and other like products marketed in the United States. Thus, they are also responsible for evaluating and conducting research on CBD products before awarding them GRAS (generally recognized as safe) status, which means a specific drug or product is considered safe and effective for its intended use.

FDA-approval on CBD

Despite the rapid growth of the CBD market, there is only one FDA-approved CBD product in the United States to this day – a prescription medicine called Epidiolex that is used for treating seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in kids. The drug contains a purified form of CBD and can only be purchased with a prescription from a licensed healthcare provider.


Aside from Epidiolex, though, there are no other FDA-approved products containing CBD. Still, the fact that the agency has granted GRAS status to a drug with CBD as a main active ingredient only goes to show that the therapeutic properties of cannabidiol are not unfounded.

FDA on the Marketing of CBD Products

The FDA is fully aware that several states have already passed laws allowing the use of CBD products for both recreational and medicinal purposes. The agency maintains that they need more time to probe further into the science of cannabidiol, which will require thorough research and clinical trials before they can conclude certain products as GRAS.

“To date, FDA has not approved a marketing application for cannabis for the treatment of any disease or condition and thus has not determined that cannabis is safe and effective for any particular disease or condition.”

As the FDA’s role is to review data and ensure that a drug or product meets statutory standards before awarding approval, it’s up to the manufacturers, advocates, and scientific investigators to conduct the studies and submit evidence to back up their claims.

CBD Legal and Safety Issues

An FDA report presented to the U.S. House Committee on Appropriations and the U.S. Senate Committee on Appropriations, states that:

“FDA recognizes the significant public interest in CBD products. However, there are many questions about the characteristics of currently marketed CBD products because the Agency lacks significant information on what CBD-containing products are on the market and there are little data available on those products themselves.”

In the same report, the agency wrote:

“Of the 31 products tested for cannabinoids, 21 products specified the amount of CBD in the product (e.g., CBD amount per serving). Of these 21 products, seven products (33 percent) contained CBD within 20 percent of the amount indicated.

Of the 10 products that did not indicate the amount of CBD included in the product, six contained CBD, and four did not. In addition, 15 of the 31 products (48%) contained THC. The results obtained for these 34 products are from limited sample size and cannot be used to draw definitive conclusions and further testing is warranted.”


The most prevalent issues concerning cannabidiol the FDA has to deal with are (1) mislabeling and (2) the outlandish claims that manufacturers have been spreading about the benefits and effectiveness of CBD products.

Over the years, the organization tested drugs and products with CBD and found out that many have more or less than the levels of CBD they claim to contain. They have also been monitoring, calling out, and issuing warnings to companies declaring CBD can cure diseases or, as of late, treat coronavirus. Also, the FDA has concluded that “THC and CBD products are excluded from the dietary supplement definition.”

Reform advocates have repeatedly voiced their concerns about the lack of quality control in the CBD industry. According to the FDA, they are in the process of creating those rules. In the meantime, though, they will continue to allow the sale of CBD products in the market while they collaborate with industry leaders and work on regulations to ensure safety and quality.

 

 

 

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