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Examining the Relationship Between CBD and the FDA

Posted by Kerry Hinkle on

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Understanding CBD Claims and The FDA 

The FDA, no doubt you are familiar with this federal agency. But are you familiar with their relationship with CBD?

Of course there is the obvious, CBD is the shiny new car in the medical industry, it only makes sense they would be regulated by the Food and Drug Agency.

 

If you have explored the internet in search of facts regarding CBD, then you know there is a little more to their relationship, you just might not have been fully aware of it.

The FDA and CBD have a complex, yet young and still promising, relationship. There are many steps a drug like CBD must embark on before it can be fully accepted in the medical world. 

What I am trying to get at is, we cannot yet make claims about CBD and the health advantages it potentially offers - hence the word ‘potentially’. 

 

What are claims? In the medical industry they are facts. If you make a claim about a drug’s benefits, then you are essentially making a fact about what that drug can do for your body.

Making faulty claims can be misleading to the public, who will then buy this certain drug with the full belief it will cure them of their ailment. 

And this is all wonderful, don’t get me wrong! I will not go on a tirade about how the FDA is overbearing or creating unfair regulations for the very promising medicinal value of CBD.

No. I am going to explore more about the world of medical claims and how they have impacted the hemp industry.

I want to examine how reading about CBD can feel dissatisfying at times and the struggles of trying to write about the health advantages it can offer.

Any reputable site is going to avoid making claims. At times it might make you feel as though CBD is not actually effective, that people are exaggerating its benefits.

This is untrue, there are just tons of rules as to what you can and cannot say, so let’s talk about the do’s and don’t of what you are allowed to say about CBD.

 

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A Little History About The FDA 

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Formed on June 30, 1906 with the passing of the Federal Food and Drugs Act and signed into power by President Theodore Roosevelt. The FDA is a federal agency that is a part of the Department of Health and Human Services.

It is their responsibility to monitor medical products, food, tobacco, and cosmetics to ensure that they are safe for the public to use. 

 

“FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health".

 

The FDA and the laws it has enacted were created for one purpose: to stop misbranded and adulterated drugs and food. A food item, cosmetic, or medical product is considered adulterated if a harmful substance is found within the product.

During this era, the pre-FDA era, misinformation was rampant in the health industry. Unfortunately, this led to a high amount of adulterated products to get on the market.

What a wild and untamed time, I cannot imagine the feeling of not knowing who or what to trust. There were no laws to regulate what companies could or could not claim about their product.

Companies were taking advantage of these unregulated times up until a certain Diphtheria antitoxin came on the scene. In 1901, a cure for the deadly Diphtheria, an infectious disease primarily affecting children, was discovered.

This cure was not a modern miracle, no. Instead, it ended up taking the lives of 13 children in St. Louis, Missouri. One of the test subjects for the antitoxin, which happened to be a horse, died of tetanus.

Not all of the antitoxin were not discarded, some were tragically still sent to physicians. This is why the American government stepped in, this is why we have a federal agency dedicated to protecting the quality of our drugs and foods.

 

The FDA works to regulate the development of  new drugs, such as CBD, with the implementation of clinical trials.

According to FDA.org, in order for pharmaceutical companies to become approved for the market and able to be sold to consumers, they must first pass four phases of clinical trials. 


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The FDA and Its Relationship With CBD

The FDA has not yet defined CBD as a dietary supplement - products containing minerals, botanicals, and vitamins that are taken by mouth- which means, the FDA has not officially approved CBD to be safe for consumers.

Don’t be alarmed! Like many other times we have uttered this phrase on our site, this is all about research...or lack thereof.

 

The FDA is looking for definitive proof that CBD is 100% safe for medical and therapeutic use. 

There is a concern with the idea that CBD “can’t harm”, leading people to believe it is completely harmless. This does not match with the data the FDA has gathered so far.

In their studies they have determined a small range of side effects with CBD. Most are not harmful like: dry mouth, diarrhea, and changes in alertness and mood.

Now that isn’t the whole story... The FDA has uncovered more concerning issues such as liver injury and a decrease in male fertility.

Note: more information regarding those last two side effects can be found on the FDA website.

 

Also on that website you can find this quote, “As part of the drug review and approval process for the prescription drug containing CBD, it was determined that the risks are outweighed by the benefits”. So, a lot of mixed feeling about CBD coming from the FDA.

 

Despite the potential risks they have found, they do not compare to the positive health benefits CBD could provide. If you were to take away one thing here it is this: research.

There just has not been enough clinical research done with CBD and other hemp products, I cannot state that enough. The FDA cannot approve of a new medication unless they are certain it will not cause harm.

Hopefully, more data can be obtained to prove that these health risks were irregularities, eliminating their doubts, and allowing all CBD products to be approved.

As of now, they have only approved of one CBD product: Epidiolox, a prescription drug used to treat two rare forms of epilepsy. 

 

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Making Dangerous Claims About CBD

This is what the FDA fears most: dangerous claims. They do not want companies running around making false claims about CBD; like, saying it is a miracle elixir that cures all diseases.

Claims are why many CBD writers have to tip-toe around the languages they choose.

As we mentioned earlier, claims are facts in the medical world; they can mislead the consumer in unfair ways.

If your company consistently does not follow these guidelines, then they risk being fined and eventually disbanded

They especially do NOT want companies making any disease claims. A disease claim is, “any language that explicitly states or infers that a product can treat, prevent, or mitigate symptoms of an illness or the illness itself, such as cancer, the common cold, or insomnia”. 

Unfortunately, some CBD companies are not adhering to these rules and marketing products with unproven medical claims.

 

The FDA is concerned that these false claims could lead to consumers avoiding important medical care like, proper diagnosis or treatments. 

Like I mentioned earlier, CBD has not been included as a dietary supplement. Because of this, people in the CBD industry are not permitted to explicitly say that your product has any medicinal value. 

I refer to this whole process as beating around the cannabis-bush. We in the industry are aware of the potential health benefits of CBD, we just cannot fully share them with you.

 

Instead, we must use different words and phrases to mask the real point we are trying to get across.

I believe this whole process is called ‘puffery’ in the advertisement world, being highly vague or subjective. 

Here are some examples you have probably come across while reading. “CBD helps promote relaxation”, instead of “CBD helps reduce anxiety”; anxiety is considered to be a medical term.

Or “CBD helps improve your mood” rather than “CBD will help with your depression”.

They are labeled this way to avoid making claims that could jeopardize business, not because CBD provides minimal medicinal benefits.

If you are a fellow CBD blogger or getting started in the industry, then I would avoid these terms: pain, cure, anxiety, PTSD, insomnia, depression, cancer, arthritis, or Alzheimers (among many others).


U.S. self regulator gives its stamp of approval to 13 hemp firms

The U.S Hemp Authority 

So how do you know you are buying a safe to use CBD? Well, it's simple really. Make sure the product you plan to buy, or the company you plan to buy from are approved by the U.S Hemp Authority, the leading voice in the CBD world. 

The U.S. Hemp Authority was originally established in 2017 with the formation of the U.S Hemp Roundtable.

Their goal was to create a sense of safety and consumer confidence towards CBD and other hemp related products.

 

Not far after its conception, they launched their Guidelines Procedures, which they are continually updating and changing to create the best possible requirements.

Basically, the  purpose of the initiative was to establish the ‘do’s and don’ts’ for the hemp industry, with the guidance of industry leaders.

The U.S Hemp Authority has created a self-regulating system with their  high standards for products and best practices for manufacturers. 

This is why we stress it so often that you only buy products that have been certified and why we only sell certified products.

Their approval means the product and the company itself are credible.

Unfortunately, there are a lot of untrustworthy suppliers out there trying to sell bad products.

Make sure to confirm that the product you wish to buy has been certified by the U.S Hemp Authority. 

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What I Should Know Before Purchasing CBD

The FDA not approving CBD can be frustrating at times, but their thoroughness is understandable.

It is their purpose to make sure all new medicines are 100% safe for consumption and CBD should be no different, no matter how promising the health benefits may be. 

Though, this has not stopped some companies from going forward with the idea that CBD can fix all.

These inappropriate claims are misleading to the customer, who purchase CBD with the belief it will cure them from insomnia, depression, or what have you.

 

It is sad to see people exploit CBD as a miracle drug, creating a false image of this wonderful product.

Thankfully, there are rules in place to crackdown on these unreliable companies. Making these unlawful claims will eventually lead to a fine, or the loss of your company.

If all of this still leaves you uncertain about CBD, then remember this one thing: The U.S Hemp Authority.

Their sole purpose is to make sure all hemp related products are safely manufactured and distributed.

Always make sure that the products you want to buy are certified by the U.S Hemp Authority.

 

The content on this site is not intended to be a substitute for professional medical advice, diagnosis or treatment. While research has shown that CBD has the potential to help provide beneficial outcomes for several complaints, it is advisable to seek the advice of a physician or other qualified healthcare provider when you have questions regarding any medical condition and when starting, augmenting or discontinuing any existing health routine. 

FDA Disclaimer: Any statements made within this website have not been evaluated by the Food and Drug Administration. No products produced, manufactured, marketed, or distributed are intended to diagnose, treat, cure or prevent any disease. Consult your physician before beginning any supplements or botanical extracts. If pregnant or breast feeding, consult with your physician before use. For use by adults 18+. Keep out of reach of children.

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