FDA’s view on CBD Oil

fda cbd oilOver the last year, the reputation of CBD oil has taken a growth spurt.

It’s no surprise, really – CBD oil has been applauded from helping with everything from anxiety and depression to even heart disease. 

CBD oil has now been used by over 64 million Americans and is now legal in every state. In addition, CBD oil has also become very popular among pet owners in recent years. 

Even retailers such as CVS and Walgreens are looking into stocking the product in a handful of states, marketed as ‘alternative care products’.

However, the FDA continues to publish statements and warnings on its use. Here at Kyro CBD we also published an article on common side effects of CBD oil to ensure our readers are well-informed. 

On December 20, 2018, the Agriculture Improvement Act of 2018 was signed into law. This act changes federal law in regards to growing cannabis and derivatives of cannabis with less than 0.3% psychoactive compound delta-9-tetrahydrocannabinol (THC) on a dry weight basis.

THC is the compound in cannabis which gives the ‘high’ to users. Products with less than 0.3% are highly unlikely to affect the body with one dose but show an improvement in health over time.

This led the FDA towards an approval – as although the chemical affects the body it does so in a way that benefits the health of those taking it, rather than taking over the body.

Some cannabis products are around 100% more potent than this legal limit, so it should be noted CBD oil is fairly tame and therefore is really only around to help to control health conditions, both mentally and physically.

Cannabis (also referred to as hemp) was removed from the FDA’s Controlled Substance Act, which makes it completely legal under federal law.

Colleen Keahey, president of the Hemp Industry Association, told CR in an interview that this could result in the USA doubling or even tripling in domestic cultivation within the next year.

Legal counsel of the U.S. Hemp Roundtable Jonathan Miller believes companies will also be able to transfer hemp across state lines without risk of prosecution.

Under the law, farmers can now obtain crop insurance, take out loans and protect their finances when it comes to growing hemp. This allows those who decide to grow the crop to be much more covered against bursts of bad weather and makes the potential of profits much larger.

Epidiolex, a prescription drug made from cannabidol (CBD) kicked off debates when it was approved by the FDA in June 2018. It was the first CBD drug to be approved in America and is taken to treat rare, severe forms of epilepsy.

In a statement following its legalization, the FDA said: “This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies.”

It has to be noted that in addition to this, the FDA statement also reads: “Just as important for the FDA and our commitment to protect and promote the public health is what the law didn’t change: Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act.

This will still allow Congress to have power over patient and citizen health while providing safe and accessible ways for people to access products containing cannabis and cannabis-derived products.

The FDA has said it will ‘advance new steps to better define our public health obligations in this area’ while continuing to ‘closely scrutinize products that could pose risks to consumers’.

All cannabis-derived products continue to await approval from the FDA before sales begin. Those which claim to ‘cure’ certain diseases such as cancer and dementia are treated as new drugs, and therefore must undergo the FDA drug approval process.

It’s very clear that while the FDA has legalized CBD oil, it is not prepared to make it easy for manufacturers to sell any old products to its consumers.

The organization said: “We’ll take enforcement action needed to protect public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and are being marketed in violation of the FDA’s authorities.

“The FDA has sent warning letters in the past to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer.

“Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.”

The agency regularly tests products and has said many are found contain different levels of CBD than they claim. It has warned the public to be wary of such products.

A recent warning letter was sent to a company to change its product descriptions and cures to claim diseases. It warned the company that its CBD products were illegal, misleading and unsafe.

It noted that although the company does not directly address its products as dietary supplements, in some product descriptions the words ‘as a hemp supplement…’ were used.

It is interesting to point out that the company was also using a nutrition facts label, which insinuated the products were food.

A public hearing is set to take place on May 31, 2019 to share comments, experiences, and challenges with CBD oil, as well as giving stakeholders the opportunity to share their public health and safety issues with the sale of hemp-containing products.

An internal agency working group has also been formed to look into and experiment with introducing CBD oil to dietary supplements and/or food, to look at the law’s point of view, what would need to be adapted and what marketing would be needed to ensure public health was at the heart of the launch.

The FDA has created a webpage with frequently asked questions for those who want to learn more on the topic of CBD and CBD oil. It includes questions such as ‘Why hasn’t FDA approved more products containing cannabis or cannabis-derived compounds for medical uses?’ and ‘What is FDA’s reaction to states that are allowing cannabis to be sold for medical uses without the FDA’s approval?’.

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