At the beginning of April, the FDA (US Food and Drug Administration) announced that they were going to carry out a review of CBD rules and regulations on a federal level across the US.  With the world of CBD rapidly changing, we are always seeing new challenges and arguments for changes, and the FDA
At the beginning of April, the FDA (US Food and Drug Administration) announced that they were going to carry out a review of CBD rules and regulations on a federal level across the US.  With the world of CBD rapidly changing, we are always seeing new challenges and arguments for changes, and the FDA is taking a step in the right direction in regard to this.
Since the introduction of the new Farm Bill in 2018, the US has seen unprecedented movement in the hemp industry. Indeed, it is due to the 2018 Farm Bill that hemp and its products are now allowed to be produced and traded across the country.
Things have changed in the USA because of the 2018 Farm Bill. CBD – or cannabidiol is a natural compound which is present in the cannabis – or hemp plant. Hemp is a particular strain of cannabis which is low in THC (very low in fact – less than 0.3%). THC or tetrahydrocannabinol is another compound found in cannabis, which makes you high, meaning that hemp is non-intoxicating. With mounting evidence to show how CBD and other compounds from the plant can be good for our health, the authorities have been forced to accept some of it into the legal market.
When extracts are taken from the hemp plant, the most significant compound is CBD and so by using hemp as the base plant, CBD products can be made without the risk of its user getting high.
The Farm Bill has taken hemp off the controlled substances list and therefore liberated a lot about the hemp industry in the USA. But it has also left many grey areas – such as CBD, for example.
When the Farm Bill finally came into force in 2018, Congress made it very clear that the FDA would still have the authority to regulate any products which contained cannabis or cannabis-derived products under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and section 351, of the Public Health Service Act.
At the moment, FDA regulations don’t allow businesses to add ‘active ingredients that are drug products’ into food and drink and this is why we have seen the FDA and local authorities threatening to close down establishments which are selling CBD rich products.
CBD is categorised as a drug, as it was approved relatively recently as the active ingredient in Epidiolex – a medication which is now used to help to treat children with a rare form of epilepsy. This has led to confusion around CBD and meant that the FDA and other authorities have been threatening to clamp down on some places which have been adding CBD to food – some restaurants for example.
It is due to these grey areas around whether CBD can be classified as a drug or not, and how it can be integrated into US society, that the FDA announced that they would carry out a review into it at the beginning of April.
The review was set to consist of four new steps:
1. Setting up a public hearing on 31st May for farmers, CBD producers, researchers, sellers, users and others in the CBD industry to make their voice heard, share experiences, frustration and air their opinions on CBD.
2. Forming a high level, group of people who can look into the potential for dietary supplements, food and drink containing CBD to be legally and federally marketed.
3. To provide clear updates online to help people inside and outside of the CBD industry to be able to understand the FDA rules and regulations with regard to CBD.
4. Clamping down on companies who make unfounded (usually medicinal) claims about cannabis-derived products.
The review is actually being welcomed by many people in the CBD industry as it will hopefully not only give clarity to those in the industry, allowing them to know exactly where they stand but also to allow the FDA to be fully up to date with changes in the industry.
They are looking for feedback which can help them to get a better idea about how it is best to regulate CBD and CBD products as well as better understand how safe it is.
The most important thing about the FDA review for the booming CBD industry in the USA is that it will give some clarity into the way that people and businesses can conduct themselves legally.
And this is a lesson which can be learned by the UK as well.
In the UK we have a step less of confusion, as we don’t have the additional layer of state laws as well as federal ones. However, we do still have a fair amount of confusion around CBD.