Frequently Asked Questions About FDA Regulations On CBD

CBD For Period Pains
CBD For Period Pains
FDA Regulations On CBD
FDA Regulations On CBD

CBD, the therapeutic and daily health supplement that gained immense popularity in the recent years is regulated by the Food and Drug Administration (FDA) department in the US. The compound extracted from cannabis plants was legalized in 2018 according to the US farm Bill. The bill clearly stated that the source of CBD has to be hemp plants and the THC content in the products should be maintained below 0.3% for them to be considered legal.

In this session, we answer some of the frequently asked questions about FDA regulations on CBD.

What Does The US Farm Bill Definition Of Hemp Mean For FDA Regulated Products?

The agricultural Improvement Act of 2018 generally referred to as US Farm Bill was signed on December 20, 2018. According to the US Farm Bill, hemp is defined as the plant Cannabis sativa L. and any of its parts including the seeds, cannabinoids, isomers with a THC concentration less than 0.3% by dry weight basis. The renewed definition of hemp removed it from the CSA (Controlled Substance Act), indicating that cannabis and its derivatives that contain less than 0.3% are no longer controlled substances as per the federal laws.

The Farm Bill preserved the authority of FDA to regulate the production, sale and transport of cannabis and is derivatives as per section 351 of Public Health Service Act and FD&C Act.

Has FDA Approved Any CBD Therapeutic Drug?

Till date, FDA hasn’t approved the marketing of cannabis compounds as treatment for any health condition. But it has approved the use of Epidolex, a CBD infused drug used for the treatment of Dravet syndrome and Lennox-Gastaut syndrome, two serious epileptic conditions.

Epidolex is the only FDA approved CBD drug but FDA has approved three cannabis related drugs, Marinol,Syndros and Cesamet. Marinol and Syndros are used for anorexia treatment and include dronabidiol and THC as active ingredients. Cesamet includes the active ingredient nabilone that has a similar chemical structure as that of THC.

Why Does FDA Specifically Instruct To Keep The THC Content Below 0.3% In CBD Products?

If present even in moderately high doses, THC can cause a euphoric effect in the users. Marijuana plant that belongs to cannabis family is a rich source of THC, which is why it still belongs to the lit of controlled substances. Even when a therapeutic has equal ratio of CBD and THC, it cannot be considered as a CBD product because the THC content will be greater than the allowable limit.

Whatever be the purpose you pick a CBD product whether as a therapeutic or health supplement, it should be ensured that the THC content is less than 0.3% if the benefits of CBD is what you expect.