Posted on

cbd government

3. Has FDA approved any medical products containing cannabis or cannabis-derived compounds such as CBD?

FDA has approved Epidiolex, which contains a purified form of the drug substance CBD for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 1 years of age and older. It has also approved Epidiolex for the treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age or older. That means FDA has concluded that this particular drug product is safe and effective for its intended use.

Consumer Information

[1] Gray, et al. Identifying Prenatal Cannabis Exposure and Effects of Concurrent Tobacco Exposure on Neonatal Growth. Clinical Chemistry. 2010; 56(9): 1442-1450.

A. To conduct clinical research that can lead to an approved new drug, including research using materials from plants such as cannabis, researchers need to work with the FDA and submit an IND application to the Center for Drug Evaluation and Research (CDER). The IND application process gives researchers a path to follow that includes regular interactions with the FDA to support efficient drug development while protecting the patients who are enrolled in the trials. For research for use as an animal drug product, researchers would establish an investigational new animal drug (INAD) file with the Center for Veterinary Medicine to conduct their research, rather than an IND with CDER.

15. Can I import or export cannabis-containing or cannabis-derived products?

Cannabidiol (CBD) is a non-psychoactive cannabinoid present in the cannabis plant (Cannabis sativa L) along with many other cannabinoids that may either exhibit psychoactive or non-psychoactive properties.

CBD plant extract or plant isolates have gained salience as an ingredient in food supplements and in some cosmetic products, and there has been a proliferation of such products, available online and on the high street.

Kit Malthouse MP, Minister of State for Crime and Policing, wrote to the Chair of Advisory Council on the Misuse of Drugs (ACMD), to seek advice on the issue of CBD products which are not medicines; specifically on the controlled cannabinoids that could be present and the concentrations that they could be present at.

As an isolated substance, CBD is not a controlled drug. However the process of extracting or isolating CBD from the cannabis plant may co-extract other cannabinoids and products could unintentionally include other non-psychoactive or, more significantly, psychoactive cannabinoid substances.

The report on the international ring trial on CBD and controlled cannabinoids in consumer products will be published on the Government Chemist website later this month.

Industrial hemp is cannabis that contains 0.3% THC or less in the flowering heads and leaves.

Health Canada oversees the production of cannabis products. Health Canada is also responsible for overseeing the distribution and sale of:

All phytocannabinoids are regulated under the new Cannabis Act. The Act came into force on October 17, 2018.

Industrial hemp

Hemp producers may not extract the CBD themselves, unless they also have a cannabis processing or research licence.

This licence could be:

As a result, CBD and products containing CBD are subject to all of the rules and requirements that apply to cannabis under the Cannabis Act and its regulations. This includes CBD derived from industrial hemp plants, as well as CBD derived from other varieties of cannabis.

You must have a processing licence to manufacture products containing CBD for sale, no matter what the source of the CBD is.