CBD Regulatory Landscape

CBD Regulatory Landscape

In June 2018, U.S. Food and Drug Administration (FDA) approved the first oral solution drug (Epidiolex®-a purified form of CBD oil) comprised of CBD as an active ingredient derived from marijuana to treat rare, severe forms of epilepsy. Under orphan approval status Epidiolex® was approved in Europe on the 19th of September 2019 for treating two types of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. There is no other pure CBD approved as a licensed drug at this time.

CBD is available as a food supplement in Europe however as of January 2019 the European Food Safety Authority (EFSA) has issued regulation in relation to the supply of CBD as a Food Supplement.

They have re-classified CBD as a “novel food”. The authorities require suppliers of CBD food supplement to undertake a series of clinical testing to prove their CBD is safe for consumer use.

We have complied to all of the testing requirements of ESFA and UK FSA food safety regulations, our application has been submitted successfully and are listed on the ESFA portal.

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