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FDA Proposed Cannabis Derived Productment GFI Reshaping Industry

Philadelphia, Aug 2020


In Feb 2020, FDA issued an opinion to encourage the cannabis industry to consider moving to the botanical drug development pathway for their products if they think those projects treat or prevent illness. In late July 202o, FDA issued a draft Cannabis Derived Product GFI to clear define a product development pathway for cannabis derived products.

In the past, cannabis-derived products can only take the route of diary supplement because there are multiple constitutes in the drug products and there is no study on mechanism of action for claimed disease treatment or prevention. The 2016 version of Botanical Drug Development GFI opens up a door for botanical products, like cannabis derived or herbal medicine, to qualify for IND by waiving the requirement of 1) identifying active ingredient, 2) describe mechanism of action.

Cannabis-derived products are currently diary supplement. Market demands for cannabis products are weak due to public sentiment and government regulation. Cannabis companies are facing dilemma.

The draft Cannabis-derived Compounds GFI and Botanical Drug Development GFI together provide an prescription drug development pathway for the cannabis products. It is anticipated that some cannabis companies wll shift gears to become pharmaceutical companies.

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