FSA reduces recommended safe daily dose of CBD by over 80%

Expert says FSA recommendation is “conservative and sufficiently precautionary”

The Food Standards Agency (FSA) has drastically reduced the recommended safe daily dose of cannabidiol (CBD), the cannabis extract used in many consumable goods from gummies to mints, oils to tea bags.

The FSA says the change is based on new evidence from the industry and updated advice from its independent scientific committee, which suggests that long-term daily chronic use of pure form CBD (≥98% purity) at intake levels higher than 10 mg CBD/day could contribute to the development of adverse effects over time, most notably in the liver.  Previous advice, dating from 2020, set the limit at 70mg per day. 10 mg is about 4-5 drops of 5% CBD oil.

Professor Robin May, Chief Scientific Advisor, FSA said: “The more CBD you consume over your lifetime, the more likely you are to develop long-term adverse effects, like liver damage or thyroid issues. The level of risk is related to how much you take, in the same way it is with some other potentially harmful products such as alcoholic drinks.”

Emily Miles, CEO, FSA said: “We have always advised the public to think carefully about taking edible CBD products and as with all foods, we continue to review our advice based on the evidence we gather from industry.

The FSA says its previous consumer advice, in February 2020, recommending that healthy adults do not take more than 70mg of CBD per day, ‘was based on limited evidence where CBD was studied as a medicine, and where the dosage is determined by balancing the benefit of the drug with the potential side-effects’.  The updated advice is based on the review of data specific to CBD use in food.

Miles added, “We understand that this change to our advice will have implications for products currently on the market that contain more than 10mg of CBD per serving. We will be working closely with industry to minimise the risk, to ensure consumers are not exposed to potentially harmful levels of CBD.” 

“There is an argument that the guidance is too cautious, but I think it alleviates potential concerns about long-term dosing.”

Professor Harry Sumnall, Professor of Substance Use, School of Psychology and Public Health Institute, Liverpool John Moores University says that while clinical studies show adverse effects of acute administration of high doses of CBD, these are generally not serious.

“Reviews seem to suggest that daily doses of up to 400mg are generally well tolerated in humans.  However, much of the research is from short term studies and there is a lack of toxicological data on long-term administration of CBD.”

Sumnall adds that the FSA considered rodent toxicity studies and applied a standard 100-fold uncertainty factor to estimate an equivalent dose for humans. They then applied an additional 3-fold uncertainty factor, giving a final 300-fold safety factor. “I think that the FSA recommendation is conservative and sufficiently precautionary. There is an argument that the guidance is too cautious, but I think it alleviates potential concerns about long-term dosing.”

The Association for the Cannabinoid Industry (ACI) says the FSA’s updated guidance is “causing substantial anxiety among brands, manufacturers, retailers and the public.” The organisation is seeking clarification on the process behind the FSA’s new recommended safe daily dose, and its statement says that having sought scientific, legal and regulatory advice, the ACI is requesting further clarity from the regulator and relevant committees, particularly around the datasets and criteria used.

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