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CBD, FSA reviews recommendations to consumers in UK

On 12 October 2023, the Food Standards Agency (FSA, UK) updated its recommendations on the consumption of CBD, reducing the provisional acceptable daily dose as a precaution.

The studies collected as part of the approval procedures for cannabidiol as a 'novel food' suggest limiting the daily consumption of pure CBD (>98%) by adults to 70 to 10 mg. (1)

1) FSA, UK. New recommendations on CBD consumption

The ACNFP Committees (Advisory Committee on Novel Foods and Processes) and COT (Committee on Toxicity) of the Food Standards Agency have published a joint position on the consumption of CBD, in light of new scientific evidence collected in the context of its evaluation as a 'novel food'. (2)

The new recommendations they consider the average exposure to CBD through foods, drinks and dietary supplements. Some studies suggest that the daily intake of pure CBD (>98%) in quantities greater than 10 mg (0,15 mg/kg body weight) could contribute to causing, in the long term, adverse health effects such as:

– liver and thyroid disorders,
– drowsiness,
– interactions with some drugs.

FSA therefore recommends consumers to check the quantity of CBD contained in each portion on the labels of food products and consider 10 mg per day as a reference parameter.

2) Population groups considered

The agencies British and Scottish authorities responsible for food safety, on the other hand, do not indicate a provisional acceptable daily dose of CBD for people belonging to vulnerable population groups (i.e. pregnant and breastfeeding women, children, 'intended parents' and 'people taking prescription drugs'). medical'), suggesting that they take cannabidiol under the supervision of a doctor.

3) Reasons for the revision

Revision of the provisional acceptable daily dose of CBD by FSA – indeed drastic, from 70 to 10 mg/day (3) – is explained by the different approaches to risk assessment adopted, respectively, for drugs and foods:

– safety tests and dosages of drugs are determined by balancing their treatment effects with potential side effects, also taking into account the duration of treatment,

– foods, including food supplements, cannot, on the other hand, boast any disease prevention or treatment properties. (4) Their safety must therefore be evaluated in absolute terms, without having regard to their potential beneficial effects (5,6).

4) 'CBD as a novel food'? The useful ideas offered by FSA

Food Standards Agency, in reviewing its recommendations on the consumption of CBD, on closer inspection offers useful insights into the scientific evidence necessary to carry out the authorization procedures for cannabidiol as a novel food:

– the previous recommendation was based on 'limited evidence where CBD has been studied as a drug, where the dosage is determined',

– the new recommendation instead considers a scenario of 'chronic exposure', i.e. the continuous and prolonged daily consumption of foods.

EFSA moreover, he had already underlined how the scientific studies included in the first 19 'novel food' authorization dossiers concerned a drug (Epidiolex) and not CBD as an ingredient in foods and/or food supplements. (7)

Our team di FARE is available to operators who intend to carry out authorization dossiers for 'novel food', food additives and other substances and/or ingredients and/or regulated products, as well as 'Nutrition and Health Claims,

Dario Dongo

Footnotes

(1) Food Standards Agency and Food Standards Scotland update consumer advice for CBD. 12 October 2023 https://tinyurl.com/yc48rzen

(2) FSA. Joint position paper from the Advisory Committee on Novel Foods and Processes (ACNFP) & Committee on Toxicity (COT) on establishing a provisional acceptable daily intake (ADI) for pure form (≥98%) cannabidiol (CBD) in foods, based on new evidence https://tinyurl.com/39c2xx36

(3) Dario Dongo. CBD, the Food Standards Agency updates British consumers. GIFT (Great Italian Food Trade).

(4) The thin 'red line' that demarcates foods from medicines is drawn in the Nutrition and Health Claims Regulation (EC) No 1924/06, where commercial information relating to foods can boast the ability to prevent risk factors of diseases (for example, by contributing to the reduction of blood cholesterol. NHCR, article 14). However, it is not permitted to state, on food labels and advertising, 'the property of preventing, treating, or curing a human disease' (e.g. pathologies and/or cardiovascular events). This prohibition is provided for in the Food Information Regulation (EU) No 1169/11, Article 7, paragraph 3

(5) General Food Law therefore defines food safety in terms of safety in the short and long term, also taking into account the possible effects on descendants (i.e. endocrine interference, genotoxicity) and cumulative chronic toxic effects. See Regulation (EC) No 178/02, article 14

(6) Food must also be safe for vulnerable categories of consumers. To this end, the risk assessment must also consider the information accompanying the foods (EC Reg. No 178/02, art. 14). This rule, if you look closely:

– finds correct application in the case of allergens, the presence of which must always be indicated even in cases of foods sold loose, or pre-wrapped, or administered by food outlets (EU Reg. 1169/11, articles 21 and 44, Annex IV) ,

– however, it is not applied in the case of alcoholic beverages, which still lack uniform labeling rules aimed at at least warning minors and pregnant women about the risks associated with their consumption

(7) Dario Dongo, Andrea Adelmo Della Penna. CBD like Novel Food, EFSA's yellow light. GIFT (Great Italian Food Trade).

 

Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.

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