Time Trends of Tetrahydrocannabinol (THC) in a 2008–2021 German National Survey of Hemp Food Products

Dräger, Hannah; Barthlott, Ines; Golombek, Patricia; Walch, Stephan G.; Lachenmeier, Dirk W.

doi:10.3390/foods11030486

Cited by 10 publications

(6 citation statements)

References 20 publications

(45 reference statements)

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“…The values were also compared with literature values of ∆ 9 -THC analyzed in food supplements between 2018 and 2021. These were generated within the framework of official food control in Germany according to validated and externally accredited methods [11]. a The data were taken from the EU's Rapid Alert System for Food and Feed (RASFF) or from a general survey in the literature [11].…”

Section: Resultsmentioning

confidence: 99%

“…There is a great deal of uncertainty about the risk assessment of Δ 9 -THC in food, so work should be done to establish limits within the context of the novel food approva Normal probability distribution of ∆ 9 -tetrahydrocannabinol levels in food supplements comparing data from the RASFF system assessed as being of serious risk and undecided risk level with literature data [11]. The red line marks the suggested level above which a serious risk can be typically assumed.…”

Section: Resultsmentioning

confidence: 99%

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The Challenge of Risk Assessment of Tetrahydrocannabinol (THC) in Cannabidiol (CBD) Oils and Food Supplements: An Approach for Deriving Maximum Limits

et al. 2022

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Information about unsafe foods or feeds must be exchanged between European Union (EU) member states as quickly as possible. This is why the EU’s Rapid Alert System for Food and Feed (RASFF) exists. It helps to ensure that products that may be harmful to health do not enter the market or can be specifically withdrawn from the market. Different notifications are used depending on the risk and urgency. This article provides an overview of the 61 notifications in the RASFF between 2020 and 2022 on the Δ9-tetrahydrocannabinol (Δ9-THC) content in cannabidiol (CBD) oils and CBD food supplements. These products are available on the EU market despite the lack of novel food approval. Δ9-THC is a naturally occurring psychotropic compound extracted from the hemp plant Cannabis sativa that can have adverse effects on consumers (such as drowsiness, dizziness, tachycardia, or changes in blood pressure). In a previous German national survey, 23 of the 125 products tested (18%) exceeded the lowest observed adverse effect level (LOAEL) of Δ9-THC. In comparison, for products identified as a serious risk in the RASFF, the Δ9-THC concentrations were generally higher (up to 2410 mg/kg) and 14 of 34 products (41%) exceeded the LOAEL. Considering these data, a threshold of 500 mg/kg (0.05%) may be proposed to define a serious risk, as the LOAEL would not be exceeded in typical consumption scenarios below this level and serious risks, as well as narcotic effects in the product group of food supplements, could be excluded. This threshold could be used in the interim until the full toxicological assessment is available within the novel food approval procedure.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

The Challenge of Risk Assessment of Tetrahydrocannabinol (THC) in Cannabidiol (CBD) Oils and Food Supplements: An Approach for Deriving Maximum Limits

et al. 2022

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“…2 of 8 authorisation. Despite being widely advertised and sold in increasing quantities, all available CBD oils and CBD-containing food supplements in the EU are, therefore, currently placed on the market with an infringement of the food laws [4]. This is not a niche anymore as the total EU CBD market was valued at EUR 1.6 billion in 2020 [5].…”

Section: Introductionmentioning

confidence: 99%

Does Cannabidiol (CBD) in Food Supplements Pose a Serious Health Risk? Consequences of the EFSA Clock Stop Regarding Novel Food Authorisation

Lachenmeier¹,

Sproll²,

Golombek³

et al. 2022

Preprint

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In the European Union (EU), cannabidiol products require pre-marketing authorisation under the novel food regulation. Currently, 19 CBD applications are under assessment at the European Food Safety Authority (EFSA). During the initial assessment of the application files, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) located several knowledge gaps in their 07 June 2022 statement on safety of cannabidiol as a novel food that need to be addressed before the evaluation of CBD can be concluded. Namely, the effect of CBD on the liver, gastrointestinal tract, endocrine system, nervous system, psychological function, and reproductive system needs to be clarified. Nevertheless, the available literature allows a benchmark dose (BMD)-response modelling of several bioassays, resulting in a BMD lower confidence limit (BMDL) of 20 mg/kg bw/day for liver toxicity in rats. Human data in healthy volunteers found increases in the liver enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in a study at 4.3 mg/kg bw/day, which was defined by EFSA NDA panel as a lowest observed adverse effect level (LOAEL). The EFSA NDA panel currently concluded that the safety of CBD as a novel food cannot be evaluated, leading to a so-called clock stop of the applications until the applicants provide the required data. Meanwhile, the authors suggest that CBD products still available as food supplements on the EU market despite the lack of authorisation must be considered as “unsafe”. Products exceeding a health-based guidance value of 10 mg/day must be considered as being “unfit for consumption” (Article 14(1) and (2) (b) of Regulation No 178/2002), while the ones in exceedance of the human LOAEL must be considered “injurious to health” (Article 14(1) and (2) (a) of Regulation No 178/2002).

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“…Hence, CBD products to be marketed as foods or food supplements in the EU, need prior authorisation. Despite being widely advertised and sold in increasing quantities, all available CBD oils and CBD-containing food supplements in the EU are, therefore, currently placed on the market with an infringement of the food laws [4]. This is not a niche anymore as the total EU CBD market was valued at EUR 1.6 billion in 2020 [5].…”

Section: Introductionmentioning

confidence: 99%

Does Cannabidiol (CBD) in Food Supplements Pose a Serious Health Risk? Consequences of the EFSA Clock Stop Regarding Novel Food Authorisation

Lachenmeier¹,

Sproll²,

Golombek³

et al. 2022

Preprint

Self Cite

View full text Add to dashboard Cite

At present, foods containing cannabidiol (CBD) and other cannabinoids are internationally being widely advertised and sold in increasing quantities. In the European Union (EU), these products require pre-marketing authorisation under the novel food regulation, so that all available CBD oils and CBD-containing food supplements in the EU are currently placed on the market with an infringement of the food laws. Currently, 19 CBD applications are under assessment at the European Food Safety Authority (EFSA). During the initial assessment of the application files, EFSA located several knowledge gaps that need to be addressed before the safety evaluation of CBD can be concluded. Namely, the effect of CBD on the liver, gastrointestinal tract, endocrine system, nervous system, psychological function, and reproductive system needs to be clarified. Nevertheless, the available literature allows a benchmark dose (BMD)-response modelling of several bioassays, resulting in a BMD lower confidence limit (BMDL) of 20 mg/kg bw/day for liver toxicity in rats. Human data in healthy volunteers found increases in the liver enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in a study at 4.3 mg/kg bw/day, which was defined by EFSA as a lowest observed adverse effect level (LOAEL). The EFSA panel currently concluded that the safety of CBD as a novel food cannot be evaluated, leading to a so-called clock stop of the applications until the applicants provide the required data. Meanwhile, the authors suggest that CBD products still available on the EU market despite the lack of authorisation must be considered as “unsafe”. Products exceeding a reference dose of 10 mg/day must be considered as being “unfit for consumption” (Article 14(1) and (2) (b) of Regulation No 178/2002), while the ones in exceedance of the human LOAEL must be considered “injurious to health” (Article 14(1) and (2) (a) of Regulation No 178/2002).

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Time Trends of Tetrahydrocannabinol (THC) in a 2008–2021 German National Survey of Hemp Food Products

Cited by 10 publications

References 20 publications

The Challenge of Risk Assessment of Tetrahydrocannabinol (THC) in Cannabidiol (CBD) Oils and Food Supplements: An Approach for Deriving Maximum Limits

The Challenge of Risk Assessment of Tetrahydrocannabinol (THC) in Cannabidiol (CBD) Oils and Food Supplements: An Approach for Deriving Maximum Limits

Does Cannabidiol (CBD) in Food Supplements Pose a Serious Health Risk? Consequences of the EFSA Clock Stop Regarding Novel Food Authorisation

Does Cannabidiol (CBD) in Food Supplements Pose a Serious Health Risk? Consequences of the EFSA Clock Stop Regarding Novel Food Authorisation

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