scholarly journals Are adverse effects of cannabidiol (CBD) products caused by tetrahydrocannabinol (THC) contamination?

F1000Research ◽  
2021 ◽  
Vol 8 ◽  
pp. 1394
Author(s):  
Dirk W. Lachenmeier ◽  
Stephanie Habel ◽  
Berit Fischer ◽  
Frauke Herbi ◽  
Yvonne Zerbe ◽  
...  
Keyword(s):  
Adverse Effect ◽  
Adverse Effects ◽  
Mass Spectrometric ◽  
Dose Effect ◽  
German Market ◽  
Food Ingredients ◽  
Adverse Effect Level ◽  
Effect Level ◽  
Tandem Mass Spectrometric ◽  
Liquid Chromatographic

Cannabidiol (CBD)-containing products are widely marketed as over the counter products, mostly as food supplements. Adverse effects reported in anecdotal consumer reports or during clinical studies were first assumed to be due to hydrolytic conversion of CBD to psychotropic Δ9-tetrahydrocannabinol (Δ9-THC) in the stomach after oral consumption. However, research of pure CBD solutions stored in simulated gastric juice or subjected to various storage conditions such as heat and light with specific liquid chromatographic/tandem mass spectrometric (LC/MS/MS) and ultra-high pressure liquid chromatographic/quadrupole time-of-flight mass spectrometric (UPLC-QTOF) analyses was unable to confirm THC formation. Another hypothesis for the  adverse effects of CBD products may be residual Δ9-THC concentrations in the products as contamination, because most of them are based on hemp extracts containing the full spectrum of cannabinoids besides CBD. Analyses of 181 food products of the German market (mostly CBD oils) confirmed this hypothesis: 21 products (12%) contained Δ9-THC above the lowest observed adverse effect level (2.5 mg/day). Inversely, CBD was present in the products below the no observed adverse effect level. Hence, it may be assumed that the adverse effects of some commercial CBD products are based on a low-dose effect of Δ9-THC and not due to effects of CBD itself. The safety, efficacy and purity of commercial CBD products is highly questionable, and all of the products in our sample collection showed various non-conformities to European food law such as unsafe Δ9-THC levels, hemp extracts or CBD isolates as non-approved novel food ingredients, non-approved health claims, and deficits in mandatory food labelling requirements. In view of the growing market for such lifestyle products, the effectiveness of the instrument of food business operators' own responsibility for product safety and regulatory compliance must obviously be challenged, and a strong regulatory framework for hemp products needs to be devised.

scholarly journals Are side effects of cannabidiol (CBD) products caused by tetrahydrocannabinol (THC) contamination?

F1000Research ◽  
2020 ◽  
Vol 8 ◽  
pp. 1394 ◽  
Author(s):  
Dirk W. Lachenmeier ◽  
Stephanie Habel ◽  
Berit Fischer ◽  
Frauke Herbi ◽  
Yvonne Zerbe ◽  
...  
Keyword(s):  
Side Effects ◽  
Adverse Effects ◽  
Mass Spectrometric ◽  
Health Claims ◽  
Dose Effect ◽  
Full Spectrum ◽  
German Market ◽  
Food Ingredients ◽  
Tandem Mass Spectrometric ◽  
Liquid Chromatographic

Cannabidiol (CBD)-containing products are widely marketed as over the counter products, mostly as food supplements, to avoid the strict rules of medicinal products. Side-effects reported in anecdotal consumer reports or during clinical studies were first assumed to be due to hydrolytic conversion of CBD to psychotropic Δ9-tetrahydrocannabinol (THC) in the stomach after oral consumption. However, research of pure CBD solutions stored in simulated gastric juice or subjected to various storage conditions such as heat and light with specific liquid chromatographic/tandem mass spectrometric (LC/MS/MS) and ultra-high pressure liquid chromatographic/quadrupole time-of-flight mass spectrometric (UPLC-QTOF) analyses was unable to confirm THC formation. Another hypothesis for the side-effects of CBD products may be residual THC concentrations in the products as contamination, because most of them are based on crude hemp extracts containing the full spectrum of cannabinoids besides CBD. Analyses of 67 food products of the German market (mostly CBD oils) confirmed this hypothesis: 17 products (25%) contained THC above the lowest observed adverse effects level (2.5 mg/day). Inversely, CBD was present in the products below the no observed adverse effect level. Hence, it may be assumed that the adverse effects of some commercial CBD products are based on a low-dose effect of THC and not due to effects of CBD itself. The safety, efficacy and purity of commercial CBD products is highly questionable, and all of the products in our sample collection showed various non-conformities to European food law such as unsafe THC levels, full-spectrum hemp extracts as non-approved novel food ingredients, non-approved health claims, and deficits in mandatory food labelling requirements. In view of the growing market for such lifestyle products, the effectiveness of the instrument of food business operators' own responsibility for product safety must obviously be challenged.

scholarly journals Are side effects of cannabidiol (CBD) products caused by tetrahydrocannabinol (THC) contamination?

F1000Research ◽  
2020 ◽  
Vol 8 ◽  
pp. 1394 ◽  
Author(s):  
Dirk W. Lachenmeier ◽  
Stephanie Habel ◽  
Berit Fischer ◽  
Frauke Herbi ◽  
Yvonne Zerbe ◽  
...  
Keyword(s):  
Side Effects ◽  
Adverse Effects ◽  
Mass Spectrometric ◽  
Health Claims ◽  
Dose Effect ◽  
Full Spectrum ◽  
German Market ◽  
Food Ingredients ◽  
Tandem Mass Spectrometric ◽  
Liquid Chromatographic

Cannabidiol (CBD)-containing products are widely marketed as over the counter products, mostly as food supplements, to avoid the strict rules of medicinal products. Side-effects reported in anecdotal consumer reports or during clinical studies were first assumed to be due to hydrolytic conversion of CBD to psychotropic Δ9-tetrahydrocannabinol (Δ9-THC) in the stomach after oral consumption. However, research of pure CBD solutions stored in simulated gastric juice or subjected to various storage conditions such as heat and light with specific liquid chromatographic/tandem mass spectrometric (LC/MS/MS) and ultra-high pressure liquid chromatographic/quadrupole time-of-flight mass spectrometric (UPLC-QTOF) analyses was unable to confirm THC formation. Another hypothesis for the side-effects of CBD products may be residual Δ9-THC concentrations in the products as contamination, because most of them are based on crude hemp extracts containing the full spectrum of cannabinoids besides CBD. Analyses of 67 food products of the German market (mostly CBD oils) confirmed this hypothesis: 17 products (25%) contained Δ9-THC above the lowest observed adverse effects level (2.5 mg/day). Inversely, CBD was present in the products below the no observed adverse effect level. Hence, it may be assumed that the adverse effects of some commercial CBD products are based on a low-dose effect of Δ9-THC and not due to effects of CBD itself. The safety, efficacy and purity of commercial CBD products is highly questionable, and all of the products in our sample collection showed various non-conformities to European food law such as unsafe Δ9-THC levels, full-spectrum hemp extracts as non-approved novel food ingredients, non-approved health claims, and deficits in mandatory food labelling requirements. In view of the growing market for such lifestyle products, the effectiveness of the instrument of food business operators' own responsibility for product safety must obviously be challenged.

scholarly journals Are side effects of cannabidiol (CBD) products caused by tetrahydrocannabinol (THC) contamination?

F1000Research ◽  
2019 ◽  
Vol 8 ◽  
pp. 1394 ◽  
Author(s):  
Dirk W. Lachenmeier ◽  
Stephanie Habel ◽  
Berit Fischer ◽  
Frauke Herbi ◽  
Yvonne Zerbe ◽  
...  
Keyword(s):  
Side Effects ◽  
Adverse Effects ◽  
Mass Spectrometric ◽  
Health Claims ◽  
Dose Effect ◽  
Full Spectrum ◽  
German Market ◽  
Food Ingredients ◽  
Tandem Mass Spectrometric ◽  
Liquid Chromatographic

Cannabidiol (CBD)-containing products are widely marketed as over the counter products, mostly as food supplements, to avoid the strict rules of medicinal products. Side-effects reported in anecdotal consumer reports or during clinical studies were first assumed to be due to hydrolytic conversion of CBD to psychoactive Δ9-tetrahydrocannainol (THC). However, research of pure CBD solutions stored in simulated gastric juice or subjected to various storage conditions such as heat and light with specific liquid chromatographic/tandem mass spectrometric (LC/MS/MS) and ultra-high pressure liquid chromatographic/quadrupole time-of-flight mass spectrometric (UPLC-QTOF) analyses was unable to confirm THC formation. Another hypothesis for the side-effects of CBD products may be residual THC concentrations in the products as contamination, because most of them are based on crude hemp extracts containing the full spectrum of cannabinoids besides CBD. Analyses of 28 food products of the German market containing hemp extract as an ingredient (mostly CBD oils) confirmed this hypothesis: 10 products (36%) contained THC above the lowest observed adverse effects level (2.5 mg/day). Inversely, CBD was present in the products below the no observed adverse effect level. Hence, it may be assumed that the adverse effects of some commercial CBD products are based on a low-dose effect of THC and not due to effects of CBD itself. The safety, efficacy and purity of commercial CBD products is highly questionable, and all of the products in our sample collection showed various non-conformities to European food law such as unsafe THC levels, full-spectrum hemp extracts as non-approved novel food ingredients, non-approved health claims, and deficits in mandatory food labelling requirements. In view of the growing market for such lifestyle products, the effectiveness of the instrument of food business operators' own responsibility for product safety must obviously be challenged.

1,1,2,2-Tetrafluoroethane (HFC-134) (2018)

2019 ◽  
Vol 35 (3) ◽  
pp. 196-203
Keyword(s):  
Adverse Effect ◽  
Adverse Effects ◽  
Toxicity Study ◽  
Whole Body ◽  
Exposure Level ◽  
Inhalation Toxicity ◽  
Hfc 134A ◽  
Adverse Effect Level ◽  
Effect Level ◽  
Whole Body Inhalation

1,1,2,2-Tetrafluoroethane (HFC-134) is a colorless gas used as a foam expansion agent and heat transfer fluid. HFC-134 has a low acute inhalation toxicity with an LC50 of >244,000 ppm. The no-observed adverse effect level (NOAEL) and lowest-observed adverse effect level for cardiac sensitization (in epinephrine-challenged beagle dogs) were 75,000 and 100,000 ppm, respectively. A subacute 4-week GLP inhalation toxicity study exposed male and female Crl: CD®BR rats (10/sex) to 0, 2000, 10,000, or 50,000 ppm via whole-body inhalation. Transient and non-dose-response–related body weight changes were observed throughout the exposure period, but no statistically significant, test substance-related adverse effects were observed in any clinical observations, chemistry, hematology, or pathology. This study identified a NOAEL for HFC-134 of 50,000 ppm, the highest exposure level tested. HFC-134 is not genotoxic in in vitro studies; however, no in vivo studies are available. No developmental or maternal toxicity was found in female rats exposed to HFC-134 up to 50,000 ppm via whole-body inhalation in two different studies. Based on data for a similar material (HFC-134a), HFC-134 is not expected to be extensively metabolized or to cause genetic toxicity or carcinogenicity. The HFC-134 workplace environmental exposure level (WEEL) is based primarily on the subacute 4-week inhalation toxicity study in rats with the NOAEL of 50,000 ppm selected as the point of departure for the derivation of the 8-h TWA, health-based WEEL value. The developmental toxicity study also had a NOAEL of 50,000 ppm and was the highest exposure level tested. The subacute inhalation NOAEL was adjusted to account for interindividual variability, subacute to chronic duration, animal to human extrapolation, daily duration of exposure, and residual uncertainty. In addition, the lack of adverse effects noted in the toxicology studies for HFC-134a was considered. The resulting 8-h TWA WEEL value of 1000 ppm is expected to provide a significant margin of safety against the production of any potential adverse health effects in workers following long-term inhalation exposure to HFC-134.

scholarly journals Food allergens: threshold levels and methodologies for risk management

Food systems ◽  
2022 ◽  
Vol 4 (4) ◽  
pp. 246-254
Author(s):  
E. V. Kryuchenko ◽  
Yu. A. Kuzlyakina ◽  
I. M. Chernukha ◽  
V. S. Zamula
Keyword(s):  
Risk Assessment ◽  
Risk Management ◽  
Food Products ◽  
Food Allergies ◽  
Food Allergens ◽  
Probability Models ◽  
Food Ingredients ◽  
Threshold Levels ◽  
Adverse Effect Level ◽  
Effect Level

Food allergies and allergen management are important problems of the public health and food industry. The idea of determining allergen concentrations in food ingredients and food products that are capable of causing severe allergic reactions is of great interest for regulatory bodies as well as consumer associations and the industry all over the world. In this connection, scientists proposed different approaches to determining the basis for assessment of severity of risks of food allergens for health of patients suffering from food allergy similar to methods of risk assessment for other hazards associated with food products (for example, chemical, microbiological). To assess risk of allergens, three different approaches were proposed: i) traditional risk assessment using the no observed adverse effect level (NOAEL)) and uncertainty factors; (ii) approach based on the benchmark dose (BMD)) and margin of exposure (MoE)); and (iii) probability models. These approaches can be used in risk management in food production and in the development of warning marking about the presence of allergens. The reliability of risk assessment will depend on a type, quality and quantity of data used for determining both population threshold levels (or threshold distributions) and an impact of an allergenic product/ingredient on a particular individual.

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