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This paper reports the presence of undeclared drugs in the herbal slimming supplement Sulami®. The four cases of the adverse drug reactions related to Sulami® were reported to the Dutch Pharmacovigilance Centre (Lareb) or the Dutch Poisons Information Centre (DPIC). The analysis of all four collected samples revealed adulteration with sibutramine and canrenone. Both drugs can cause serious adverse drug reactions. From a legal point of view, it is clear that Sulami® does not meet the legal requirement for safety. As defined in the European General Food Law Regulation, food business operators are responsible for food safety. This also applies to online store owners who sell herbal preparations. Thus, it is clear that it is forbidden to sell Sulami® on the European and Dutch market. Collaboration between involved national authorities makes it possible to identify risky products. This allows the nationally responsible regulators to take targeted action. They can call on users to report sell points what makes it possible to arrest the sellers and confiscate the dangerous products. Beyond the national, also, the European enforcement organizations should take legal measures where possible, to protect public health. The Heads of Food Safety Agencies Working Group on Food Supplements "an Initiative on European level" is a good example of efforts to improve consumer safety. [ABSTRACT FROM AUTHOR]

Tea tree (Melaleuca alternifolia) essential oil is widely used as an antiseptic. It mainly consists of monoterpenes with terpinen‐4‐ol as the major constituent. The aim of this study was to review literature on safety data about tea tree oil and to assess its safety by investigating 159 cases of adverse reactions possibly caused by the oil, reported to the World Health Organization (WHO) from December 1987 until September 2021. To extract these data, VigiBase, the WHO global database of individual case safety reports maintained by the Uppsala Monitoring Centre (UMC), was used. All cases were categorized and analysed and 16 serious cases further assessed. It was concluded that tea tree oil should never be administered orally, as it can lead to central nervous system depression and pneumonitis. Applied topically, skin disorders may occur, especially when the oil had been exposed to light or air. This yields monoterpene oxidation products, being potent skin irritants. Tea tree oil stored under appropriate conditions and not exceeding the expiration date should be considered safe to use by non‐vulnerable people for non‐serious inflammatory skin conditions, although the occurrence of adverse reactions such as contact allergies is difficult to predict. [ABSTRACT FROM AUTHOR]

Serious concerns are expressed on the safe use of red yeast rice (RYR) supplements. The aim of the present study was to analyse cases received by Lareb on RYR‐related adverse health events. These cases were analysed for the number of reports, number of adverse drug reactions (ADRs), causality, seriousness of the reaction, latency‐period, age and sex of the patients, concomitant medication and type of reporter. A total of 94 individual reports were collected by Lareb, corresponding with 187 ADRs. The analysis showed most reported ADRs were labelled musculoskeletal and connective tissue disorders (n = 64), gastrointestinal disorders (n = 33) and general disorders and administration site conditions (n = 23). The use of RYR supplements should be considered as a significant safety concern. Exposure to monacolin K could lead to serious adverse effects. To fully assess the safety profile of RYR supplements, more research is necessary to compose a complete ADR profile of RYR supplements. [ABSTRACT FROM AUTHOR]