Volume 31, Issue 11, 2 November 2014, Pages 1783-1793
a Netherlands Food and Consumer Product Safety Authority (NVWA), Consumer and Safety Division, Utrecht, Netherlands
b National Institute for Public Health and the Environment (RIVM), Center for Health Protection, Bilthoven, Netherlands
c RIKILT Institute of Food Safety, Wageningen, Netherlands
b National Institute for Public Health and the Environment (RIVM), Center for Health Protection, Bilthoven, Netherlands
c RIKILT Institute of Food Safety, Wageningen, Netherlands
Abstract
Herbal food supplements claiming to reduce weight may contain active pharmacological ingredients (APIs) that can be used for the treatment of overweight and obesity. The aim of this study was to determine whether herbal food supplements for weight loss on theDutch market contain APIs with weight loss properties. Herbal food supplements intended for weight loss (n = 50) were sampled from August 2004 to May 2013. An HPLC-DAD-MS/MS method was used to screen for the presence of the APIs in herbal supplements. In 24 samples the APIs sibutramine, desmethylsibutramine (DMS), didesmethylsibutramine (DDMS), rimonabant, sildenafil and/or the laxative phenolphthalein were identified 41 times. The presence of these APIs was, however, not stated on the label. The potential pharmacological effects of the detected APIs were estimated using data from reported effective doses of approved drugs. Use of 20 of the 24 herbal food supplements may result in potential pharmacological effects. Furthermore, risk assessment of phenolphthalein, a suspected carcinogen and found to be present in 10 supplements, based on the margin of exposure (MOE) approach, resulted in MOE values of 96–30 000. MOE values lower than 10 000 (96–220) were calculated for the daily intake levels of four out of these 10 supplements in which phenolphthalein was found. However, taking into account that weight loss preparations may be used for only a few weeks or months rather than during a lifetime, MOE values may be two to three orders of magnitude higher. The current study shows that the use of food supplements with sibutramine, DMS, DDMS and/or phenolphthalein could result in pharmacological effects. © 2014, © 2014 Taylor & Francis.
Author keywords
(di)desmethylsibutramine; herbal food supplements; phenolphthalein; rimonabant; sibutramine
Indexed keywords
Engineering controlled terms: Commerce; Drug dosage
(di)desmethylsibutramine; Food supplements; phenolphthalein; Rimonabant; sibutramine
Engineering main heading: Risk assessment
EMTREE drug terms: carcinogen; dinorsibutramine; norsibutramine; phenolphthalein; rimonabant; sibutramine; sildenafil; unclassified drug; antiobesity agent; phenolphthalein
EMTREE medical terms: Article; diet supplementation; exposure; food analysis; high performance liquid chromatography; market; Netherlands; risk assessment; tandem mass spectrometry; weight reduction; analysis; diet supplementation; diet therapy; human; obesity
MeSH: Anti-Obesity Agents; Chromatography, High Pressure Liquid; Dietary Supplements; Food Analysis; Humans; Netherlands; Obesity; Phenolphthalein; Risk Assessment; Tandem Mass Spectrometry; Weight Loss
Medline is the source for the MeSH terms of this document.
Medline is the source for the MeSH terms of this document.
Chemicals and CAS Registry Numbers: phenolphthalein, 5768-87-6, 77-09-8; rimonabant, 158681-13-1, 168273-06-1; sibutramine, 106650-56-0; sildenafil, 139755-83-2;Anti-Obesity Agents; Phenolphthalein
ISSN: 19440049Source Type: Journal Original language: English
Publisher: Taylor and Francis Ltd.
