title: Active pharmaceutical ingredients detected in herbal food supplements for weight loss sampled on the Dutch market.
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 the Dutch 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.
authors.affiliation: a Netherlands Food and Consumer Product Safety Authority (NVWA) , Consumer and Safety Division , Utrecht , the Netherlands.
authors.forename: Noortje M
authors.initials: NM
authors.lastname: Reeuwijk
authors.forename: Bastiaan J
authors.initials: BJ
authors.lastname: Venhuis
authors.forename: Dries
authors.initials: D
authors.lastname: de Kaste
authors.forename: Ron L A P
authors.initials: RL
authors.lastname: Hoogenboom
authors.forename: Ivonne M C M
authors.initials: IM
authors.lastname: Rietjens
authors.forename: Martijn J
authors.initials: MJ
authors.lastname: Martena
mesh_terms: D019440:Anti-Obesity Agents / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D019587:Dietary Supplements / Q000032:analysis*; D005504:Food Analysis; D006801:Humans; D009426:Netherlands; D009765:Obesity / Q000178:diet therapy*; D020113:Phenolphthalein / Q000032:analysis / Q000633:toxicity; D018570:Risk Assessment; D053719:Tandem Mass Spectrometry; D015431:Weight Loss
chemical_list: D019440:Anti-Obesity Agents; D020113:Phenolphthalein
keywords: (di)desmethylsibutramine; herbal food supplements; phenolphthalein; rimonabant; sibutramine