title: Raspberry ketone in food supplements--High intake, few toxicity data--A cause for safety concern?
abstract: Raspberry ketone (4-(4-hydroxyphenyl)-2-butanone) is marketed on the Internet as a food supplement. The recommended intake is between 100 and 1400 mg per day. The substance is naturally occurring in raspberries (up to 4.3 mg/kg) and is used as a flavouring substance. Toxicological studies on raspberry ketone are limited to acute and subchronic studies in rats. When the lowest recommended daily dose of raspberry ketone (100 mg) as a food supplement is consumed, it is 56 times the established threshold of toxicological concern (TTC) of 1800 μg/day for Class 1 substances. The margin of safety (MOS) based on a NOAEL of 280 mg/kg bw/day for lower weight gain in rats is 165 at 100 mg and 12 at 1400 mg. The recommended doses are a concern taking into account the TTC and MOS. Investigations of raspberry ketone in quantitative structure-activity relationship (QSAR) models indicated potential cardiotoxic effects and potential effects on reproduction/development. Taking into account the high intake via supplements, the compound's toxic potential should be clarified with further experimental studies. In UK the pure compound is regarded as novel food requiring authorisation prior to marketing but raspberry ketone is not withdrawn from Internet sites from this country.
authors.affiliation: Technical University of Denmark, National Food Institute, Mørkhøj Bygade 19, DK-2860 Søborg, Denmark. Electronic address: leab@food.dtu.dk.
authors.forename: Lea
authors.initials: L
authors.lastname: Bredsdorff
authors.affiliation: Technical University of Denmark, National Food Institute, Mørkhøj Bygade 19, DK-2860 Søborg, Denmark. Electronic address: ebawe@food.dtu.dk.
authors.forename: Eva Bay
authors.initials: EB
authors.lastname: Wedebye
authors.affiliation: Technical University of Denmark, National Food Institute, Mørkhøj Bygade 19, DK-2860 Søborg, Denmark. Electronic address: nign@food.dtu.dk.
authors.forename: Nikolai Georgiev
authors.initials: NG
authors.lastname: Nikolov
authors.affiliation: Technical University of Denmark, National Food Institute, Mørkhøj Bygade 19, DK-2860 Søborg, Denmark. Electronic address: tohal@food.dtu.dk.
authors.forename: Torben
authors.initials: T
authors.lastname: Hallas-Møller
authors.affiliation: Technical University of Denmark, National Food Institute, Mørkhøj Bygade 19, DK-2860 Søborg, Denmark. Electronic address: kpil@food.dtu.dk.
authors.forename: Kirsten
authors.initials: K
authors.lastname: Pilegaard
mesh_terms: D000818:Animals; D002074:Butanones / Q000633:toxicity*; D019587:Dietary Supplements / Q000032:analysis* / Q000633:toxicity*; D005421:Flavoring Agents / Q000633:toxicity; D019055:No-Observed-Adverse-Effect Level; D021281:Quantitative Structure-Activity Relationship; D051381:Rats; D012449:Safety
chemical_list: D002074:Butanones; D005421:Flavoring Agents; C035522:raspberry ketone
keywords: 4-(4-hydroxyphenyl)-2-butanone; Flavouring; Food supplement; Margin of safety; Natural; Novel food; Raspberry ketone; Threshold of toxicological concern; Toxicity; Weight loss