title: Assessing herbal products with health claims.
abstract: Herbs, herbal extracts, or phytochemicals are broadly used as foods, drugs, and as traditional medicines. These are well regulated in Europe, with thorough controls on both safety and efficacy or validity of health claims. However, the distinction between medicines and foods with health claims is not always clear. In addition, there are several cases of herbal products that claim benefits that are not scientifically demonstrated. This review details the European Union (EU) legislative framework that regulates the approval and marketing of herbal products bearing health claims as well as the scientific evidence that is needed to support such claims. To illustrate the latter, we focus on phytoecdysteroid (PE)-containing preparations, generally sold to sportsmen and bodybuilders. We review the limited published scientific evidence that supports claims for these products in humans. In addition, we model the in silico binding between different PEs and human nuclear receptors and discuss the implications of these putative bindings in terms of the mechanism of action of this family of compounds. We call for additional research to validate the safety and health-promoting properties of PEs and other herbal compounds, for the benefit of all consumers.
authors.affiliation: a European Commission, Joint Research Centre (JRC), Institute for Health and Consumer Protection (IHCP), Public Health Policy Support Unit, Ispra (VA) , Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Lapenna
authors.forename: Raymond
authors.initials: R
authors.lastname: Gemen
authors.forename: Jan
authors.initials: J
authors.lastname: Wollgast
authors.forename: Andrew
authors.initials: A
authors.lastname: Worth
authors.forename: Petros
authors.initials: P
authors.lastname: Maragkoudakis
authors.forename: Sandra
authors.initials: S
authors.lastname: Caldeira
mesh_terms: D000818:Animals; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D026461:Ecdysteroids / Q000737:chemistry / Q000494:pharmacology; D005062:European Union / Q000458:organization & administration; D029001:Herbal Medicine / Q000331:legislation & jurisprudence / Q000379:methods*; D006801:Humans; D008322:Mammals; D040541:Marketing / Q000331:legislation & jurisprudence; D008519:Medicine, Traditional / Q000379:methods; D008954:Models, Biological; D008517:Phytotherapy; D028321:Plant Preparations / Q000494:pharmacology*; D010946:Plants, Medicinal / Q000737:chemistry
chemical_list: D026461:Ecdysteroids; D028321:Plant Preparations
keywords: 20-hydroxyecdysone; Herbal products; QSAR; ecdysteroids; health claims legislation; hormone nuclear receptors