Risk assessment of plant food supplements and other herbal products containing aristolochic acids using the margin of exposure (MOE) approach

Rozaini Abdullah,Sebastiaan Wesseling,Leolean Nyle Diaz,Ivonne M C M Rietjens

doi:10.1080/19440049.2016.1266098

Rozaini Abdullah, Sebastiaan Wesseling + Show 2 more

Open Access

https://doi.org/10.1080/19440049.2016.1266098

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Abstract

ABSTRACTAfter the incidences of induction of aristolochic acid nephropathy after consumption of herbal weight loss preparations that accidentally contained aristolochic acids (AAs), several countries defined national restrictions on the presence of AAs in food, including plant food supplements (PFS) and herbal products. This study investigates whether the risks associated with exposure to AAs via PFS and herbal products are at present indeed negligible. Data reported in literature on AA levels in PFS and other herbal products and also obtained from a new series of PFS in the present study were used to calculate the estimated daily intakes (EDIs) and corresponding margins of exposure (MOEs). Available literature data revealed that 206 out of 573 samples were found to contain aristolochic acid I (AAI) and/or aristolochic acid II (AAII). The results obtained from recently collected PFS revealed that both AAI and AAII were detected in three out of 18 analysed PFS at levels up to 594.8 and 235.3 µg g–1, respectively, being in line with the levels reported in literature. The EDIs resulting from intake of these PFS resulted in MOEs that were generally below 10,000, corroborating the priority for risk management. Although these results refer to PFS collected by targeted sampling strategies, the data reveal that AA-containing PFS are still freely available. When considering that the use of these samples may be limited to shorter periods of time, the EDIs might be lower, but MOE values would still be lower than 10,000 for more than 50% of the AA-containing PFS and herbal products. In conclusion, the presence of AAs in PFS and herbal products even several years after instalment of the legal restrictions still raises concern, especially for people who frequently use the respective PFS and herbal products.

Highlights

Plant food supplements (PFS) and other herbal products are widely consumed for their perceived health benefits
A risk assessment for aristolochic acids (AAs) resulting from the intake of PFS and herbal products was performed using the margins of exposure (MOEs) approach
It is interesting to note that Aristolochia sp. have been banned from being present in food, including food supplements, AAs can still be found in some of the PFS. This conclusion is in line with what was found for other PFS samples and analysed after instalment of the ban in the Netherlands, the UK, the United States, Canada and Australia in 2001 (USFDA 2001; IARC 2002; Martena et al 2007), and in Taiwan in 2003 (Lai et al 2010)

Summary

Introduction

Plant food supplements (PFS) and other herbal products are widely consumed for their perceived health benefits. It is important to note that most of these traditional botanical products have never been the subject of thorough pre-marketing toxicological safety assessment as required, for example, for modern pharmaceuticals or food additives (Schilter et al 2003; Speijers et al 2010). Based on their traditional use for long periods of time, these botanical preparations are often assumed to be safe. AAs have been proven to cause nephrotoxicity, genotoxicity and carcinogenicity and have been classified by the IARC in group 1, meaning that there is sufficient evidence that they cause tumours in humans (IARC 2002)

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