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Determination of ethylene oxide in botanical dietary supplements used in the treatment of IBD by gas chromatography-tandem mass spectrometry

The contamination of botanical dietary supplements with pesticide and fungicide ethylene oxide (EO) is well-recognized problem worldwide. Contamination of botanicals with pathogenic bacteria is attributed in part to growing conditions and environment, sanitation and hygiene practices among harvest workers, and lack of good agricultural and manufacturing practices within some developing countries. Processing methods for botanicals include fumigation with EO, irradiation, and vacuum-assisted steam. Moreover, capsule shells as the most used delivery system of botanical dietary supplements can be sterilized with EO by manufacturers before releasing to user enterprises. [1, 2] Due to its mutagenic and carcinogenic properties, herbal dietary supplements need to comply with the maximum residue level established by regulatory agencies. [3, 4] It is important to ensure that the levels of residual EO and its by-product 2-chloroethanol (2-CE) obtained by the reaction of acetaldehyde and chloride ion pose a minimal risk to the patient. The aim of this research was the assessment of EOTotal expressed as EO equivalents as the sum of native EO and 2-CE in 53 samples of dietary supplements used in the treatment of inflammatory bowel disease (IBD). 28 samples were obtained from local pharmacies and health food stores and 26 were purchased from the Internet. The dietary supplements analyzed in this work were in multiple oral dosage forms including tablets (6), hard capsules (25), soft capsules (4), powders (16) and liquid extracts (2). The main botanical ingredients included turmeric, Indian frankincense and green chiretta. The samples were analyzed using GC-MS/MS (model TQ8050, Shimadzu). In 25 samples (43%) EO and 2-CE were quantified in the range from 0.02 to 3.29 mg/kg. 2 samples (1 hard capsule and 1 tablet) contained levels higher than 1 mg/kg. This study provides a reference for regulatory bodies to routinely control the quality of botanical dietary supplements and to prevent EO residues from jeopardizing patients’ health.

IBD, dietary supplements, GC/MS/MS

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