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

Abdullah R, Diaz LN, Wesseling S, Rietjens IM

Food Addit Contam Part A Chem Anal Control Expo Risk Assess, 2017 Feb;34(2):135-144.
PMID: 27892830 DOI: 10.1080/19440049.2016.1266098

After 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.

Matched MeSH terms: Drugs, Chinese Herbal/analysis*
Fulltext Microbial and heavy metal contamination in commonly consumed traditional Chinese herbal medicines

Ting A, Chow Y, Tan W

J Tradit Chin Med, 2013 Feb;33(1):119-24.
PMID: 23596824

The increasing popularity and widespread use of traditional Chinese herbs as alternative medicine have sparked an interest in understanding their biosafety, especially in decoctions that are consumed. This study aimed to assess the level of microbial and heavy metal contamination in commonly consumed herbal medicine in Malaysia and the effects of boiling on these contamination levels.

Matched MeSH terms: Drugs, Chinese Herbal/analysis*
The cytotoxicity and chemical constituents of the hexane fraction of Typhonium flagelliforme (Araceace)

Choo CY, Chan KL, Sam TW, Hitotsuyanagi Y, Takeya K

J Ethnopharmacol, 2001 Sep;77(1):129-31.
PMID: 11483390

The plant, Typhonium flagelliforme (Araceae), commonly known as the "rodent tuber" in Malaysia, is often used as an essential ingredient of herbal remedies for alternative cancer therapies. The hexane extract of this plant was evaluated for cytotoxic activity against in vitro culture on P388 murine leukaemia cells and showed weak IC(50) of 15 microg/ml. The partial chemical constituents were identified as methyl esters of hexadecanoic acid, octadecanoic acid, 9-octadecenoic acid and 9,12-octadecadienoic acid. In addition, several common aliphatics were identified as dodecane, tridecane, tetradecane, pentadecane, hexadecane, heptadecane, octadecane, nonadecane and eicosane. The unique methyl ester of 13-phenyltridecanoic acid was isolated and positively identified using spectroscopic methods. None of the identified compounds showed or are known to have cytotoxic behaviour.

Matched MeSH terms: Drugs, Chinese Herbal/analysis
Fulltext Over-the-Counter Herbal Weight Loss Supplements in Egypt: Label Claim, Microbiological and Pharmaceutical Quality, and Safety Assessments

Ahmed N, Nounou MI, Abouelfetouh A, El-Kamel A

Med Princ Pract, 2019;28(2):167-177.
PMID: 30517949 DOI: 10.1159/000495986

OBJECTIVES: Nutraceuticals are advertised and sold with the label claim of being natural and safe herbal products. Due to the absence of clear regulations and guidelines for safety assessments of these products, nutraceuticals are commonly adulterated in order to increase sales. The objective of the current study was to design a comprehensive evaluation system to assess the safety, efficacy, authenticity according to label claim, and pharmaceutical quality of herbal slimming products in between 2015 and 2017.
METHODS: We designed a comprehensive assessment system to evaluate the safety, authenticity according to label claim, and pharmaceutical quality of slimming nutraceuticals. Six different popular products were evaluated (Zotreem Plus®, Zotreem Extra®, Malaysian Super Slim®, AB Slim®, Chinese Super Slim®, and Metabolites®). The pharmaceutical evaluation included analyzing the samples via high-performance liquid chromatography to determine any possible adulterants. Additionally, the products' physical properties were assessed via pharmacopeial tests. Finally, a microbial evaluation and a cross-sectional observational retrospective prevalence study were conducted to assess the products' safety and efficacy. -Results: The tested products were found to be adulterated with unreported active pharmaceutical ingredients such as sibutramine, sildenafil, phenolphthalein, and orlistat. Furthermore, they contained heterogeneous amounts of adulterants and exhibited an unsatisfactory pharmaceutical and microbial quality. Finally, the observational survey conducted on users showed that high percentages of participants suffered from common side effects such as depression, diarrhea, and hypertension.
CONCLUSIONS: These products threaten the health of consumers. There is a need to raise awareness of the lethal consequences of illegal nutraceuticals.

Matched MeSH terms: Drugs, Chinese Herbal/analysis*