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Med Princ Pract. 2018 Dec 5. doi: 10.1159/000495986. [Epub ahead of print]

Over-the-counter Weight-Loss Herbal Supplements in Egypt: Label Claim, Microbiological, Pharmaceutical Quality and Safety Assessments.

Abstract

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 HPLC to determine any possible adulterants. Additionally, physical properties were assessed via pharmacopeial tests. Finally, microbial evaluation and retrospective prevalence cross-sectional observational study was conducted to assess their 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 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 the awareness on the lethal consequences of illegal nutraceuticals.

PMID:
30517949
DOI:
10.1159/000495986
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