Over-the-Counter Herbal Weight Loss Supplements in Egypt: Label Claim, Microbiological and 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 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.

Adulteration of Weight Loss Supplements by the Illegal Addition of Synthetic Pharmaceuticals

“…This drug is often found alongside sibutramine as an illegal adulterant to weight loss supplements. These findings are consistent with the results of many other studies [35,36,44,45]. People who take herbal slimming preparations that contain undeclared phenolphthalein may face an increased risk of cancer [35,36,44].…”

Possible harms ofMomordica charantia L. in humans; a systematic review

“…Especially microbial safety is of high importance to include in all these studies as food pathogens like E.coli, Salmonella and Listeria can cause effects within hours after intake (Alwakeel 2009). A microbiological and pharmaceutical quality and safety assessment on over-the-counter herbal weight loss supplements in Egypt showed that, based on microbial count, 100% of the unapproved weight loss products had poor bacteriological quality (Ahmed et al, 2019). To date, the European Pharmacopoeia TCM working group has elaborated about 80 TCM herbal monographs with ISO standards for over 14 MPs published or under development.…”

“…In addition to the possible bioactive substances of the plant, the exact plant material of the product may also play an important role. Most of the adverse events (AE) of herbal products and herbal medicines can be attributed to poor quality, processing and (im)purity of the product (Ahmed et al, 2019; Chan, 2003). This stresses the need for a critical systematic review of the available data on safety of MC use in humans.…”

Prevalence and Predictors of Self-Medication with Antifungal Drugs and Herbal Products Among University Students: A Cross-Sectional Study from Egypt

“…Unfortunately, most people are attracted to the use of herbal weight loss products because of the faulty perception that these are safe. 39 These products may however contain FDA-banned ingredients which have many side effects that could induce heart failure, cancer, and other life-threatening conditions. 40 In addition, they contain stimulants such as caffeine that may cause insomnia, depression, addiction, suicidal thoughts, and heart attacks, which could be fatal.…”