scholarly journals Vaccinium macrocarpon (Cranberry)-Based Dietary Supplements: Variation in Mass Uniformity, Proanthocyanidin Dosage and Anthocyanin Profile Demonstrates Quality Control Standard Needed

Nutrients ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 992 ◽  
Author(s):  
Giuseppe Mannino ◽  
Vita Di Stefano ◽  
Antonino Lauria ◽  
Rosa Pitonzo ◽  
Carla Gentile

Vaccinium macrocarpon (syn. American Cranberry) is employed in dietary supplements (DS) with the aim to improve urinary tract well-being. This property is linked to the antiadhesion-activity of proanthocyanidins (PACs) against uropathogenic-bacteria. However, the current European legislation has been criticized for being weak and ineffective. Indeed, recent scientific works report mislabeled, contaminated, and adulterated supplements containing dangerous or unknown compounds, or sold at toxic doses. In this work, we analysed 24 DS that claim to contain cranberry, and to have a specific dosage of PACs. Our tests included the control of the good manufacturing practice according to the European Pharmacopoeia, and the verification of the claimed dosage of PACs. Moreover, in order to confirm the real presence of cranberry in DS, chemical fingerprinting via HPLC-UV/Vis-MS/MS was employed. Our results showed that 17 DS did not comply with the uniformity test of dosage forms, and only five contained cranberry. Finally, 16 DS claimed an incorrect amount of PACs. These data suggest that several cranberry-based DS are present in the European market with insufficient quality controls. Considering that often DS are self-prescribed by consumer relying on their claim, the data obtained in this work should encourage more controls and stricter rules.

Molecules ◽  
2021 ◽  
Vol 26 (6) ◽  
pp. 1566
Author(s):  
Elena Fabris ◽  
Michela Bulfoni ◽  
Alessandro Nencioni ◽  
Emanuele Nencioni

Introduction: Alpha-galactosidase (α-Gal) is an enzyme responsible for the hydrolyzation of glycolipids and glycoprotein commonly found in dietary sources. More than 20% of the general population suffers from abdominal pain or discomfort caused by intestinal gas and by indigested or partially digested food residuals. Therefore, α-Gal is used in dietary supplements to reduce intestinal gases and help complex food digestion. Marketed enzyme-containing dietary supplements must be produced in accordance with the Food and Drug Administration (FDA) regulations for Current Good Manufacturing Practice (cGMPs). Aim: in this work we illustrated the process used to develop and validate a spectrophotometric enzymatic assay for α-Gal activity quantification in dietary supplements. Methods: The validation workflow included an initial statistical-phase optimization of materials, reagents, and conditions, and subsequently a comparative study with another fluorimetric assay. A final validation of method performance in terms of specificity, linearity, accuracy, intermediate-precision repeatability, and system precision was then executed. Results and conclusions: The proven method achieved good performance in the quantitative determination of α-Gal activity in commercial food supplements in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals (ICH) guidelines and is suitable as a rapid in-house quality control test.


2018 ◽  
Vol 56 (2) ◽  
pp. 85-89 ◽  
Author(s):  
D.A. Parry ◽  
R.S. Oeppen ◽  
M. Amin ◽  
P.A. Brennan

2017 ◽  
pp. 141-153
Author(s):  
Davor Korcok ◽  
Nada Trsic-Milanovic

Cleaning validation for pharmaceutical production equipment is a documented proof of the efficient cleaning, and one of prerequisites of good manufacturing practice in medicine production. Successful validation confirms the efficiency of the procedures of cleaning, washing, and disinfecting of the manufacturing equipment, and records results of the chemical and microbiological analyses, which are a prerequisite for a safe final dietary product. The main goal of this study was to improve the cleaning process of the production equipment by using cleaning validation procedures on the solid form production line (capsules) in the Abela Pharm d.o.o. The validation principles that are used in manufacturing of medicines can be applied to determine more efficient cleaning methods that will ensure longer periods of the status clean in the production of dietary supplements. The outcome is a practical analysis of the production equipment in view of regulatory demands, confirming that the cleaning validation measures ensure prevention of unwanted microbial growth or removal of contamination from the production equipment in order to preserve the activity, efficacy, and safety of the final dietary product.


Author(s):  
April D. Henning

<p>Participants at the non-elite level of road running often take up the sport for purposes of health, as a way of taking responsibility for their own well-being. Often, these runners use dietary supplements as a way to improve health and to potentially enhance running performance.  Supplements are distinct from banned performance enhancing drugs (PEDs), as they are legal and widely available, though very loosely regulated. Research demonstrates that the line between supplements and banned PEDs is increasingly blurry as cases of cross-contaminated and mislabeled supplements continue to be found.  Such products may pose health risks to unsuspecting consumers. Despite anti-doping agencies’ warnings to elite runners about these risks, non-elite runners are rarely told by any sport or anti-doping body to be wary of supplements.  They are, however, inundated with media coverage of doping scandals usually involving only a few of the substances banned in sport. In short, these runners are often left to navigate supplement use on their own and many conflate supplement availability with safety. This article explores these routine dietary supplement practices among non-elite runners.  Drawing from interviews with 28 non-elite runners in New York City, I discuss the perceptions and understandings of doping and dietary supplement use within the context of health culture.  Interview data reveal that the social acceptance of dietary supplements and their widespread use among the broader public reinforce the notion among non-elite runners that such products are objectively safe and healthy. I argue that based on their assumptions of supplement safety, non-elite runners view dietary supplements as distinctly different from PEDs and that this difference encourages their use as health and performance aids.</p>


Author(s):  
Akanksha Behl ◽  
Amarnath Mishra ◽  
G. P. Sharma

: Food forensics is an emerging branch that applies scientific knowledge for the verification and authentication of food supplements. The term “dietary supplement” refers to a diverse set of preparations that are deemed to be essential for the well-being of a human body. These supplements consist of various physiologically active substances that produce effects on the body. However, a major issue with these supplements is that they are neither considered as medicines, nor as a food product. Due to this, such food supplements are prone to adulteration and counterfeiting. In this review, three widely used supplements, namely Curcuma longa, Withania somnifera, and Garcinia cambogia supplements are considered. Chemistry, pharmacology, and benefits of three are being discussed along with the analytical techniques for their analysis. Chromatographic techniques are popular for the examination of dietary supplements. Several such analytical techniques are being used to detect and identify the physiologically active constituents as well as adulterants in dietary products. This review intends to demonstrate the overall issues regarding dietary supplements.


Author(s):  
Keigo Sato ◽  
Kota Kodama ◽  
Shintaro Sengoku

Good manufacturing practice (GMP) is advocated and implemented as a standardized procedure for manufacturing dietary supplements. However, in Japan as a case, only half of the manufacturers in this field so far adopt it. To address this issue, the present study aims to explore the effect of key characteristics of a company on the adoption of and compliance with GMP for dietary supplements. The focus is on the effect of expertise in the pharmaceutical industry. The relationships between company characteristics and the adoption of GMP were analyzed for 90 manufacturers in the dietary supplement industry in Japan. A binomial logistic regression analysis showed that each of the following three factors had a positive and significant effect on the company’s adoption of GMP: company size in terms of revenue (odds ratio = 1.04, p = 0.019), possession of a manufacturing license for pharmaceutical products (13.7, p = 0.003), and number of own product categories manufactured (3.93, p = 0.00009). These findings strongly suggest that the company’s manufacturing capability of pharmaceutical products works as a key driver for the better adoption of a quality standard in the dietary supplement industry in Japan. Few considerations were made for conditions of the adoption and implementation of GMP. The present study empirically contributes by providing key clues for issues in the dietary supplement industry and by forming a theoretical base for policymakers and the regulatory authorities.


PLoS ONE ◽  
2021 ◽  
Vol 16 (4) ◽  
pp. e0249897
Author(s):  
Ishrat Jahan ◽  
Abul Bashar Mohammad Neshar Uddin ◽  
A. S. M. Ali Reza ◽  
Md. Giash Uddin ◽  
Mohammad Shahadat Hossain ◽  
...  

Background Dietary supplements (DS) are products that improve the overall health and well-being of individuals and reduce the risk of disease. Evidence indicates a rising prevalence of the use of these products worldwide especially among the age group 18–23 years. Aim The study investigates the tendencies and attitudes of Bangladeshi undergraduate female students towards dietary supplements (DS). Methods A three-month (March 2018-May 2018) cross-sectional face-to-face survey was conducted in undergraduate female students in Chittagong, Bangladesh using a pre-validated dietary supplement questionnaire. The study was carried among the four private and three public university students of different disciplines in Chittagong to record their prevalent opinions and attitudes toward using DS. The results were documented and analyzed by SPSS version 22.0. Results Ninety two percent (N = 925, 92.0%) of the respondents answered the survey questions. The prevalence of DS use was high in undergraduate female students. The respondents cited general health and well-being (n = 102, 11.0%) and physician recommendation (n = 101, 10.9%) as a reason for DS use. Majority of the students (n = 817, 88.3%) used DS cost monthly between USD 0.12 and USD 5.90. Most of the students (n = 749, 81.0%) agreed on the beneficial effect of DS and a significant portion (n = 493, 53.3%) recommended for a regular use of DS. Highly prevalent use of dietary supplements appeared in Chittagonian undergraduate female students. They were tremendously positive in using DS. The results demonstrate an increasing trend of using DS by the undergraduate females for both nutritional improvement and amelioration from diseases. Conclusion Dietary supplements prevalence was so much higher in students of private universities as compared to students of public universities. Likewise, maximal prevalence is indicated in pharmacy department compared to other departments. Students preferred brand products, had positive opinions and attitudes towards dietary supplements.


2020 ◽  
Vol 103 (5) ◽  
pp. 1378-1393
Author(s):  
Bharathi Avula ◽  
Satyanarayanaraju Sagi ◽  
Mubashir H Masoodi ◽  
Ji-Yeong Bae ◽  
Adil F Wali ◽  
...  

Abstract Background Propolis is a resinous substance produced by bees. Propolis extracts have been used for anti-inflammatory and antimicrobial activities. The use of propolis dietary supplements has been increasing in the United States and the rest of the world. Objective A simple, economic, and valid analytical method is needed for quality assessment of dietary supplements and extracts claiming to contain propolis. Methods A ultra-high performance liquid chromatography (UHPLC) quadropole time-of-flight-MS method was used to characterize the chemical composition of northern Indian propolis. Fourteen major phenolic compounds were quantified using a UHPLC-DAD method. An HPTLC method was used to develop chemical fingerprinting profiles for propolis extracts and dietary supplements. The seven propolis extracts and 14 dietary supplements purchased in the U.S. were analyzed using the UHPLC-DAD-QToF method. Results Fifty-seven compounds belonging to phenolic, coumarin, fatty acid, and terpene classes were identified in propolis extracts. Based on quantification results, the content of 14 phenolic compounds in propolis extracts varied from 19–32% in dietary supplements, a significant variation to the recommended daily intake (0.2–94 mg/day). Conclusions/Highlights The developed analytical methods can be used for quality assessment of propolis extracts and dietary supplements.


Author(s):  
Donghoon Kim ◽  
Inbae Ji ◽  
John N. Ng’ombe ◽  
Kwideok Han ◽  
Jeffrey Vitale

This study analyzes the self-reported intake of dietary supplements (DS) and their effects on perceived health well-being from a survey with 1210 adult respondents in Korea. To account for selectivity bias from observable confounders, we use a propensity score matching (PSM) model. Our findings show that demographics, health concerns, family history of disease, frequency of hospital visits, and regular exercise are positively associated with intake of DS among consumers. Results from PSM show that the intake of DS leads to significant improvements in perceived health well-being among DS takers relative to DS non-takers regardless of gender, urban residence, having self-reported diseases or not. The paper concludes with implications for policies that promote intake of DS in Korea.


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