scholarly journals Corporate Characteristics and Adoption of Good Manufacturing Practice for Dietary Supplements in Japan

2020 ◽  
Vol 17 (13) ◽  
pp. 4748 ◽  
Author(s):  
Keigo Sato ◽  
Kota Kodama ◽  
Shintaro Sengoku
Keyword(s):  
Dietary Supplements ◽  
Dietary Supplement ◽  
Quality Standard ◽  
Good Manufacturing Practice ◽  
Pharmaceutical Products ◽  
Product Categories ◽  
Adoption And Implementation ◽  
Key Characteristics ◽  
Key Driver ◽  
A Company

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.

scholarly journals Dietary supplement use in elementary school children: a Japanese web-based survey

2021 ◽  
Vol 26 (1) ◽  
Author(s):  
Kazue Ishitsuka ◽  
Satoshi Sasaki ◽  
Hidetoshi Mezawa ◽  
Mizuho Konishi ◽  
Maki Igarashi ◽  
...  
Keyword(s):  
Dietary Supplements ◽  
Dietary Supplement ◽  
Sports Participation ◽  
Web Based ◽  
Mineral Supplements ◽  
Supplement Use ◽  
Health Related Behaviors ◽  
Health Related ◽  
Dietary Supplement Use ◽  
Frequency Of Sports Participation

Abstract Background A variety of dietary supplements are commercially available. However, the efficacy and safety of dietary supplement use in children are not well established. Understanding dietary supplement use is important for developing public health policy regarding dietary supplements. This study aimed to investigate the types of dietary supplements used and characteristics of dietary supplement users among Japanese elementary school children. Method We conducted a cross-sectional web-based questionnaire study. Dietary supplement use, socio-demographics, and health-related behaviors were assessed through mother-reported questionnaire. Types of dietary supplements were identified based on ingredient using product barcodes and brand names. Multivariate logistic regression analysis was conducted to investigate the socio-demographics and health-related behaviors associated with supplement use. Results Among 4933 children, 333 (6.8%) were identified as dietary supplement users. The most common supplement was amino acids or protein (1.4%), followed by n–3 fatty acids or fish oil (1.0%), probiotics (1.0%), multivitamins (0.9%), multivitamin-minerals (0.8%), and botanicals (0.8%). Overall, any dietary supplement use was significantly associated with the highest frequency of sports participation (odds ratio [OR], 2.58; 95% confidence interval [CI], 1.65–4.02), highest household income (OR, 1.87; 95% CI, 1.13–3.10), highest maternal educational level (OR, 1.82; 95% CI, 1.31–2.52), and male sex (OR, 1.38; 95% CI, 1.09–1.75). The highest frequency of sports participation was significantly associated with higher odds of use of amino acids or protein (OR, 6.06; 95% CI, 1.78–20.6) and multivitamins (OR, 3.56; 95% CI, 1.11–11.5), compared to the lowest frequency of sports participation. Conclusion This study showed that Japanese children primarily use non-vitamin, non-mineral supplements. Non-vitamin, non-mineral supplements should thus be included in future studies aimed at monitoring dietary supplement use. We also found that dietary supplement use in children was associated with sports participation. Guidelines for dietary supplement use for children, in particular sport participants, are needed.

scholarly journals Intra-Laboratory Validation of Alpha-Galactosidase Activity Measurement in Dietary Supplements

Molecules ◽  
2021 ◽  
Vol 26 (6) ◽  
pp. 1566
Author(s):  
Elena Fabris ◽  
Michela Bulfoni ◽  
Alessandro Nencioni ◽  
Emanuele Nencioni
Keyword(s):  
Dietary Supplements ◽  
Good Manufacturing Practice ◽  
Activity Measurement ◽  
Intermediate Precision ◽  
Method Performance ◽  
Intestinal Gas ◽  
Technical Requirements ◽  
Ich Guidelines ◽  
Alpha Galactosidase

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.

scholarly journals Use of dietary supplements in pregnant women in relation to sociodemographic factors – a report from The Environmental Determinants of Diabetes in the Young (TEDDY) study

2013 ◽  
Vol 16 (8) ◽  
pp. 1390-1402 ◽  
Author(s):  
Carin Andrén Aronsson ◽  
Kendra Vehik ◽  
Jimin Yang ◽  
Ulla Uusitalo ◽  
Kristen Hay ◽  
...  
Keyword(s):  
Vitamin D ◽  
Pregnant Women ◽  
Dietary Supplements ◽  
Dietary Supplement ◽  
Maternal Age ◽  
Environmental Determinants ◽  
Supplement Use ◽  
The Usa ◽  
Dietary Supplement Use ◽  
Prospective Longitudinal

AbstractObjectivesThe aim of the present study was to examine the prevalence and associated factors of dietary supplement use, particularly supplements containing vitamin D and fatty acids, in pregnant women enrolled in a multi-national study.DesignThe Environmental Determinants of Diabetes in the Young (TEDDY) study is a prospective longitudinal cohort study. Maternal dietary supplement use was self-reported through questionnaires at month 3 to 4 postpartum.SettingSix clinical research centres; three in the USA (Colorado, Georgia/Florida and Washington) and three in Europe (Sweden, Finland and Germany).SubjectsMothers (n 7326) to infants screened for high-risk HLA-DQ genotypes of type 1 diabetes.ResultsNinety-two per cent of the 7326 women used one or more types of supplement during pregnancy. Vitamin D supplements were taken by 65 % of the women, with the highest proportion of users in the USA (80·5 %). Overall, 16 % of the women reported taking fatty acid supplements and a growing trend was seen in all countries between 2004 and 2010 (P < 0·0001). The use was more common in Germany (32 %) and the USA (24 %) compared with Finland (8·5 %) and Sweden (7·0 %). Being pregnant with the first child was a strong predictor for any supplement use in all countries. Low maternal age (<25 years), higher education, BMI ≥ 25·0 kg/m2 and smoking during pregnancy were factors associated with supplement use in some but not all countries.ConclusionsThe majority of the women used dietary supplements during pregnancy. The use was associated with sociodemographic and behavioural factors, such as parity, maternal age, education, BMI and maternal smoking.

scholarly journals Optimization of spectrophotometric method for determination nattokinase activity in dietary supplements

2020 ◽  
Vol 3 (2) ◽  
pp. 96-103
Author(s):  
Dieu Thu Nguyen Thi ◽  
Dung Hoang Viet ◽  
Hong Ngoc Nguyen Thi ◽  
Thanh An Vu Thi ◽  
Thanh Hoa Mac Thi ◽  
...  
Keyword(s):  
Quality Control ◽  
Reaction Time ◽  
Dietary Supplements ◽  
Dietary Supplement ◽  
Reaction Temperature ◽  
Spectrophotometric Method ◽  
Fibrinolytic Activity ◽  
Valuable Contribution ◽  
Label Product ◽  
Measured Activity

Nattokinase is an enzyme with a strong fibrinolytic activity that can be used for preventing thrombolytic diseases. The fibrinolytic activity of the Nattokinase in dietary supplements is determined by spectrophotometric method. In this study, the conditions of the assay were examined and finally optimized as pH: 8.5, reaction temperature: 40oC, and reaction time: 60 minutes. The proposed method was validated and successfully applied to determine the Nattokinase activity in 10 dietary supplements. The results showed that the proportion of measured activity compared to label product activity were within in the range 79.1 - 98.0%. The effect of herbal compounds and excipients on Nattokinase activity were also surveyed. From the evaluated results and application to commercial samples, this method will be a valuable contribution to quality control of dietary supplement products containing Nattokinase. &nbsp;

scholarly journals Hacking a reputation: crisis communication and the Ashley Madison data breach

2021 ◽  
Author(s):  
Katherine Owczar
Keyword(s):  
Social Media ◽  
Crisis Communication ◽  
Case Scenario ◽  
Data Breach ◽  
News Sources ◽  
Adoption And Implementation ◽  
Organizational Crises ◽  
Ashley Madison ◽  
A Company ◽  
Sense Of Power

[Para. 1] At a time where online activists are targeting and obtaining the intellectual property of companies on a regular basis, how should a company communicate and mitigate the data breach to ensure that its valued customers feel protected, or in the best case scenario, prevent it altogether? The adoption and implementation of a sound crisis communication and management strategy is thus a fundamental operative for the success of any organization. Organizational crises can fundamentally disrupt and harm companies, organizations and individuals alike; they are characterized as “non-routine, severe event[s] that [can] destroy [its] reputation or operations” (Koerber, 2017). When a crisis arises for an organization, it is imperative that they have a strong sense of clarity regarding the issue at hand – specifically, they must understand the context and “background narrative that gives interpretative shape to [its] foreground issues” (Arnett, Deiuliis, Corr, 2017). Perhaps most emblematic of these background narratives is the circulation of competing information and perspectives, by both social media and traditional news sources. With the rise of social media and the 24/7 news cycle, a new sense of power and inflated ability to frame an issue has been afforded to many publics – particularly due to the ability of these mediums to rapidly transmit and receive information. These affordances have the potential to be either beneficial or detrimental to a company when faced with a crisis. While an organization can benefit from strategic media relations and effective crisis communication, even the most established of firms can have their voice become convoluted or be reprimanded if communication is poorly executed.

scholarly journals The Prevalence of Dietary Supplement Use Among Elementary, Junior High, and High School Students: A Nationwide Survey in Japan

Nutrients ◽  
2018 ◽  
Vol 10 (9) ◽  
pp. 1176 ◽  
Author(s):  
Etsuko Kobayashi ◽  
Chiharu Nishijima ◽  
Yoko Sato ◽  
Keizo Umegaki ◽  
Tsuyoshi Chiba
Keyword(s):  
High School ◽  
High School Students ◽  
Adverse Events ◽  
Dietary Supplements ◽  
Dietary Supplement ◽  
Parental Education ◽  
Junior High ◽  
The Internet ◽  
Supplement Use ◽  
Dietary Supplement Use

The prevalence of dietary supplement use, such as vitamins, minerals, or fish oil, has increased among children in Japan; however, whether children are using dietary supplements appropriately remains unclear. This study aimed to determine dietary supplement use among children. In August 2017, a nationwide internet preliminary survey of 265,629 mothers aged from 25 to 59 years old was undertaken. Of these, 19,041 mothers of children attending either elementary school, junior high school, or high school were selected. Among them, 16.4% were currently providing their children with dietary supplements and 5.2% had previously given dietary supplements to their children. The prevalence of dietary supplement use was higher in boys than in girls, and the prevalence increased according to their grade. A total of 2439 participants were eligible to undertake a targeted survey on dietary supplement use. Dietary supplements were being taken to maintain health, supplement nutrients, and enhance growth in both boys and girls, and many children (37.5%) were provided with vitamin and mineral supplements. Mothers mainly obtained information concerning dietary supplements via the internet, and supplements were purchased in drug stores or via the internet. The prevalence of dietary supplement use in mothers was 65.4% and may be associated with the prevalence rates in children. Some mothers reported adverse events (3.6%) in their children, such as stomachache, diarrhea, nausea and vomiting, and constipation. The cause-and-effect relationships for adverse events were not clear, but some children were given products for adults. Children are more influenced by dietary supplements compared to adults. To prevent adverse events due to inappropriate use, parental education concerning dietary supplements is essential.

scholarly journals National Athletic Trainers' Association Position Statement: Evaluation of Dietary Supplements for Performance Nutrition

2013 ◽  
Vol 48 (1) ◽  
pp. 124-136 ◽  
Author(s):  
Jackie L. Buell ◽  
Rob Franks ◽  
Jack Ransone ◽  
Michael E. Powers ◽  
Kathleen M. Laquale ◽  
...  
Keyword(s):  
Dietary Supplements ◽  
Dietary Supplement ◽  
Sport Participation ◽  
Athletic Trainers ◽  
Position Statement ◽  
Educational Process ◽  
Athletic Trainer ◽  
Federal State ◽  
Safety And Efficacy ◽  
National Athletic Trainers Association

Objectives To help athletic trainers promote a “food-first” philosophy to support health and performance, understand federal and sport governing body rules and regulations regarding dietary supplements and banned substances, and become familiar with reliable resources for evaluating the safety, purity, and efficacy of dietary supplements. Background The dietary supplement industry is poorly regulated and takes in billions of dollars per year. Uneducated athletes need to gain a better understanding of the safety, eligibility, and efficacy concerns associated with choosing to take dietary supplements. The athletic trainer is a valuable athletic team member who can help in the educational process. In many cases, athletic trainers are asked to help evaluate the legality, safety, and efficacy of dietary supplements. For this position statement, our mission is to provide the athletic trainer with the necessary resources for these tasks. Recommendations Proper nutrition and changes in the athlete's habitual diet should be considered first when improved performance is the goal. Athletes need to understand the level of regulation (or lack thereof) governing the dietary supplement industry at the international, federal, state, and individual sport-participation levels. Athletes should not assume a product is safe simply because it is marketed over the counter. All products athletes are considering using should be evaluated for purity (ie, truth in labeling), safety, and efficacy.

Development of biotechnology and assessment of antitumor properties of dietary supplements of tissue origin on cell cultures

2021 ◽  
pp. 33-34
Author(s):  
Наталья Александровна Кольберг ◽  
Сергей Леонидович Тихонов ◽  
Наталья Валерьевна Тихонова ◽  
Светлана Александровна Леонтьева
Keyword(s):  
Dietary Supplements ◽  
Tumor Cells ◽  
Dietary Supplement ◽  
Cell Cultures ◽  
Mammalian Cells ◽  
Broiler Chickens ◽  
Cytotoxic Effect ◽  
Antitumor Properties ◽  
Tissue Origin ◽  
Mcf 7

Разработана технология БАД из фабрициевой сумки цыплят-бройлеров. Доказано, что полученная БАД на нарушает жизнеспособность клеток млекопитающих и не проявляет цитотоксических свойств на метаболизм здоровых клеток, что свидетельствует о ее безопасности. Доказан выраженный цитотоксический эффект БАД на опухолевые клетки линии MCF-7. The technology of dietary supplements from the factory bag of broiler chickens has been developed. It was proved that the obtained dietary supplement does not violate the viability of mammalian cells and does not exhibit cytotoxic properties on the metabolism of healthy cells, which indicates its safety. A pronounced cytotoxic effect of dietary supplements on MCF-7 tumor cells has been proven.

Sustainable Business Transformation in Supply Chains

Web Services ◽  
2019 ◽  
pp. 204-220
Author(s):  
Fawzy Soliman
Keyword(s):  
Cloud Computing ◽  
Supply Chains ◽  
Business Models ◽  
Modern Society ◽  
Cloud System ◽  
Sustainable Business ◽  
Business Transformation ◽  
Adoption And Implementation ◽  
Key Characteristics ◽  
The Impact

Cloud computing is a usage model that is characterised by five key characteristics, four deployment models and three service models. The drivers and disadvantages of the adoption and implementation of cloud computing are discussed. The topic is further discussed in relation to the impact of cloud computing on supply chains. The cloud technology has become an important invention in modern society. This chapter examines the benefits and risks brought by the cloud system. The chapter explores the possible changes during transformation that might result in the implementation of cloud systems in firms. The business models presented due to the implementation of cloud system are also illustrated in this chapter.

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