Dietary Supplements and Drug Constituents: thePharmanex v. Shalala Case and Implications for the Pharmaceutical and Dietary Supplement Industries

Author(s):  
Daniel A. Kracov ◽  
Paul D. Rubin ◽  
Lisa M. Dwyer
2021 ◽  
Vol 26 (1) ◽  
Author(s):  
Kazue Ishitsuka ◽  
Satoshi Sasaki ◽  
Hidetoshi Mezawa ◽  
Mizuho Konishi ◽  
Maki Igarashi ◽  
...  

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.


2013 ◽  
Vol 16 (8) ◽  
pp. 1390-1402 ◽  
Author(s):  
Carin Andrén Aronsson ◽  
Kendra Vehik ◽  
Jimin Yang ◽  
Ulla Uusitalo ◽  
Kristen Hay ◽  
...  

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.


Author(s):  
Dieu Thu Nguyen Thi ◽  
Dung Hoang Viet ◽  
Hong Ngoc Nguyen Thi ◽  
Thanh An Vu Thi ◽  
Thanh Hoa Mac Thi ◽  
...  

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;


Nutrients ◽  
2018 ◽  
Vol 10 (9) ◽  
pp. 1176 ◽  
Author(s):  
Etsuko Kobayashi ◽  
Chiharu Nishijima ◽  
Yoko Sato ◽  
Keizo Umegaki ◽  
Tsuyoshi Chiba

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.


2013 ◽  
Vol 48 (1) ◽  
pp. 124-136 ◽  
Author(s):  
Jackie L. Buell ◽  
Rob Franks ◽  
Jack Ransone ◽  
Michael E. Powers ◽  
Kathleen M. Laquale ◽  
...  

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.


2021 ◽  
pp. 33-34
Author(s):  
Наталья Александровна Кольберг ◽  
Сергей Леонидович Тихонов ◽  
Наталья Валерьевна Тихонова ◽  
Светлана Александровна Леонтьева

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.


Nutrients ◽  
2020 ◽  
Vol 12 (3) ◽  
pp. 847
Author(s):  
Amanda Rodrigues Amorim Adegboye ◽  
Omorogieva Ojo ◽  
Gulshanara Begum

Previous studies have shown that the use of dietary supplements is associated with the prevention of birth defects, negative pregnancy outcomes and cardiovascular diseases. However, there might be some ethnic disparities in supplement usage suggesting that women who could benefit from it are not frequent users. This study aimed to characterise the use of dietary supplement among Black African and Black Caribbean women living in the United Kingdom (UK). Furthermore, it evaluated possible associations between the use of dietary supplements and health and diet awareness. A total of 262 women self-ascribed as Black African and Black Caribbean living in the UK completed a comprehensive questionnaire on socio-demographic factors, diet, use of supplements and cultural factors. The main outcome variable was the regular use of any type of dietary supplement. Use of vitamin D and/or calcium was also explored. A stepwise logistic regression analysis was applied to identify predictors of regular use of dietary supplements. A total of 33.2% of women reported regular use of any dietary supplements and 16.8% reported use of vitamin D and/or calcium. There were no significant ethnic differences in the use of dietary supplements. Reporting use of the back of food packaging label (odds ratio (OR) 2.21; 95% CI 1.07–4.55); a self-rated healthy diet (OR 2.86; 95% CI 1.19–6.91) and having cardiovascular disease (CVD), hypertension and/or high cholesterol (OR 3.81; 95% CI 1.53–9.49) increased the likelihood of using any dietary supplement. However, having poorer awareness decreased the likelihood (OR 0.94; 95% CI 0.88–0.99) of using any dietary supplement. For the use of vitamin D and/or calcium supplements, the main predictor was having CVD, hypertension and/or high cholesterol (OR 4.43; 95% CI 1.90–10.35). The prevalence of dietary supplement use was low among African and Caribbean women. Thus, awareness of potential benefits of some dietary supplements (e.g., vitamin D) among the Black population should be promoted.


2002 ◽  
Vol 85 (6) ◽  
pp. 1360-1369 ◽  
Author(s):  
Catharina Y W Ang ◽  
Yanyan Cui ◽  
Hebron C Chang ◽  
Wenhong Luo ◽  
Thomas M Heinze ◽  
...  

Abstract St. John's wort ( Hypericum perforatum L.) preparations, a top-selling botanical dietary supplement used primarily as an antidepressant, has recently been used as an ingredient in some food products sold as functional foods. A rapid extraction technique followed by a liquid chromatographic (LC) method was developed to determine 4 characteristic bioactive compounds (pseudohypericin, hypericin, hyperforin, and adhyperforin) from St. John's wort in dietary supplements and functional foods to which it was added. Solid samples, including including dried leaf/flower mixture, dietary supplement capsules, tea bags, puff and snack bar, were extracted with methanol by sonication.Noncarbonated, fruit-flavored drinks were centrifuged and mixed with methanol. Compounds were then determined by isocratic, reversed-phase LC with UV detection at 2 wavelengths and further identified or confirmed by photodiode array spectra and LC/mass spectrometry. Within-laboratory method variations (% RSD) were satisfactory. Very low amounts, if any, of the 4 components were found in drink and puff samples, and none was found in the snack bar. The methods developed provide a useful means for the determination of St. John's wort components in dietary supplements and functional foods.


Author(s):  
Hanmei Liu ◽  
Shiya Zhang ◽  
Hanshuang Zou ◽  
Yuanlin Pan ◽  
Qiping Yang ◽  
...  

Dietary supplement use is increasing globally, especially among children. However, few studies have been conducted to examine dietary supplement use among Chinese children. The aim of this study was to examine the prevalence of dietary supplement use and the associated factors in primary school students. A cross-sectional study was conducted in four primary schools in Hunan province, China. A total of 706 Chinese parents/caregivers of school children aged 6–12 years old were enrolled. Self-administrated questionnaires were used to collect information about the children’s dietary supplement use, and their socio-demographic characteristics. The prevalence of dietary supplement use in primary school students was 20.4%. Calcium (16.7%), vitamin C (9.2%), and vitamin D (8.5%) were the most commonly used types of dietary supplement. The main reasons for parents/caregivers to purchase dietary supplements for their children were immunity improvement (43.6%), and for growth promotion (36.5%). Some caregivers (26.4%) purchased dietary supplements online, including from dubious or unknown sellers. However, 37.5% of caregivers did not receive formal guidance on supplementation even if they purchased their supplements through formal channels. Parents/caregivers were unclear about the appropriate choices for children’s dietary supplement use. Guidelines and counseling regarding dietary supplements for children may be helpful in public health work.


2015 ◽  
Vol 113 (12) ◽  
pp. 1993-2000 ◽  
Author(s):  
Christina L. F. Kofoed ◽  
Jane Christensen ◽  
Lars O. Dragsted ◽  
Anne Tjønneland ◽  
Nina Roswall

The prevalence of dietary supplement use varies largely among populations, and previous studies have indicated that it is high in the Danish population compared with other European countries. The diversity in supplement use across countries indicates that cultural and environmental factors could influence the use of dietary supplements. Only few studies investigating the use of dietary supplements have been conducted in the Danish population. The present cross-sectional study is based on 54 948 Danes, aged 50–64 years, who completed self-administrated questionnaires on diet, dietary supplements and lifestyle between 1993 and 1997. A health index including smoking, physical activity, alcohol and diet, and a metabolic risk index including waist circumference, urinary glucose and measured hypertension were constructed. Logistic regression was used to investigate these determinants in relation to the intake of dietary supplements. We found that 71 % of the participants were dietary supplement users; female sex, older age groups and higher educated participants were more likely to be users of any dietary supplements. One additional point in the health index was associated with 19, 16 and 9 % higher likelihood of being user of any, more common and less common supplements, respectively. In the metabolic risk index, one additional point was associated with 17 and 16 % lower likelihood of being user of any supplement and more common supplements, respectively. No significant association was found for less common supplement use. In conclusion, those with the healthiest lifestyle were more likely to use dietary supplements. Thus, lifestyle and dietary composition should be considered as confounders on supplement use and health outcomes.


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