scholarly journals Field Survey of Dietary Supplements and Foods with Probiotics Added – Annotation of USA Label Compliance

2021 ◽  
Vol 8 (4) ◽  
pp. 35-41
Author(s):  
Tsukasa Jonathan Tanaka

As US regulatory framework lays the foundation of safety aspects and the efficacy of clinical effects of food products, specifically dietary supplement products, the reality of regulatory compliance is not well understood. Especially, live microorganisms as dietary supplements have many challenges in label compliance due to the unclear regulatory framework, but also due to the complexity of such living organisms. Field surveys were conducted in Southern California, USA (specifically in the Orange County and Los Angeles County regions) at local retailers or online from January 2019 to April 2021. Dietary supplements and food categories that included probiotics specifically into formula were assessed for label compliance and ingredient safety through manual annotations and curation of information. The data were observed and documented statistically. Eighty (80) unique products were collected where the number of probiotic strains ranged from 34 to 1 strain. Thirty-three (33) unique statement of identity were recorded, range of violations were maximum 9 to minimum 0. Violations were checked against the US label compliance per Chapter 21 of the Code of Federal Regulations (CFR) in food and dietary supplement label compliance regulations. Eighty-one (81) unique probiotics were observed where 33 were not confirmed of GRAS (generally recognized as safe) status, and 6 had no NDI (new dietary ingredient) status. Most labels were not in compliance with all the regulatory nuances that were found. Although most probiotics were only listed on the species level, it is still a topic worthwhile the discussion of increasing regulatory awareness to the industry. Non-compliance with labels could be mitigated by such educational outreach.

1999 ◽  
Vol 2 (1) ◽  
pp. 35-38 ◽  
Author(s):  
Malden C Nesheim

AbstractThe market for dietary supplements in the USA was estimated as about 11.8 billion dollars in 1997 with a growth rate of 10–14 % projected in the next 3 years. Data from the Food and Drug Administration collected in 1995 indicate that over 55 % of adults surveyed used some type of dietary supplement. The marketing of dietary supplements in the USA has been essentially deregulated by the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA). This legislation defined dietary supplements, made manufacturers responsible for the safety of supplements and allowed certain statements of nutrition support to be made on supplement labels. The US Congress in passing the DSHEA indicated that supplements should be available on the market so that consumers could make decisions about their use for themselves and their families. Unfortunately, information about the research base for supplement claims is not readily accessible to health professionals and consumers. There is a need for authoritative reviews of the data underlying supplement claims to assist public health professionals in their role of providing advice to the public about dietary supplements.


2021 ◽  
Vol 8 (4) ◽  
pp. 70-75
Author(s):  
Tsukasa Jonathan Tanaka

This article review focused on the analysis of the journal article “More Information Needed on Probiotic Supplement Product Labels” by Merenstein et al., 2019, published in the Journal of General Internal Medicine. The aim of such a review was to communicate a short critique as well as highlighting the need for fieldwork in regulatory compliance. Here, the review started with a general summary of the article, but also in conjunction with the literature review that the authors established. This was necessary to understand the article in its field of expertise whilst giving a clearer purpose on the need for more fieldwork of this kind. Without such understanding, it would have been difficult to understand the regulatory compliance of dietary supplement label regulations in the US. Then, a thorough analysis and deconstruction of the articles structure, as well as article critique, were established. The authority of the paper and other topics such as authority, accuracy, relevance, etc., were examined for effectiveness in conveying the research question that the authors were concerned with; that more information may be needed for product labels in probiotic supplements in the US. Lastly, the graphs, tables, and figures were evaluated to make a conclusion about the study as well as a discussion on the recent advances related to the label compliance of probiotic supplements. The paper, albeit was on the shorter side, was effective and was also simple in establishing a need for more information on the label. Thus, more transparency on clinical substantiation is needed.


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.


1998 ◽  
Vol 7 (1) ◽  
pp. 25-51
Author(s):  
Carule Fabricant

I would like to begin by juxtaposing two very different pictures of global travel taken from recent articles in the popular media and considering their implications both for contemporary postcolonial theory and for our readings of “third world” fictional texts. In one article from the summer of 1997 (Newton 6-7), the Los Angeles New Times displayed on its cover a slender man in his thirties staring hopelessly out from behind a barred window. The caption read: “No Way Out: Romanian Gavrila Moldovan Risked His Life to Come to America. The INS Promptly Locked Him Up on Terminal Island. Three and a Half Years Later, He’s Still in Jail.” The accompanying story described Moldovan’s desperate flight out of Romania after being declared a “noncitizen” for writing an anti-government news article, which rendered him vulnerable to immediate arrest, and after his parents died in a suspicious car “accident.” Having slipped aboard a container ship bound for the United States together with some fellow countrymen (three of whom died en route), he was discovered and unceremoniously dumped ashore in Panama, only to stow away shortly thereafter on another container ship headed for the Port of Los Angeles. After finally reaching his destination, a “euphoric” Moldovan explained to the US authorities awaiting him at the port: “I come here to be in freedom.... ’” His “welcome” consisted of being arrested and locked up in the INS Processing Center on Terminal Island, in which, though never charged with any crime, he remained for several years before being transferred to Kern County Jail in Bakersfield, where he is currently languishing amongst a population of men awaiting trial for serious crimes (6-7)—one of thousands of refugees and immigrants who have been, and continue to be, incarcerated in prisons that have contracts with the INS, for lack of proper documents, for minor infringements of the law, or because they are denied political asylum despite compelling evidence of their vulnerability to government reprisal at home.


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;


Sign in / Sign up

Export Citation Format

Share Document