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Overview of third-party dietary supplement certification organizations and services. a GMP¼Good Manufacturing Practice.
Source publication
Contexts in source publication
Context 1
... on each organization are pre- sented in Figure 1. This article describes the regulatory framework for dietary supplements, these third-party orga- nizations, the standards they follow, and the mechanics of their certification programs. ...
Citations
... Vitamin sales were 32% in 2014. 1 Numerous products of new dietary supplements have entered the market since the Dietary Supplement and Health Education Act (DSHEA) of 1994. When the DSHEA was passed, roughly 600 dietary supplement companies in the United States offered approximately 4,000 products. ...
... Additionally, it is important to choose brands certified by third-party organizations (e.g., NSF, BSCG, Informed-Sport, Cologne List), which verify the identity, quality, and quantity of ingredients. When applicable, these organizations also verify the freshness (for liquid oils) and disintegration (for tablets) of the supplements [14]. ...
Bonilla DA, Petro JL, Kreider RB, Cannataro R. Sports Medicine: Nutritional Sciences and Nutritional Biochemistry, Focusing on Nutritional Supplements from the FFNFO Framework to Contamination. Life. 2024; 14(11):1392. https://doi.org/10.3390/life14111392
... In addition, there are independent organizations that will test and certify dietary supplements to ensure the quality of dietary supplements based on standards for purity, potency, and accuracy of labeling (Table 4). [42] In other words, the intent of these quality seals is to indicate that these products do not contain compounds that are not listed on the label, that they contain the dose of the compound that is stated, and that they are manufactured in a way to reduce the risk of contamination. These organizations often offer a seal of certification for supplements that "pass" the testing, which can provide consumers a layer of reassurance regarding supplement quality. ...
The use of dietary supplements by patients with chronic liver disease is prevalent and rising. Despite the known risks of dietary supplements, including hepatotoxicity, adulteration, and contamination, patients with chronic liver disease often turn to dietary supplements to support their liver and/or overall health but are not necessarily empowered with the information or guidance from their liver practitioner to do so. This article provides practitioners with a framework for balancing the risks and benefits of dietary supplements in patients with chronic liver disease, offering examples of independent resources and certifications to use this framework in clinical practice. We offer 3 common clinical scenarios to highlight how the use of this framework can improve communication and decision-making in clinical practice. By adapting principles from Integrative Medicine, this article advocates for a patient-centered approach to dietary supplements in patients with chronic liver disease, encouraging open dialogue between clinicians and their patients to facilitate informed decision-making and personalized care.
... Oversight of dietary supplements is particularly challenging, since it is estimated that they are used by 80% of all adults (Levinson, 2012). However, only 23% do so based on the advice of their healthcare professional (Akabas et al., 2016). Furthermore, since quality standardization of supplements is minimal, there are significant safety, quality, and efficacy concerns (Ronis et al., 2018). ...
In recent years, the development of sensor and wearable technologies have led to their increased adoption in clinical and health monitoring settings. One area that is in early, but promising, stages of development is the use of biosensors for therapeutic drug monitoring (TDM). Traditionally, TDM could only be performed in certified laboratories and was used in specific scenarios to optimize drug dosage based on measurement of plasma/blood drug concentrations. Although TDM has been typically pursued in settings involving medications that are challenging to manage, the basic approach is useful for characterizing drug activity. TDM is based on the idea that there is likely a clear relationship between plasma/blood drug concentration (or concentration in other matrices) and clinical efficacy. However, these relationships may vary across individuals and may be affected by genetic factors, comorbidities, lifestyle, and diet. TDM technologies will be valuable for enabling precision medicine strategies to determine the clinical efficacy of drugs in individuals, as well as optimizing personalized dosing, especially since therapeutic windows may vary inter-individually. In this mini-review, we discuss emerging TDM technologies and their applications, and factors that influence TDM including drug interactions, polypharmacy, and supplement use. We also discuss how using TDM within single subject (N-of-1) and aggregated N-of-1 clinical trial designs provides opportunities to better capture drug response and activity at the individual level. Individualized TDM solutions have the potential to help optimize treatment selection and dosing regimens so that the right drug and right dose may be matched to the right person and in the right context.
... 52 Third-party organizations, such as Consumer Lab, National Sanitation Foundation International, 53 and United States Pharmacopeia, provide third-party chemical analyses and certification programs to verify supplement dose and ingredients. 54,55 The National Sanitation Foundation Certified for Sport program, in particular, evaluates supplements for prohibited substances or masking agents, and serves as the only independent third-party program recognized by the US Anti-Doping Agency and several professional sports organizations aiming to reduce risks associated with dietary supplement use. 53 The current study is limited by the self-report nature of the web-based survey, which can be subject to recall bias, and thus affect the internal validity of results. ...
Background
The prevalence of dietary supplement intake among preadolescent endurance runners is currently unknown.
Objective
Our aim was to describe use of dietary supplements, higher-risk supplements, and sport foods among preadolescent endurance athletes and identify associated characteristics of dietary supplement users in this population.
Design
This was a retrospective, cross-sectional study.
Participants/setting
Participants were 2,113 preadolescent endurance runners (male: n = 1,255, female: n = 858; mean age ± standard deviation = 13.2 ± 0.9 years).
Main outcome measures
Use of dietary supplements, higher-risk dietary supplements, and sport foods on 2 or more days per week during the past year.
Statistical analyses performed
Mann-Whitney U tests, χ² tests, univariate and multivariate analyses.
Results
Twenty-six percent (n = 551) of preadolescent runners used dietary supplements on 2 or more days per week during the past year; 1.3% (n = 27) reported taking higher-risk supplements. Compared with male runners, female runners reported higher use of 1 or more supplements (32.5% vs 21.7%; P < .001) and 4 or more supplements (4.0% vs 1.9%; P = 0.005), multivitamin/minerals (24.2% vs 14.4%; P < .001), vitamin D (12.4% vs 5.6%; P < .001), calcium (8.9% vs 4.8%; P < .001), iron (3.1 vs 1.1%; P < .001), probiotic supplements (8.2% vs 1.3%; P < .001), and diet pills (0.5% vs 0.0%; P = .02). Male runners reported higher use of creatine (1.3% vs 0.0%; P < .001) and sport foods, including protein bars and drinks (19.5% vs 8.4%; P < .001), energy bars (23.5% vs 9.7%; P < .001), and carbohydrate-electrolyte drinks (27.9% vs 13.3%; P < .001) than female runners. Factors independently associated with a higher likelihood for dietary supplement use included weight loss in the past year, female (vs male) gender, following a vegetarian diet, skipping meals, attempting to gain weight, and history of a running-related bone stress injury.
Conclusions
More than one-quarter of preadolescent runners regularly consumed dietary supplements. Behaviors consistent with dietary restriction and history of bone stress injury were associated with higher likelihood for supplement use. Further work to understand supplement use patterns and potential value for nutrition education is advised to optimize health of preadolescent runners.
... Each of the factor chosen is based on the findings from several studies made by several researchers who agreed that it would affect the prevalence of dietary supplement (Alfawaz et al., 2017;Kobayashi et al., 2017;Fattahzadeh-ardalani et al., 2016;Al-Naggar & Chen, 2011). Akabas et al. (2016) defined dietary supplement as products that are consumed to complete or enhance the diet without containing any tobacco. It is also consumed to help prevent diseases, maintain health, or provide extra energy to the body (Barnes et al., 2016;Fattahzadeh-ardalani et al., 2016). ...
... It is also consumed to help prevent diseases, maintain health, or provide extra energy to the body (Barnes et al., 2016;Fattahzadeh-ardalani et al., 2016). The number of people that consumed dietary supplement is more than half of the population in the United States, and this has been approved by several researchers (Blumberg et al., 2017;Akabas et al., 2016;Knapik et al., 2016;Barnes et al., 2016). In addition, the number of people consuming supplement in the United States keeps increasing with its percentage becoming closer to 100% (Blumberg et al., 2017). ...
... Protein supplements are classified as any ergogenic aid outside an athlete's standard diet designed to increase the quantity of amino acids consumed for enhanced training adaptations (Maughan et al., 2007). In 2014, dietary supplements were already a $36.7 billion industry in the United States (Akabas et al., 2016). Between 1970 and2006 dietary supplement use in the USA increased from 38% to 54% among women, and from 28% to 43% among men (Gache et al., 2011). ...
Sport supplements classified as foods (and not as medicine) must contain specified amounts and qualities of protein before a prescribed list of health-benefit claims may be made on labels or in marketing activities. The objective of the current study was to investigate the protein composition and quality of high-protein sports supplements currently available to consumers within South Africa, and possibly other countries. This study will provide a better understanding of the current protein powder supplement industry to inform food control agencies for their future policy and program development. Actual protein contents analyzed were statistically different (p<0.05) from the respective labels in 68.6% of the 70 products. Five products (7%) had protein content values differing by more than 25% of that stated on the product label. In addition, amino acid content (indicative of protein quality) was assessed on a subsample of 15 products. According to current draft label regulations of foods, the protein quality of 40% of these products was below the threshold, thus disqualifying them to make any protein benefit claims on product labels or in other marketing activities. The results of this study indicate that more widespread South Africa government controls and or enforcement of existing regulations need to be enacted and maintained.
... Supplements conforming to the respective organization's quality specifications can bear that organization's seal of approval on their label. 17 The absence of a seal, does not indicate inferior quality because the high costs of analyzing each ingredient may prevent some manufacturers from having its products tested. ...
It is the position of the Academy of Nutrition and Dietetics that micronutrient supplements are warranted when requirements are not being met through the diet alone. Those with increased requirements secondary to growth, chronic disease, medication use, malabsorption, pregnancy and lactation, and aging may be at particular risk for inadequate dietary intakes. However, the routine and indiscriminate use of micronutrient supplements for the prevention of chronic disease is not recommended, given the lack of available scientific evidence. A few specific age and disease states that may benefit from micronutrient supplementation are discussed. The most common dietary supplements used by both children and adults in the United States contain micronutrients. Consumers may not be well informed about the safety and use of these products, and some may have difficulty interpreting product labels. Thus, the expertise of registered dietitian nutritionists and nutrition and dietetic technicians, registered, is needed to guide the safe and appropriate selection and use of micronutrient supplements. To accomplish this, registered dietitian nutritionists and nutrition and dietetic technicians, registered, must keep up to date on efficacy, safety, and the regulatory issues influencing the use of these products. This position paper aims to increase awareness of current issues relevant to micronutrient supplementation and of the resources available to assist registered dietitian nutritionists and nutrition and dietetic technicians, registered, in evaluating their potential benefits and adverse outcomes.
... Cost may be an issue for smaller companies, and larger companies may not see any market advantage to certification and forego the added scrutiny. 2,16 In a study of military commissaries, only 12% of the dietary supplements on shelves were independently certified. 16 However, there seems to be an increase in the number of dietary supplement manufacturers seeking certification. ...
Context:
With the increasing use of unregulated dietary supplements, athletes are at continued risk from adverse medical events and inadvertent doping.
Evidence acquisition:
A review of Clinical Key, MEDLINE, and PubMed databases from 2012 to 2017 was performed using search terms, including dietary supplement, contamination, doping in athletes, inadvertent doping, and prohibited substances. The references of pertinent articles were reviewed for other relevant sources.
Study design:
Clinical review.
Level of evidence:
Level 3.
Results:
Poor manufacturing processes and intentional contamination with many banned substances continue to occur in dietary supplements sold in the United States. Certain sectors, such as weight loss and muscle-building supplements, pose a greater threat because they are more likely to be contaminated.
Conclusion:
Athletes will continue to be at risk for adverse events and failed doping tests due to contaminated dietary supplements until legislation changes how they are regulated. In the interim, there are several steps that can be taken to mitigate this risk, including improved education of medical staff and athletes and use of third party-certified products.
... Dietary supplements are ingested purposely to supply nutrients that are lacking in the diet, strengthen body immunity, support subjects with genetic biochemical and physiological variations and fight disease conditions (Tumir et al., 2010;Krejčová et al., 2012;Ruterbusch, 2015). The formulations are often taken without doctor's advice or knowledge (Akabas et al., 2016) and are available to the populace as over-the-counter-medicines. The regulation of production and marketing of dietary supplements are less stringent compared to conventional medicines. ...
Concentrations of 19 elements (As, Ca, Cd, Co, Cr, Cu, Fe, Hg, K, Mg, Mn, Mo, Na, Ni, P, Pb, Sn, V, and Zn) were determined in 18 dietary supplements widely available on the Nigerian market. The purpose of the study was to assess their potential toxicity and adequacy to meet the respective recommended dietary allowance (RDA). Hg was quantified by atomic absorption spectrometry and other elements by inductively coupled plasma mass spectrometry or inductively coupled plasma optical emission spectrometry after closed − vessel microwave digestion of samples. Method accuracy rates evaluated with certified reference materials (Peach, Tomato, and Spinach Leaves) ranged from 85 to 105% for the elements. Regarding essential elements, the highest concentrations (μg/g) found in supplements were: Na 98400; Ca 82600; P 27800; Fe 9940; Zn 5980; K 5840; Mn 4090; Mg 2440; Cu 1470; Co 0.34; Mo 37.7; Ni 4.91; V 1.23; and Cr 18.3. Concerning toxic elements, the highest amount (μg/g) found was As 1.13; Cd 0.2; Pb 1.86; Sn 0.49; and Hg 0.29. One daily dose of supplement contributed < 20% of the dietary intake requirement for five macro– elements. Elemental contents above their RDAs (number of supplements in parenthesis) were: Mn (1); Cu (3); Mo (1); Fe (2); and Zn (2). The maximum allowable levels of Cu, Mn, Mo, Pb, and Zn were exceeded by 2, 3, 1, 6, and 2 supplements, respectively. The estimated daily intake (EDI) of 10 elements met the USP Advisory panel oral permissible daily exposure (PDE) recommendation. However, the EDI of Mn, Pb, and Zn; and Cu, Co, Fe, Ni, Pb, and Zn exceeded the limits set for oral PDE and other regulatory thresholds, respectively.
