Article

Dietary Supplements are Not all Safe and Not all Food: How the Low Cost of Dietary Supplements Preys on the Consumer

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Abstract

Dietary supplements are regulated as food, even though the safety and efficacy of some supplements are unknown. These products are often promoted as ‘natural.’ This leads many consumers to fail to question the supplements' safety, and some consumers even equate ‘natural’ with safe. But, ‘natural’ does not mean safe. For example, many wild berries and mushrooms are dangerous although they are natural. Another example is tobacco—a key ingredient in cigarettes: it is natural, but overwhelming studies have established the harm of cigarette smoke. The Food and Drug Administration (FDA) requires safety and efficacy testing prior to market entry for drugs. In contrast, the FDA only has limited ability to regulate the entry of new dietary supplements into the marketplace because supplements are treated as food. Two main arguments support the current regulatory structure of dietary supplements: (1) cost and (2) access. But lower cost and increased access to dietary supplements do not necessary have any relationship to safety and efficacy. Manufacturers' marketing techniques tout the health benefits of their supplements. Meanwhile, consumers are ingesting supplements without scientific studies indicating whether or not they are harmful. The FDA Food Safety and Modernization Act, signed into law on January 4, 2011, did not address the safety concerns regarding dietary supplements. This article discusses the regulatory deficiencies concerning dietary supplements and proposes novel solutions to address this specific sector of the food supply. This article advocates for the use of scientific data to support a multi-tiered classification system to ensure that dietary supplements on the market are safe.

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... In addition, DS is marketed as "natural" which is often perceived to be safe by the public. 3 However, numerous herbal and dietary supplements including St. John's wort, echinacea, chromium, glucosamine, vitamins A/C/D, and selenium (all of which our patient consumed) have been associated with acute kidney injury. 4 Furthermore, our patient's borderline selenium toxicity likely altered native selenoproteins further exacerbating patient's underlying kidney failure. ...
... 6 Dietary Supplements Health and Education Act allows DS to not be regulated as drugs but rather as food with minimal oversight from the Food and Drug Administration (FDA). 3 While the FDA requires safety and efficacy documentation prior to market entry for drugs, DS is not held to the same standard and can be brought to the market with relative ease. 3 The FDA can remove a DS from the market if the DS provides a danger to public health, but that process requires considerable time and resources to prove danger allowing for questionable products to remain on the market. ...
... 3 While the FDA requires safety and efficacy documentation prior to market entry for drugs, DS is not held to the same standard and can be brought to the market with relative ease. 3 The FDA can remove a DS from the market if the DS provides a danger to public health, but that process requires considerable time and resources to prove danger allowing for questionable products to remain on the market. 6 In addition to safety, quality is also not enforced. ...
Article
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While dietary supplements are generally “safe,” they must be appropriately consumed as they have different regulatory standards than traditional pharmaceutical medications and require oversight to ensure that a good thing does not become harmful. image
... Similarly, Huat (2010) defined dietary/health supplement products may include active ingredients such as vitamins, minerals, amino acids, natural substances of plant/animal origin, enzymes, and substances with nutritional/physiological function. Basically, the physiological function of these product includes to boost the overall health and energy (Sax, 2015), provide immune system support, reduce the risks of illness and age-related conditions, and improve performance in athletic (Sax, 2015) and mental activities as well as to support the healing process during illness and disease. ...
... Similarly, Huat (2010) defined dietary/health supplement products may include active ingredients such as vitamins, minerals, amino acids, natural substances of plant/animal origin, enzymes, and substances with nutritional/physiological function. Basically, the physiological function of these product includes to boost the overall health and energy (Sax, 2015), provide immune system support, reduce the risks of illness and age-related conditions, and improve performance in athletic (Sax, 2015) and mental activities as well as to support the healing process during illness and disease. ...
... On deceptive advertisement, few authors (Hoogenraad & Duivenvoorde, 2015;Ippolito, 2003Ippolito, -2004Sax, 2015;Mohd Nor, Sheau, Liew & Rajah, 2014;Handsley & Nehmy, 2014) discussed on the doubt that advertising provides much information useful to consumers or competition. Some fear that without strong and legal constraints, the selling intent behind advertising will lead to considerable deception and consumer harm and competitive forces will not fill in important missing information (Gibson and Taylor, 2005). ...
... Similarly, Huat (2010) defined dietary/health supplement products may include active ingredients such as vitamins, minerals, amino acids, natural substances of plant/animal origin, enzymes, and substances with nutritional/physiological function. Basically, the physiological function of these product includes to boost the overall health and energy (Sax, 2015), provide immune system support, reduce the risks of illness and age-related conditions, and improve performance in athletic (Sax, 2015) and mental activities as well as to support the healing process during illness and disease. ...
... Similarly, Huat (2010) defined dietary/health supplement products may include active ingredients such as vitamins, minerals, amino acids, natural substances of plant/animal origin, enzymes, and substances with nutritional/physiological function. Basically, the physiological function of these product includes to boost the overall health and energy (Sax, 2015), provide immune system support, reduce the risks of illness and age-related conditions, and improve performance in athletic (Sax, 2015) and mental activities as well as to support the healing process during illness and disease. ...
... On deceptive advertisement, few authors (Hoogenraad & Duivenvoorde, 2015;Ippolito, 2003Ippolito, -2004Sax, 2015;Mohd Nor, Sheau, Liew & Rajah, 2014;Handsley & Nehmy, 2014) discussed on the doubt that advertising provides much information useful to consumers or competition. Some fear that without strong and legal constraints, the selling intent behind advertising will lead to considerable deception and consumer harm and competitive forces will not fill in important missing information (Gibson and Taylor, 2005). ...
Conference Paper
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Globalization has transformed many industries from the traditional/conventional ambiance to a modern and a technology based industry. Among the transformed industry are the food and pharmaceutical industry which led to the dietary supplements industry. Dietary supplements are products that are labeled as dietary supplements and are not represented for use as a conventional food or as a sole item of a meal or diet. Supplements can be marketed for ingestion in various forms such as capsule, powder, soft gel, tablet, liquid, teas, or any other form. Although dietary supplements have aided in the maintenance of the quality of life, yet the market is flooded with dietary supplements that are marketed with deceptive or misleading description. Advertisements in the media, has become a vital source of information about dietary supplements for consumers. Hence, the extent to which the manufacturers of these dietary supplements adhere to the standards and guidelines of good advertising practices remains relatively unexplored in Malaysia. Where the existing regulatory framework provides for the control of marketing for pharmaceutical related product, the law is absent in providing the same for food related products. The inadequacy existing laws such as the Trade Description Act 2011, Consumer Protection Act 1999, The Food Act 1983, related guidelines, circulars and directives that govern the marketing of dietary supplements may pose a threat to the sustainability of the industry. This paper aims to view these laws and the loopholes that might be apparent in them and suggest reforms for the marketing of dietary supplements.
... In Europe, the European . False claims include misbranding and illegal advertising, which violate FDA and FTC laws respectively [11,12]. ...
... The lack of clinical trials proving the safety and efficacy of dietary supplements can be explained because the regulations do not demand it as opposed to pharmaceuticals that are vetted for a certain degree of proven efficacy and safety, and where usually new medicines often lasts several years and costs millions. Moreover, those clinical trials are not a research priority basically because the products are defined as foods and in most the cases they are not financially feasible [12]. ...
... The number one adulterant in dietary supplement is drugs, followed by an unquantified number of NDIs that were not submitted to the FDA prior to marketing. Both are illegal [12]. ...
Article
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Background: Multi-level marketing (MLM) of nutrition products has experienced dramatic growth in recent decades. ‘Wellness’ is the second most popular niche in the MLM industry and represents 35 % of sales among all the products in 2016. This category includes dietary supplements, weight management and sports nutrition products. The aim of this paper is to analyse whether this practice is legal and ethical. Methods: An analysis of available documentary information about the legal aspects of Multi-level marketing business was performed. Ethical reflexion was based on the “principlism” approach. Results: We argue that, while being a controversial business model, MLM is not fraudulent from a legal point of view. However, it is an unethical strategy obviating all the principles of beneficence, nonmaleficence and autonomy. What is at stake is the possible economic scam and the potential harm those products could cause due to unproven efficacy, exceeding daily nutrient requirements and potential toxicity. The sale of dietary and nutrition supplements products by physicians and dieticians presents a conflict of interests that can undermine the primary obligation of physicians to serve the interests of their patients before their own. Conclusion: While considering that MLM of dietary supplements and other nutrition products are a legal business strategy, we affirm that it is an unethical practice. MLM products that have nutritional value or promoted as remedies may be unnecessary and intended for conditions that are unsuitable for self-prescription as well.
... 40,41 Consumers are generally drawn to dietary supplements because of their convenience and presumption of safety and effi cacy (compared with pharmaceutical drugs). 42 However, dietary supplements are not as well regulated as foods and drugs. 43 Quality control standards for supplements vary by manufacturers, leading to inconsistencies in composition and purity. ...
... 43 Quality control standards for supplements vary by manufacturers, leading to inconsistencies in composition and purity. 42 Discrepancies between factual and claimed statements, claims not supported with scientific evidence, and cases of contamination are commonly reported. 44,45 Third-party organizations such as the American Botanical Council are doing extensive work on standards for confi rming the active components of botanicals and supplements. ...
Article
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Nonalcoholic fatty liver disease (NAFLD), a multisystem, prevalent liver disease, can be managed with lifestyle interventions, including diet, given the lack of well-established pharmacologic therapies. This review explores the different dietary approaches that have been found effective in the management of NAFLD, offering a unique resource to healthcare professionals.
... For ginger, we are aware of only a single short-term clinical trial (n = 35 treated) testing a ginger product of uncharacterized composition, demonstrating benefits in reducing RA joint symptoms (34). Because botanical products, unlike drugs, are chemically complex, a lack of characterization of product content in these botanical clinical trials is a particular concern, a limitation compounded by the relative lack of US federal oversight of the content of botanical DS sold (35)(36)(37). Of the other 2 top NVNM DS documented here, more data are available for fish oil/ω-3 PUFU in RA, with evidence of moderate quality demonstrating efficacy in reducing RA joint symptoms and improving risk factors for cardiovascular disease, a systemic manifestation of RA (38)(39)(40). ...
... From a safety standpoint, it is notable that concurrent use of NVNM DS with RA pharmaceuticals was reported by almost half of the participants, including concurrent use of 3 or more NVNM DS by more than one-third. Because adverse pharmacodynamics or pharmacokinetic interactions between DS and pharmaceuticals are not uncommon (12)(13)(14) and NVNM DS content is variable and minimally regulated (35)(36)(37), frequent use of any NVNM DS, including turmeric, the most common, should provide a cautionary note for health care providers when assessing clinical responses in RA populations. Focusing on turmeric as an example, as is true for many NVNM DS frequently used for RA (9), although preclinical evidence supports RA treatment efficacy (43,44), clinical evidence of both efficacy and safety is scant for RA (30)(31)(32)(33). ...
Article
Background: Over-the-counter, natural product-based (nonvitamin, nonmineral) dietary supplement (NVNM DS) use is common in adults with rheumatoid arthritis (RA), a group at risk for drug-DS interactions, due to polypharmacy, but this use is underreported to health care providers. Recent dramatic changes in US sales of specific NVNM DS suggest that the prevalence and types of NVNM DS used in RA populations may also have shifted. Objectives: A study was undertaken to identify current and past use of specific NVNM DS for RA disease treatment and to examine associations between use of NVNM DS, RA pharmaceuticals, and/or vitamin or mineral (VM) DS. Methods: We developed a survey instrument to capture current and ever use of specific NVNM DS, VM DS, and RA pharmaceuticals, with 696 subjects self-reporting an RA diagnosis recruited online or in clinic for survey participation. Analyses were limited to 611 subjects reporting RA diagnosis after age 18 y and treatment with specific RA pharmaceuticals. Results: Most participants reported DS use, with current usage prevalence 49.6% (n = 303), 83.5% (n = 510), or 87.6% (n = 535) for NVNM, VM, or any DS, respectively. While not having appeared in previous RA surveys, turmeric and ginger were among the top 3 NVNM DS in current use, along with fish oil/ω-3 (n-3) PUFA. Concurrent NVNM DS use was reported by 48.2% (n = 243) of participants currently using RA pharmaceuticals (n = 504) and was more common in those using disease-modifying antirheumatic drugs only (no biologics). Most methotrexate users (83%) reported concurrent folate supplementation, with one-third also using turmeric, which is notable because methotrexate and turmeric have been associated with hepatotoxicity. Conclusion: Individuals with RA commonly use NVNM DS in combination with RA pharmaceuticals, including a previously undocumented but popular use of turmeric or ginger supplements with an unclear risk/benefit ratio.
... In the United States, the safety and distribution of dietary supplements are controlled by the FDA (Food and Drug Administration), whose equivalent in EFSA (Europe is the European Food Safety Authority) (3). The act that directly regulates the implementation of dietary supplements in the USA is DSHEA (Dietary Supplement Health and Education Act) of 1994, whereas in Europe ñ Directive 2002/46/EC, which unequivocally differentiates between food supplements and medicinal products (4)(5)(6). ...
... Based on the definition classifying dietary supplements as foodstuffs, they constitute a group of specific products present in the forms that enable patients to administer them on their own designed to complement dietary deficiencies. In view of large similarities, especially in the forms of administration, a lot of consumers do not notice the difference between dietary supplements and OTC (over-thecounter) drugs (6,8). ...
... Macro-minerals (mg/kg dry basis) perception of enhanced health benefits and safety, the current findings could be used to propose a potential business opportunity in valorisation of such shells into high value nutraceuticals 56,57 . The high Ca content in the tested samples also highlighted the potential of utilisation as a supplement for animals, especially egg-laying poultry. ...
Article
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Molluscan shellfish aquaculture contributes to 42.6% of global aquaculture production. With a continued increase in shellfish production, disposal of shell waste during processing is emerging as an environmental and financial concern. Whilst major commercial species such as Crassostrea spp. has been extensively investigated on usage of its shell, with information that are crucial for valorisation, e.g. safety and crystal polymorphs, evaluated. There is currently little understanding of utilisation opportunities of shell in several uprising Australian commercially harvested species including Akoya Oyster (Pinctada fucata), Roe’s Abalone (Haliotis roei) and Greenlip Abalone (Haliotis levigata), making it challenging to identify ideal usages based on evidence-based information. Therefore, in this study, an interdisciplinary approach was employed to characterise the shells, and thereafter suggest some potential utilisation opportunities. This characterisation included crude mineral content, elemental profiling and food safety evaluation. As well, physical, chemical, and thermal stability of the shell products was assessed. TGA result suggests that all shells investigated have high thermal stability, suggesting the possibility of utilisation as a functional filler in engineering applications. Subsequent FTIR, SEM and XRD analyses identified that CaCO3 was the main compositions with up to 77.6% of it found to be aragonite. The spectacular high aragonite content compared to well-investigated Crassostrea spp. suggested an opportunity for the utilisation of refined abalone shell as a source of biomedical engineering due to its potent biocompatibility. Additionally, safety evaluations on whole shell also outlined that all investigated samples were safe when utilised as a crude calcium supplement for populations > 11 years old, which could be another viable options of utilisation. This article could underpin abalone and akoya industries actions to fully utilise existing waste streams to achieve a more sustainable future.
... The benefits from the preparation processes are not only limited to macronutrients, but also to micronutrients, e.g. vitamins and minerals, necessary for the growth and development of organisms [4]; [5]. Moreover, plant foods also give us phytonutrients which can easily be destroyed by the heat applied during the cooking. ...
Article
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This paper explores the impact of cooking technique and vegetable nutritional components. As a crucial provider of nutrients, food goes through profound changes when cooked, hence its effect on macro-and micro-nutrients. Protein denaturation, which may lead to the breakdown of the tertiary structure resulted from the effect of heat, acid, alkali, or ultraviolet radiation, is a process that disrupts the original characteristics of proteins. Proteins basically remain more secure than vitamins while cooking, but they risk denaturation after overcooking or exposure to high heat. Although micronutrients like vitamins and minerals needed for growth are stable in their content and behavior, they can change their content and behavior during cooking process as they cannot withstand heat. The paper underlines the multiple impacts of cooking techniques on vegetables by pointing out that some techniques of heat application might result in inferior nutritional quality. Bioactive compounds that are in vegetables, undergo changes in the physical attributes, the sensory properties and bioactive content based on the techniques such as boiling, steaming or microwaving. Besides, during food preparation such as washing, peeling and cutting almost everything like flavor, texture or final nutritional values is already determined. The cooking method chosen in a wide range including microwave, pressure cooker, open pan or steaming has a great impact on the nutrient composition. Bacterial contamination in eggs, which is a health safety concern that can cause nutrients losing and even harm consumer health, stresses the need for cooking to preserve nutrients and protect consumers. The modern consumer who cares about the nutritional values and benefits of home cooked meals must be aware of the magnitude of method of cooking on the content of nutrients. Being a fact that more and more consumers after minimally processed and additive free snacks and nutrition information about cooking method is critical. The study concludes the study by suggesting that additional research is needed so as to develop the guidelines for the best cooking methods that promote nutrient conservation, safety, and palatability.
... In the literature review on the nature of FSC in terms of food supplements, it can be seen that studies mainly focus on the compliance of foods with food safety standards in terms of the substances they contain (55) and the quality of the substances contained in foods (87). This situation is associated with the low acquisition costs of food supplements (88) and the content prone to falsification (89). Therefore, it can be said that FSCs affect the shaping of individuals' HC. ...
Article
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In recent years, health crises have led consumers to make more frequent purchases of food supplements. The global food supplement market, which reached 61.20billionin2020,isestimatedtoreach61.20 billion in 2020, is estimated to reach 163.12 billion by 2022 and $350.96 billion by 2032. However, many consumers still have concerns about the safety of food supplements. Within the scope of the research, firstly, the health consciousness (HC) level of food supplement consumers was determined. Secondly, food safety knowledge (FSK) and food safety concerns (FSCs) were measured. Thirdly, consumers’ attitudes (ATUs), subjective norms (SNs), and behavioral intentions (BIs) toward food supplements were determined within the scope of the theory of reasoned action. The study used a convenient sampling, and 327 participants were included in the sample population. The data for the analysis was collected using the online survey method in the third quarter of 2023. The relationships between hypothesized items in the structural model were tested using the Smart-PLS. The validity and reliability of the measurement model were evaluated at the start of the structural equation modelling approach using confirmatory factor analysis (CFA). Regression analyses were performed in the structural model phase to evaluate overall fit and suggested relationships by way of the Smart-PLS. In light of the findings, it was determined that the interaction between HC and ATU was mediated by FSK, and the interaction between HC and the SN was mediated by FSK. Consequently, this research presents a variety of theoretical and practical implications to give clues for consumers’ health regarding food supplement consumption.
... These supplements, often created and marketed to stimulate weight loss, 2 include "vitamins, essential minerals, protein, amino acids, and herbs." 3 Influencers' foray into the realm of dietary supplements has had a significant impact on the marketing industry, as demonstrated by their enormous advertising revenue, with estimates that influencer marketing would reach "$10-20 billion in 2020, with close to 80% of brands participating." 1 With regard to the regulation of this industry, the federal government plays a role via both the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), which "both serve to protect consumers by ensuring safe, effective products and accurate marketing to consumers." 2 However, the regulatory environment for dietary supplements, which has been criticized as being inadequate in the face of hazards, 4 has serious pitfalls when confronting promotion of these supplements by social media influencers. This article explores the federal regulatory mechanisms in place to govern dietary supplements and proposes strategies for how US law-both administrative regulation and common law-can strengthen the regulation of dietary supplements in the new era of influencers. ...
Article
Social media influencers promote a wide variety of products, including dietary supplements. Dietary supplements are regulated as foods, not drugs, by the US Food and Drug Administration and the Federal Trade Commission. This article details weaknesses in administrative and common law regulatory approaches to addressing some influencers' negligent misrepresentation claims about dietary supplements.
... Dietary supplements are regarded as nonfood but not drug products that are taken to improve health or prevent diseases [57], even though most of the products are unsafe and usually marketed as natural [58]. Dietary supplement use has increased globally [59] and have become of particular interest to consumers and pharmaceutical companies [60,61] in addition to being a significant part of complementary medicines to maintain or improve health [62,63]. ...
Article
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Supplements for smoking-related lung diseases are considered as nonfood products and thought to improve health. Multivitamins and antioxidants are the most commonly dietary supplements used by cancer and asthma patients. There are currently no clear regulatory guidelines that include dietary supplements and their effect on lung cancer and asthma patients, particularly in smokers. Several countries have taken steps to overcome challenges in regulating dietary supplements in the marketplace. These challenges include inadequate assurance of safety/efficacy, inaccuracy of product labeling, misleading health claims, and lack of analytical techniques for dietary supplements. There is a need to establish standards and regulation of dietary supplement use in patients with lung cancer and asthma. The aim of this entry is to expand knowledge on dietary supplements use and smoking-related lung diseases (lung cancer and asthma).
... Some individuals turn to sleep aids such as supplements and medications. However, their side effects can be significant, and it is unknown if they actually reset the body clock [64]. ...
Article
For elite athletes who exercise at a high level, sleep is critical to overall health. Many studies have documented the effects of sleep deprivation in the general population, but few studies exist regarding specific effects in the athlete. This review summarizes the effects of sleep deprivation and sleep extension on athletic performance, including reaction time, accuracy, strength and endurance, and cognitive function. There are clear negative effects of sleep deprivation on performance, including reaction time, accuracy, vigor, submaximal strength, and endurance. Cognitive functions such as judgment and decision-making also suffer. Sleep extension can positively affect reaction times, mood, sprint times, tennis serve accuracy, swim turns, kick stroke efficiency, and increased free throw and 3-point accuracy. Banking sleep (sleep extension prior to night of intentional sleep deprivation before sporting event) is a new concept that may also improve performance. For sports medicine providers, the negative effects of sleep deprivation cannot be overstated to athletes. To battle sleep deprivation, athletes may seek supplements with potentially serious side effects; improving sleep quality however is simple and effective, benefiting not only athlete health but also athletic performance.
... [10][11][12] Despite their therapeutic potential, turmeric DS in the US are categorized and regulated as dietary supplements, as defined by the Dietary Supplement Health and Education Act of 1994 (DSHEA), with oversight of content and quality assurance left largely to the manufacturer, and federal regulation primarily limited to product removal from the marketplace if adverse effects occur and are reported. [13,14] To help fill what has been seen by some as a regulatory void, [15] several independent organizations (e.g. Consumer Lab, NSF International, US Pharmacopeia [USP], UL International) evaluate the quality of DS in Molecular Nutrition & Food Research This article is protected by copyright. ...
Article
Scope Turmeric is a top selling dietary supplement (DS) in the United States with rapidly expanding usage. Therefore, turmeric DS formulations available for sale in an urban US retail marketplace were analyzed, and point of sale information was related to measures of quality relevant to safety. Methods and Results Eighty‐seven unique turmeric DS were identified; a majority (94%) contained turmeric‐derived curcuminoid extracts (TD‐CE), which were combined with other bioactives in 47% of products, including piperine (24%), an additive that could alter the metabolism of concurrent medications. While curcuminoid content was within 80% of anticipated for a majority of products analyzed (n = 35), curcuminoid composition (% curcumin) did not meet USP criteria for TD‐CE in 59% and was suggestive of possible unlabeled use of synthetic curcumin in some. Lead content was associated with inclusion of turmeric root and exceeded USP limits in one product. Residues of toxic class 1 or 2 solvents, which are not needed for TD‐CE isolation, were present in 71% of products, although quantified levels were within USP‐specified limits. Conclusion Assessment of turmeric DS quality at point of sale is difficult for consumers and may best be managed in partnership with knowledgeable health care professionals. This article is protected by copyright. All rights reserved
... T he prevalence of dietary supplement use is an increasing trend in the United States. 1 As defined by the Dietary Supplement Health and Education Act 1994, herbs and dietary supplements fall under general Food and Drug Administration supervision but have not been actively regulated. [2][3][4][5] These products are typically advertised as safe, despite lacking scientific studies to assess their efficacy or safety. 1,6,7 Most supplements are taken without health care provider oversight, with individuals depending on product information found on the Internet and in advertisements, many times containing inaccurate or misleading information. ...
Article
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Objective: To assess whether dietary supplements that are herbal and/or animal-derived products, marketed for enhancing metabolism or promoting energy, "adrenal fatigue," or "adrenal support," contain thyroid or steroid hormones. Methods: Twelve dietary adrenal support supplements were purchased. Pregnenolone, androstenedione, 17-hydroxyprogesterone, cortisol, cortisone, dehydroepiandrosterone sulfate, synthetic glucocorticoids (betamethasone, dexamethasone, fludrocortisone, megestrol acetate, methylprednisolone, prednisolone, prednisone, budesonide, and triamcinolone acetonide) levels were measured twice in samples in a blinded fashion. This study was conducted between February 1, 2016, and November 1, 2016. Results: Among steroids, pregnenolone was the most common hormone in the samples. Budesonide, 17-hydroxyprogesterone, androstenedione, cortisol, and cortisone were the others in order of prevalence. All the supplements revealed a detectable amount of triiodothyronine (T3) (63-394.9 ng/tablet), 42% contained pregnenolone (66.12-205.2 ng/tablet), 25% contained budesonide (119.5-610 ng/tablet), 17% contained androstenedione (1.27-7.25 ng/tablet), 8% contained 17-OH progesterone (30.09 ng/tablet), 8% contained cortisone (79.66 ng/tablet), and 8% contained cortisol (138.5 ng/tablet). Per label recommended doses daily exposure was up to 1322 ng for T3, 1231.2 ng for pregnenolone, 1276.4 ng for budesonide, 29 ng for androstenedione, 60.18 ng for 17-OH progesterone, 277 ng for cortisol, and 159.32 ng for cortisone. Conclusion: All the supplements studied contained a small amount of thyroid hormone and most contained at least 1 steroid hormone. This is the first study that measured thyroid and steroid hormones in over-the-counter dietary "adrenal support" supplements in the United States. These results may highlight potential risks of hidden ingredients in unregulated supplements.
... The unregulated use of largely unsubstantiated structure-function claims has been cited as a concern among public health professionals (Zakaryan et al. 2012) due to the fact that it is nearly impossible to differentiate between substantiated health claims and these more suggestive structure-function claims (Sax 2015) (See example ads in the Appendix A1). Concerns focus on their potential to misleadingly imply that supplements treat diseases (Crawford et al. 2005;Zakaryan et al. 2012). ...
Article
This study examines the effect of advertising on demand for vitamins—products with spiraling sales despite little evidence of efficacy. We merge seven years (2003-2009) of advertising data from Kantar Media with the Simmons National Consumer Survey to estimate individual-level vitamin print and television ad exposure effects. Identification relies on exploiting exogenous variation in year-to-year advertising exposure by controlling for each individual’s unique media consumption. We find that increasing advertising exposure from zero to the mean number of ads increases the probability of consumption by 1.2 and 0.8 percentage points (or 2 and 1.4 percent) in print and television respectively. Stratifications by the presence of health conditions suggests that in print demand is being driven by both healthy and sick individuals.
... The supplement industry is not well regulated, and many products available might be ineffective. Furthermore, a lack of standardization exists, which means that some products might contain contaminants (including pharmaceuticals) or doses of the bioactive compound in excess of that reported on the label 149 . For these reasons, health-care professionals need to be able to identify products that might be beneficial for their patients, especially those who refuse pharmacological therapy. ...
Article
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Dyslipidaemia is characterized by increased blood levels of total or LDL cholesterol and triglycerides, or decreased HDL cholesterol levels, and is a risk factor for cardiovascular disease. Dyslipidaemia has a high worldwide prevalence, and many patients are turning to alternatives to pharmacotherapy to manage their lipid levels. Lifestyle modification should be emphasized in all patients to reduce cardiovascular risk and can be initiated before pharmacotherapy in primary prevention of cardiovascular disease. Many functional foods and natural health products have been investigated for potential lipid-lowering properties. Those with good evidence for a biochemical effect on plasma lipid levels include soy protein, green tea, plant sterols, probiotic yogurt, marine-derived omega-3 fatty acids and red yeast rice. Other products such as seaweed, berberine, hawthorn and garlic might confer some limited benefit in certain patient groups. Although none of these products can reduce lipid levels to the same extent as statins, most are safe to use in addition to other lifestyle modifications and pharmacotherapy. Natural health products marketed at individuals with dyslipidaemia, such as policosanol, guggulsterone and resveratrol, have minimal definitive evidence of a biochemical benefit. Additional research is required in this field, which should include large, high-quality randomized controlled trials with long follow-up periods to investigate associations with cardiovascular end points.
... This does not necessarily mean that they are safe and effective. Because supplements are classified as food, the U.S. Food and Drug Administration does not require the same scrutiny for safety and efficacy as is mandatory for prescribed medications (Sax, 2015). There is a limit on the claims supplements can make on labels, in advertisement, and in testimonials. ...
Article
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Purpose We surveyed the benefit of dietary supplements to treat tinnitus and reported adverse effects. Method A website was created for people with tinnitus to complete a variety of questions. Results The 1,788 subjects who responded to questionnaires came from 53 different countries; 413 (23.1%) reported taking supplements. No effect on tinnitus was reported in 70.7%, improvement in 19.0%, and worsening in 10.3%. Adverse effects were reported in 6% (n = 36), including bleeding, diarrhea, headache, and others. Supplements were reported to be helpful for sleep: melatonin (effect size, d = 1.228) and lipoflavonoid (d = 0.5244); emotional reactions: melatonin (d = 0.6138) and lipoflavonoid (d = 0.457); hearing: Ginkgo biloba (d = 0.3758); and concentration Ginkgo biloba (d = 0.3611). The positive, subjective reports should be interpreted cautiously; many might have reported a positive effect because they were committed to treatment and expected a benefit. Users of supplements were more likely to have loudness hyperacusis and to have a louder tinnitus. Conclusions The use of dietary supplements to treat tinnitus is common, particularly with Ginkgo biloba, lipoflavonoids, magnesium, melatonin, vitamin B12, and zinc. It is likely that some supplements will help with sleep for some patients. However, they are generally not effective, and many produced adverse effects. We concluded that dietary supplements should not be recommended to treat tinnitus but could have a positive outcome on tinnitus reactions in some people.
Article
Goji berry leaf (GL) has been used for medicinal foods for its pharmacological effects, including anti-oxidative and anti-obesity activities. Nevertheless, toxicological information on GL is limited for developing health functional ingredient. The aim of the research was to evaluate the single dose acute, 14-day repeated oral toxicity, and genotoxicity of standardized roasted GL extract (rGL) rich in kaempferol-3-O-sophoroside-7-O-glucoside. Tested rGL was found to be stable as kaempferol-3-O-sophoroside-7-O-glucoside, showing 0.7-2.1% of analytical standard variance. According to the single dose toxicity for 14 days, the lethal dose of rGL was determined to be ≥ 2000 mg/kg. Repeated doses of 0-1000 mg/kg of rGL per day for 14 days did not show any toxicity signs or gross pathological abnormalities. No genotoxic signs for the rGL treatment appeared via bacterial reverse mutation up to 5000 μg/plate. There was no significant increase in chromosomal aberration of rGL irrespective of metabolic activation by using CHO-K1 cells (p > 0.05). Regarding carcinogenic toxicity, chromosomal aberrations were not induced at 2000 mg of rGL/kg by using the in vivo bone marrow micronucleus test (p > 0.05). Results from the current study suggest that rGL could be used as a functional ingredient to provide various effects with safety assurance.
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Multi-level marketing (MLM) of dietary supplements and other nutrition products that have nutritional value or promoted as remedies may be unnecessary and intended for conditions that are unsuitable for self-prescription. The respect of the principles of beneficence, nonmaleficence and autonomy is at stake. The general public should avoid nutrition and health-related multi-level products, while government agencies should become involved as well. Clinical nutrition scientific societies should define policies and recommendations on how, by whom and when dietary supplements should be prescribed.
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Internationally, efforts promoting greater transparency and improved management strategies for conflicts of interest (COI) have gained traction in healthcare settings. This particularly pertains to the development and use of clinical practice guidelines (CPG). Mounting evidence indicates that pharmaceutical industry payments to GPG authors and developers influence clinical recommendations, including drug selection, often to benefit commercial interests and at the expense of patients. To prevent undue influence of COI and develop trustworthy CPG, authors and developing organizations should establish strict COI management policies, including full disclosure. Such policies should include details about the monetary values and funding sources of all payments and gifts from pharmaceutical companies. Authors and developers should refuse any payments or gifts while drafting CPG. CPG developers should establish clear and comprehensive COI definitions and create monitoring committees that implement COI policies, promote external review, and track COI declared by CPG authors using existing payment databases.
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The spread of misinformation and disinformation related to science and technology has impeded public and policy efforts to mitigate threats such as COVID-19 and anthropogenic climate change. In the digital age, such so-called fake science can propagate faster and capture the public imagination to a greater extent than accurate science. Therefore, ensuring the most reliable science reaches and is accepted by audiences now entails understanding the origins of fake science so that effective measures can be operationalized to recognize misinformation and inhibit its spread. In this chapter, we review the potential weaknesses of science publishing and assessment as an origin of misinformation; the interplay between science, the media, and society; and the limitations of literacy as an inoculation against misinformation; and we offer guidance on the most effective ways to frame science to engage non-expert audiences. We conclude by offering avenues for future science communication research.
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This Article tackles the critical problem of COVID-19 vaccine hesitancy and provides a normative framework for legal policies to address such hesitancy in the ongoing pandemic. The foundation of this Article rests in decision-making theories that allow policymakers to understand individual misperception of risk as compared to evidence-based assessment of risk. Vaccine-hesitant individuals assign a high risk to the COVID-19 vaccine and a low risk to the disease—a perception that is disconnected from the science. The backbone of this Article is the timeline of the COVID-19 pandemic and the underlying science of the disease and vaccines. The timeline provides a factual background to demonstrate how vaccine hesitancy to the COVID-19 vaccine emerged. The instant pandemic also demonstrates changes in how individuals see themselves in society, receive information, and are persuaded by economic forces. This Article combines the individual’s decision-making process with modern day variables to suggest interventions that can undo anti-vaccine damage. While the novelty of the normative framework provided herein is instructive for current COVID-19 vaccine hesitancy issues, this framework can be applied to other areas in which individual’s perceptions of risk are disconnected from evidence-based assessment of risk.
Article
Objective Despite limited evidence, children with neurodevelopmental and psychological disorders may be having dietary interventions incorporated into treatment. Little is known about psychologists’ role in influencing these decisions. Method Australian psychologists working with children (N=60) completed the Nutritional Competence Tool, and questions exploring psychologist attitudes, self-reported competence and practices associated with the use of dietary interventions for children presenting for psychological treatment of psychological disorders. Results Most respondents reported positive attitudes towards dietary interventions. Incorporating dietary interventions into clinical practice was common, with 56.7% reporting they would be likely to recommend one or more dietary interventions pre-specified for one of the conditions explored. Participants were most likely to endorse the use of dietary interventions for children presenting with oppositional defiant disorder, conduct disorder or other behavioural problems. Conclusion Despite training in evidence-based practice, some registered psychologists have positive attitudes towards dietary modifications in the treatment of children with psychological conditions, and may be susceptible to recommending dietary interventions, regardless of the limited evidence base. The conditions for which recommendations were most likely, as well as diets most commonly recommended had hallmark features of “fads”, raising several ethical concerns. Further research should determine how widespread this practise is. Key Points What is already known about this topic: • Dietary interventions do not have a robust evidence-base in treating psychological and neurodevelopmental disorders. • Children often receive dietary modification to aid the amelioration of symptoms of psychological and neurodevelopmental disorders. • Limited research suggests that psychologists may be contributing to the use of complementary and alternative treatments. What this paper adds: • Some psychologists have positive attitudes towards dietary interventions for a range of psychological disorders in childhood. • Some psychologists report that they are likely to recommend dietary interventions for children presenting for psychological treatment. • Oppositional defiant disorder and conduct disorder were the conditions most likely elicit information about dietary interventions or recommendations to consider a dietary interventions.
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Turmeric dietary supplement sales, which accounted for US$69 million in spending in 2016, have been increasing exponentially in the USA, making this one of the most popular botanical supplements sold in the USA. Herbal supplement use, which is generally regarded as safe by consumers, is not usually reported to healthcare providers. We reported here on a case of autoimmune hepatitis, occurring in a 71-year-old woman taking turmeric dietary supplements for the maintenance of cardiovascular health, which resolved rapidly following discontinuation of the turmeric supplements. Of particular note, turmeric use was not documented in the patient’s medical records and the potential causative role of the turmeric supplementation was ultimately identified by the patient rather than the healthcare providers. To our knowledge, this is the first documented report of turmeric supplement-induced autoimmune hepatitis.
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Against the background of proven efficacy in mild to moderate depressive disorders and an excellent tolerability profile in monotherapy, there is sufficient evidence from interaction studies and case reports to suggest that St John’s wort may induce the cytochrome P450 (CYP) 3A4 enzyme system and the P-glycoprotein drug transporter in a clinically relevant manner, thereby reducing efficacy of co-medications. Drugs most prominently affected and contraindicated for concomitant use with St John’s wort are metabolised via both CYP3A4 and P-glycoprotein pathways, including HIV protease inhibitors, HIV non-nucleoside reverse transcriptase inhibitors (only CYP3A4), the immunosuppressants ciclosporin and tacrolimus, and the antineoplastic agents irinotecan and imatinib mesylate. Efficacy of hormonal contraceptives may be impaired as reflected by case reports of irregular bleedings and unwanted pregnancies. Drugs with a narrow therapeutic index should be monitored more closely when St John’s wort is added, discontinued or the dosage is changed. The St John’s wort constituent hyperforin is probably responsible for CYP3A4 induction via activation of a nuclear steroid/pregnane and xenobiotic receptor (SXR/PXR) and hypericin may be assumed to be the P-glycoprotein inducing compound, although the available evidence is less convincing. Combinations of St John’s wort with serotonergic agents and other antidepressants should be restricted to prescription-only, by experienced clinicians, due to potential central pharmacodynamic interactions. In conclusion, providing certain precautions and contraindications are followed, and adequate information is given to healthcare professionals and patients, the safe and effective use of quality-tested St John’s wort products can be ensured.
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More than a third of children and adolescents in the United States take vitamins even though professional medical organizations do not endorse their use in healthy children. Regardless of their efficacy, children’s vitamin products are aggressively promoted. Therefore, the goal of this study was to describe and analyze advertisements related to vitamins in the following three popular parenting magazines, Parents, Parenting Early Years, and Parenting School Years. A total of 135 magazines across four years were reviewed. There were 207 advertisements for children’s vitamins, all in the form of chewy or gummy. None of these advertisements included a dosage or a warning. Almost all (92.3%) included a cartoon in the advertisement. Almost a quarter (23.2%) of the advertisements promoted their product with the theme of prevention and more than half (51.2%) included the theme of peace of mind. Parenting magazines are a popular medium for providing exposure to products geared towards children. Companies that market children’s vitamins in these magazines can increase awareness among parents of the risks by providing warning and dosage information in their advertisements. Magazines can also play a role by encouraging responsible marketing and providing editorial content on children’s vitamins and potential consequences of pediatric overdose.
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After decades of study, researchers still can't agree on whether nutritional supplements actually improve health.
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Concurrent use of herbs may mimic, magnify, or oppose the effect of drugs. Plausible cases of herb-drug interactions include: bleeding when warfarin is combined with ginkgo (Ginkgo biloba), garlic (Allium sativum), dong quai (Angelica sinensis), or danshen (Salvia miltiorrhiza); mild serotonin syndrome in patients who mix St John's wort (Hypericum perforatum) with serotonin-reuptake inhibitors; decreased bioavailability of digoxin, theophylline, cyclosporin, and phenprocoumon when these drugs are combined with St John's wort; induction of mania in depressed patients who mix antidepressants and Panax ginseng; exacerbation of extrapyramidal effects with neuroleptic drugs and betel nut (Areca catechu); increased risk of hypertension when tricyclic antidepressants are combined with yohimbine (Pausinystalia yohimbe); potentiation of oral and topical corticosteroids by liquorice (Glycyrrhiza glabra); decreased blood concentrations of prednisolone when taken with the Chinese herbal product xaio chai hu tang (sho-salko-to); and decreased concentrations of phenytoin when combined with the Ayurvedic syrup shankhapushpi. Anthranoid-containing plants (including senna [Cassia senna] and cascara [Rhamnus purshiana]) and soluble fibres (including guar gum and psyllium) can decrease the absorption of drugs. Many reports of herb-drug interactions are sketchy and lack laboratory analysis of suspect preparations. Health-care practitioners should caution patients against mixing herbs and pharmaceutical drugs.
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Little is known about adverse reactions to dietary supplements because these events are underreported. The Food and Drug Administration’s ability to regulate dietary supplements has a long and complicated history and the battle over regulation continues. On a simple level, the debate over regulation of dietary supplements boils down to manufacturers’ desire not to be regulated and personal autonomy to make decisions about what supplements to take versus the FDA’s charge to protect the public from harmful drugs and devices. At present, dietary supplements are regulated as food, not drugs. The arguments surrounding this debate fall along a spectrum. These arguments, however, are reminiscent of the debates surrounding the regulation of tobacco. The tobacco companies fought hard to keep the FDA out of regulation, some members of the public argued that they should be allowed to take personal responsibility, and the FDA fought to bring tobacco within its regulatory authority. This article seeks to re-examine the debate over dietary supplement regulation through the lens of lessons learned from the tobacco industry. This article proposes new approaches and concerns regarding the future of the FDA and its role in regulating the dietary supplement industry.
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This Article proposes a new direction for addressing financial conflicts of interest, which plague biomedical research and threaten scientific integrity. This Article descriptively states the controversy surrounding financial conflicts of interest by explaining how these conflicts arise and the damage that can be created as a result. By describing the scientific process, the Article explains that changes to the academic environment may allow the public-private interaction to proceed, without creating the problems associated with financial conflicts of interest. Financial conflicts of interest are created when the profit-seeking motive of a private funding source unduly influences an academic scientist's primary responsibilities. The problem with financial conflicts of interest has grown since the passage of the Bayh-Dole Act in 1980. The cornerstone of current policies to address financial conflicts of interest is disclosure, which is inadequate and unsatisfying. The analysis herein changes the trajectory of current approaches in this area by proposing that an analysis of the underlying environment and behavior leading to conflicts of interest must be considered. This Article proposes the use of behavioral economics to craft a policy that effectively addresses conflicts of interest. To this end, this Article applies research from the field of psychology to understand both the environment of academic scientists as well as to begin to understand how academic scientists make decisions. Drawing on psychology literature, this article proposes that academic scientists may experience cognitive dissonance when faced with a situation in which a conflict of interest may arise. This helps to understand why an academic scientist may make a decision that creates a conflict of interest. In addition, this Article utilizes the results of an empirical study conducted by myself and a colleague. In this study, we asked faculty at five medical schools to respond to an anonymous survey containing hypothetical situations in which a conflict may arise. The combination of the psychology literature and our empirical study can provide support to the creation of new policies. Policy proposals include implementation of default rules, education, and changes to academic requirements. Furthermore, this Article considers ways to incentivize medical centers to implement effective policies as well as changes to intellectual property law.
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Although dietary supplements are commonly taken to prevent chronic disease, the long-term health consequences of many compounds are unknown. We assessed the use of vitamin and mineral supplements in relation to total mortality in 38,772 older women in the Iowa Women's Health Study; mean age was 61.6 years at baseline in 1986. Supplement use was self-reported in 1986, 1997, and 2004. Through December 31, 2008, a total of 15,594 deaths (40.2%) were identified through the State Health Registry of Iowa and the National Death Index. In multivariable adjusted proportional hazards regression models, the use of multivitamins (hazard ratio, 1.06; 95% CI, 1.02-1.10; absolute risk increase, 2.4%), vitamin B(6) (1.10; 1.01-1.21; 4.1%), folic acid (1.15; 1.00-1.32; 5.9%), iron (1.10; 1.03-1.17; 3.9%), magnesium (1.08; 1.01-1.15; 3.6%), zinc (1.08; 1.01-1.15; 3.0%), and copper (1.45; 1.20-1.75; 18.0%) were associated with increased risk of total mortality when compared with corresponding nonuse. Use of calcium was inversely related (hazard ratio, 0.91; 95% confidence interval, 0.88-0.94; absolute risk reduction, 3.8%). Findings for iron and calcium were replicated in separate, shorter-term analyses (10-year, 6-year, and 4-year follow-up), each with approximately 15% of the original participants having died, starting in 1986, 1997, and 2004. In older women, several commonly used dietary vitamin and mineral supplements may be associated with increased total mortality risk; this association is strongest with supplemental iron. In contrast to the findings of many studies, calcium is associated with decreased risk.
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The content of ephedra alkaloids in herbal dietary supplements containing ephedra (ma huang) was studied. The ephedra alkaloid content of 20 ephedra-containing supplements was determined by high-performance liquid chromatography. Contents of (-)-ephedrine, (+)-pseudoephedrine, (-)-methylephedrine, (-)-norephedrine, and (+)-norpseudoephedrine were measured. Ephedra alkaloid content varied considerably among products. Total alkaloid content ranged from 0.0 to 18.5 mg per dosage unit. Ranges for (-)-ephedrine and (+)-pseudoephedrine were 1.1-15.3 mg and 0.2-9.5 mg, respectively. (+)-Norpseudoephedrine, a Schedule IV controlled substance, was often present. Significant lot-to-lot variations in alkaloid content were observed for four products. For one product, lot-to-lot variations in the content of (-)-ephedrine, (+)-pseudoephedrine, and (-)-methylephedrine exceeded 180%, 250%, and 1000%, respectively. Half of the products exhibited discrepancies between the label claim for ephedra alkaloid content and actual alkaloid content in excess of 20%. One product was devoid of ephedra alkaloids. Assay of 20 ephedra-containing dietary supplements showed that alkaloid content often differed markedly from label claims and was inconsistent between two lots of some products.
Article
Dietary supplements that contain ephedra alkaloids (sometimes called ma huang) are widely promoted and used in the United States as a means of losing weight and increasing energy. In the light of recently reported adverse events related to use of these products, the Food and Drug Administration (FDA) has proposed limits on the dose and duration of use of such supplements. The FDA requested an independent review of reports of adverse events related to the use of supplements that contained ephedra alkaloids to assess causation and to estimate the level of risk the use of these supplements poses to consumers. We reviewed 140 reports of adverse events related to the use of dietary supplements containing ephedra alkaloids that were submitted to the FDA between June 1, 1997, and March 31, 1999. A standardized rating system for assessing causation was applied to each adverse event. Thirty-one percent of cases were considered to be definitely or probably related to the use of supplements containing ephedra alkaloids, and 31 percent were deemed to be possibly related. Among the adverse events that were deemed definitely, probably, or possibly related to the use of supplements containing ephedra alkaloids, 47 percent involved cardiovascular symptoms and 18 percent involved the central nervous system. Hypertension was the single most frequent adverse effect (17 reports), followed by palpitations, tachycardia, or both (13); stroke (10); and seizures (7). Ten events resulted in death, and 13 events produced permanent disability, representing 26 percent of the definite, probable, and possible cases. The use of dietary supplements that contain ephedra alkaloids may pose a health risk to some persons. These findings indicate the need for a better understanding of individual susceptibility to the adverse effects of such dietary supplements.
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The aim of this work is to identify the medicines which interact with the herbal remedy St John's wort (SJW), and the mechanisms responsible. A systematic review of all the available evidence, including worldwide published literature and spontaneous case reports provided by healthcare professionals and regulatory authorities within Europe has been undertaken. A number of clinically significant interactions have been identified with prescribed medicines including warfarin, phenprocoumon, cyclosporin, HIV protease inhibitors, theophylline, digoxin and oral contraceptives resulting in a decrease in concentration or effect of the medicines. These interactions are probably due to the induction of cytochrome P450 isoenzymes CYP3A4, CYP2C9, CYP1A2 and the transport protein P-glycoprotein by constituent(s) in SJW. The degree of induction is unpredictable due to factors such as the variable quality and quantity of constituent(s) in SJW preparations. In addition, possible pharmacodynamic interactions with selective serotonin re-uptake inhibitors and serotonin (5-HT(1d)) receptor-agonists such as triptans used to treat migraine were identified. These interactions are associated with an increased risk of adverse reactions. In Sweden and the UK the potential risks to patients were judged to be significant and therefore information about the interactions was provided to health care professionals and patients. The product information of the licensed medicines involved has been amended to reflect these newly identified interactions and SJW preparations have been voluntarily labelled with appropriate warnings.
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There exists increasing concern that the Dietary Supplements Health and Education Act (“DSHEA”) has proven ineffective and perhaps counterproductive. Most illustratively, consider a recent and remarkably candid remark from Tommy Thompson, then Secretary of Health and Human Services: “I really think Congress should take a look at the food supplement law again. It doesn't make any sense to me .” A health law that makes no sense to the Secretary of Health of Health and Human Services should certainly draw the attention of academics and policy-makers alike. Much of the debate concerning DSHEA regards the disparity in legislative treatment between dietary supplements, foods, and pharmaceutical drugs. Specifically, while pharmaceutical drugs must undergo years of costly pre-market testing, most dietary supplements—like most foods—can immediately enter the market, and only after repeated instances of adverse reactions can the Food and Drug Administration (“FDA”) remove them.
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A protective effect of folate against the development of neural tube defects (NTDs), specifically, anencephaly and spina bifida, is now well recognized, having been established by a chain of clinical research studies over the past half century. This article summarizes the more important of these studies, which have led to the current situation in which all women capable of becoming pregnant are urged to ingest folic acid regularly. The recommended intakes are 4 mg/d for those at high risk (by virtue of a previous NTD pregnancy outcome) and 0.4 mg/d for all others. However, a reduction in NTD births did not follow promulgation of these recommendations, and so folic acid fortification was mandated in the United States and some other countries. Although some controversy remains about the adequacy of fortification levels, the process was followed by significant improvement in folate indexes and a reduction of 25-30% in NTD frequency (about one-half of the proportion of cases assumed to be responsive to folate). The folate-NTD relation represents the only instance in which a congenital malformation can be prevented simply and consistently. Nevertheless, several research gaps remain: identification of the mechanism by which the defect occurs and how folate ameliorates it; characterization of the relative efficacy of food folate, folic acid added to foods, and folic acid by itself; delineation of the dose-response relations of folate and NTD prevention; and more precise quantification of the dose needed to prevent recurrences.
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Although multivitamins, multiminerals, and similar terms (eg, multis or multiples) are commonly used, they have no standard scientific, regulatory, or marketplace definitions. Thus, multivitamins-multiminerals refers to products with widely varied compositions and characteristics. Multivitamin-multimineral composition databases use label values as surrogates for analyzed values. However, actual vitamin and mineral amounts often deviate from label values. Vitamin and mineral bioavailability for dietary supplements also lacks a standard scientific and regulatory definition and validated in vitro and animal models that accurately reflect human bioavailabilities. Systematic information on the bioavailability and bioequivalence of vitamins and minerals in marketed products and on potential drug interactions is scarce. Because of limited information on product characteristics, our ability to directly compare results across studies, estimate changes in usage patterns or intakes over time, and generalize from published results to marketed products is problematic.
Article
We examined dietary supplement use for weight loss and perceptions about safety, efficacy, and regulatory oversight of these products. A random digit-dialed telephone survey was conducted in 2005-2006, with a representative sample of 3,500 US adults. The survey assessed the beliefs and practices related to weight control. Outcome measures included the prevalence of dietary supplement use for weight reduction, demographic profile of supplement users, and knowledge about safety, efficacy, and regulation of dietary supplements. Of the adults who made a serious weight-loss attempt (n = 1,444), 33.9% reported ever using a dietary supplement for weight loss. Supplement use was more common among women (44.9%) vs. men (19.8%); those aged 25-34; African Americans (48.7%) or Hispanics (41.6%) vs. whites (31.2%); less educated (38.4% high school degree or less vs. 31.1% some college or more); lower income households (41.8% made <40Kvs.30.340K vs. 30.3% made > or =40K); obese (40.7%) vs. overweight (29.1%); those who made more lifetime weight-loss attempts (42.0% made > or =3 vs. 22.1% made <3); and those who used more weight-loss methods (48.2% used > or =4 vs. 25.2% used <4). Many users and non-users of dietary supplements had misperceptions about these products-many believed they are evaluated for safety and efficacy by the Food and Drug Administration (FDA) before marketing, and that dietary supplements are safer than over-the-counter (OTC) or prescription medications. Use of dietary supplements for weight loss is common. More information about dietary supplements is necessary to correct misperceptions and encourage the use of safe and effective weight-loss methods.
Vitamins on Trial: After Decades of Study, Researchers Still Can't Agree on Whether Nutritional Supplements Actually Improve Health
  • Wenner Moyer
Making Sense of Supplements: Suggestions for Improving the Regulation of Dietary Supplements in the United States
  • Thomas