Regulation Of Dietary Supplements Research Articles

Vitamin A-containing dietary supplements from German and US online pharmacies: market and risk assessment.

Vitamin A supplements are used by many people, and the number of newly registered dietary supplements is continuously increasing. The preparations fall under food law and are not subject to the strict controls of pharmaceuticals. Risk indications and maximum quantity recommendations, e.g., from the Bundesinstitut für Risikobewertung (BfR) and the U.S. Food and Drug Administration (FDA) are not binding, which means that overdoses and potentially serious health problems can easily occur. The hepatotoxicity and teratogenicity of vitamin A are well documented, and other negative effects of high doses of vitamin A are also being discussed. Nevertheless, preparations with exorbitantly high doses are freely available for sale and unrestricted. In this study, 75 supplements containing vitamin A available in Germany and 26 available in the USA were critically examined on the basis of various parameters such as the recommended daily dose according to the manufacturer, daily therapy costs (DTC), the presence of warnings about overdose, use during pregnancy and breastfeeding, and information on adverse effects/interactions. The aim was to gain insights into their risk potential and to examine the need for closer monitoring and stricter guidelines for these preparations. The results show some considerable country-specific differences. Overall, there are serious deficiencies in compliance with the labeling requirements for both the German and the US preparations, and the dosages are often far too high in view of the applicable expert recommendations. Overall, these deficits can pose a risk for consumers that is difficult to assess in its entirety, especially for vulnerable consumer groups. It should be noted that the US preparations perform better overall than the German preparations. This suggests better regulation of dietary supplements in the US market. Based on the available data and literature research, it is doubtful whether the intake of vitamin A-containing preparations, without a diagnosed vitamin A deficiency, has a positive health benefit. Furthermore, it should be examined whether vitamin A should continue to be offered over-the-counter as a food supplement.

Review of Dietary Supplement Regulation

Review of Dietary Supplement Regulation

A comparative evaluation of Regulatory requirements for Registration of Dietary Supplements in Brazil, Russia, India, China and South Africa

Nutraceuticals are products that are rich in nutrients and provide health benefits, because of many factors like lifestyle changes and change in the dietary habits of people now a day, these products are widely used. Among all the other categories of Nutraceuticals Dietary supplement comprises huge part of Nutraceuticals. They are distinguishable from conventional food or drugs. They are intended to use to supplement the normal diet. The terms, nomenclature and definitions of the dietary supplements vary throughout the world. Different countries have their own regulation and legislative requirements. In regulated countries streamlined regulations are there, while well-structured and streamlined regulations for Nutraceuticals are lacking in other countries. In developing and emerging nations the regulation of dietary supplements are constantly evolving. It is necessary that the product complies all the regulatory requirements before they are placed on the market. The proposed study is based on the regulation and legislative requirements of dietary supplements in Brazil, Russia, India and South Africa.

The Lack of Standardization and Pharmacological Effect Limits the Potential Clinical Usefulness of Phytosterols in Benign Prostatic Hyperplasia.

The prevalence of benign prostatic hyperplasia (BPH) markedly increases with age. Phytotherapeutic approaches have been developed over time owing to the adverse side effects of conventional medications such as 5-reductase inhibitors and α1-adrenergic receptor antagonists. Therefore, dietary supplements (DS) containing active compounds that benefit BPH are widely available. Phytosterols (PSs) are well recognized for their role in maintaining blood cholesterol levels; however, their potential in BPH treatment remains unexplored. This review aims to provide a general overview of the available data regarding the clinical evidence and a good understanding of the detailed pharmacological roles of PSs-induced activities at a molecular level in BPH. Furthermore, we will explore the authenticity of PSs content in DS used by patients with BPH compared to the current legislation and appropriate analytical methods for tracking DS containing PSs. The results showed that PSs might be a useful pharmacological treatment option for men with mild to moderate BPH, but the lack of standardized extracts linked with the regulation of DS containing PSs and experimental evidence to elucidate the mechanisms of action limit the use of PSs in BPH. Moreover, the results suggest multiple research directions in this field.

Narrative Review: The FDA's Perfunctory Approach of Dietary Supplement Regulations Giving Rise to Copious Reports of Adverse Events.

Background: The Food and Drug Administration (FDA) originated from the passage of the 1906 Pure Food and Drugs act aimed to rein in the long-standing abuse in the consumer product marketplace. The act was passed to prohibit interstate commerce of misbranded and adulterated foods, drinks, drugs. Thus, promoting the FDA's mission to protect the public health by regulating human and veterinary drugs, biological products, medical devices, food supply, cosmetics, and tobacco to ensure safety, efficacy, and security. Progressing further in 1994, the Dietary Supplement Health and Education Act (DSHEA) was established designating specific label requirements, providing regulatory framework, and authorizing the FDA to promulgate good manufacturing practices for dietary supplements. This act defined and classified "dietary supplements" and "dietary ingredients" as food requiring all over the counter products (OTC) products to consist of labeling that is easy to understand and meets the FDA quality, effectiveness, and safety standards. However, under the umbrella of OTC products, the FDA fell short in its regulation of the expansive dietary supplement market. The objective of this study is to discern how the lack of efficacy in the FDA's regulations of OTC dietary supplements inevitably inspired more harm than benefit. Methods: This review comprised of case studies including young adolescents and adult consumers who experienced adverse events from the use of dietary supplements. Products which showed highest prevalence in adverse event reports through the Food and Drug Administration CFSAN Adverse Event Reporting System (CAERS) included but not limited to; Vitamin E (vitamin derivative), Beta-sitosterol (plant sterol) Yohimbine, Kava Kava Kratom, Garcinia Cambogia, (herbal products) and OxyElite Pro (marketed weight loss product). The primary endpoint was evaluating the FDA's regulations on dietary supplement safety protocols. The secondary endpoint was assessing the actions of the FDA in response to these case events. Results: Overall, between 2004 to 2021, a total of 79,071 adverse events related to the use of dietary supplements were reported to the Center for Food Safety and Applied Nutrition. Vitamin E products for example, marketed for decades for their antioxidant benefits in turn have shown significant evidence of toxicity and an increased risk of bleeding outweighing its potential benefit. The FDA's response was simply implementing a label guideline update, yet this update had evidence of minimal effect as the number of cases gradually continued to increase. Likewise, herbal products such as Kava Kava, Yohimbine, Kratom, and Garcinia Cambogia, in addition to weight regulating products, such as OxyElite Pro and HydroxyCut, have been linked to organ failure, hepatic, renal, cardiac toxicity, and death respectively. The FDA merely responded through instating public consumer warnings of their effects with consumption and limited recalls of certain products. Conclusion: With the easy accessibility of these products, the general public is more inclined to its use without proper guidance and monitoring from their healthcare team, posing as a major concern for possible interactions, contraindications and unfavorable outcomes. With proper implementation of stringent regulations post findings from increased studies on efficacy and safety, cases of adverse events could have been reduced significantly or averted completely. The FDA's minimalistic efforts consisting of only post-marketing monitoring and retrospective actions of label modifying have time and time again shown flaws as seen in the growing series of reports. By emending the over-the-counter supplement review process to reflect that of prescription medication, the magnitude of adverse events can be diminished. The process should include preclinical research in addition to clinical research, FDA thorough examination of data prior approval and post marketing surveillance.

Dietary Supplements: A Gateway to Doping?

Dietary supplements are widely used among athletes, but many may be unaware of the potential for unintentional doping, especially considering that supplements can often be contaminated with prohibited substances. The reason behind the widespread use of dietary supplements among athletes is often cited as being for the purposes of enhancing health or performance. However, many athletes turn to unreliable sources of information, and often lack knowledge of dietary supplement regulations. The aim of this narrative review is to explore the current research surrounding the psychological constructs (such as norms, attitudes, and beliefs) related to dietary supplement use among athletes that may lead to inadvertent doping. This review also covers possible programme structures that may be effective at preventing inadvertent doping.

The Regulation of Dietary Supplements in the United States.

Is it legal to make health claims for a product sold in the United States without being required to prove those claims? Yes, but only if those claims relate to dietary supplements, not drugs. The world of dietary supplement regulation is quite unlike any other. First, dietary supplements are not drugs, but "food" in the regulatory scheme. The US Food and Drug Administration has no authority to approve or deny approval to manufacturers for the marketing of dietary supplements. There is, however, a general prohibition against marketing drugs that are "adulterated or misbranded." The author discusses information for pharmacists relative to this topic.

Which Features of Dietary Supplement Industry, Product Trends, and Regulation Deserve Physicians' Attention?

Patients expect that dietary supplements they purchase-and physicians expect that dietary supplements they recommend-are safe, accurately labeled, quality products. Since many dietary supplements, especially vitamins and minerals, are key parts of evidence-based interventions for patients with many conditions, illegal, fraudulent, adulterated, or improperly labeled products should be regarded as sources of clinical and ethical concern. Adverse events (AEs) can occur and, when they do, relevant data should be carefully collected and analyzed. This article considers how many physicians' and patients' confusion about dietary supplement regulation can undermine quality caregiving and responses to AEs. This article also summarizes a recent American Medical Association Council on Science and Public Health report on dietary supplement supply and marketing practices and on physicians' roles in guiding patients when dietary supplement use is clinically indicated.

Acne Supplements Sold Online.

IntroductionAs no centralized database of acne supplements is available, we aimed to provide an overview of these products, with a focus on safety.ObjectivesThe objectives of this study were to document the number, formulation, contents, and marketing strategies utilized by acne supplements sold online.MethodsAn online search was conducted between March and May 2020. Products were included in the study if they used the terms: “whitehead”, “blackhead”, or “acne”. Data were extracted from the website, box, and Supplement Facts label.Results49 products were identified, which contained 146 unique ingredients. These included vitamins, minerals, food extracts, botanical extracts, amino acids, animal products, and distinct microbial strains. Few (4.1%) products were tested by third parties.ConclusionsThis survey of acne supplements available online raised concerns regarding lack of warning labels, teratogenicity, exceedingly large levels of vitamins and minerals, and lack of third-party testing. Given the limited regulation and oversight of dietary supplements, it is imperative that physicians educate patients on the potential risks of these products.

Regulation of Dietary Supplements and Nutraceutical Products in the United States: An Argument for Greater Oversight and Uniform Standards.

Regulation of Dietary Supplements and Nutraceutical Products in the United States: An Argument for Greater Oversight and Uniform Standards.

On the relevance of toxicological and hygienic assessment and market regulation of herbal dietary supplements made from Mitragyna speciosa Korth (Rubiaceae family)

Ukraine today does not regulate the sale of products made of Kratom (Mitragyna speciosa Korth. (from the family Rubiaceae) and does not take measures to control the quality and safety of this product, despite its rapid spread throughout the country. Аim of the Work is to summarize the results of scientific research on the toxicity of alternative opioids contained in Mitragyna speciosa and combined products based on them. Material and methods. Reports from the World Health Organization (WHO), the European Monitoring Center for Drugs and Drug Addiction (EMCDDA), the United Nations Office on Drugs and Crime, the results of scientific reviews and individual studies on biochemistry, toxicology, forensic identification of substances contained in products made from Mitragyna speciosa, over the past 10 years (Elsevier, PubMed, ToxNet). Results and Discussion. Recently, kratom has been cultivated on different continents and entered the market under the name "Kратом", in English-language sources - "Kratom". Kratom leaves are dried and sold in the form of green powder, tablets, capsules, extracts and gummies. In Ukraine, kratom is sold under hundreds of commercial names on the Internet as "Kratom", "Kratom product", "Kratom organic tea", "Kratom ethnic tea", "Kratom tea" and others. More than 40 structurally related alkaloids, as well as several flavonoids, terpenoid saponins, polyphenols and various glycosides were found in kratom leaves. The pharmacological and toxic effects of kratom for most of its components have not been studied enough. Like other dietary supplements, kratom products should be standardized for alkaloids, microbial contamination, pesticides, heavy metals, residual solvents, benzo(a)pyrene, aflatoxins, etc., with appropriate labeling requirements. Conclusions. Quality products should enter the Ukrainian market - standardized leaf extract of kratom, or other safe products made on its basis. However, recent studies show that mitraginine contained in kratom has great potential for medical science as a model for developing new approaches in very relevant areas of medicine: to treat pain and get rid of opioid dependence. Key Words: Mitragyna speciosa, alternative opioids, toxicity.

Drug adulteration of sexual enhancement supplements: a worldwide insidious public health threat

Worldwide, the consumption of dietary supplements for the enhancement of sexual performance is common. Consumers are generally fond of these products because they often want to avoid drugs, preferring "natural" than "chemical" solutions. This is challenging, as many of these supplements labelled "herbal" or "natural" are actually adulterated with drugs, mainly phosphodiesterase-5 inhibitors. This phenomenon is facilitated by fewer demanding regulations for marketing supplements. Thus, consumers may be widely exposed to serious adverse events, such as acute liver injury, kidney failure, pulmonary embolism, stroke or even death. We aim to warn physicians about this issue. This multidisciplinary review simultaneously deals with clinical consequences of this phenomenon, analytical toxicology and regulation. Indeed, after outlining this worldwide issue and highlighting that a drug-adulterated dietary supplement is actually a falsified drug, we discuss its main contributing factors. Then, we describe some examples of adverse events of which a case of sildenafil-tadalafil-induced ischaemic stroke that benefited medical care in our hospital. Furthermore, we present some means to avoid adulteration and discuss their limitations that may be explained by the heterogeneity of the regulation of dietary supplements between countries. Doing so, we point out the requirement of a global harmonization of this regulation for an efficient eradication of this public health threat. Meanwhile, dietary supplements should be considered adulterated until proven otherwise. Thus, we encourage physicians to investigate these products in the drug histories of their patients, especially when clinical conditions cannot be explained by classical aetiologies.

Nutritional supplement for indigenous intestinal microflora: manufacturing, quality and effectiveness evaluation

The pharmaceutical composition of a nutritional supplement, which has a profound effect on the maintenance and development of the indigenous intestinal microflora, has been scientifically proven. The nutritional supplement is obtained by combining the encapsulation technology with the pellet technology to ensure that the pharmaceutical composition remains intact and the product appeals to consumers. The combination of encapsulation and pellet technology is highly beneficial to the manufacturing process as the delivery of the ingredients, which are very different in absorption and penetration rates, is improved, controlled and becomes very site-specific, while at the same time offering even distribution. The quality of the nutritional supplement has been proven and the product complies with the compulsory sanitary-hygienic and sanitarytoxicological regulations for dietary supplements. Clinical trials for the new nutritional supplement were performed to ensure the safety and the effectiveness of the product. Sixty volunteers aged from 33 to 72 were involved in the clinical trials. All of the volunteers were diagnosed with different intestinal microbiota disorders, among them a decreased number of microbial symbionts (bifidobacteria, lactobacilli, Escherichia coli (Lac +), the presence of Klebsiella pnenmoniae and opportunistic pathogens like Candida alticans. Patients with intestinal microbiota disorders were prescribed to take 1 capsule of the nutritional supplement twice a day for a period of 30 days together with other medicine prescribed to improve the biocenosis. Having taken part in the clinical trials, nearly 90% of patients, who had previously experienced such symptoms as bloating, gas, different abdominal pains, cramping, diarrhoea and constipation, demonstrated microbiota restoration, along with the overall health improvement. Considering the findings of the clinical trials, it should be noted that the use of ‘Panbiom’ nutritional supplement can play an important role in keeping the immune system healthy, with short chain fatty acids becoming the main focus of attention. Short chain fatty acids are the key to stimulating the immune response, as they support the regulatory T cells, prevent pathological changes and lessen the symptoms. The nutritional supplement composition and the manufacturing process were developed and tested at the scientific research-to-production facilities of Art-Life Scientific Production Association in Tomsk. All the mandatory documentation was obtained and fully complies with the requirements for nutritional supplements.

Labeling of Cannabidiol Products: A Public Health Perspective.

Introduction: Interest in the therapeutic use of cannabidiol (CBD) has reached a fever-pitch in recent months, as CBD-containing products appear everywhere from online retailers to grocery stores and gas stations. The widespread availability of hemp-derived CBD products is confounding given that CBD is a U.S. Food and Drug Administration (FDA)-approved drug, and thus precluded from being added to food and beverages, or included in dietary supplements. The use by manufacturers of disease-related claims on marketing materials and product labels, along with the federal legalization of hemp in December 2018, has created political pressure on FDA to promulgate regulations. Conclusions: Accurate and informative labeling of hemp and hemp-derived CBD products is an important public health issue. FDA-regulated product labels are considered an essential tool for protecting consumers and enabling informed decision-making. Untruthful or unsubstantiated health-related claims, and unallowed Drug Claims, in marketing materials and on labels of CBD products may create harm by enticing consumers to forgo more evidence-based medical interventions. Furthermore, missing or inaccurate labeling of the amount of CBD, delta-9 tetrahydrocannabinol (THC), and potentially harmful contaminants such as pesticides, naturally-occurring yeast and mold or heavy metals may result in harm and/or lack of efficacy. Manufacturers of these products may reasonably be expected to understand and adhere to FDA regulations for labeling and marketing of food, dietary supplements and drugs, both over-the-counter (OTC) and prescription, even though FDA has interpreted federal law as excluding them from these categories. As manufacturers prepare for forthcoming regulations, a better understanding of the basic framework for FDA labeling and marketing regulations for food, dietary supplements and drugs is warranted.

Safety Concerns of Skin, Hair and Nail Supplements in Retail Stores.

Background: Dietary supplements promoted for “skin, hair, and nail” health are becoming increasingly popular, although there is a lack of regulatory oversight. As no centralized database or repository for these supplements is available, the aim of this study was to provide an overview of supplements in a sample of retail stores, with a focus on safety concerns.Methods: Dermatology supplements were defined as those that featured the words “skin”, “hair”, “nails”, “beauty”, or “glow” in the product name or tagline. Seven stores including drug, grocery, department, and cosmetics stores were surveyed within a three-mile radius. Data were extracted from the Supplement Facts label of each product.Results: A total of 176 separate supplements were identified, containing a total of 255 distinct ingredients. These included vitamins, minerals, food extracts, botanicals, animal products (collagen, fish oils), amino acids, a hormone, and distinct microbial strains.Conclusion: This survey of “dermatology” supplements available in local retailers raised several safety concerns, including potential interactions, teratogenicity risks, a lack of independent third-party testing, lack of warning labels, and nutrient “overdosing”. Given limited regulation of dietary supplements, it is imperative that physicians educate patients on the potential risks. These include risks related to supplement ingredients and dosages, as well as risks related to the lack of regulatory oversight. Patients must also be educated about the multiple gaps in our knowledge of dietary supplements, especially in terms of efficacy and long-term safety.

Dietary Supplement Use in the United States

The history and trends in use of dietary supplements as documented in the National Health and Nutrition Examination Survey are summarized. The safety and efficacy of selected supplements are discussed. The current regulation of dietary supplements is not robust because legislation governing enforcement is weaker than it is for drugs.

Veterinary Pet Supplements and Nutraceuticals.

Veterinary pet supplements and nutraceuticals are widely used by dog, cat and horse owners across the United States, generating millions of dollars in revenue for manufacturers. Despite the widespread use of these veterinary products, oversight and regulation remain limited as compared to human dietary supplement regulations. This review describes the current regulation, quality control, safety and efficacy of pet supplements and nutraceuticals targeted towards the dog, cat and horse.

Nutraceutical regulations: An opportunity in ASEAN countries.

In today's era of increased standards of lifestyle and life expectancy, there has been a constant demand for supplements by consumers. Nutraceuticals are among the supplements in demand. Although there is a big opportunity for the nutraceutical business, there are no uniform regulatory requirements in different regions. Nations are looking to the nutraceutical sector to help keep their populations healthy and safe by introducing certain rules and regulations. Generally, developed countries have regulations in place, but there are some countries, such as those in the Asia Pacific regions or in Association of Southeast Asian Nations (ASEAN) countries, that have not yet fine-tuned their regulations for nutraceutical products. The ASEAN countries involve highly commercialized markets such as Singapore, Thailand, Malaysia, and the Philippines. The overall nutraceutical market of ASEAN countries is growing at a compound annual growth rate of ∼8.4%. About 40% of the ASEAN population consumes nutraceuticals on a daily basis. ASEAN countries are forming harmonized regulations for dietary supplements. This could be a big opportunity for manufacturers to introduce their products into the ASEAN market. A special unit of the Traditional Medicine and Health Supplements Product Working Group (TMHA PWG) helps manufacturers understand the regulatory procedures of these countries. Despite countries' own special requirements, manufacturers can follow the standards and harmonized guidelines put forth by TMHA PWG. The aim of this review is to introduce the regulatory procedure and requirements for international business developers to launch any new nutraceutical products into the ASEAN market.

Roadmap for Quality by Design Implementation for Dietary Supplements.

Recently, there is a growing interest in quality by design (QbD) in the dietary supplements industry. Effective QbD implementation necessitates a comprehensive understanding of multiple factors such as; the relationship between the critical qualities attributes (CQAs) and the scientific properties of the dietary supplement, the relationship between the manufacturing process, CQAs and the variability in raw materials. There are still two critical challenging concerns to be addressed in the implementation of QbD for herbal drugs. First, the quality variation of botanical raw materials and second, the difficulty in defining the satisfactory ranges of CQAs. In order to tackle these challenges, this review provides a snapshot of the numerous techniques that can be used in the identification and characterization of the botanical raw materials, therefore, will help in the successful QbD implementation for botanicals and dietary supplements. In order to implement this approach and to be considered in the current dietary supplement regulations, fruitful discussions and collaborations between academia, industry and regulatory agencies are required.

Evaluation of Fucoxanthin Content in Popular Weight Loss Supplements: The Case for Stricter Regulation of Dietary Supplements

Misbranded and counterfeit dietary supplements have been an issue on which the US Food and Drug Administration has been vigilantly regulating. The ubiquity of online-shoppable weight-loss supplements and their unrestricted consumption by people with obesity are serious matters of concern. Fucoxanthin, a brown-seaweed-extracted carotenoid has exhibited anti-obesity property in some clinical trials through its ability to over express uncoupling protein (UCP1) in the white adipose tissue, which leads to fat burning. However, since the clinical trials apply pure fucoxanthin instead of fucoxanthin-bearing dietary supplements, a critical analysis is warranted to quantify fucoxanthin in brown seaweeds to validate their rationale in weight loss mechanism. This study examined ten randomly chosen online-sourced brands of fucoxanthin-containing dietary supplements and analyse the content using High-Performance Liquid Chromatography (HPLC) equipped with UV-Vis and photodiode array detector. Our exploration revealed that, of these 10 products, 3 (30%) did not have any detectable quantity of fucoxanthin, 5 (50%) contained only trace amount of it, ranging from 0.001-0.01 mg per capsule, and only 2 (20%) products contained 0.4 mg or 2 mg of fucoxanthin, meeting their label claim. This worrying finding may be interpreted that the existing ease-of-access and pervasive nature of online-sourced dietary supplements require more stringent regulatory screening.