RESUMEN
Various dietary supplements are used as prevention, and in some cases treatment, of a large number of pathological processes in the human body. The purchase of such dietary supplements on various online platforms, including marketplaces, as evidenced by the results of monitoring the Russian online market for 2021-2022, turned out to be the riskiest for human life and health: the components actually contained do not correspond to the declared ones, the presence of Dietary supplement of prohibited substances, lack of a state registration certificate, the presence of which confirms the safety of such dietary supplement for use. The listed violations in the conditions of complete lack of control during the sale of dietary supplements on marketplaces confirm the danger to health, and in some cases, to human life. Uncontrolled use of such products can lead to serious side effects and complications: allergic reactions, kidney failure, liver failure, complications from the gastrointestinal tract, nervous system and genitourinary tract. In this regard, issues related to ensuring the safety of human health and life in the event of their purchasing dietary supplements on marketplaces are relevant. The analysis carried out in the study confirmed the existence of a problem of unreliable declaration of imported dietary supplements on marketplaces by participants in foreign economic activity. In this regard, this article examines the requirements of technical regulations that must be observed when importing dietary supplements into the territory of the EAEU, studies in detail the issue of the possibility of selling imported dietary supplements on marketplaces, and formulates appropriate conclusions and recommendations for eliminating identified problems, which will eliminate possible sales of low-quality products on the marketplace. and prohibited products and identify sellers selling dietary supplements with violations.
Asunto(s)
Suplementos Dietéticos , Humanos , Federación de Rusia , Comercio/legislación & jurisprudencia , Seguridad de Productos para el Consumidor/legislación & jurisprudenciaAsunto(s)
Plásticos , Alemania , Humanos , Seguridad de Productos para el Consumidor/legislación & jurisprudencia , Seguridad de Productos para el Consumidor/normas , Legislación Alimentaria , Contaminación de Alimentos/legislación & jurisprudencia , Contaminación de Alimentos/prevención & control , Contaminación de Alimentos/análisisRESUMEN
OBJECTIVES: To determine the compliance of online vendors to the UK Opticians Act 1989 Section 27 requirements and safety regulations for cosmetic contact lens (CCL) sales and the quality of online CCL health information. METHODS: The top 50 websites selling CCLs on each three search engines, namely Google, Yahoo, and Bing, were selected. Duplicates were removed, and the remaining websites were systematically analyzed in February 2023. UK legal authorization for CCL sales was assessed using the Opticians Act Section 27 and safety regulations determined by the presence of Conformité Européene (CE) marking. The quality and reliability of online information was graded using the DISCERN (16-80) and JAMA (0-4) scores by two independent reviewers. RESULTS: Forty-seven eligible websites were analyzed. Only six (12.7%) met the UK legal authorization for CCL sales. Forty-nine different brands of CCLs were sold on these websites, of which 13 (26.5%) had no CE marking. The mean DISCERN and JAMA benchmark scores were 26 ± 12.2 and 1.3 ± 0.6, respectively (intraclass correlation scores: 0.99 for both). CONCLUSIONS: A significant number of websites provide consumers with easy, unsafe, and unregulated access to CCLs. Most online stores do not meet the requirements set out in the Opticians Act for CCL sales in the United Kingdom. A significant number of CCLs lack CE marking, while the average quality of information on websites selling CCLs is poor. Together, these pose a risk to consumers purchasing CCLs from unregulated websites, and therefore, further stringent regulations on the online sales of these products are needed.
Asunto(s)
Información de Salud al Consumidor , Internet , Humanos , Reino Unido , Información de Salud al Consumidor/normas , Cosméticos/normas , Lentes de Contacto , Seguridad de Productos para el Consumidor/legislación & jurisprudencia , Seguridad de Productos para el Consumidor/normasRESUMEN
INTRODUCTION: Medical devices (MDs) have a long history of use, and come with regulatory frameworks to ensure user safety. Although topically applied MDs in the form of gels and creams might be used on damaged skin, their composition is often similar to that of cosmetic products applicable to intact skin, especially in terms of preservatives and fragrances. However, unlike cosmetics, these products are not subject to compound-specific restrictions when used in MDs. OBJECTIVE: This study aimed to identify and quantify preservatives and fragrances in topically applied MDs and assess their safety towards the Cosmetic Regulation (EC) 1223/2009. METHOD: Sixty-nine MDs available on the EU market were subjected to previously validated liquid chromatography tandem mass spectrometry (LC-MS/MS) and gas chromatography-mass spectrometry (GC-MS) methods to identify and quantify occurring preservatives and fragrances. RESULTS: Findings revealed that 32% of the examined MDs did not provide comprehensive ingredient lists, leaving users uninformed about potential risks associated with product use. Furthermore, 30% of these MDs would not meet safety standards for cosmetic products and, most significantly, 13% of the analysed samples contained ingredients that are prohibited in leave-on cosmetics. CONCLUSION: Results highlight the pressing demand for more stringent requirements regarding the labelling and composition of MDs to enhance patient safety. Improved regulation and transparency can mitigate potential risks associated with the use of topically applied MDs.
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Cromatografía de Gases y Espectrometría de Masas , Conservadores Farmacéuticos , Conservadores Farmacéuticos/análisis , Conservadores Farmacéuticos/efectos adversos , Humanos , Perfumes/efectos adversos , Perfumes/análisis , Cosméticos/análisis , Cosméticos/efectos adversos , Equipos y Suministros/efectos adversos , Unión Europea , Espectrometría de Masas en Tándem , Cromatografía Liquida , Seguridad de Productos para el Consumidor/legislación & jurisprudencia , Administración TópicaRESUMEN
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) amends the Food, Drug and Cosmetic Act (FDCA), elevating the standard of proof of safety (better known as a "safety standard") for cosmetics to the standard of a "reasonable certainty [of] safe."a standard equal to that of food ingredients. The standards of the proof of safety differ for various classes of FDA-regulated product categories e.g., cosmetics, dietary supplements, food ingredients and food itself. This manuscript describes the various standards of proof, the essential differences between the standards, key elements required to achieve a particular standard and, compares the standards to more familiar legal terms such as "a preponderance of the evidence" or "beyond reasonable doubt." The standards of proof for these product categories are also ranked according to increasing threshold for achievement of "safe" status. Lastly, this manuscript suggests how the requirements for the high standard of a "reasonable certainty of safe" (or "reasonable certainty of no harm") might be met.
Asunto(s)
Seguridad de Productos para el Consumidor , Cosméticos , United States Food and Drug Administration , Animales , Humanos , Seguridad de Productos para el Consumidor/normas , Seguridad de Productos para el Consumidor/legislación & jurisprudencia , Cosméticos/normas , Medición de Riesgo , Estados Unidos , United States Food and Drug Administration/normasRESUMEN
Organic and inorganic ultraviolet (UV) filters are used in topical sunscreens and other applications to prevent or limit damage following exposure to UV light. Increasing use of UV filters has contributed to a growing number of investigations examining potential effects on human health and the environment. Worldwide environmental monitoring data demonstrate that UV filters reach aquatic environments through two main input sources - direct (i.e., washoff from swimmers/bathers) and indirect (i.e., incomplete wastewater treatment removal) - and can be taken up by various algal, plant, and animal species and sediments. In areas where industrial wastewater sources or significant recreational activities result in a greater input load, levels may be elevated and could impart an increased risk on native species health. In vitro, at higher levels typically not measured in the environment, effects on growth and reproduction are observed in different species, including fish, coral reef, and plants. Despite this, predicted no-effect concentrations for UV filters are generally above measured environmental concentrations. Recent legislative activity banning the use of certain UV filters has heightened awareness of their environmental ubiquity and precipitated a need for a thorough examination of evidence linking their ecological presence with adverse outcomes. In order to gauge the true potential risk to native ecosystems associated with UV filters, future studies should consider factors inherent both to finished sunscreen products (e.g., metabolic fate/transport and effect of inactive ingredients) and to the sampled environment (e.g., species sensitivity, presence of other contaminants, water flow, and photodegradation).
Asunto(s)
Organismos Acuáticos/efectos de los fármacos , Protectores Solares/efectos adversos , Contaminación Química del Agua/prevención & control , Animales , Seguridad de Productos para el Consumidor/legislación & jurisprudencia , Seguridad de Productos para el Consumidor/normas , Monitoreo del Ambiente/estadística & datos numéricos , Humanos , Protectores Solares/administración & dosificación , Protectores Solares/legislación & jurisprudencia , Protectores Solares/normas , Natación , Rayos Ultravioleta/efectos adversosRESUMEN
Recent and pending bans in specific jurisdictions of some organic ultraviolet (UV) filters have resulted in significant concern and controversy over the potential impacts of these contaminants in the marine environment. Organic UV filters have been quantified in the aquatic environment as contaminants in water, sediments, and the tissues of aquatic organisms. The limited available laboratory studies on the toxicity of UV filters to keystone marine species such as reef-building corals describe a wide variety of impacts, from significant acute effects to no observed effects. However, interpretation of results is complicated by differences in methodology, and exposures to single agents in vitro may not reflect the effects of longer exposure to finished sunscreens containing UV filters in combination with numerous other chemicals. Relatively short-term observations of laboratory effects thus may not translate to real-life field conditions, where organisms may be subject to the effects of long-term chronic exposure to UV filters as well as other environmental contaminants and stressors. The lack of current understanding of the full impacts of UV filters, both in the laboratory and in the environment, represents a significant challenge in interpreting the environmental risk associated with the widespread use of sunscreens.
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Antozoos/efectos de los fármacos , Organismos Acuáticos/efectos de los fármacos , Agua de Mar/química , Protectores Solares/efectos adversos , Contaminación Química del Agua/prevención & control , Animales , Seguridad de Productos para el Consumidor/legislación & jurisprudencia , Seguridad de Productos para el Consumidor/normas , Monitoreo del Ambiente/estadística & datos numéricos , Humanos , Medición de Riesgo , Natación , Rayos Ultravioleta/efectos adversosRESUMEN
BACKGROUND: During food or feed contamination events, it is of utmost importance to ensure their rapid resolution to minimize impact on human health, animal health and finances. The existing Rapid Alert System for Food and Feed (RASFF) is used by the European Commission, national competent authorities of member countries and the European Food Safety Authority to report information on any direct or indirect human health risk arising from food or feed, or serious risks to animal health or the environment in relation to feed. Nevertheless, no methods exist to to collectively evaluate this vast source of supply chain information. METHODS: To aid in the extraction, evaluation and visualization of the data in RASFF notifications, we present the Rapid Alert Supply Network Extractor (RASNEX) open-source tool available from https://doi.org/10.5281/zenodo.4322555 freely. Among RASNEX's functions is the graphical mapping of food and feed supply chain operators implicated in contamination events. RASNEX can be used during ongoing events as a support tool for risk analysis using RASFF notifications as input. RESULTS: In a first use case, we showcase the functionality of RASNEX with the RASFF notification on a 2017/2018 contamination event in eggs caused by the illegal use of fipronil. The information in this RASFF notification is used to visualize nine different flows of main and related food products. In a second use case, we combine RASFF notifications from different types of food safety hazards (Salmonella spp., fipronil and others) to obtain wider coverage of the visualized egg supply network compared to the first use case. Actors in the egg supply chain were identified mainly for Italy, Poland and Benelux. Other countries (although involved in the egg supply chain) were underrepresented. CONCLUSIONS: We hypothesize that biases may be caused by inconsistent RASFF reporting behaviors by its members. These inconsistencies may be counteracted by implementing standardized decision-making tools to harmonize decisions whether to launch a RASFF notification, in turn resulting in a more uniform future coverage across European food and feed supply chains with RASNEX.
Asunto(s)
Seguridad de Productos para el Consumidor/legislación & jurisprudencia , Contaminación de Alimentos/prevención & control , Interfaz Usuario-Computador , Animales , Pollos , Huevos/análisis , Huevos/microbiología , Unión Europea , Cadena Alimentaria , Contaminación de Alimentos/análisis , Humanos , Insecticidas/análisis , Pirazoles/análisis , Salmonella/patogenicidadRESUMEN
In Malaysia, inexpensive toys are sold in various urban and rural shops. Although safety regulations for toys are available in Malaysia there are limited reports about the chemicals in toys. Thus, this study aimed to assess the levels of phthalates (bis-[2-ethylhexyl] phthalate [DEHP], diethyl phthalate [DEP], diisobutyl phthalate [DiBP] and dibutyl phthalate [DBP]) in inexpensive toys sold at local markets in Kuala Lumpur (Malaysia) and its health risks to children. All 30 toys analysed exceeded the European Union limit (0.1 % by mass) indicating that the phthalate used as plasticizers is still prominent in toys. Bis-[2-ethylhexyl] phthalate (DEHP) was the highest detected phthalate in toy sample which was manufactured in Malaysia and sold without Malaysian Conformity Mark. Significant association was found between phthalate levels and country, indicating a need to monitor and raise public awareness about potential toxic chemicals in inexpensive toys and children's products. There are few inexpensive toys that have a hazard index value of more than one, which is associated with developmental toxicity and causes developmental effects in children. Given the severity and complexity of these toys to children health, there is a need for regular monitoring and effective enforcements to develop an acceptable baseline level of children toys products manufactured in or imported to Malaysia. Furthermore, risk management efforts should also include all the stakeholders involved in toy production, policy makers as well as consumers to ensure only toy products with proper labels being sole and purchased.
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Dibutil Ftalato/análogos & derivados , Dibutil Ftalato/toxicidad , Dietilhexil Ftalato/toxicidad , Exposición a Riesgos Ambientales/análisis , Plastificantes/toxicidad , Juego e Implementos de Juego , Niño , Información de Salud al Consumidor/ética , Seguridad de Productos para el Consumidor/legislación & jurisprudencia , Monitoreo del Ambiente/métodos , Humanos , Malasia , Medición de RiesgoAsunto(s)
Publicidad/legislación & jurisprudencia , Seguridad de Productos para el Consumidor/legislación & jurisprudencia , Difamación/legislación & jurisprudencia , Aceites de Pescado , Fraude/legislación & jurisprudencia , Salud Pública/legislación & jurisprudencia , Animales , Humanos , Nueva Zelanda , BallenasAsunto(s)
Ingestión de Alimentos , Cuerpos Extraños , Antipiréticos/envenenamiento , Aspirina/envenenamiento , Niño , Seguridad de Productos para el Consumidor/legislación & jurisprudencia , Embalaje de Medicamentos/legislación & jurisprudencia , Historia del Siglo XX , Humanos , Imanes/efectos adversos , Pediatría/historia , Centros de Control de Intoxicaciones , Intoxicación/epidemiología , Edición , Estados UnidosAsunto(s)
Seguridad de Productos para el Consumidor/legislación & jurisprudencia , Servicio de Urgencia en Hospital/tendencias , Cuerpos Extraños/epidemiología , Regulación Gubernamental , Imanes , Adolescente , Niño , Preescolar , Femenino , Humanos , Lactante , Modelos Lineales , Masculino , Aceptación de la Atención de Salud/estadística & datos numéricos , Estados UnidosRESUMEN
Menthol, which is a natural cyclic monoterpene alcohol with a minty smell, is one of the main constituents of essential oils that naturally occur in some aromatic plants, such as Mentha × piperita L. This natural compound shows many biological properties, such as anesthetic, analgesic, antibacterial and antifungal, immunomodulating, and skin penetration-enhancing. It is added to a variety of goods, such as food, oral-care products, OTC products, cosmetics, and tobacco products. Menthol is not just a simple flavoring agent, especially when it comes to tobacco products. Its ability to 'mask' the negative effects of nicotine and its additional positive sensory effects makes it the most common additive in such products. For the customers, mentholated tobacco products may be mistakenly perceived as less harmful for health, which may increase their consumption. However, as the evidence shows, menthol cigarettes are no safer than conventional cigarettes and may lead to more frequent disease exacerbation during prolonged exposure to smoke from such products. In addition, because of its complex interactions with nicotine, menthol may affect smoking behavior and may increase addiction to nicotine. For those reasons, the European Union banned flavored cigarettes (whose sale size reached more than 3% of the total tobacco product market) by implementing the Tobacco Products Directive (2014/40/EU) on 20th May 2020. While the menthol ban was based on health concerns, the ultimate effect on consumers, regarding potential quitting, is yet to be determined.
Asunto(s)
Seguridad de Productos para el Consumidor , Aromatizantes/efectos adversos , Mentol/efectos adversos , Productos de Tabaco/efectos adversos , Fumar Tabaco/efectos adversos , Tabaquismo , Animales , Comercio , Seguridad de Productos para el Consumidor/legislación & jurisprudencia , Europa (Continente) , Unión Europea , Humanos , Mentol/análogos & derivados , Medición de Riesgo , Cese del Hábito de Fumar , Productos de Tabaco/legislación & jurisprudencia , Fumar Tabaco/legislación & jurisprudenciaRESUMEN
BACKGROUND: Glass tables can break and cause traumatic injury. This public health issue is avoidable by adequate regulatory measures. We describe the burden and characteristics of these injuries using the National Electronic Injury Surveillance System (NEISS) database and data from a level 1 trauma center. METHODS: NEISS data was extracted from 2009 to 2015. Injuries were classified by type, severity, and involvement of faulty glass using predetermined criteria. A retrospective chart review of a level 1 trauma center data was performed. Epidemiologic and outcomes data are reported. RESULTS: 3241 cases were reviewed from NEISS. 56% of injuries were attributable to faulty tables. 15% were severe. A bimodal age distribution of age under 7 and early 20s was observed. Commonly injured areas were the upper extremity and forehead. 24 trauma center cases were reviewed. 21% presented with hemodynamic instability, 34% had major organ, body cavity or joint space injuries, and 58% required surgical intervention. 30-day mortality rate was 8%. More than 54% required inpatient care. CONCLUSION: Glass table injuries are common, estimated at over 2.5 million per year. Regulation of glass quality may prevent injury. SUMMARY: Glass table injuries are more common than may be recognized and represent a public health problem that can be mitigated through proper regulatory measures.
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Accidentes Domésticos/estadística & datos numéricos , Seguridad de Productos para el Consumidor , Vidrio , Diseño Interior y Mobiliario , Heridas y Lesiones/etiología , Accidentes Domésticos/legislación & jurisprudencia , Accidentes Domésticos/prevención & control , Adolescente , Adulto , Anciano , Niño , Preescolar , Seguridad de Productos para el Consumidor/legislación & jurisprudencia , Seguridad de Productos para el Consumidor/normas , Bases de Datos Factuales , Humanos , Lactante , Diseño Interior y Mobiliario/legislación & jurisprudencia , Diseño Interior y Mobiliario/normas , Persona de Mediana Edad , New Jersey/epidemiología , Estudios Retrospectivos , Factores de Riesgo , Heridas y Lesiones/diagnóstico , Heridas y Lesiones/epidemiología , Adulto JovenRESUMEN
The European Union (EU) continuously takes ensuring the safe use of manufactured nanomaterials (MNMs) in consumer products into consideration. The application of a common approach for testing MNMs, including the use of optimized protocols and methods' selection, becomes increasingly important to obtain reliable and comparable results supporting the regulatory framework. In the present study, we tested four representative MNMs, two titanium dioxides (NM100 and NM101) and two silicon dioxides (NM200 and NM203), using the EU FP7-NANoREG approach, starting from suspension and dispersion preparations, through to their characterization and final evaluation of biological effects. MNM dispersions were prepared following a refined NANOGENOTOX protocol and characterized by dynamic light scattering (DLS) in water/bovine serum albumin and in media used for in vitro testing. Potential genotoxic effects were evaluated on human bronchial BEAS-2B cells using micronucleus and Comet assays, and pro-inflammatory effects by cytokines release. Murine macrophages RAW 264.7 were used to detect potential innate immune responses using two functional endpoints (pro-inflammatory cytokines and nitric oxide [NO] production). The interaction of MNMs with RAW 264.7 cells was studied by electron microscopy. No chromosomal damage and slight DNA damage and an oxidative effect, depending on MNMs, were observed in bronchial cells. In murine macrophages, the four MNMs directly induced tumor necrosis factor α or interleukin 6 secretion, although at very low levels; lipopolysaccharide-induced NO production was significantly decreased by the titania and one silica MNM. The application of this approach for the evaluation of MNM biological effects could be useful for both regulators and industries.
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Política de Salud/legislación & jurisprudencia , Inmunidad Innata/efectos de los fármacos , Nanopartículas del Metal/toxicidad , Nanotecnología/legislación & jurisprudencia , Dióxido de Silicio/toxicidad , Titanio/toxicidad , Pruebas de Toxicidad , Animales , Bronquios/efectos de los fármacos , Bronquios/inmunología , Bronquios/metabolismo , Bronquios/patología , Supervivencia Celular/efectos de los fármacos , Ensayo Cometa , Seguridad de Productos para el Consumidor/legislación & jurisprudencia , Citocinas/metabolismo , Células Epiteliales/efectos de los fármacos , Células Epiteliales/inmunología , Células Epiteliales/metabolismo , Células Epiteliales/patología , Europa (Continente) , Unión Europea , Regulación Gubernamental , Humanos , Mediadores de Inflamación/metabolismo , Macrófagos/efectos de los fármacos , Macrófagos/inmunología , Macrófagos/metabolismo , Macrófagos/patología , Ratones , Micronúcleos con Defecto Cromosómico/inducido químicamente , Pruebas de Micronúcleos , Formulación de Políticas , Células RAW 264.7 , Medición de RiesgoAsunto(s)
Ropa de Cama y Ropa Blanca , Seguridad de Productos para el Consumidor , Equipo Infantil , Opinión Pública , Adolescente , Adulto , Anciano , Ropa de Cama y Ropa Blanca/efectos adversos , Ropa de Cama y Ropa Blanca/economía , Ropa de Cama y Ropa Blanca/normas , Seguridad de Productos para el Consumidor/legislación & jurisprudencia , Seguridad de Productos para el Consumidor/normas , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estados Unidos , Adulto JovenRESUMEN
BACKGROUND: Nutraceutical is a term that is a combination of nutrition and pharmaceutical. They are believed to improve physical and mental health and provide therapeutic benefit in disease conditions. Nutraceuticals are claimed to be beneficial in several disease conditions which include cardiovascular disorder, neurodegenerative disorders, metabolic disorders and cancer prevention. OBJECTIVE: In the current review, we will study the current regulatory framework in some of the major countries of the world by comparing different parameters of these regulations. FINDINGS: Global nutraceutical market is currently expanding at a rapid pace but there are some restraints to the market growth which include poor quality manufacturing and unharmonized regulations leading to trade barriers across the globe. Although there are laws and regulations in place which govern nutraceutical products in different countries, these regulations lack harmonization and differ from country to country. Some of the countries follow stringent regulations, whereas, in some of the countries, well-structured and stern regulations for nutraceuticals are lacking. CONCLUSION: The development of a well regulated, harmonized and research-driven approach can help boost the confidence of consumers in nutraceutical products in the world thereby driving the nutraceutical market.