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Introduction: The Consumer Product Safety Improvement Act (CPSIA) was passed in 2008 to establish safety standards and improve the quality of children's products. Coronavirus Disease 2019 (COVID-19) led to a "stay-at-home" quarantine. The purpose of this study is to evaluate trends of pediatric burns and analyze the relationship with the CPSIA and COVID-19., Methods: The National Electronic Injury Surveillance System database was used to identify thermal and electric pediatric burns from 2002 to 2021. To evaluate the association of the CPSIA and COVID-19, burns before and after the law was passed, and the pandemic, were analyzed. Sex, ethnicity, age, injured body part, product, and disposition were determined. Chi-squared analysis was performed., Results: A total of 21,962 burns met inclusion criteria, with 1409 electrical and 20,553 thermal burns. Majority of cases were male (58.3%) and involved household appliances (34.2%). For the CPSIA cohort, there was an average of 1274.1 burns per year before 2009, which decreased to 1003.3 burns per year after 2009. Before 2009, most burns affected the hand (44.5%), which increased after 2009 and remained the most-affected body part (48.1%, P < 0.001). For the COVID-19 cohort, there was an average of 1133.5 burns per year before 2020, which decreased to 779.5 burns per year after 2020., Conclusions: The CPSIA and COVID-19 pandemic may have led to a decreased incidence of pediatric burns from electronic devices. Pediatric populations are still at high risk for hand burns and household appliance burns. Providers should be aware of burn trends to inform guardians about the risks., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Are all food ingredients, dietary supplement ingredients and even foods, required to meet the same safety standards? Are they all equally safe? If so, then why do the various categories have different expressions describing their safety, such as "reasonable certainty of no harm" for food ingredients and "reasonable expectation of no harm" for dietary supplement ingredients? The basis for these different expressions is that they are not standards of safety, but standards of proof of safety. Just as in criminal vs. civil courts, the threshold for proving guilt or fault is different, so too are there differences between various categories of consumer products regulated by the US Food and Drug Administration. This manuscript describes the threshold requirements for each standard, as well as to the identity of the decision makers on what is safe, their credentials as decision makers and the databases mandated for their use., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

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., Competing Interests: The authors have no funding or conflicts of interest to disclose., (Copyright © 2024 Contact Lens Association of Ophthalmologists.)

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., (© 2024 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

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.

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., Competing Interests: Declaration of competing interest The author declares that he has no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

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., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

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., Competing Interests: The authors have declared that no competing interests exist.

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., (© 2021 S. Karger AG, Basel.)

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)., (© 2021 S. Karger AG, Basel.)

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., Competing Interests: Declaration of competing interest The authors declare no conflicts of interest related to this work., (Copyright © 2020 Elsevier Inc. All rights reserved.)

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., (© 2020 John Wiley & Sons, Ltd.)

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.

The medical device industry has long been subject to criticism for lack of price transparency and minimal regulations surrounding device approval, which have functioned as barriers to providing quality and cost-effective care. Recent health care reforms aimed at overcoming these barriers, including improving market approval regulations, increasing postmarket surveillance, and using comparative effectiveness research, have drastically changed industry practices. These reforms have also prompted increasingly cost-aware health care practices, which have encouraged new trends in medical device innovation such as frugal innovation and deinstitutionalization. This article explores the challenges faced by industry, physicians, and patients in light of these reforms., Competing Interests: Disclosure NIH NIAMS grant K23AR073928., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: In 2001, the EU nickel directive was introduced to prevent contact allergy to nickel. Contact allergy to palladium and/or cobalt is often seen together with contact allergy to nickel., Objectives: To compare the contact allergy prevalence of nickel, palladium, and cobalt allergy before and after the introduction of the EU nickel directive in consecutive patients with dermatitis., Methods: A retrospective analysis of patch test results from 1995-2016 was performed (n = 18 264). Chi-square tests were used to examine trends for nickel, palladium, and cobalt across test years. Logistic regression was used for associations., Results: The prevalence of nickel allergy decreased significantly in the youngest age group (6-30 years) for both female and male patients from 1995-1999 to 2012-2016: females: 33.4% to 19.1% (P < .001); males: 5.9% to 2.1% (P < .05). The concomitant reactions between nickel and palladium and nickel and cobalt among young females, respectively, also decreased significantly. Isolated palladium and cobalt allergy remained stable (1.4% and 2.3%, respectively) during the same time period for both men and women., Conclusions: The prevalence of nickel has decreased among young females and males suspected of contact allergy in Southern Sweden after the introduction of the EU nickel directive. There has been no change in isolated palladium or cobalt allergy., (© 2019 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Highlights After the introduction of the EU regulatory interventions, nickel sensitization decreased significantly in the group of females aged ≤25 years. Women born between 1966 and 1975 presented the higheest prevalence of sensitization to nickel, then prevalence of sensitization gradually decreased with a minimum in more recent years. Nickel sensitization is higher in Italian patients compared to people living in other EU coutries. Additional interventions are needed to address nickel sensitization., (© 2019 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

This paper argues that the Food and Drug Administration's (FDA) policy for health and wellness apps is ethically problematic. Currently, the FDA does not regulate health and wellness apps that are not intended for medical use. As a result of this hands-off policy, preventing harm to consumers is left primarily to developers and app marketplaces. We argue that the FDA's duties to prevent harm and maintain accountability to the American public require that they play a much stronger role. We also discuss concerns about efficiency and fostering innovation, and argue that while they should help shape FDA regulation of health and wellness apps, they do not justify complete absence of FDA involvement., (© 2019 John Wiley & Sons Ltd.)

This article addresses the data protection and product safety regulatory models currently applied to consumer-facing health technologies. It explains how the design and structures of existing data protection and safety regulation in the U.S. have resulted in exceptionally thin protection for the users of consumer-facing devices and products that rely on or that facilitate consumer collection or aggregation of health and wellness data. It also examines some appealing legislative alternatives to the current thin model used in the U.S. and suggests a framework for prioritizing ameliorative regulation. To better understand existing regulatory models, their deficiencies, and how they should be reformed, the article employs an analytical model describing these regulatory systems across two axes. The vertical axis describes the quantity or depth of regulation, such as, for example, the strictness of the rules imposed by the regulatory model. The horizontal axis describes the reach of the regulation, the behaviors, products, or industries to which the regulation applies.

Cell therapies hold significant promise for the treatment of injured or diseased musculoskeletal tissues. However, despite advances in research, there is growing concern about the increasing number of clinical centres around the world that are making unwarranted claims or are performing risky biological procedures. Such providers have been known to recommend, prescribe, or deliver so called 'stem cell' preparations without sufficient data to support their true content and efficacy. In this annotation, we outline the current environment of stem cell-based treatments and the strategies of marketing directly to consumers. We also outline the difficulties in the regulation of these clinics and make recommendations for best practice and the identification and reporting of illegitimate providers. Cite this article: Bone Joint J 2020;102-B(2):148-154.

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., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Introduction: Cosmetics and personal care products are ubiquitous. Consumer pressure arising from recent episodes of products found to be unsafe has led to new policy proposals to modernize cosmetics regulation in the United States., Methods: We reviewed contemporary cosmetics regulation and collected major past and current policy proposals relating to cosmetics regulation with a focus on public health controversies., Results: Under a structure originally established in 1938 that places regulation of cosmetics under the Food and Drug Administration (FDA), cosmetics manufacturers in the United States are not required to register their products or forward consumer complaints to the FDA, leading to broad under-reporting of adverse events. The FDA has limited authority to mandate product recalls. The existing FDA database system that collects adverse events related to cosmetics has limited public health utility. Current proposals for new cosmetics regulations seek to establish better systems for data collection and mandatory manufacturer registrations funded by cosmetic manufacturers. Additional policy changes could include a premarket review process for cosmeceuticals (cosmetics that make drug-like claims) and more advanced real-world data safety monitoring tools., Conclusions: With continued consumer concern and several recent cosmetic-related public health controversies, the FDA should be given more resources and broader authority to protect consumer safety., (© 2019 Wiley Periodicals, Inc.)

Seafood has become one of the most heavily traded food commodities in the era of globalization. International seafood supply chains are complex and contend with many difficulties in bringing an enormous variety of products to market. A major challenge involves accurately labelling products such that they comply with a diverse set of regulatory frameworks, ranging from country-of-origin through to the final point of consumer sale. Thanks to DNA barcoding, seafood mislabelling is now recognized as a global problem, with potentially negative impacts on human health, economy and the environment. Mislabelling can result from species misidentification, use of inappropriate common names, incomplete and/or out-dated regulatory frameworks, or through market substitution. While prior studies have focused primarily on retail and food service establishments, this study used barcoding to assess rates of finfish mislabelling at multiple points in the supply chain within Ontario, Canada. A total of 203 specimens from 12 key targeted species were collected from varied importers, registered processing plants and retailers in Southern Ontario and identified using DNA barcoding. Species identity of samples was used to assess conformity of labelling against the Canadian Food Inspection Agency's (CFIA) Fish List, which revealed an overall mislabelling rate of 32.3% among targeted species. The mislabelling rate was significantly different between samples collected from importers and retailers. Among the mislabelled samples were seven samples that originated from US and were properly labelled according to US Food and Drug Administration (FDA) Seafood List. This study evaluated the integrity of chain of custody documents and identified discrepancies in 43 samples (21.4%). Implementing seafood traceability throughout the supply chain and harmonizing labelling regulations between countries can help to ensure industry compliance in a globalized market, while sampling at multiple points in the supply chain can help to reveal causes., (Copyright © 2018. Published by Elsevier Ltd.)

Background Regulators increasingly rely on registries for decision making related to high-risk medical devices in the United States. However, the limited uniform standards for registries may create substantial variability in registry implementation and utility to regulators. We surveyed the current landscape of US cardiovascular device registries and chart the extent of inconsistency in goals, administration, enrollment procedures, and approach to data access. Methods and Results A systematic review using Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines identified studies (1995-2017) referencing cardiovascular device registries with a US-based institution. Registries were then evaluated by reviewing associated articles and websites. Extracted data included device type, primary scientific aim(s), funding, stewardship (eg, administration of registry procedures), enrollment procedures, informed consent process, and mechanisms to access data for research. The 138 cardiovascular device registries in the cohort covered devices addressing interventional cardiology (65.9%), arrhythmias (15.2%), heart failure (10.1%), and valvular disease (10.1%). While the majority (55.8%) were industry-funded, stewardship was predominantly overseen by academic centers (74.0%). Most registry participation was voluntary (77.5%), but a substantial minority (19.7%) were required as a condition of device implantation. Informed consent requirements varied widely, with written consent required in only 55.1% of registries. Registry data were primarily accessible only to stewards (84.1%), with 13.8% providing pathways for external applications. Conclusions The majority of cardiovascular device registries were funded privately under the auspices of academic institutions, which set the rules for data access. The substantial variation between cardiovascular device registries suggests a role for regulators to further strengthen guidelines to improve quality, consistency, and ethical standards.

Nanotoxicology and nanosafety has been a topic of intensive research for about more than 20 years. Nearly 10 000 research papers have been published on the topic, yet there exists a gap in terms of understanding and ways to harmonize nanorisk assessment. In this review, we revisit critically ignored parameters of nanoscale materials (e.g. band gap factor, phase instability and silver leaching problem, defect and instability plasmonic versus inorganic particles) versus their biological counterparts (cell batch-to-batch heterogeneity, biological barrier model design, cellular functional characteristics) which yield variability and nonuniformity in results. We also emphasize system biology approaches to integrate the high throughput screening methods coupled with in vivo and in silico modeling to ensure quality in nanosafety research. We emphasize and highlight the recommendation regarding bridging the mechanistic gaps in fundamental research and predictive biological response in nanotoxicology. The research community has to develop visions to predict the unforeseen problems that do not exist yet in context with nanotoxicity and public health hazards due to the burgeoning use of nanomaterial in consumer's product.

Purpose: This perspective explores the safety profile of ocular cosmetics and explores the role ophthalmologists can play in mitigating potential ocular harm from unsafe products., Methods: N/A., Results: Cosmetics and personal care products represent a large industry that is currently unregulated in any meaningful way. Products intended for use around the eyes carry a risk of serious side effects including contact dermatitis and bacterial infection. Currently, legislation has been proposed to change regulation to provide more meaningful oversight of cosmetics., Conclusions: Ophthalmologists are often the first to recognize patterns in harmful products intended for use around the eye and can help mitigate potential future ocular harm by reporting adverse events to the Food and Drug Administration and by advocating for cosmetic regulation change.

The European Court of Justice's recent ruling that the new techniques for crop development are to be considered as genetically modified organisms under the European Union's regulations exacerbates the need for a critical evaluation of those regulations. The paper analyzes the regulation from the perspective of moral and political philosophy. It considers whether influential arguments for restrictions of genetically modified organisms provide cogent justifications for the policies that are in place, in particular a pre-release authorization requirement, mandatory labelling, and de facto bans (in the form of withholding or opting out of authorizations). It is argued that arguments pertaining to risk can justify some form of pre-release authorization scheme, although not necessarily the current one, but that neither de facto bans nor mandatory labelling can be justified by reference to common arguments concerning naturalness, agricultural policy (in particular the promotion of organic farming), socio-economic effects, or consumers' right to choose.

Personal lubricants and lubricants used in condoms contain a number of ingredients which are also present in cosmetic products. These have to comply to the medical device regulation (745/2017) which should provide the same level of consumer protection, if not more, as foreseen in the legal framework of cosmetics (1223/2009). In the current study we developed an analytical method capable of identifying and quantifying 15 ingredients, commonly found in lubricants and cosmetics. Based upon their most important toxicological endpoint, the substances involved were grouped in three toxicological classes provoking either irritation, contact allergic dermatitis or systemic toxicity. The method was applied on 30 condoms and 54 personal lubricants present on the EU market. Their safety was assessed using the same reasoning as commonly applied for cosmetic ingredients. Higher mucosae susceptibility, the main exposed area for lubricants, was taken into account in this assessment. The results show that the majority of the products studied are safe. Nevertheless, for some products the safety could not be confirmed. The results also highlight the fact that there is no consensus for a number of ingredients, used as well in cosmetics as in medical devices. Alignment between both legislations would improve the safety of these products and further raise the general level of consumer protection., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Health apps are a booming, yet under-regulated market, with potential consumer harms in privacy and health safety. Regulation of the health app market tends to be siloed, with no single sector holding comprehensive oversight. We sought to explore this phenomenon by critically analysing how the problem of health app regulation is being presented and addressed in the policy arena., Methods: We conducted a critical, qualitative case study of regulation of the Australian mental health app market. We purposively sampled influential policies from government, industry and non-profit organisations that provided oversight of app development, distribution or selection for use. We used Bacchi's critical, theoretical approach to policy analysis, analysing policy solutions in relation to the ways the underlying problem was presented and discussed. We analysed the ways that policies characterised key stakeholder groups and the rationale policy authors provided for various mechanisms of health app oversight., Results: We identified and analysed 29 policies from Australia and beyond, spanning 5 sectors: medical device, privacy, advertising, finance, and digital content. Policy authors predominantly framed the problem as potential loss of commercial reputations and profits, rather than consumer protection. Policy solutions assigned main responsibility for app oversight to the public, with a heavy onus on consumers to select safe and high-quality apps. Commercial actors, including powerful app distributors and commercial third parties were rarely subjects of policy initiatives, despite having considerable power to affect app user outcomes., Conclusion: A stronger regulatory focus on app distributors and commercial partners may improve consumer privacy and safety. Policy-makers in different sectors should work together to develop an overarching regulatory framework for health apps, with a focus on consumer protection., (© 2019 The Author(s); Published by Kerman University of Medical Sciences. This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.)

Objective: To explore self-inflicted retinal burns from laser pointers in children., Methods: Literature review of laser pointer retinal injuries in childhood and online survey of UK Consultant Ophthalmologists. A cohort of local children with self-inflicted injury is described. The matter is topical. We review progress in recent legislation and policy change in the UK., Results: Four of 77 case reports of laser burns in childhood analysed reported psychological or behavioural issues. Three of four children in our cohort had such issues. Delay in diagnosis occurred in two of our patients. Structural retinal damage persisted for over 12 months in all four children (seven eyes). Our survey of UK ophthalmologists found 159 cases of injury (85% male), 80% under 20 years of age. The majority of the laser pointers were purchased online. Many patients (36%) suffered moderate vision loss (6/18 to 6/60 Snellen), while 17% (at least 11 patients) suffered severe vision loss (<6/60 Snellen)., Conclusion: We highlight the risk of macular damage and vision loss from handheld lasers specifically in children with behavioural, learning or mental health issues. The diagnosis may be difficult or delayed in such children. In children with uncertain macular changes, ophthalmologists should explore the history for possible instances of exposure to handheld lasers pointers. Regulatory authorities and manufacturers of handheld lasers need to be aware of the risk to children. Furthermore, there is a need to better inform parents, carers and teachers of the risk of ocular self-injury from such lasers pointers.

What Is Known and Objective: Hawaii will ban two major ingredients of sunscreens. This article reviews the reasons and future directions. Hawaii recently enacted legislation that will ban the use of two major ingredients of the majority of commonly used sunscreens. The reason for the ban is the ingredients' putative deleterious impact on marine ecosystems, particularly coral reefs. But sunscreens also save lives by decreasing the risk of UV-induced skin cancers. We review both sides of the issue and potential implications for the healthcare system., Comment: Coral reefs consist of organisms in delicate equilibria that are susceptible to small changes in their surroundings. Recent natural and man-made disruptions, direct or indirect, such as changes in ocean temperature and chemistry, ingress of invasive species, pathogens, pollution and deleterious fishing practices, have been blamed for the poor health, or even the outright destruction, of some coral reefs. The most popular sunscreen products contain two ingredients-oxybenzone and octinoxate-that have also been implicated in coral toxicity and will be banned. This creates a healthcare dilemma: Will the protection of coral reefs result in an increase in human skin cancers?, What Is New and Conclusion: Concentration estimates and mechanism studies support an association-direct or indirect (via promotion of viral infection)-of sunscreens with bleaching of coral reefs. A ban on the two most common sunscreen ingredients goes into effect in Hawaii on January 1, 2021. Proponents suggest that this is a trend, just the first of many such bans worldwide; opponents warn of a dire increase in human skin cancers. As a result, alternative sunscreen compounds are being sought., (© 2018 John Wiley & Sons Ltd.)

The European Food Safety Authority (EFSA) mandates two sets of statistical tests in the comparative assessment of a genetically-modified (GM) crop: difference testing to demonstrate whether the GM crop is different from its appropriate non-traited control; and equivalence testing to demonstrate whether it is equivalent to conventional references with an history-of-safe-use. The equivalence testing method prescribed by EFSA confounds the so-called GM trait effect with genotypic differences between the reference varieties and non-traited control. Critically, these genotypic differences, which we define as a 'control background effect', are the result of conventional plant breeding. Thus, the result of EFSA equivalence testing often has little or nothing to do with the GM trait effect, which should be the sole focus of the comparative assessment. Here, an integrated method is introduced for both difference and equivalence testing that considers the differences of the three genotype groups (GM, control, and references) as a two-dimensional random variable. A novel statistical model is proposed, called the trait model, that treats the effects of the GM and control materials as fixed for their difference, and as random for their common background. For significance testing, the covariance structure of the three genotype groups is utilized to decompose the differences into the trait effect and the control background effect. The trait difference is then derived as a conditional mean, given the background effect. The comparative assessment can then focus on the conditional mean difference, which is independent of the control background effect. Furthermore, the trait model is flexible enough to include various types of genotype-by-environment (G×E) interactions inherent to the experimental design of the trial. Numerical evaluations and simulations show that this new method is substantially more efficient than the current EFSA method in reducing both Type I and Type II errors (protecting both the consumer and producer risk) after the background effect is removed from the test statistic, and successfully addresses two major criticisms (i.e. statistical model lack of G×E, and study-specific equivalence criterion) that have been raised., Competing Interests: Changjian Jiang, Chen Meng, and Adam Schapaugh are currently employed by Monsanto Company, a leading developer of biotechnology traits. During preparation of the manuscript they were employed by Monsanto Company. This does not alter the authors’ adherence to all the PLOS ONE policies on sharing data and materials.

People are often looking for that quick fix when it comes to their health. With dietary supplements so readily available on the market, the public assume that they have been through rigorous testing. Dietary supplements are not tested as much as consumers believe. The Food and Drug Administration (FDA) does not initiate the same type of testing and analysis for supplements as it does for food, drink and medication. Given that people are now choosing supplemental meal replacements and the like, as opposed to whole foods, regulations drastically need to be stepped up in an effort to emphasise public safety. An authoritative body needs to stop manufacturers from taking advantage of an already vulnerable marketplace. I suggest a new form of regulation that takes the pressure away from the FDA and into the hands of someone who wholly focuses on the supplement market. Dietary supplements have revolutionised the "health" world; however, the only way that the market can keep growing is through enacting more stringent rules and regulations--at the same time allowing consumers to maintain their autonomy and freedom when purchasing., (Copyright by Cleveland State University.)