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Drowning is a leading cause of fatality among children in the United States. In children younger than 15 years of age there were, on average, an estimated 371 pool- or spa-related fatal drownings reported per year for 2018 through 2020. This study reviewed narrative case reports obtained from the United States Consumer Product Safety Commission (CPSC) to understand pool barrier location, type, and functionality as methods of pool/spa access for childhood submersion incidents. Retroactive analysis of 1,523 fatal and non-fatal submersion incidents among children aged 13 years old and younger was conducted using the CPSC in depth investigation dataset from 2000-2017. Narrative descriptions were coded according to the attributes of barrier location, functionality, and method of access. To our knowledge, these characteristics of barriers have not been previously investigated to this depth. Outcomes indicate that consumer education campaigns should target households with swimming pools/spas and reiterate key findings that (1) submersion incidents occur even when barriers are present and (2) multiple layers of protection against unauthorized pool/spa access are critically important for residential pools/spas. Additionally, improved documentation of barriers is imperative to better understand and prevent drowning among children. [ABSTRACT FROM AUTHOR]

The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined the FDA's statutory authority to regulate dietary supplement products as a category of food in the United States. As we celebrate 30 years post-DSHEA, it is important to reflect on its significance for public health, influence on the continuously evolving and expanding product category, the current regulatory framework, and potential opportunities or modernizing oversight to ensure a strong and well-regulated marketplace. An estimated three-fourths of U.S. consumers report use of dietary supplements, and the product market has grown substantially since the passage of DSHEA, from approximately 4,000 products in 1994 to 80,000+ present day. This growth represents a current $60 billion domestic and $200 billion international market for dietary supplements. Scientists, public health officials, health care providers, patients, consumer advocacy organizations, and the U.S. Food and Drug Administration have all called for reform to what has been described as 'outdated' regulation of dietary supplements. Advancing at an even faster rate is published scientific evidence in the space. This special issue of the Journal of Dietary Supplements comprises a collection of articles authored by academicians, legal scholars, representatives of U.S. government agencies, and industry scientists that critically examine the successes, challenges, and opportunities for improving specific aspects of DSHEA and domestic health policy. This editorial provides historical context and milestones of dietary supplement regulation in the U.S. post-DSHEA and offers an overview of the research contained within the special issue. Advancing toward a more transparent and safer marketplace requires trustworthy supply chains, increased adherence to quality standards, additional labeling requirements, and enhancement of post-market surveillance. This special issue seeks to contribute to the broader understanding of dietary supplement regulation and its future direction. [ABSTRACT FROM AUTHOR]

The United States Pharmacopeia (USP) is an independent, nonprofit science-based organization whose mission is to improve global health through public standards and related products for medicines, food and dietary supplements. Probiotic-based dietary supplements are increasingly popular in the marketplace and USP has developed fourteen monographs specific to probiotic ingredients, including representatives from the Genera Lactobacillus, Bacillus, Streptococcus, and Bifidobacterium. These monographs include the definition of the article, tests for identification, quantification assays (enumeration in the case of probiotics), limits for contaminants, and other quality parameters when appropriate. In addition to quality, the USP also considers the safety of probiotics for monograph development. This report includes an overview of the USP admission evaluation process for probiotics as well as a tabular summary of the probiotic monographs currently available. Pharmacopeia monographs can guide manufacturers and brand owners and protect consumers through establishment of quality standards. [ABSTRACT FROM AUTHOR]

Background: Suicide-related presentations to pediatric emergency departments (PED) have increased in recent years. PED providers have the opportunity to reduce suicide risk by counseling on restricting access to lethal means. Supplementing lethal means counseling (LMC) with safety device distribution is effective in improving home safety practices. Data on PED-based LMC in high-risk patient populations is limited. The objective of this study was to determine if caregivers of children presenting to PED for mental health evaluation were more likely to secure all household firearms if given cable-style gun locks in addition to LMC. Methods: In this randomized controlled trial, caregivers completed a survey regarding storage practices of firearms and medication in the home. Participants were randomized to receive LMC (control) or LMC plus 2 cable-style gun locks (intervention). Follow-up survey was distributed 1 month after encounter. Primary outcome was proportion of households reporting all household firearms secured at follow-up. Secondary outcomes included: removal of lethal means from the home, purchase of additional safety devices, use of PED-provided locks (intervention only), and acceptability of PED-based LMC. Results: Two hundred participants were enrolled and randomized. Comparable portions of study groups completed follow-up surveys. Control and intervention arms had similar proportions of households reporting all firearms secured at baseline (89.9% vs. 82.2%, p = 0.209) and follow-up (97.1% vs. 98.5%, p = 0.96), respectively. Other safety behaviors such as removal of firearms (17.6% vs. 11.8%, p = 0.732), removal of medication (19.1% vs. 13.2%, p = 0.361), and purchase of additional safety devices (66.2% vs. 61.8%, p = 0.721) were also alike between the two groups. Both groups held favorable views of PED-based counseling. Within the intervention group, 70% reported use of provided locks. Preference for a different style of securement device was the most cited reason among those not using PED-provided locks. Conclusions: PED-based LMC is a favorably-viewed, effective tool for improving home safety practices in families of high-risk children. Provision of cable-style gun locks did not improve rate of firearm securement compared LMC alone—likely due to high baseline rates of firearm securement and preference for different style of lock among non-utilizers. Clinical Trial Registration: ID: NCT05568901. Clinicaltrials.gov. https://clinicaltrials.gov/. Retrospectively registered October 6, 2022. First participant enrollment: June 28, 2021. [ABSTRACT FROM AUTHOR]

Background: E-cigarettes are the most-used tobacco product among US adolescents and are associated with nicotine addiction. This qualitative investigation aimed to understand adolescents' experiences and perceptions with nicotine addiction, and related influences of addiction, to inform product regulation, health communication, and cessation resource development. Methods: Between May 2020 and December 2021, in-depth, semi-structured individual interviews were conducted with 47 California (United States) adolescents ages 13–17 who reported recent tobacco use (primarily e-cigarette use). The topic of addiction both arose organically and followed specific interviewer questions. Researchers used thematic analysis techniques to identify unifying themes related to addiction. Results: Adolescents described e-cigarette addiction in ways that reflected a loss of control over their routines and activities and as physical symptoms, including reward and withdrawal. While some viewed addiction risk as a reason not to vape, others perceived it possible to use e-cigarettes and avoid or manage addiction. Specific characteristics of e-cigarette devices, particularly disposable nicotine-salt products, including flavors, "cool" designs, concealable size and odor, low price, and ease-of-use, were seen as enhancing addiction risk. Quit attempts were difficult and usually unsupported by adults or formal cessation aids. Conclusions: For many adolescents, addiction is a major component of their experience with e-cigarettes, often in ways that disrupt their routines and reduce their quality of life. Tobacco control or regulation could target e-cigarette product characteristics to decrease potential for addiction among adolescents. Needed are youth-targeted public communication about nicotine addiction and adolescent-tailored, evidence-based cessation support. [ABSTRACT FROM AUTHOR]

OBJECTIVE: We reviewed recent reports of recalled children's products contaminated with lead to learn more about what could be done to inform public health partners about the recalls in a timely manner to assist with broader consumer notification for proactive lead poisoning prevention efforts. METHODS: Centers for Disease Control and Prevention staff reviewed lead-related recall notices for children's products issued during June 2022 through April 2024. Recall notices were extracted from the Consumer Product Safety Commission using Really Simple Syndication feed technology to identify and capture the most current recall information. Specific product details in the database were extracted and analyzed descriptively to identify response trends and best practices. RESULTS: Centers for Disease Control and Prevention's automated tool identified 30 recalls from Consumer Product Safety Commission. Lead-contaminated toys were the most frequent type of product recalled (n = 11, 37%). Most products were manufactured in China (n = 24, 86%). Products were on the market for an average of 25 months before they were recalled. No injuries were reported. The 30 recalls resulted in a combined number of 914 598 recalled units sold. CONCLUSIONS: The current approach to protecting children from lead hazards in consumer products could be augmented by timely notifying the public health community about recalls so they can broadly disseminate information through their channels to reduce lead exposure in children. Additional steps to reduce lead contamination in children'sproductswhen sourcing raw materials and components may help to decrease the number of recalls. [ABSTRACT FROM AUTHOR]

Combination products (CPs) combine two or more product types such as drugs, devices, and/or biological products for increased safety and clinical effectiveness. The emergence of innovative CPs poses new challenges for regulatory agencies in assigning jurisdiction for premarket review and oversight. In US, the 1990 Safe Medical Devices Act defines and provides classification criteria for CPs, and the US government has developed a regulatory process through multiple acts, including the 21st Century Cures Act of 2016. Meanwhile, regulators in the European Union (EU) and the Republic of Korea have recently recognized the importance of premarket pathways for CPs. The European Medicines Agency (EMA) has issued guidelines and explanations on compliance issues related to drug–device CPs under MDR. EMA doesn't have the definitions of CPs, but uses the term drug–device combination products (drug-device CPs). CPs are categorized as drugs or medical devices, which follow their relevant regulatory framework. The Ministry of Food and Drug Safety (MFDS) in Korea has legal definitions of CPs under the Notice of the MFDS. CPs are designated as drugs or medical devices according to their primary mode of actions (PMOA) and follow regulatory processes through the framework of drugs or medical devices. This study aims to comprehensively summarize the regulatory oversight of CPs by analyzing the regulatory policies and legal frameworks in the US, the EU, and Korea. The regulatory challenges encountered when developing CPs are also discussed. With specific emphasis on the combination of drugs and devices, this study provides in-depth insights into the regulatory landscape, shedding light on the unique challenges associated with the development of CPs for this particular intersection of drugs and devices. [ABSTRACT FROM AUTHOR]

The purpose of this research is to focus on the most practised Artificial Food Colourants (AFCs) creating a demand in the consumer food market and neglecting food safety by the stakeholders, as these AFCs have been proven to be harmful to human health. The problem question that has been addressed here is whether the labeling policy and the consumer awareness of AFC are in tandem with; how the Indian judiciary fared in delivering their judgements towards the prevalence of non-permitted AFCs in the Indian food market to tell them as successful for the healthier consumer food industry. The main objective is to examine the consumers's awareness on AFC on the International Numbering System for Food Additives (INS) and their mentioning on the label of food products along with the regulatory measures for approvals of AFCs in Europe, USA and India for comparison. It is revealed that consumers' awareness of INS is not very significant; FSSAI permits only eight AFCs for consumption, nevertheless, other non-permitted AFCs were also found to be used and the Indian government has acted responsibly on various occasions by entering the manufacturing premises to inspect the food, collect samples for testing the adulteration by submitting to the food analyst, thereby curbing such activities and grabbing such offenders to the court. The concept of food safety dimensions in consensus with AFC practices, the health and legal issues associated with AFC consumption, the Indian Government's policies and the response of the judiciary related to food colourants safety are discussed in this paper. A doctrinal research method is followed by analysing the legal literature such as the regulatory provisions, government policies and noteworthy cases from the Indian judiciary and drawing support from empirical research evidencing the poor knowledge of consumers on AFCs being added in the food. Therefore, a serious policy awareness among consumers with respect to AFCs, being responsible and taking ownership towards one's own health and their family members by taking steps in questioning the consumer forum, avoiding purchase of such packed food which does not adhere to the labeling standards and being consumer friendly. Stringent regulations in labeling standards of packaged food in the USA and Europe due to the import nature of their products are the need of the hour. [ABSTRACT FROM AUTHOR]

This study evaluates the epidemiology of nonfatal head injuries among children aged 1 to 4 years associated with consumer products and identifies the specific consumer products associated with these injuries. Data for children aged 1 to 4 years who presented to emergency departments (EDs) from 2015 to 2019 for a nonfatal head injury were extracted from the National Electronic Injury Surveillance System. An estimated 1 032 429 (95% confidence interval [CI]: 675 822-1 389 063) children presented to US EDs for head injuries, averaging 566 injuries daily. The average rate of head injury did not change over the 5-year study period (slope = −0.003; P =.852); it was highest among children aged 1 year (2.06 per 100 children aged 1 year), which was nearly 3 times that of children aged 4 years (rate ratio = 2.75; 95% CI: 2.73-2.77). Most injuries occurred at home (80.4%) and occurred from interacting with home furnishings (45.1%). This study underscores the need for increased head injury mitigation efforts among young children. [ABSTRACT FROM AUTHOR]

Artificial Intelligence (AI) carries the potential for unprecedented disruption in radiology, with possible positive and negative consequences. The integration of AI in radiology holds the potential to revolutionize healthcare practices by advancing diagnosis, quantification, and management of multiple medical conditions. Nevertheless, the ever‑growing availability of AI tools in radiology highlights an increasing need to critically evaluate claims for its utility and to differentiate safe product offerings from potentially harmful, or fundamentally unhelpful ones. This multi‑society paper, presenting the views of Radiology Societies in the USA, Canada, Europe, Australia, and New Zealand, defines the potential practical problems and ethical issues surrounding the incorporation of AI into radiological practice. In addition to delineating the main points of concern that developers, regulators, and purchasers of AI tools should consider prior to their introduction into clinical practice, this statement also suggests methods to monitor their stability and safety in clinical use, and their suitability for possible autonomous function. This statement is intended to serve as a useful summary of the practical issues which should be considered by all parties involved in the development of radiology AI resources, and their implementation as clinical tools. [ABSTRACT FROM AUTHOR]

Objective The objectives of this Society of Breast Imaging (SBI)-member survey study were to assess the current imaging patterns for evaluation of symptomatic and asymptomatic breast implant integrity, including modalities used and imaging intervals. Methods A 12-question survey assessing the frequency of imaging modalities used to evaluate implant integrity, approximate number of breast implant integrity studies requested per month, intervals of integrity studies, and referring provider and radiology practice characteristics was distributed to members of the SBI. Results The survey response rate was 7.6% (143/1890). Of responding radiologists, 54.2% (77/142) were in private, 29.6% (42/142) in academic, and 16.2% (23/142) in hybrid practice. Among respondents, the most common initial examination for evaluating implant integrity was MRI without contrast at 53.1% (76/143), followed by handheld US at 46.9% (67/143). Of respondents using US, 67.4% (91/135) also evaluated the breast tissue for abnormalities. Among respondents, 34.1% (46/135) reported being very confident or confident in US for diagnosing implant rupture. There was a range of reported intervals for performing implant integrity studies: 39.1% (43/110) every 2-3 years, 26.4% (29/110) every 4-5 years, 15.5% (17/110) every 6-10 years, and 19.1% (21/110) every 10 years. Conclusion For assessment of implant integrity, the majority of respondents (53.2%, 76/143) reported MRI as initial imaging test. US is less costly, but the minority of respondents (34.1%, 46/135) had confidence in US performance. Also, the minority of respondents (39.1%, 43/110) performed implant integrity evaluations every 2-3 years per the FDA recommendations for asymptomatic surveillance. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic exposed vulnerabilities of the United States' routine and emergency supply chains of medicines and critical equipment. These vulnerabilities underscore an urgent need to prevent routine and emergency shortages by making drug manufacturing more transparent and by tracking how key supplies get to end users. Near real-time surveillance systems must be developed to monitor fluctuations in supplies of medicines and equipment. Implementation of such systems will require getting key stakeholders (clinicians, administrators, community members, manufacturers, and policy makers) to collaborate. [ABSTRACT FROM AUTHOR]

U.S. law imposes strict recording and reporting requirements on all entities that manufacture and distribute controlled substances. As a result, the prescription opioid crisis has unfolded in a data-saturated environment. This article asks why the systematic documentation of opioid transactions failed to prevent or mitigate the crisis. Drawing on a recently disclosed trove of 1.4 million internal records from Mallinckrodt Pharmaceuticals, a leading manufacturer of prescription opioids, we highlight a phenomenon we propose to call data diversion, whereby data ostensibly generated or collected for the purpose of regulating the distribution of controlled substances were repurposed by the industry for the opposite aim of increasing sales at all costs. Systematic data diversion, we argue, contributed substantially to the scale of drug diversion seen with opioids and should become a focus of policy intervention. [ABSTRACT FROM AUTHOR]

The use of veterinary biologicals is an integral component of poultry health programs. All veterinary biologicals are licensed and sold by manufacturing firms under strict regulation by the U.S. Department of Agriculture to ensure purity, potency, efficacy, and safety of the product. The licensing process for a new vaccine is a complex process involving a defined set of studies for each type of vaccine that are performed by the biologics firm, according to approved protocols, with results submitted to the Center for Veterinary Biologics for review. There are 10 classifications of veterinary biologicals and four types of licenses. Manufacturing and testing procedures are also defined within the licensing process. Licensing requirements were initially codified into law. In addition, guidance documents in the form of memoranda and notices have been published to address licensing for additional classes of vaccines and disease agents. This overview of vaccine licensure in the United States is offered to provide a better understanding of the process, the participants, and the factors that influence the time required to produce a commercial product. Estudio recapitulativo- Requisitos de licencia para productos biológicos veterinarios avícolas en los Estados Unidos. El uso de productos biológicos veterinarios es un componente integral de los programas de salud avícola. Todos los productos biológicos veterinarios están autorizados y son vendidos por empresas fabricantes bajo estricta regulación del Departamento de Agricultura de los Estados Unidos para garantizar la pureza, potencia, eficacia y seguridad del producto. El proceso de concesión de licencia para una nueva vacuna es un proceso complejo que implica un conjunto definido de estudios para cada tipo de vacuna que son llevados a cabo por la empresa productora de biológicos, según protocolos aprobados y los resultados se envían al Centro de Productos Biológicos Veterinarios para su revisión. Existen 10 clasificaciones de biológicos veterinarios y cuatro tipos de licencias. Los procedimientos de fabricación y de prueba también se definen dentro del proceso de concesión de licencias. Los requisitos para la concesión de licencias se codificaron inicialmente como ley. Además, se han publicado documentos de orientación en forma de memorandos y avisos que han sido publicados para abordar la concesión de licencias para clases adicionales de vacunas y agentes patógenos. Esta revisión de los procesos de licencia de vacunas en los Estados Unidos se ofrece para brindar una mejor comprensión del proceso, los participantes y los factores que influyen en el tiempo necesario para producir un producto comercial. [ABSTRACT FROM AUTHOR]

Liquid laundry detergent packet exposures modestly declined in the mid-2010s among children less than 6 years of age due to public awareness and voluntary product safety standards. We aimed to assess longitudinal trends in the number and rate of liquid laundry detergent packet exposures in the United States by age. Data from the National Poison Data System were analyzed to characterize liquid laundry detergent packet exposures between January 2014 and December 2022. From 2014–2022, there were 114,826 single and polysubstance exposures to liquid laundry detergent packets. Children less than 6 years of age (86.8 percent) were most commonly exposed. When evaluating multi-year trends, we found that the annual exposure rate per 1 million children less than 6 years old increased by 16.8 percent from 392.6 in 2018 to 458.7 in 2020. Subsequently, the annual exposure rate in children less than 6 years of age declined by 6.8 percent from 2020 to 2022 (427.4 exposures per 1 million). The annual rate of adolescent exposures increased by 85.4 percent from 2014 (4.1 exposures per 1 million) to 2017 (7.6 exposures per 1 million), with a subsequent increase of 155.3 percent from 2017 to 2018 (19.4 exposures per 1 million). Among adults, the annual exposure rate increased by 147.1 percent from 2014 (1.7 exposures per 1 million) to 2022 (4.2 exposures per 1 million). The number of more serious medical outcomes and hospital admissions among children less than 6 years of age declined by 44.3 percent and 68.6 percent, respectively, between 2014 and 2018. Despite declines in the number, rate, and severity of liquid laundry detergent packet exposures among children less than 6 years old, the exposure burden remains high. Additionally, exposures have increased among older children, adolescents, and adults. Renewed safety efforts are warranted to protect prior public health gains and further reduce exposures. [ABSTRACT FROM AUTHOR]

Reliance-based pathways for the marketing authorization of medical products have been identified as valuable regulatory tools for the timely provision of effective, safe, quality medicines for people worldwide; however, little research has been conducted on the best way to measure the public health impact of using reliance-based pathways. The current mixed methods study was designed to explore which characteristics or "metrics" could be used to measure the impact of reliance-based pathways. A quantitative survey (n = 70) and in-depth interviews (IDIs) (n = 10) were employed to query various stakeholders (e.g., industry, regulatory authorities, NGOs) about the metrics they believed would be important to include in a framework designed to measure the impact of reliance-based regulatory pathways on advancing public health. Based on survey results, (1) ability to meet targeted product assessment timeline, (2) increased access to expertise, which is limited or not available in the agency, (3) shortened median number of days (annually) to market for medical products, (4) lower morbidity and mortality rates due to greater access to medical products, and (5) movement toward technical standards harmonization were the Top Five most important metrics to be included in a framework. IDI results suggest that, while important, the relevance of the Top Five metrics may vary by region or regulatory authority. Interviewed stakeholders intuitively believe reliance-based regulatory pathways are a worthwhile endeavor; however, there must be "harmonization" within the reliance ecosystem that creates a strong understanding of the factors necessary for reliance-based pathways to be utilized in a successful manner. [ABSTRACT FROM AUTHOR]

Objectives: This evaluation assesses the quantity, uniqueness, and innovative nature of the past 20 years of Rx-to-OTC (RTO) switches, where a current prescription (Rx) product is reclassified for over-the-counter (OTC) status. Broadening access to more OTC drugs with well-established safety and efficacy could help to reduce healthcare expenditure and address public health challenges. Methods: The FDA-maintained RTO switch list website was accessed to generate the primary dataset. Each product listed was assessed for the current OTC availability in the United States of its active ingredient, pharmacological class, and indication to determine its innovative quality. Descriptive statistics were employed in this study. Results: From January 2002 through August 2022 there were 45 RTO switches. Among these, 51.1% involved a new to OTC active ingredient, 22.2% involved a new pharmacological class, 6.6% involved a new indication, and 82.2% were considered follow-on products that introduced a new to OTC active ingredient or new dosage form of an already marketed active ingredient to treat an existing OTC indication. A small minority (6.6%) were considered an exceptional innovation that would offer US consumers a genuinely novel OTC product, providing a new to OTC active pharmaceutical ingredient, pharmacological class, and indication. Overall, there was 1 exceptional innovation every 6.7 years. Conclusions: Over 40 RTO switches have come to the OTC market in the past 20 years; however, exceptional innovations that expand access to new to OTC active ingredients for new indications are rare. Policies and strategies that result in more innovative switches that can benefit consumers and public health should be evaluated. [ABSTRACT FROM AUTHOR]

Background: Preventing firearm-involved injuries is a critical public health priority. Firearm locking devices can prevent firearm injuries, such as suicide and unintentional shootings, as well as theft. Various firearm locking devices exist; however, little is known about firearm owners' preferred locking devices for secure firearm storage. In this systematic review, we examined existing literature on preferred locking devices for secure storage of personal firearms among United States (US) firearm owners with the purpose of understanding practical implications and needs for future research. Methods: We searched 8 major databases, as well as the grey literature, for English-language sources published on or before January 24, 2023, that empirically examined firearm locking device preferences. Following PRISMA guidelines, coders independently screened and reviewed 797 sources using pre-determined criteria. Overall, 38 records met inclusion criteria and were included in this review. Results: The majority of studies measure and report on participant use of various types of locking devices, but few go on to measure preference between device options and the attributes and features that may contribute to an individual's preference. Included studies suggest that a preference for larger devices, such as lockboxes and gun safes, may exist among US firearm owners. Conclusions: Review of included studies suggests that current prevention efforts may not be aligned with firearm owners' preferences. Additionally, findings from this systematic review emphasize the need for additional methodological rigorous research to understand firearm locking device preferences. Expanded knowledge in this area will result in actionable data and foundational best practices for programming that encourages behavior change concerning secure storage of personal firearms to prevent injury and death. [ABSTRACT FROM AUTHOR]

Elbow fractures comprise 15% of all fractures in children. Our study identifies risk factors and consumer products that contribute to pediatric elbow fractures. The National Electronic Injury Surveillance System was used to collect demographic and consumer product information between 2010 and 2019 for patients younger than 17 years who presented to the emergency department with elbow fractures. Of the 458,433 elbow fractures, the average age of the patients was 7.4 ± 4.1 years and 55.6% were male children. The most common consumer product was sports and recreation equipment, followed by home furnishings. Male patients (P <.0001) and patients 8 years and older (79.2% vs 51.1%, P <.0001) experienced significantly greater rates of injury with sports and recreation equipment. This study evaluates the products associated with pediatric elbow fractures and highlights the importance of safe sports and recreation equipment use and the role of parental counseling in preventing falls from furniture. [ABSTRACT FROM AUTHOR]

The article offers information on research and developments (R&D) related to nutrition in the U.S. The Centers for Disease Control's (CDC) new report finds an increase in the consumption of dietary supplements among adults as well as children. A study on infant formula products refers to the controversial claims regarding nutrition in these formulas. A study conducted in 2018 identified a link between type 2 diabetes and diet.

As more information about the potential risks and complications related to breast implants has become available, the United States Food and Drug Administration (FDA) has responded by implementing changes to improve patient education, recalling certain devices and updating the recommendations for screening for silicone implant rupture. In addition to staying up-to-date with FDA actions and guidance, radiologists need to maintain awareness about the types of implants they may see, breast reconstruction techniques including the use of acellular dermal matrix, and the multimodality imaging of implants and their complications. Radiologists should also be familiar with some key differences between the updated FDA guidelines for implant screening and the imaging recommendations from the American College of Radiology Appropriateness Criteria. The addition of US as an acceptable screening exam for silicone implant rupture by the FDA is one of the most notable changes that has potentially significant implications. [ABSTRACT FROM AUTHOR]

The article examines the U.S. Food and Drug Administration's (FDA) lack of authority to restrict the use of harmful chemicals in nail products which pose occupational health hazards to nail salon technicians. It examines the most pervasive nail product chemicals and their potential effects on occupational health. It analyzes the negative impact of the rigid cosmetic framework of the FDA on its pre- and post-market authority and its power to address nail product safety issues.

BACKGROUND AND OBJECTIVES: Flavored non-tobacco oral nicotine products (eg, nicotine pouches and nontherapeutic nicotine gum, lozenges, tablets, gummies), are increasingly marketed in the United States. Prevalence of non-tobacco oral nicotine product use among adolescents is unknown. METHODS: We calculated prevalence of ever and past 6-month use of nicotine pouches, other non-tobacco oral nicotine products (ie, gum, lozenges, tablets, and/or gummies), e-cigarettes, cigarettes, hookah or waterpipe, cigars, cigarillos, and snus among high school students in Southern California between September and December 2021. Generalized linear mixed models tested associations of sociodemographic factors and tobacco-product use with use of any non-tobacco oral nicotine product. RESULTS: Among the sample (n = 3516), prevalence was highest for e-cigarettes (ever: 9.6%, past 6-month: 5.5%), followed by non-tobacco oral nicotine products (ever: 3.4%, past 6-month: 1.7%), and <1% for other products. Ever users of combustible tobacco (adjusted odds ratio [aOR] = 77.6; 95% confidence interval [CI] = 39.7-152) and ever users of noncombustible tobacco (aOR = 40.4; 95% CI= 24.3-67.0) had higher odds of ever using non-tobacco oral nicotine products, compared to never users of combustible and noncombustible tobacco. Use of any non-tobacco oral nicotine product was greater for Hispanic (versus all other races/ethnicities except Asian, aOR = 2.58; 95% CI = 1.36-4.87), sexual minority (versus heterosexual, aOR=1.63; 95% CI = 1.03-2.57), gender minority (versus male, aOR = 2.83; 95% CI = 1.29-6.19), and female (versus male, aOR=1.92, 95% CI = 1.20-3.06) participants. CONCLUSIONS: Non-tobacco oral nicotine products were the second most prevalent nicotine product used by adolescents. They were disproportionately used by certain racial or ethnic, sexual, or gender minority groups, and those with a history of nicotine use. Adolescent non-tobacco oral nicotine product use surveillance should be a public health priority. [ABSTRACT FROM AUTHOR]

While corporate political activity is increasing, its effects on firms' marketing-relevant outcomes have been largely overlooked in the literature. We propose that corporate lobbying will decrease a firm's emphasis on product safety and, in turn, increase its product recalls. We further propose that the positive indirect effect of corporate lobbying on a firm's product recalls via lower emphasis on product safety will be moderated by the firm's (a) CEO's functional background and (b) focus on radical (vs. incremental) innovation. We provide empirical support for the proposed model using data on 86 U.S. medical device firms from 2005–2018. The findings extend the literature on the effects of non-market forces on firms' marketing-relevant outcomes. They also extend the literature on the antecedents of product recalls, which has, hitherto, overlooked the role of non-market forces. The findings on the moderating roles of the firm's marketing CEO and focus on radical (vs. incremental) innovation generate actionable managerial implications. [ABSTRACT FROM AUTHOR]

Objectives: The purpose of this study was to assess the nationwide incidence of ear foreign body (FB) presentations to the emergency department (ED) and analyze the most common FB consumer products encountered. Methods: The National Electronic Injury Surveillance System (NEISS) was evaluated for ED visits that included "ear foreign bodies" from 2010 through 2019. The most frequent foreign bodies were identified and organized by demographics. Results: A total of 20,545 ear FB cases were found, with an estimated 608,860 ED visits nationwide. Female patients (56%) were more likely to have jewelry and first aid equipment FBs. Males between the ages of 5 and 15 years were significantly (P < 0.05) more likely to have paper products, pens/pencils, and desk supplies in their ears. Conclusion: Ear FBs represent a substantial proportion of healthcare expenditures. Although children are the most commonly affected individuals, all ages require further education and preventive measures. [ABSTRACT FROM AUTHOR]

The article reports on the safety concern alert issued by the U.S. Food and Drug Administration (FDA) over the presence of Cronobacter and elevated levels of potassium and chloride and low levels of vitamin A in some infant formula. The recalled products include Crecelac Infant Powdered Goat-Milk Infant Formula With Iron, Farmalac Baby Powdered Infant Formula With Iron and Farmalac Baby Powdered Infant Formula With Iron Low Lactose. It identifies symptoms of Cronobacter infection in infants.

• Explores state policy contexts that inform trends in hemp-based psychoactives. • Failure to regulate hemp products informs wide accessibility for young adults. • Cannabis legalization policy does not by itself dissuade young adult hemp use. • Lack of state level regulation on hemp heighten risks and adverse related outcomes. • Trend theory can identify and promote market contexts limiting legal drug uptake. Hemp-based psychoactives comprise a burgeoning legal substance market with rising trends in use across the U.S. and Canada as well as parts of Europe. Currently, scant empirical research on the use of these Novel Psychoactive Substances (NPS) exists. By examining policy, market conditions, consumer uptake, and related risks, this research extends theory on drug trends by describing the regulatory environments that shape the emergence and popularity of psychoactive hemp-based products among young adults. Relying on ethnographic fieldwork of hemp-based markets across 3 U.S. state hemp and cannabis policy contexts as well as in-depth interviews with 40 young adult cannabis consumers recruited across 10 U.S. states, we examined how regulatory conditions shape hemp-based psychoactive markets, trends in their use, and associated risks. Young adults are motivated to consume hemp-based psychoactives due to the regulatory and market environments that facilitate the production of highly potent products that are inexpensive and easily accessible. States that regulate hemp-based psychoactives as cannabis, do not provide hemp markets with a competitive advantage and as such see minimal uptake. In the absence of hemp specific policies, substantial variations in product potencies, insufficient dosing information, and unscrupulous product packaging practices may increase related risks. Trend theory provides insight into the complex relationships that exist between drug policy, markets, and the proliferation of legal highs. Understanding the contextual significance that both market and regulatory conditions have on legal drug production, distribution, and consumption may better inform approaches to reduce the risks commonly associated with novel psychoactive substances like hemp-based psychoactives. [ABSTRACT FROM AUTHOR]

• Most cannabis edible packages contained a product descriptor or imagery that may increase appeal and decrease perceptions of harm of cannabis products. • Marketing of edibles was distinct from other cannabis products (e.g., vapes) in its focus on food industry product descriptors that may convey a health halo. • Product descriptors focused on the pharmacokinetics of cannabis and the promise of higher quality, customized experiences were on packages despite the lack of scientific evidence potentially misleading consumers and increasing the risk of harms. • Like tobacco marketing, imagery conveying healthfulness was common. • Flavor imagery included images of food which could increase the likelihood of unintended consumption by children as well as adults. Background: With states legalizing cannabis at a rapid pace, and the increasing popularity of edibles, it is important to document marketing practices to better understand how they might be appealing and misleading to consumers to guide state policymakers. Methods: A descriptive content analysis of 1229 cannabis edible packages advertised on a publicly available website between June and November 2022 and available for sale in licensed dispensaries was performed. Results: Healthy ingredient descriptors were the most common type of descriptor with 31 % of packages including words like "vegan", "gluten free" and "natural". Quality descriptors like "handcrafted" were on 28 % of packages. Other descriptors were focused on the consumer experience including expected effects (e.g., "relax") (27 %), taste or flavor (e.g., "sour") (21 %) and pharmacokinetics (e.g., "fast-acting") (19 %). Images of non-cannabis plants and outdoor nature settings were on half of packages. Images of the cannabis plant were on 33 % of packages. Flavor imagery including images of food were common (43 %). Other marketing appeals included images of people (15 %), animals (12 %) and space (10 %). Conclusions: Package marketing used by other commercial industries was common on cannabis edible packages. Edibles marketing is distinct from other cannabis products in its ability to focus on the food ingredients which could mislead consumers into thinking the cannabis, rather than the food, is healthy or less harmful. Research examining the impact of cannabis edibles marketing strategies on appeal and harm perceptions is critically needed to guide policymakers as they establish packaging regulations to optimize public health and safety. [ABSTRACT FROM AUTHOR]

This review, written from the perspective of the plasma industry, discusses plasma procurement and plasma product safety in light of the COVID‐19 pandemic. The COVID‐19 pandemic impacted the whole world and, therefore, not unexpectedly, the pharmaceutical industry too. In spite of this, the plasma protein industry has continued to provide life saving therapies to critically ill patients. Moreover, companies have collected COVID convalescent plasma (CP) to support development of investigational therapies, for example, hyperimmune globulins to potentially treat SARS‐CoV‐2 infection, and collaborated with those collecting COVID CP for direct transfusion, which has been made available under emergency use in the United States. For plasma that is fractionated to become a therapy, general knowledge of coronaviruses and numerous new studies on the structure and function of SARS‐CoV‐2 provide reassurance that existing industry precautions, including donor selection, as well as virus inactivation and removal steps during the manufacturing process are sufficient to maintain the high standards of virus safety of plasma products. The pandemic also revealed the vulnerability and inadequacy of the current plasma ecosystem. There is a need for more plasma to be collected around the world to meet the growing need for safe and efficacious plasma‐derived therapies. This requires outdated regulatory and policy restrictions to be realigned with current scientific evidence. More countries around the world should be in a position to contribute to global supply of plasma so that patients with life‐threatening conditions ‐ and often no alternative therapeutic solutions ‐ have better access to care. [ABSTRACT FROM AUTHOR]

The article presents a study by the U.S. Centers for Disease Control and Prevention (CDC) on the possible adverse events of the Pfizer-BioNTech COVID-19 vaccine in children aged 5-11 years old. Topics include the emergency use authorization (EUA) given by the Food and Drug Administration (FDA) to the vaccine for said children and the use of the Vaccine Adverse Event Reporting System (VAERS) data in the study.

This article examines the history of device oversight by the US Food and Drug Administration (FDA). Significant regulatory changes occurred in response to injuries caused by Dalkon Shield intrauterine devices. This article summarizes those changes as well as continued efforts by the FDA to strengthen device oversight and address areas of concern. [ABSTRACT FROM AUTHOR]

The article discusses research presented at the 2023 American Academy of Pediatrics National Conference & Exhibition, which evaluated the level of availability and marketing of △-8-tetrahydrocannabinol to minors online. Cited are a concerning trend in its availability and marketing to minors revealed by the study, the key aspects of the examination of 45 websites selling the product, and the crucial role that clinicians play in addressing this issue.

Introduction: National estimates for nonfatal self-directed violence (SDV) presenting at EDs are calculated from the National Electronic Injury Surveillance System – All Injury Program (NEISS–AIP). In 2005, the Centers for Disease Control and Prevention and Consumer Product Safety Commission added several questions on patient characteristics and event circumstances for all intentional, nonfatal SDV captured in NEISS–AIP. In this study, we evaluated these additional questions along with the parent NEISS–AIP, which together is referred to as NEISS–AIP SDV for study purposes. Methods: We used a mixed methods design to evaluate the NEISS–AIP SDV as a surveillance system through an assessment of key system attributes. We reviewed data entry forms, the coding manual, and training materials to understand how the system functions. To identify strengths and weaknesses, we interviewed multiple key informants. Finally, we analyzed the NEISS–AIP SDV data from 2018—the most recent data year available—to assess data quality by examining the completeness of variables. Results: National estimates of SDV are calculated from NEISS–AIP SDV. Quality control activities suggest more than 99% of the cause and intent variables were coded consistently with the open text field that captures the medical chart narrative. Many SDV variables have open-ended response options, making them difficult to efficiently analyze. Conclusions: NEISS–AIP SDV provides the opportunity to describe systematically collected risk factors and characteristics associated with nonfatal SDV that are not regularly available through other data sources. With some modifications to data fields and yearly analysis of the additional SDV questions, NEISS–AIP SDV can be a valuable tool for informing suicide prevention. Practical Applications: NEISS-AIP may consider updating the SDV questions and responses and analyzing SDV data on a regular basis. Findings from analyses of the SDV data may lead to improvements in ED care. [ABSTRACT FROM AUTHOR]

The objective of this study was to analyze labeling practices and compliance with regulatory standards for shark cartilage supplements sold in the United States. The product labels of 29 commercial shark cartilage supplements were assessed for compliance with U.S. regulations. Claims, including nutrient content, prohibited disease, and nutritional support statements, were examined for compliance and substantiation. Overall, 48.3% of the samples had at least one instance of noncompliance with labeling regulations. The most common labeling violations observed were: missing a domestic address/phone number, non-compliant nutrient content claim, missing/incomplete disclaimer, missing statement of identity, prohibited disease claims, and incomplete "Supplement Facts" label. The use of prohibited disease claims and nutritional support statements without the required disclaimer is concerning from a public health standpoint because consumers may delay seeking professional treatment for a disease. The results of this study indicate a need for improved labeling compliance among shark cartilage supplements. [ABSTRACT FROM AUTHOR]

Introduction: Erythropoietin stimulating agents (ESAs) have been established both to correct anemia and provide the clinical benefits of increased exercise capacity, reduced transfusion requirements, and improved quality of life. An increase in physician and patient adoption of biosimilars, as well as changes to healthcare reimbursement policies, have driven market competitors to innovate and expand the range of biosimilar products. While erythropoietin biosimilars have been approved by the EMA since 2007, the FDA's approval of epoetin alfa-epbx in 2018 marks the first erythropoietin biosimilar approved in the United States. Areas covered: In this article, we critically review the biology, clinical use, manufacturing, safety, and efficacy of ESAs and erythropoietin biosimilars. We then review the regulatory framework and potential impact on healthcare costs offered by erythropoietin biosimilars. Expert opinion: Due to the complex nature of manufacturing large-molecule biologics, it is important to recognize the challenges to quality assurance and overall safety posed by the introduction of biosimilars, which undergo much more limited clinical testing than their reference biologic product before coming to market. With many biologic therapies nearing patent expiration, biosimilars will become increasingly common in clinical practice. Ensuring patient safety with these products will require increased post-marketing surveillance and awareness from prescribers. [ABSTRACT FROM AUTHOR]

A biosimilar is a biologic drug that is "highly similar to a reference (originator) product, with no clinically meaningful differences between the two products in safety, purity, and potency". Regulatory approval of a biosimilar is based on analytical, structural, and functional comparisons with the reference product, comparative nonclinical (in vivo) studies, clinical pharmacokinetics and/or pharmacodynamics, and immunogenicity. In addition, comparative clinical efficacy and safety assessments are usually conducted and, taken together, comprise the "totality of the evidence" supporting biosimilarity. For a biosimilar to meet the additional designation of interchangeability in the United States (US), the applicant must demonstrate that the biological drug can be expected to produce the "same clinical result as the reference product in any given patient" and "if the biological drug is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biological drug and the reference product is no greater than the risk of using the reference product without such alternation or switch". The challenges faced in conducting clinical studies to support a designation of interchangeability, as defined in the final interchangeability guidance from the US Food and Drug Administration, are considered. Potential alternative approaches to generating adequate and sufficient clinical data to support a designation of interchangeability are also presented. [ABSTRACT FROM AUTHOR]

The distinction between food and drugs has blurred in recent years with a new — and novel — health paradigm representing a hybrid of "nutrition" and "pharmaceuticals." Nutraceuticals are formulated or processed to satisfy dietary requirements arising from physical or physiological conditions, and to treat certain diseases. This study examines the complex interface between the regulatory framework and nutraceutical marketing by drawing from the experiences of three leading global producers and markets: the United States, China, and India. It identifies opportunities in leveraging positive drivers of health marketing and the risks and challenges to market players, particularly in relation to product safety and effectiveness. Findings indicate that: 1) marketing incentives can stem from the regulatory framework; 2) regulation can yield adverse, albeit unintended, consequences on marketing activity; 3) containment or punishment of undesirable market behavior does not necessarily support the legitimate and desirable ends of health marketing; 4) uncommunicated differences between prescription nutraceutical products and nutraceutical supplements breed public confusion and misinformation, and encourage self-medication; and 5) health marketing may be effectively channeled to act as an agent of compliance and positive change. Practical implications and recommendations drawn from the comparative experiences of the three surveyed countries are addressed by way of conclusion. [ABSTRACT FROM AUTHOR]

The passage of the 2018 United States Agriculture Improvement Act removed industrial hemp, defined as Cannabis sativa L. containing less than 0.3% THC content by dry weight, from Schedule I of the Controlled Substances Act and made it an agricultural commodity. Following these changes, the popularity of hemp-derived cannabidiol (CBD) dietary supplements by consumers has greatly exceeded the scientific understanding of purported benefits, safety and composition of these botanical extracts. Further complicating CBD hemp supplement regulation, Food and Drug Administration (FDA) considers CBD to be an approved drug (Epidiolex) in the treatment of severe epilepsy disorders, Dravet and Lennox-Gastaut syndromes. At the same time, hemp-derived CBD supplements can contain a complex phytochemical matrix from the hemp plant, distinguishing the composition of these products from isolated CBD preparations. This work aims to provide clarity on differentiating botanical full-spectrum hemp extracts containing CBD from isolates, from a phytochemical, toxicological and regulatory perspective. [ABSTRACT FROM AUTHOR]

Restaurants serve more than 70 billion meals in the U.S. each year. Annually, approximately 48 million foodborne illnesses occur in the U.S., yet only over 800 foodborne disease outbreaks get reported. From 1998-2013, 56% of the 17,445 outbreaks reported were associated with restaurants. While scientifically validated cleaning and sanitation strategies are available, microbial cross-contamination from environmental surfaces remains an issue. For instance, previous research shows that the cleaning tool itself can become a source of contamination. The objective of this study was to test if a flatware rest provides a physical barrier between contaminated tabletop surfaces and eating utensils. Data confirmed that flatware rests prevented the contamination of utensils from microorganisms when compared with utensils placed directly on surfaces inoculated with E. coli, Salmonella Typhimurium, and MS2 bacteriophage (a surrogate for norovirus). This study demonstrates that flatware rests are a practical solution to prevent cross-contamination of foodborne pathogens from tabletop to utensil, and potentially are an added layer of consumer protection. [ABSTRACT FROM AUTHOR]