Editorial Material
Neurosciences
Pamela D. Scott, Anita Bajaj, David P. McMullen
Summary: Recent research and technological developments have led to an increasing number of novel and rapid-acting therapies for neuropsychiatric disorders. This article provides an overview of FDA regulations for medical devices and discusses the use of neuromodulation devices for psychiatric disorders. It emphasizes the importance of early engagement with the FDA and explores current and future treatment options. The article also offers considerations for developers in navigating the regulatory landscape, including incorporating patient perspectives.
NEUROPSYCHOPHARMACOLOGY
(2023)
Article
Medicine, General & Internal
Michelle Johnson-Motoyama, Donna K. Ginther, Patricia Oslund, Lindsay Jorgenson, Yoonzie Chung, Rebecca Phillips, Oliver W. J. Beer, Starr Davis, Patricia L. Sattler
Summary: Public assistance policies may help prevent child maltreatment by improving household resources for low-income families. A study found that the adoption of state SNAP income generosity policies was associated with reduced CPS involvement and foster care placements.
Review
Oncology
R. Angelo de Claro, Jennifer J. Gao, Tamy Kim, Paul G. Kluetz, Marc R. Theoret, Julia A. Beaver, Richard Pazdur
Summary: The Real-Time Oncology Review (RTOR) pilot project by the FDA Oncology Center of Excellence aimed to expedite drug application submissions and provide faster approvals. The project supported the submission and review of 20 oncology drug applications, with the majority being supplemental approvals and two being new molecular entity (NME) drug approvals. All applications received priority review, and innovative regulatory processes like RTOR are crucial for efficient FDA product reviews.
CLINICAL CANCER RESEARCH
(2021)
Review
Cell Biology
Rachel C. Nordberg, Gaston A. Otarola, Dean Wang, Jerry C. Hu, Kyriacos A. Athanasiou
Summary: Despite numerous studies on animal cartilage repair, long-term clinical repair of articular cartilage remains challenging. This article identifies the challenges in translating cell-based cartilage repair strategies and technologies and emphasizes the importance of understanding these barriers and finding solutions.
SCIENCE TRANSLATIONAL MEDICINE
(2022)
Article
Allergy
Aikaterini Anagnostou, Pablo Rodriguez del Rio
Summary: Food allergy is a common and chronic disease that greatly affects the lives of patients and families. Traditionally, strict food avoidance was the only management option. However, food allergen immunotherapy has emerged as an alternative intervention with proven efficacy and safety, providing several benefits to food-allergic patients.
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY-IN PRACTICE
(2023)
Article
Chemistry, Multidisciplinary
Brian E. Harvey
Summary: Nonalcoholic fatty liver disease is a growing public health crisis, with no approved drugs or biological treatments for NASH or related liver diseases. The regulatory pathway for product approval is unclear due to extra-hepatic factors and the organizational structure of FDA.
ACTA PHARMACOLOGICA SINICA
(2022)
Article
Pharmacology & Pharmacy
Mansi Krishan, Lisa Navarro, Barbara Beck, Ricardo Carvajal, Michael Dourson
Summary: The Delaney Clause, enacted in 1958, prohibits additives that induce cancer in humans or animals from being deemed safe. Recent revocations of food additive approvals illustrate the need to reassess the clause's relevance based on modern scientific advancements.
TOXICOLOGY AND APPLIED PHARMACOLOGY
(2021)
Article
Multidisciplinary Sciences
Brad Brown, Marc Allard, Michael C. Bazaco, Joseph Blankenship, Travis Minor
Summary: The study presents an analysis of the GenomeTrakr WGS Network's impact on food safety, showing that adding WGS isolates to the NCBI database is associated with reducing illnesses from WGS pathogens. According to cost benefit analysis, the program likely broke even in its second year of implementation and could produce increasing public health benefits as the network matures.
Article
Nutrition & Dietetics
Rachel Novotny, Ashley B. Yamanaka, Rica Dela Cruz, Sabine Strasburger, Carol J. Boushey, Jean Butel, Monica Esquivel, Tanisha F. Aflague, Travis Fleming, Patricia Coleman, Jonathan Deenik, Leslie Shallcross, Lynne R. Wilkens
Summary: The dietary intake of NHOPI children in the USAP did not meet US recommendations, with significant differences in food group and macronutrient intake, and higher grain intake in overweight/obese children.
JOURNAL OF NUTRITION
(2022)
Article
Education, Scientific Disciplines
Grace LeBleu, Matthew J. Landry
Summary: Hunting-based food donation programs can have a positive impact on the food security and nutritional status of vulnerable populations. Nutrition professionals can help promote awareness of these programs and provide education on wild game nutrition, safety, and food preparation.
JOURNAL OF NUTRITION EDUCATION AND BEHAVIOR
(2022)
Review
Food Science & Technology
Tao Ma, Xinna Hu, Shuyu Lu, Xiaojun Liao, Yi Song, Xiaosong Hu
Summary: The synthesis of novel functional materials from abundant food waste resources has great potential for applications and ecological benefits. Nanocellulose, with its modifiable surface, excellent mechanical strength, and high aspect ratio, is a renewable and sustainable polymer that shows promise in various applications, including the food industry. This review focuses on the structural characteristics and extraction approaches of nanocellulose, as well as recent advancements in its use in the food industry. Environmental and human health concerns related to nanocellulose production are also evaluated. The extraction and production of nanocellulose from food waste provide a platform for the sustainable utilization of biomass, and its application in green food packaging materials, emulsion stabilizers, dietary fiber, nutrition delivery, and 3D printing hydrogels have shown excellent performance. Validated standards for characterizing the structure and evaluating toxicity are essential for the commercialization of nanocellulose in the food industry.
CRITICAL REVIEWS IN FOOD SCIENCE AND NUTRITION
(2022)
Article
Food Science & Technology
Tongxin Zhi, Dan Hong, Zijie Zhang, Siting Li, Junxia Xia, Chong Wang, Yongling Wu, Yingmin Jia, Aijin Ma
Summary: The walnut derived peptide LPF exhibits protective and recovery effects on dextran sulfate sodium-induced colitis in mice. It mitigates the severity of symptoms during the development phase of colitis and shows beneficial effects during the recovery period, including increased colon length, reduced colonic cell apoptosis, decreased production of inflammatory factors, and expansion of splenic regulatory T cells. Furthermore, LPF reverses the dysbiosis of gut microbiota in colitis mice, promoting recovery of microbiota diversity and beneficial genera abundance.
FOOD RESEARCH INTERNATIONAL
(2022)
Review
Food Science & Technology
Cameron Faustman, Daniel Aaron, Nicole Negowetti, Emily Broad Leib
Summary: The Government Accountability Office (GAO) criticized FDA's oversight of GRAS food ingredients and provided recommendations, but FDA only addressed a few criticisms and some important recommendations remain unaddressed. FDA has chosen to remain uninformed about food substances self-determined as GRAS by manufacturers.
CRITICAL REVIEWS IN FOOD SCIENCE AND NUTRITION
(2021)
Article
Psychology, Multidisciplinary
Jayanthi Mistry, Fuko Kiyama
Summary: This paper presents a conceptual model for ethnic identity development and integration among Asian American children and youth, emphasizing the importance of ethnic identity development and socialization in their marginalization process. The model is represented as three overlapping circles, highlighting features of identity formation, prevalent narratives, and the dynamic interaction between individual and context in the developmental process. This model aims to generate research questions that explore how specific ethnic backgrounds, developmental status, societal racial/ethnic hierarchy, and prevalent societal narratives shape the development of Asian American ethnic-racial identity.
AMERICAN PSYCHOLOGIST
(2021)
Article
Nutrition & Dietetics
Kaitlyn Harper, Emily H. Belarmino, Francesco Acciai, Farryl Bertmann, Punam Ohri-Vachaspati
Summary: This study aims to explore the differences in participation in SNAP, WIC, and school meal programs before and during the pandemic, and its association with food security and food pantry use. The findings indicate a decline in SNAP participation among households with children during the initial months of the pandemic, while WIC participation slightly increased and school meal program participation remained stable. Significant differences in program use were observed based on race/ethnicity, income, and urbanicity before and during the pandemic. Despite higher food insecurity prevalence among SNAP participants, the gap between participants and non-participants narrowed during the pandemic. The consistently higher rates of food pantry use and food insecurity among federal nutrition assistance program participants suggest unmet food needs. These results emphasize the importance of increasing program benefits and improving access to food, particularly during challenging times.
Editorial Material
Engineering, Environmental
Carol F. Kwiatkowski, David Q. Andrews, Linda S. Birnbaum, Thomas A. Bruton, Jamie C. DeWitt, Detlef R. U. Knappe, Maricel V. Maffini, Mark F. Miller, Katherine E. Pelch, Anna Reade, Anna Soehl, Xenia Trier, Marta Venier, Charlotte C. Wagner, Zhanyun Wang, Arlene Blum
ENVIRONMENTAL SCIENCE & TECHNOLOGY LETTERS
(2021)
Review
Environmental Sciences
Ksenia J. Groh, Birgit Geueke, Olwenn Martin, Maricel Maffini, Jane Muncke
Summary: Food contact materials may cause chemical contamination, and there is still limited understanding of the hazards and impacts of food contact chemicals on health and the environment. By establishing a database and evaluating hazardous substances, it was found that 1411 substances may pose similar levels of concern but have not been officially classified, indicating a significant data gap and research need in this field.
ENVIRONMENT INTERNATIONAL
(2021)
Article
Clinical Neurology
Jose G. Romano, Hannah Gardener, Iszet Campo-Bustillo, Yosef Khan, Sofie Tai, Nikesha Riley, Eric E. Smith, Ralph L. Sacco, Pooja Khatri, Heather M. Alger, Brian Mac Grory, Deepak Gulati, Navdeep S. Sangha, Jeffrey M. Craig, Karin E. Olds, Curtis G. Benesch, Adam G. Kelly, Scott S. Brehaut, Amit C. Kansara, Lee H. Schwamm
Summary: The study found that most patients with mild strokes had poor outcomes in the study. The primary outcome was a 90-day modified Rankin Scale score of 0 to 1, with secondary outcomes including good outcomes in the Barthel Index, Stroke Impact Scale-16, and European Quality of Life. Factors such as age, gender, race, and baseline NIHSS score were identified as predictors of worse outcomes.
Article
Clinical Neurology
Pratyaksh K. Srivastava, Shuaiqi Zhang, Ying Xian, Hanzhang Xu, Christine Rutan, Heather M. Alger, Jason Walchok, Joseph Williams, James A. de Lemos, Marquita R. Decker-Palmer, Brooke Alhanti, Mitchell S. Elkind, Steve R. Messe, Eric E. Smith, Lee H. Schwamm, Gregg C. Fonarow
Summary: Patients with AIS and COVID-19 had younger age, greater stroke severity, longer evaluation and treatment times, decreased odds of discharge with modified Rankin Scale score of <= 2, and increased odds of in-hospital mortality compared with those with AIS and no COVID-19.
Article
Medicine, General & Internal
Gregory A. Roth, Sophia Emmons-Bell, Heather M. Alger, Steven M. Bradley, Sandeep R. Das, James A. de Lemos, Emmanuela Gakidou, Mitchell S. V. Elkind, Simon Hay, Jennifer L. Hall, Catherine O. Johnson, David A. Morrow, Fatima Rodriguez, Christine Rutan, Saate Shakil, Reed Sorensen, Laura Stevens, Tracy Y. Wang, Jason Walchok, Joseph Williams, Christopher Murray
Summary: In this retrospective cohort study involving 20,736 adults with COVID-19 in the United States, in-hospital mortality rates decreased after March and April and remained at a lower level from May through November, regardless of changes in patient characteristics.
Article
Cardiac & Cardiovascular Systems
Anjali Rao, Sagar Ranka, Colby Ayers, Nicholas Hendren, Anna Rosenblatt, Heather M. Alger, Christine Rutan, Wally Omar, Rohan Khera, Kamal Gupta, Purav Mody, Christopher DeFilippi, Sandeep R. Das, S. Susan Hedayati, James A. de Lemos
Summary: In patients hospitalized with COVID-19, acute kidney injury (AKI) is significantly associated with all-cause mortality and major adverse cardiac events, while chronic kidney disease (CKD) and end-stage kidney disease are not linked to these outcomes.
JOURNAL OF THE AMERICAN HEART ASSOCIATION
(2021)
Article
Environmental Sciences
Maricel Maffini, Birgit Geueke, Ksenia Groh, Bethanie Carney Almroth, Jane Muncke
Summary: The association between environmental chemical exposures and chronic diseases is concerning, and current reference doses based on male reproductive toxicity may not adequately protect against other health effects. Post-market exposures, epidemiological and clinical data should be systematically reviewed to ensure adequate health protection.
ENVIRONMENTAL HEALTH
(2021)
Review
Food Science & Technology
Birgit Geueke, Ksenia J. Groh, Maricel V. Maffini, Olwenn V. Martin, Justin M. Boucher, Yu-Ting Chiang, Frank Gwosdz, Phoenix Jieh, Christopher D. Kassotis, Paulina Lanska, John Peterson Myers, Alex Odermatt, Lindsey V. Parkinson, Verena N. Schreier, Vanessa Srebny, Lisa Zimmermann, Martin Scheringer, Jane Muncke
Summary: Food packaging plays a crucial role in today's globalized food system, but it can also contribute to the migration of hazardous chemicals into food. In order to assess the impact of food contact materials (FCMs) on human health, it is necessary to identify the chemicals they contain, known as food contact chemicals (FCCs). This study compiled a comprehensive database of migrating and extractable FCCs (FCCmigex) based on information from 1210 studies. The findings reveal that 2881 FCCs have been detected in six FCM groups, with 65% of these being previously unknown. Plastic, with 1975 detected FCCs, is the most extensively studied FCM. This knowledge expands our understanding of FCCs to 14,153 chemicals and can contribute to the development of non-hazardous FCMs, promoting safer food production and supporting a circular economy.
CRITICAL REVIEWS IN FOOD SCIENCE AND NUTRITION
(2023)
Review
Engineering, Environmental
Spyridoula Gerassimidou, Paulina Lanska, John N. Hahladakis, Elena Lovat, Silvia Vanzetto, Birgit Geueke, Ksenia J. Groh, Jane Muncke, Maricel Maffini, Olwenn V. Martin, Eleni Iacovidou
Summary: This study provides a systematic evidence map of the migration of chemicals from PET drink bottles into food, highlighting the challenges and influential factors. While recycling PET bottles is vital for reducing plastic pollution, safety and quality concerns may arise.
JOURNAL OF HAZARDOUS MATERIALS
(2022)
Article
Environmental Sciences
Melissa M. M. Melough, Maricel V. J. Maffini, Jennifer J. Otten, Sheela Sathyanarayana
Summary: This study found no significant association between recommended healthy diets and exposure to endocrine-disrupting chemicals (EDCs). However, certain healthy diets may increase EDC exposures and related adverse health outcomes, particularly in relation to thyroid hormones.
ENVIRONMENTAL RESEARCH
(2022)
Article
Environmental Sciences
Tracey J. Woodruff, Swati D. G. Rayasam, Daniel A. Axelrad, Patricia D. Koman, Nicholas Chartres, Deborah H. Bennett, Linda S. Birnbaum, Phil Brown, Courtney C. Carignan, Courtney Cooper, Carl F. Cranor, Miriam L. Diamond, Shari Franjevic, Eve C. Gartner, Dale Hattis, Russ Hauser, Wendy Heiger-Bernays, Rashmi Joglekar, Juleen Lam, Jonathan I. Levy, Patrick M. MacRoy, Maricel V. Maffini, Emily C. Marquez, Rachel Morello-Frosch, Keeve E. Nachman, Greylin H. Nielsen, Catherine Oksas, Dimitri Panagopoulos Abrahamsson, Heather B. Patisaul, Sharyle Patton, Joshua F. Robinson, Kathryn M. Rodgers, Mark S. Rossi, Ruthann A. Rudel, Jennifer B. Sass, Sheela Sathyanarayana, Ted Schettler, Rachel M. Shaffer, Bhavna Shamasunder, Peggy M. Shepard, Kristin Shrader-Frechette, Gina M. Solomon, Wilma A. Subra, Laura N. Vandenberg, Julia R. Varshavsky, Roberta F. White, Ken Zarker, Lauren Zeise
Summary: The manufacture and production of industrial chemicals continues to increase, leading to widespread population exposures and resultant health impacts. Low-wealth communities and communities of color often bear disproportionate burdens of exposure and impact. Multiple authoritative bodies and scientific consensus groups have called for actions to prevent harmful exposures via improved policy approaches. We developed consensus recommendations for health-protective, scientific approaches to reduce harmful chemical exposures, which can be applied to current US policies governing industrial chemicals and environmental pollutants.
ENVIRONMENTAL HEALTH
(2023)
Review
Environmental Sciences
Maricel V. Maffini, Swati D. G. Rayasam, Daniel A. Axelrad, Linda S. Birnbaum, Courtney Cooper, Shari Franjevic, Patrick M. MacRoy, Keeve E. Nachman, Heather B. Patisaul, Kathryn M. Rodgers, Mark S. Rossi, Ted Schettler, Gina M. Solomon, Tracey J. Woodruff
Summary: Chemical risk assessment and management can be made more efficient by grouping chemicals into categories or classes. This manuscript evaluates different approaches to grouping chemicals and proposes a decision tree approach based on the decision context and scientific considerations. The use of a class-based approach can result in a more efficient process to reduce exposure to hazardous chemicals and health risks.
ENVIRONMENTAL HEALTH
(2023)
Article
Food Science & Technology
Thomas R. Mallen, Kadijah D. Abston, Nathanial J. Parizek, Judith Negley, Kevin S. Shores, Ryan D. Canatsey, Sarah Dubail, Mark S. Maier, Maricel V. Maffini
Summary: Regulators have not provided official guidance or regulations for evaluating the safety of non-intentionally added substances (NIAS) in food packaging materials. In this study, we identified and characterized low molecular weight NIAS from an epoxy coating and conducted safety assessments. The results showed that exposure to the identified substances was minimal and that the coating's migration did not have genotoxic effects.
FOOD AND CHEMICAL TOXICOLOGY
(2023)
Review
Endocrinology & Metabolism
Carol Duh-Leong, Maricel V. Maffini, Christopher D. Kassotis, Laura N. Vandenberg, Leonardo Trasande
Summary: Endocrine-disrupting chemicals (EDCs) contribute to human disease, disability and economic damage. This Review outlines a set of evidence-based policy actions to manage, minimize or eliminate the use of EDCs, alongside a number of specific challenges and potential recommendations.
NATURE REVIEWS ENDOCRINOLOGY
(2023)
Article
Toxicology
Maricel V. Maffini, Laura N. Vandenberg
Summary: It has been 25 years since the Food Quality Protection Act was passed, mandating the US EPA to test pesticide chemicals used in food for endocrine disruption. However, the EPA has yet to fully implement the law and has not tested all pesticide chemicals for endocrine disruption, nor taken any regulatory actions.
FRONTIERS IN TOXICOLOGY
(2022)