A regulatory relic: After 60 years of research on cancer risk, the Delaney Clause continues to keep us in the past.

The Delaney Clause of the Federal Food, Drug, and Cosmetic Act became law in 1958 because of concerns that potentially harmful chemicals were finding their way into foods and causing cancer. It states, "[n]o additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal." The United States Food and Drug Administration (US FDA) and United States Environmental Protection Agency (US EPA, prior to implementation of the Food Quality Protection Act) were charged with implementing this clause. Over 60 years, advances in cancer research have elucidated how chemicals induce cancer. Significant advancements in analytical methodologies have allowed for accurate and progressively lower detection limits, resulting in detection of trace amounts. Based on current scientific knowledge, there is a need to revisit the Delaney Clause's utility. The lack of scientific merit to the Delaney Clause was very apparent when recently the US FDA had to revoke the food additive approvals of 6 synthetic flavoring substances because high dose testing in animals demonstrated a carcinogenic response. However, US FDA determined that these 6 synthetic flavoring substances do not pose a risk to public health under the conditions of intended use. The 7th substance, styrene, was de-listed because it is no longer used by industry. The scientific community is committed to improving public health by promoting relevant science in risk assessment and regulatory decision making, and this was discussed in scientific sessions at the American Association for the Advancement of Science (AAAS) 2020 Annual Meeting and the Society of Toxicology (SOT) 2019 Annual Meeting. Expert presentations included advances in cancer research since the 1950s; the role of the Delaney Clause in the current regulatory paradigm with a focus on synthetic food additives; and the impact of the clause on scientific advances and regulatory decision making. The sessions concluded with panel discussions on making the clause more relevant based on 21st-century science.

The current understanding of the benefits, safety, and regulation of cannabidiol in consumer products.

The popularity of cannabidiol (CBD) in consumer products is soaring as consumers are using CBD for general health and well-being as well as to seek relief from ailments especially pain, inflammation, anxiety, depression, and sleep disorders. However, there are limited data currently in the public domain that provide support for these benefits. By contrast, a significant amount of safety evaluation data for CBD have been obtained recently from pre-clinical and clinical studies of the CBD therapeutic Epidiolex®. Yet some key data gaps concerning the safe use of CBD still remain. Furthermore, current regulations on CBD use in consumer products remain uncertain and often conflict between the state and federal level. In light of the rapidly expanding popularity of CBD-related products in the marketplace, here we review the current understanding of the benefits, safety, and regulations surrounding CBD in consumer products. This review does not advocate for or against the use of CBD in consumer products. Rather this review seeks to assess the state-of-the-science on the health effects and safety of CBD, to identify critical knowledge gaps for future studies, and to raise the awareness of the current regulations that govern CBD use in consumer products.

Fresh Mushroom Preservation Techniques.

The production and consumption of fresh mushrooms has experienced a significant increase in recent decades. This trend has been driven mainly by their nutritional value and by the presence of bioactive and nutraceutical components that are associated with health benefits, which has led some to consider them a functional food. Mushrooms represent an attractive food for vegetarian and vegan consumers due to their high contents of high-biological-value proteins and vitamin D. However, due to their high respiratory rate, high water content, and lack of a cuticular structure, mushrooms rapidly lose quality and have a short shelf life after harvest, which limits their commercialization in the fresh state. Several traditional preservation methods are used to maintain their quality and extend their shelf life. This article reviews some preservation methods that are commonly used to preserve fresh mushrooms and promising new preservation techniques, highlighting the use of new packaging systems and regulations aimed at the development of more sustainable packaging.

Effect of Cross-Linked Alginate/Oil Nanoemulsion Coating on Cracking and Quality Parameters of Sweet Cherries.

The cracking of sweet cherries causes significant crop losses. Sweet cherries (cv. Bing) were coated by electro-spraying with an edible nanoemulsion (NE) of alginate and soybean oil with or without a CaCl2 cross-linker to reduce cracking. Coated sweet cherries were stored at 4 °C for 28 d. The barrier and fruit quality properties and nutritional values of the coated cherries were evaluated and compared with those of uncoated sweet cherries. Sweet cherries coated with NE + CaCl2 increased cracking tolerance by 53% and increased firmness. However, coated sweet cherries exhibited a 10% increase in water loss after 28 d due to decreased resistance to water vapor transfer. Coated sweet cherries showed a higher soluble solid content, titratable acidity, antioxidant capacity, and total soluble phenolic content compared with uncoated sweet cherries. Therefore, the use of the NE + CaCl2 coating on sweet cherries can help reduce cracking and maintain their postharvest quality.

Functional properties of Lactobacillus casei C24 improved by microencapsulation using multilayer double emulsion.

To provide their health effect, probiotics need to maintain their viability, adhere to the intestinal epithelium, and colonize it without losing their probiotic properties. In the present study, Lactobacillus casei was encapsulated in a double emulsion and then coated with alginate and chitosan using the layer-by-layer electrostatic deposition technique. The survival rate and functional properties of L. casei (cholesterol assimilation, surface hydrophobicity, auto-aggregation, and co-aggregation) were evaluated after the freeze-drying process and during the transit through the simulated gastrointestinal tract. Reservoir type multilayer microcapsules with a small particle size (6.2-12.2 µm) were obtained. Freeze-dried microcapsules maintained the initial cell count (9.4 log UFC/g) without affecting its functional properties. The resistance of L. casei cells to the conditions of salivary, gastric, and intestinal digestion was noticeably improved when increasing the number of layers in the microcapsules, especially when they were coated with alginate and chitosan. The alginate-chitosan layers provided additional protection to L. casei cell membranes, substantially preserving the cholesterol assimilation ability, surface hydrophobicity, auto-aggregation, and co-aggregation of L. casei after simulated in vitro digestion. This encapsulation method not only guarantees the presence of the probiotic in the gastrointestinal tract, but it does not lose its probiotic properties and ensures that it exerts its probiotic effect.

Effect of Homogenization Method and Carvacrol Content on Microstructural and Physical Properties of Chitosan-Based Films.

The use of EOs nanoemulsion to develop active edible films offers a new way to modify transport properties and to release active compounds while improving mechanical resistance, transparency, and antioxidant and antimicrobial activity. The aim of this study was to study the influence of homogenization conditions and carvacrol content on the microstructure and physical properties of edible nanoemulsified chitosan films. Film-forming emulsions (FFE) were prepared with chitosan (1.5%), Tween 80 (0.5%), and carvacrol (0.25%, 0.5%, and 1.0%); two homogenization methods were used (rotor-stator and rotor-stator followed by high-pressure homogenization). Film internal and surface microstructure was characterized by scanning electron microscopy (SEM) and film physical properties, such as mechanical, optical, and water barrier, were evaluated. Results showed that the high-pressure homogenization method promoted a significant change on film microstructure, leading to improved properties. Carvacrol droplets were smaller and homogeneously distributed in the film when 0.5% (v/v) carvacrol was incorporated (1:1 Tween 80: carvacrol ratio). As a consequence, emulsified films obtained at high pressure were less opaque, had greater elongation, and had a lower permeability to water vapor than those obtained by the rotor-stator method. Therefore, high-pressure homogenization is a good method to obtain edible emulsified films with desirable properties for food preservation.

Perspective: Guiding Principles for the Implementation of Personalized Nutrition Approaches That Benefit Health and Function.

Personalized nutrition (PN) approaches have been shown to help drive behavior change and positively influence health outcomes. This has led to an increase in the development of commercially available PN programs, which utilize various forms of individual-level information to provide services and products for consumers. The lack of a well-accepted definition of PN or an established set of guiding principles for the implementation of PN creates barriers for establishing credibility and efficacy. To address these points, the North American Branch of the International Life Sciences Institute convened a multidisciplinary panel. In this article, a definition for PN is proposed: "Personalized nutrition uses individual-specific information, founded in evidence-based science, to promote dietary behavior change that may result in measurable health benefits." In addition, 10 guiding principles for PN approaches are proposed: 1) define potential users and beneficiaries; 2) use validated diagnostic methods and measures; 3) maintain data quality and relevance; 4) derive data-driven recommendations from validated models and algorithms; 5) design PN studies around validated individual health or function needs and outcomes; 6) provide rigorous scientific evidence for an effect on health or function; 7) deliver user-friendly tools; 8) for healthy individuals, align with population-based recommendations; 9) communicate transparently about potential effects; and 10) protect individual data privacy and act responsibly. These principles are intended to establish a basis for responsible approaches to the evidence-based research and practice of PN and serve as an invitation for further public dialog. Several challenges were identified for PN to continue gaining acceptance, including defining the health-disease continuum, identification of biomarkers, changing regulatory landscapes, accessibility, and measuring success. Although PN approaches hold promise for public health in the future, further research is needed on the accuracy of dietary intake measurement, utilization and standardization of systems approaches, and application and communication of evidence.

Haralick textural features on T2 -weighted MRI are associated with biochemical recurrence following radiotherapy for peripheral zone prostate cancer.

PURPOSE: To explore the association between magnetic resonance imaging (MRI), including Haralick textural features, and biochemical recurrence following prostate cancer radiotherapy. MATERIALS AND METHODS: In all, 74 patients with peripheral zone localized prostate adenocarcinoma underwent pretreatment 3.0T MRI before external beam radiotherapy. Median follow-up of 47 months revealed 11 patients with biochemical recurrence. Prostate tumors were segmented on T2 -weighted sequences (T2 -w) and contours were propagated onto the coregistered apparent diffusion coefficient (ADC) images. We extracted 140 image features from normalized T2 -w and ADC images corresponding to first-order (n = 6), gradient-based (n = 4), and second-order Haralick textural features (n = 130). Four geometrical features (tumor diameter, perimeter, area, and volume) were also computed. Correlations between Gleason score and MRI features were assessed. Cox regression analysis and random survival forests (RSF) were performed to assess the association between MRI features and biochemical recurrence. RESULTS: Three T2 -w and one ADC Haralick textural features were significantly correlated with Gleason score (P < 0.05). Twenty-eight T2 -w Haralick features and all four geometrical features were significantly associated with biochemical recurrence (P < 0.05). The most relevant features were Haralick features T2 -w contrast, T2 -w difference variance, ADC median, along with tumor volume and tumor area (C-index from 0.76 to 0.82; P < 0.05). By combining these most powerful features in an RSF model, the obtained C-index was 0.90. CONCLUSION: T2 -w Haralick features appear to be strongly associated with biochemical recurrence following prostate cancer radiotherapy. LEVEL OF EVIDENCE: 3 J. Magn. Reson. Imaging 2017;45:103-117.

Tumor de células granulares del esófago: reporte de un caso / Esophageal granular cell tumor: Case report

Introducción: el tumor de células granulares del esófago (TCG) es una neoplasia rara y su diagnóstico preciso se basa en el examen histopatológico. Con el incremento de la endoscopia como medida de tamizaje se ha visto un leve aumento en la incidencia, por lo que debe tenerse en cuenta como diagnóstico diferencial en el momento de abordar una lesión subepitelial. Metodología: presentación de un caso clínico con TCG cuya endoscopia de vías digestivas altas (EVDA) muestra una lesión subepitelial en el tercio distal del esófago, y que debido a las características histopatológicas, clínicas y ecosonográficas se decide seguimiento y manejo expectante. Conclusiones: es importante el conocimiento de las características, comportamientos y estrategias de manejo del TCG, puesmuchos son asintomáticos y estables en el seguimiento, por lo que no necesitan tratamientos agresivos. Por el riesgo de malignidad, es importante su control riguroso.

Introduction: Esophageal granular cell tumors (GCTs) are rare. Their precise diagnosis is based on histopathological examination of the specimen. However, owing to the use of endoscopy as a screening tool the incidence of these lesions has presently mildly increased and must be considered as a differential diagnosis of subepithelial lesions. Methodology: A case is presented of a GCT as a subepithelial lesion in the distal part of the esophagus found by esophagogastroduodenoscopy (EGD). Conservative management and follow-up was decided due to the histopathological, clinical and ultrasound features of the lesion. Conclusions: Knowledge regarding GCTs´i characteristics, behavior and management is important for many are asymptomatic and remain clinically stable during follow-up, requiring no aggressive treatment. A rigorous follow-up is recommended due to its malignant potential.

Hallazgos en la retina de pacientes con VIH - Sida en el Hospital de San José. Serie de casos / Retinal findings in HIV-AIDS patients at Hospital San José. Case series

En los Estados Unidos se infectan aproximadamente 50000 personas con el VIH cada año. En Colombia desde 1985 se ha reportado 95187 personas portadoras del VIH. Un alto porcentaje de los pacientes con VIH-SIDA (entre el 50% y el 70%) desarrollan manifestaciones oftalmológicas, siendo la retina el tejido ocular más frecuentemente comprometido, presentando principalmente retinitis por Citomegalovirus (CMV) y microvasculopatía retiniana.

In the United States approximately 50,000 people become infected with HIV each year. In Colombia since 1985 has reported 95187 people carrying HIV. A high percentage of patients with HIV-AIDS (between 50% and 70%) develop ophthalmic manifestations, being the more frequently aff ected ocular tissue the retina, it is commonly affected mainly by the presence of cytomegalovirus retinitis (CMV) and HIV microangiopathy.

Cirugía de pterigio. Hospital de San José de Bogotá D.C / Pterygium surgery at Hospital San José Bogotá DC

El pterigio, degeneración corneana no involutiva, es una alteración inflamatoria y proliferativa de la superficie ocular con engrosamiento y degeneración elastótica de la conjuntiva. La exposición a radiación solar ultravioleta, calor, polvo y agentes virales participan en su evolución. Objetivo: describir los resultados de cirugía de pterigio en el Hospital de San José de Bogotá DC. Método: serie de casos de todos los pacientes con este diagnóstico operados entre enero 2010 y diciembre 2011. Resultados: se revisaron 176 historias y se incluyeron 113 ojos. Las complicaciones más frecuentes fueron dellen corneano 7,9%, reproducción 5% y retracción de plastia 3,5%, identificadas en los primeros tres meses posoperatorios. La frecuencia de reproducción fue mayor en los casos de pterigio reproducido (33%), en comparación con el primario 4,4%. Conclusión: a pesar de los efectos secundarios conocidos de la mitomicina, quienes la usaron en el posoperatorio en dosis bajas no presentaron efectos adversos y su uso fue seguro. Dado el bajo porcentaje de reproducción en este estudio, se recomienda que en la resección de pterigios extensos o reproducidos, sea considerado el uso de membrana amniótica...

AbstractPterygium refers to a corneal degeneration not capable of involution constituting an inflammatory and proliferative alteration of the ocular surface characterized by elastotic growth and degeneration of the conjunctiva. It is associated with and thought to be caused by, ultraviolet-light exposure, heat, dust and viral agents. Objective: to describe pterygium removal surgery results obtained at Hospital de San José, Bogotá DC. Method: case series of all patients with this diagnosis operated between January 2010 and December 2011. Results: we reviewed 176 clinical records and included 113 eyes. Most frequent complications were corneal dellen 7.9%, recurrence 5% and plasty retraction 3.5%, identified in the first three months after the surgery. They were more usual in the cases of reproduced pterygium (33%), compared with primary pterygium 4.4%. Conclusion: despite the known side effects of mitomycin patients who received low-dose mitomycin after surgery did not experience adverse effects and its use was safe. Due to the low percent of recurrence found in this study, the use of amniotic membrane is recommended for extensive pterygium removal and for regrown pterygium excision...

Factores asociados a mortalidad en pacientes con falla cardiaca descompensada / Factors associated with mortality in patients with decompensated heart failure

Introducción: la falla cardiaca (FC) es una de las principales causas de morbimortalidad a nivel mundial, la cual ha experimentado aumento gradual de su incidencia sin variación importante en su desenlace en las dos últimas décadas. En Colombia muy pocos estudios evalúan factores asociados a mortalidad por falla cardiaca. Métodos: estudio de cohorte prospectivo en el que se incluyeron pacientes con diagnóstico de falla cardiaca descompensada al momento del ingreso a urgencias, entre febrero de 2010 y marzo de 2013. Se calculó el tamaño de muestra y se realizó un análisis multivariado para la evaluación de los factores de riesgo asociados a mortalidad intrahospitalaria y a 30 días. Resultados: se incluyeron 462 pacientes. La mortalidad hospitalaria fue de 8.9% y a 30 días de 13.8%, en el modelo multivariado para el desenlace mortalidad intrahospitalaria se observó que la única variable con significancia estadística fue el BUN ≥43 mg/dL (OR, 3.45 [IC 95% 1.54-7.74], p= 0.003). Para la mortalidad a 30 días, la estancia hospitalaria >5 días (OR, 2.23 [IC 95% 1.20-4.12], p= 0.011), el BUN ≥43 mg/dL (OR, 2.55 [IC 95% 1.31-4.94], p= 0.005) y el NT-proBNP ≥ 4630 pg/dL (OR, 2.47 [IC 95% 1.30-4.70], p= 0.006). Conclusiones: la mortalidad intrahospitalaria de los pacientes con falla cardiaca descompensada en la población evaluada fue alta. En los análisis multivariados, se encontró que el BUN ≥ 43 mg/dL fue el único factor de riesgo independiente asociado a mortalidad intrahospitalaria; mientras que la mortalidad a 30 días se relacionó además con el NT-proBNP y la estancia hospitalaria superior a cinco días.

Introduction: heart failure is one of the main causes of morbidity and mortality worldwide; it has experienced a gradual increase in incidence with no significant variation in outcome in the last two decades. In Colombia there are no studies to evaluate risk factors for mortality, which is the subject of this study. Methods: prospective cohort study in which patients with diagnosis of decompensated heart failure on admission to the emergency department between February 2010 and March 2013 were included. The sample size was calculated and a multivariate analysis was performed to evaluate the risk factors associated with in-hospital and 30-day mortality. Results: 462 patients were included. Hospital mortality was 8.9% and 30-day mortality 13.8%; in the multivariate model for hospital mortality outcome was observed that the only variable with statistic significance was BUN ≥ 43 mg/dL (OR, 3.45 [95% CI 1.54- 7.74], p = 0.003). For 30 day mortality, hospital stay > 5 days (OR, 2.23 [95% CI 1.20-4.12], p = 0.011), BUN ≥43 mg/dL (OR, 2.55 [95% CI 1.31-4.94] , p = 0.005) and NT-proBNP ≥ 4630 pg/dL (OR, 2.47 [95% CI 1.30-4.70], p = 0.006). Conclusions: in-hospital mortality in patients with decompensated heart failure in the study population was high. In multivariate analysis, it was found that BUN ≥ 43 mg/dL was the only independent risk factor associated with hospital mortality, while the 30-day mortality was also associated with NT-proBNP and hospital stay greater than five days.

Effects of high hydrostatic pressure (HHP) on the protein structure and thermal stability of Sauvignon blanc wine.

Protein haze development in bottled white wines is attributed to the slow denaturation of unstable proteins, which results in their aggregation and flocculation. These protein fractions can be removed by using bentonite; however, a disadvantage of this technique is its cost. The effects of high hydrostatic pressure (HHP) on wine stability were studied. Fourier transform infrared spectroscopy experiments were performed to analyse the secondary structure of protein, thermal stability was evaluated with differential scanning calorimetry, while a heat test was performed to determine wine protein thermal stability. The results confirmed that high pressure treatments modified the α-helical and ß-sheet structures of wine proteins. Throughout the 60 days storage period the α-helix structure in HHP samples decreased. Structural changes by HHP (450 MPa for 3 and 5 min) improve thermal stability of wine proteins and thus delay haze formation in wine during storage.

Injerto-parche de esclera en perforación corneana secundaria a queratitis periférica ulcerativa / Scleral graft patch in corneal perforation due to peripheral ulcerative keratitis

Objetivo: reportar un caso de perforación corneana manejado con injerto-parche de esclera. Diseño: reporte de caso. Discusión: las perforaciones corneanas requieren tratamiento quirúrgico urgente para reducir las complicaciones. Contamos con varias opciones de acuerdo al tamaño de la perforación incluyendo adhesivo tisular, transplante de membrana amniótica y queratoplastia penetrante. El injerto-parche de esclera es otra alternativa útil para el tratamiento de esta condición. Conclusiones: describimos el caso de una perforación corneana secundaria a queratitis ulcerativa periférica (QPU) asociada a Síndrome de Sjögren que fue manejada con un aloinjerto de esclera.

Objective: to report a case in which scleral patch graft was used to treat a corneal perforation. Design: case report. Discussion: corneal perforations require urgent management to reduce subsequent ocular morbidity. Depending on its size and location, treatment options include corneal gluing, amniotic membrane transplantation and corneal transplantation. Scleral patch grafting is another feasible alternative for treating this condition.Conclusions: We described a case of scleral allograft use in the management of corneal perforation due to peripheral ulcerative keratitis associated with Sjögren's syndrome.

Drugs and other product choices.

Dermatologists have at their disposal a wide range of products to recommend or prescribe to their patients, all of which are regulated in some way by the Food and Drug Administration (FDA). However, the degree to which FDA has confirmed the safety and efficacy of a dermatological product can vary widely. Most prescription and some over-the-counter drugs and medical devices are approved by the FDA based on scientific data. Most over-the-counter drugs are marketed in compliance with FDA regulations based on expert medical review. The FDA clears most medical devices based on their substantial equivalence to other legally marketed devices. Cosmetics, medical foods, and dietary supplements are subject only to general postmarket prohibitions against adulterated and misbranded products, although the FDA may review ingredient safety and specific claims for dietary supplements. Some product information is available on FDA's Web site, but the prudent physician should supplement that information by reviewing available scientific literature.