Defining "High-In" Saturated Fat, Sugar, and Sodium to Help Inform Front-of-Pack Labeling Efforts for Packaged Foods and Beverages in the United States.

: To help consumers make healthier choices, the US Food and Drug Administration (FDA) has been charged with developing a front-of-package label (FOPL) to appear on US packaged foods and beverages. One option being explored is the use of "high-in" FOPLs for added sugar, sodium, and saturated fat using a threshold of ≥20% of the recommended daily value (%DV) per portion/serving size to define "high-in". While research has addressed what FOPL designs are most effective at visually communicating "high-in", less attention has been paid to the nutrient profile model (NPM) used to decide which products should receive these labels.

A policy approach to identifying food and beverage products that are ultra-processed and high in added salt, sugar and saturated fat in the United States: a cross-sectional analysis of packaged foods.

Background: Governments globally aim to reduce the intake of unhealthy foods. Many policies exist that aim to address foods high in saturated fat, salt and sugar (HFSS) but the identification of ultra-processed foods (UPF) have presented a greater challenge due to the lack of an appropriate policy definition. To support policymakers, we provide approaches that can support governments to identify both HFSS foods and UPFs.

Food Additives in Ultra-Processed Packaged Foods: An Examination of US Household Grocery Store Purchases.

Background: Food additives have been used mainly in the past century to perform specific functions in foods. Some types of food additives have been linked to adverse health outcomes, yet there is little research examining food additives in the US food supply.

Objective: To examine the proportion of products purchased by US households containing four common technical food additives using time-specific food composition data and examine whether purchases have changed over time.

Mitigating ipatasertib-induced glucose increase through dose and meal timing modifications.

Ipatasertib, an AKT inhibitor, in combination with prednisone and abiraterone, is under evaluation for the treatment of metastatic castration-resistant prostate cancer (mCRPC). Hyperglycemia is an on-target effect of ipatasertib. An open-label, single-arm, single-sequence, signal-seeking study (n = 25 mCRPC patients) was conducted to evaluate the glucose changes across four different treatment periods: ipatasertib alone, ipatasertib-prednisone combination, ipatasertib-prednisone-abiraterone combination (morning dose), and ipatasertib-prednisone-abiraterone combination (evening dose).

Do sugar warning labels influence parents' selection of a labeled snack for their children? A randomized trial in a virtual convenience store.

Despite growing evidence that warning labels reduce purchases of sugary drinks, less is known about warnings' impact on purchases of sugary snacks. This paper aimed to experimentally test whether a front-of-package label warning about high sugar content ("sugar warning label") would reduce parents' likelihood of selecting a labeled snack versus a non-labeled snack for their child in a food store setting. Participants (n = 2,219 parents of at least one child aged 1-5y) were recruited via an online panel and asked to complete a shopping task in a virtual convenience store.

Applying and comparing various nutrient profiling models against the packaged food supply in South Africa.

Objective: This study aimed to apply the newly developed Chile Adjusted Model (CAM) nutrient profiling model (NPM) to the food supply in South Africa (SA) and compare its performance against existing NPM as an indication of suitability for use to underpin food policies targeted at discouraging consumption of products high in nutrients associated with poor health.

Design: Cross-sectional analysis of the SA-packaged food supply comparing the CAM to three other NPM: SA Health and Nutrition Claims (SA HNC), Chilean Warning Octagon (CWO) 2019, and Pan-American Health Organisation (PAHO) NPM.

Setting: The SA-packaged food supply based on products stocked by supermarkets in Cape Town, SA.

Clinical Pharmacology Perspectives for Adoptive Cell Therapies in Oncology.

Adoptive cell therapies (ACTs) have shown transformative efficacy in oncology with five US Food and Drug Administration (FDA) approvals for chimeric antigen receptor (CAR) T-cell therapies in hematological malignancies, and promising activity for T cell receptor T-cell therapies in both liquid and solid tumors. Clinical pharmacology can play a pivotal role in optimizing ACTs, aided by modeling and simulation toolboxes and deep understanding of the underlying biological and immunological processes. Close collaboration and multilevel data integration across functions, including chemistry, manufacturing, and control, biomarkers, bioanalytical, and clinical science and safety teams will be critical to ACT development.

Whole Grain and Refined Grains: An Examination of US Household Grocery Store Purchases.

Background: The health benefits related to intake of whole grain foods are well established. Consumption of whole grains in the US population is low, and whole grain content can vary greatly depending upon the specific products that are purchased.

Objectives: To examine the proportion of products purchased by US households containing whole grain and refined grain ingredients using time-specific food composition data, and examine whether purchases differ between income, race or ethnicity, and household make-up.

The WHO South-East Asia Region Nutrient Profile Model Is Quite Appropriate for India: An Exploration of 31,516 Food Products.

The rapid rise in prevalence of overweight/obesity, as well as high prevalence of type 2 diabetes and other nutrition-related noncommunicable diseases, has led the Food Safety and Standards Authority of India (FSSAI) to propose a front-of-package labeling (FOPL) regulation. An effective FOPL system applies a nutrient profile model that identifies foods high in sugar, sodium, and saturated fat that would receive a warning label for consumers to effectively discern between more and less healthy foods. Previous Nutrition Alchemy data collected by the food industry ( = 1306 products) estimated that approximately 96% of foods in India would have at least one warning label based on the FSSAI proposed FOPL.

Types and Amounts of Nonnutritive Sweeteners Purchased by US Households: A Comparison of 2002 and 2018 Nielsen Homescan Purchases.

Background: Purchases of foods containing nonnutritive sweetener (NNS) alone or in combination with caloric sweeteners (CS) has increased in recent years in the United States. At the same time clinical evidence is emerging of different cardiometabolic effects of each NNS type.

Objective: To examine the prevalence and volume purchased of commonly consumed types of NNS in packaged food and beverage products comparing 2002 and 2018 using data from nationally representative samples of US households.

Applying Nutrient Profiling Systems to Packaged Foods and Drinks Sold in Jamaica.

The Pan American Health Organization (PAHO) and Chile stage III nutrient profiling systems (NPSs) were applied to packaged beverages/foods sold in Jamaica to: (a) identify products with excess nutrients of concern (NOC) under each NPS; (b) assess differences between these NPS, and (c) discuss the advantages and disadvantages of each NPS when applied to Jamaica's food supply. Data on 6261 branded multi-ingredient packaged products were collected from the city of Kingston in 2018; of these, 4739 products, comprised of 3423 foods (from 15 food groups) and 1316 beverages (from four beverage groups), provided sufficient information. Products containing excessive NOC under each NPS were identified and the proportions of categories with excess NOC were compared using correlation coefficients.

Tobacco Smoking, Substance Use, and Mental Health Symptoms in People with HIV in an Urban HIV Clinic.

The prevalence of tobacco smoking among people with HIV (PWH) ranges from 40% to 70%. Additionally, tobacco smoking is higher among low-income individuals, yet few studies have examined tobacco smoking in low socioeconomic status PWH. Using data from a cohort of PWH receiving care in an urban HIV clinic, we characterized factors associated with current and former smoking and with initiation/re-initiation and cessation of tobacco use.

Nutrition Quality of Packaged Foods in Bogotá, Colombia: A Comparison of Two Nutrient Profile Models.

Background: Front-of-package warning labels are an increasingly common policy and have been implemented to inform consumers of the nutritional quality of ultra-processed foods. This study examined the proportion of Colombian products that could be subjected to such regulations.

Methods: Two nutrition profile models were compared: the Pan American Health Organization (PAHO) model, and the nutrient profile established under the Chilean food labeling and advertising law (Chilean model).

Persistent disparities over time in the distribution of sugar-sweetened beverage intake among children in the United States.

Background: Recent research suggests that sugar-sweetened beverage (SSB) consumption has been declining among US children aged 2-18 y. However, most studies focused on changes in mean intake, ignore high SSB consumers and do not examine intake among vulnerable groups and, including adolescents, low-income households, and several racial/ethnic minorities.

Objective: The aim was to estimate usual SSB intake from NHANES surveys from 2003-2004 to 2013-2014 to examine shifts at both the median and 90th percentile among US children, evaluating the extent to which intake disparities in total SSBs and subtypes have persisted.

Nutritional Profile of Purchases by Store Type: Disparities by Income and Food Program Participation.

Introduction: Policymakers have focused on the food retail environment for improving the dietary quality for Supplemental Nutrition Assistance Program (SNAP) participants. Yet little is known about where SNAP households make food and beverage purchases or how purchases may vary by store type, SNAP participation, and income level. The objective of this study was to examine the association between SNAP-income status (participant, income-eligible non-participant, higher-income non-participant) and healthfulness of household purchases across store types.

Non-Nutritive Sweeteners in the Packaged Food Supply-An Assessment across 4 Countries.

Increased interest among consumers in the reduction of dietary sugar intake has led to the wider availability of food products containing non-nutritive sweeteners (NNS). However, the extent to which NNS are currently being used by manufacturers to sweeten processed food and beverage products, and how NNS may be displacing added sugars as a sweetener is unknown. The current study utilized branded food composition databases from Australia, Mexico, New Zealand and the US to determine the percentage of processed food and beverage products for which there are nutrition data containing NNS and to compare total sugar density (g per 100 mL for beverages and g per 100 g for foods) between products with and without NNS.

Federal Nutrition Program Revisions Impact Low-income Households' Food Purchases.

Introduction: The Special Supplemental Nutrition Program for Women, Infants and Children (WIC) required major revisions to food packages in 2009; effects on nationwide low-income household purchases remain unexamined.

Methods: This study examines associations between WIC revisions and nutritional profiles of packaged food purchases from 2008 to 2014 among 4,537 low-income households with preschoolers in the U.S.

Development of a food composition database to monitor changes in packaged foods and beverages.

In order to monitor nutritional changes in the US food supply and assess potential impact on individual dietary intake, an approach was developed to enhance existing standard food composition tables with time-varying product- and brand-specific information for barcoded packaged foods. A "Crosswalk" was formed between barcoded products and USDA foodcodes in a time-specific manner, such that sales-weighted average nutritional profiles were generated for each foodcode based on corresponding products (275,000 to 350,000 per 2-year cycle). This Crosswalk-enhanced food composition table was applied to dietary intake data from the National Health and Nutrition Examination Survey (cycles 2007-2008, 2009-2010, and 2011-2012).

Assessment of cabozantinib treatment on QT interval in a phase 3 study in medullary thyroid cancer: evaluation of indirect QT effects mediated through treatment-induced changes in serum electrolytes.

Purpose: This study evaluated factors impacting QTc interval in a phase 3 trial of cabozantinib in progressive, metastatic, medullary thyroid cancer (MTC).

Methods: Electrocardiogram (12-lead ECG) measurements were obtained at screening, and at pre-dose, and 2, 4, and 6 h post-dose on Days 1 and 29 in a phase 3 study in patients with MTC treated with cabozantinib (140 mg/day). Central tendency analyses were conducted on baseline-corrected QTc values.