Adoption of the voluntary conflict of interest statement on PubMed.

In 2017, the National Library of Medicine (NLM) added a voluntary field for conflict of interest (COI) statements ("posted COI") on the abstract page of PubMed, but the extent to which it is used is unknown. This repeated cross-sectional study examined journals and articles indexed on PubMed from 2016 through 2021. We described the proportion of all journals with at least one article that included a posted COI and the percentage of all articles that included a posted COI over time.

Restructuring the FDA's Food Program: Promises and Pitfalls.

Following an outbreak of Cronobacter sakazakii infection in infant formula, the US Food and Drug Administration commissioned a series of reports and then undertook a major reorganization of its food program. This article describes the changes that went into effect on 1 October 2024, why those changes are likely to improve the new Human Foods Program, and additional work that must be undertaken to enhance the agency's impact upon public health.

Personalized nutrition: aligning science, regulation, and marketing.

Interest in personalized nutrition among researchers and industry has grown rapidly in recent years and shows no signs of abating. In this paper, we discuss the growth of the personalized nutrition market, the evidence for the approach, and the regulatory landscape for personalized nutrition products. We found that regulatory gaps have led to market growth of products with unknown efficacy that are making bold, and possibly unsubstantiated, claims.

How Salty Is Too Salty? Designing Sodium Warning Label Policies to Identify High-Sodium Items on Restaurant Menus in the United States.

Two U.S. cities require chain restaurants to label menu items that exceed 100% of the Daily Value (DV) for sodium, informing consumers and potentially prompting restaurant reformulation.

Competitive Foods' Nutritional Quality and Compliance with Smart Snacks Standards: An Analysis of a National Sample of U.S. Middle and High Schools.

Snacks and beverages are often sold in addition to meals in U.S. schools ("competitive foods"), but their current nutritional quality and compliance with national Smart Snacks standards are unknown.

Effects of in-store marketing on food and beverage purchases: a longitudinal study of households with children.

Objective: Most food retailers display foods in prominent locations as a marketing strategy (i.e. 'placement promotions').

Evaluation of health and economic effects of United States school meal standards consistent with the 2020-2025 dietary guidelines for Americans.

Background: The current school meal nutrition standards, established in 2010, are not fully aligned with the 2020-2025 Dietary Guideline for Americans (DGA). This study evaluates the potential short-term and long-term health and economic benefits of strengthening the school meal standards on added sugars, sodium, and whole grains to be aligned with current guidelines.

Methods: We used comparative risk assessment frameworks based on nationally representative data incorporating current demographics, dietary habits, and risk factors of United States children aged 5-18 y from 3 cycles of the National Health and Nutrition Examination Survey (2013-2018).

In-Store Marketing and Supermarket Purchases: Associations Overall and by Transaction SNAP Status.

Introduction: In-store placement promotions are used widely in supermarkets, but their effects on customer purchases remain largely unknown. This study examined associations of supermarket placement promotions with customer purchases overall and by Supplemental Nutrition Assistance Program (SNAP) benefit use.

Methods: Data on in-store promotions (e.

Spurious early ecological association suggesting BCG vaccination effectiveness for COVID-19.

Background: Several ecologic studies have suggested that the bacillus Calmette-Guérin (BCG) vaccine may be protective against SARS-CoV-2 infection including a highly-cited published pre-print by Miller et al., finding that middle/high- and high-income countries that never had a universal BCG policy experienced higher COVID-19 burden compared to countries that currently have universal BCG vaccination policies. We provide a case study of the limitations of ecologic analyses by evaluating whether these early ecologic findings persisted as the pandemic progressed.

COVID-19 vaccine misinformation in English-language news media: retrospective cohort study.

Objectives: To describe COVID-19 vaccine misinformation and track trends over time in traditional news media.

Design: Retrospective cohort study of a large database of online articles, July 2020-June 2021.

Setting: English-language articles from 100 news outlets with the greatest reach.

Agreement of treatment effects from observational studies and randomized controlled trials evaluating hydroxychloroquine, lopinavir-ritonavir, or dexamethasone for covid-19: meta-epidemiological study.

Objective: To systematically identify, match, and compare treatment effects and study demographics from individual or meta-analysed observational studies and randomized controlled trials (RCTs) evaluating the same covid-19 treatments, comparators, and outcomes.

Design: Meta-epidemiological study.

Data Sources: National Institutes of Health Covid-19 Treatment Guidelines, a living review and network meta-analysis published in , a living systematic review with meta-analysis and trial sequential analysis in (The LIVING Project), and the Epistemonikos "Living OVerview of Evidence" (L·OVE) evidence database.

Adverse events and labeling issues related to suspected sesame allergy reported in an online survey.

Background: Allergen avoidance is critical for those with immunoglobulin E-mediated food allergy, but can only be successful with accurate product information. Although the Food and Drug Administration maintains the Center for Food Safety and Nutrition Adverse Event Reporting System to collect adverse event (AE) reports related to foods, there is substantial underreporting, and information regarding product labeling issues is limited.

Objective: The purpose of this study was to describe allergic reactions associated with accidental oral exposure to sesame and the role of product labeling.

Trials for second generation Covid-19 vaccines: Revisiting the debate over placebo use in developing country clinical trials.

This article compares the current debate over the use of placebos in developing country clinical trials of second generation Covid-19 vaccines with the debates over previous paradigmatic cases raising similar issues. Compared to the earlier zidovudine and Surfaxin trials, Covid-19 vaccine trials are likely to confer lower risk to placebo groups and to offer a greater number and variety of alternative study designs. However, turning to the developing world to conduct studies that would be unacceptable in developed countries, simply on the ground that Covid-19 vaccines are generally unavailable in developing countries, is not ethically justifiable.

Opioid exposure associated with poppy consumption reported to poison control centers and the U.S. Food and Drug Administration.

Objective: To assess characteristics of exposures to contaminated poppy and identify trends in exposure and poppy-related deaths.

Methods: Cross-sectional analysis of adverse events associated with exposure to poppy products (primarily poppy seeds) from the American Association of Poison Control Centers' National Poison Data System (NPDS), 2000-2018, supplemented with analysis of overdoses and deaths related to poppy from the U.S.

Key Evidence Supporting Prescription Opioids Approved by the U.S. Food and Drug Administration, 1997 to 2018.

Background: Little is known about the evidence required by the U.S. Food and Drug Administration (FDA) for new approvals of opioid analgesics.

Evaluation of the Extended-Release/Long-Acting Opioid Prescribing Risk Evaluation and Mitigation Strategy Program by the US Food and Drug Administration: A Review.

Importance: Extended-release/long-acting (ER/LA) opioids have caused substantial morbidity and mortality in the United States, yet little is known about the efforts of the US Food and Drug Administration (FDA) and drug manufacturers to reduce adverse outcomes associated with inappropriate prescribing or use. This review of 9739 pages of FDA documents obtained through a Freedom of Information Act request aimed to investigate whether the FDA and ER/LA manufacturers were able to assess the effectiveness of the ER/LA Risk Evaluation and Mitigation Strategy (REMS) program by evaluating manufacturer REMS assessments and FDA oversight of these assessments.

Observations: The REMS program was implemented largely as planned.

Systematic overview of Freedom of Information Act requests to the Department of Health and Human Services from 2008 to 2017.

Background: The Freedom of Information Act (FOIA) provides access to unreleased government records that can be used to enhance the transparency and integrity of biomedical research. We characterized FOIA requests to Department of Health and Human Services (HHS) agencies, including request outcomes, processing times, backlogs, and costs.

Methods: Using HHS FOIA annual reports, we extracted data on the number of FOIA requests received and processed by HHS agencies between 2008 and 2017, as well as request outcomes.

Caffeinated energy drinks: adverse event reports to the US Food and Drug Administration and the National Poison Data System, 2008 to 2015.

Objective: To describe and compare caffeinated energy drink adverse event (AE) report/exposure call data from the US Food and Drug Administration Center for Food Safety and Applied Nutrition's Adverse Event Reporting System (CAERS) and the American Association of Poison Control Centers' National Poison Data System (NPDS).

Design: Cross-sectional.

Setting: Data were evaluated from US-based CAERS reports and NPDS exposure calls, including report/exposure call year, age, sex, location, single v.

Public Disclosure of the Filing of New Drug and Therapeutic Biologics Applications With the US Food and Drug Administration.

This cross-sectional study reviews New Drug Applications for new molecular entities and Biologics License Applications for new and biosimilar biological products submitted to the US Food and Drug Administration to assess how frequently applicants disclose applications in the media.

Assessment of the FDA Risk Evaluation and Mitigation Strategy for Transmucosal Immediate-Release Fentanyl Products.

Importance: Transmucosal immediate-release fentanyls (TIRFs), indicated solely for breakthrough cancer pain in opioid-tolerant patients, are subject to a US Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS) to prevent them from being prescribed inappropriately.

Objectives: To evaluate knowledge assessments of pharmacists, prescribers, and patients regarding appropriate TIRF use; to describe sponsor assessments, based on claims data, of whether the REMS program was meeting its goals; and to characterize how the FDA responded to REMS assessments.

Design, Setting, And Participants: Qualitative analysis of 4877 pages of FDA documents obtained through a Freedom of Information Act request, including 6 annual REMS assessment reports (2012-2017), FDA evaluations of these reports, and FDA-sponsor correspondence about safety issues.

Impact of the US Food and Drug Administration registration of antiretroviral drugs on global access to HIV treatment.

Background: Since 2004, the US Food and Drug Administration's (USFDA) dedicated drug review process in support of President's Emergency Plan for AIDS Relief (PEPFAR) has made safe, effective and quality antiretrovirals (ARVs) available for millions of patients. Furthermore, the WHO and Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) can add the USFDA-reviewed products to their respective formularies, through a novel process of 'one-way reliance'. We assessed the number of ARVs made available through WHO and Global Fund based on the USFDA review.