An investigation of the genotoxic potential of a well-characterized yerba mate extract.

Yerba Mate () is historically used as a beverage and its extracts are considered traditional medicine in South America. Extract use has been expanding to North American and European markets and the currently available genetic toxicology literature indicate discrepancies in genotoxicity findings for yerba mate. As botanical extract use expands, assumption in safety should be made with caution assuring a good understanding of the test material characterization.

Assessment of the in vivo genotoxic potential of three smoke flavoring primary product mixtures.

Smoke flavorings are mixtures generated from wood pyrolysis that are filtered to remove tar and are often considered healthier alternatives to conventional smoking processes. While the latter is mostly unregulated, smoke-flavoring primary products (SFPPs) are undergoing the 10-year required re-evaluation in the European Union (EU). To comply with recent smoke flavor guidance, in vivo micronucleus studies in rats and transgenic rodent (TGR) mutation assays in Muta™Mice were conducted on three SFPPs.

Cannabidiol safety considerations: Development of a potential acceptable daily intake value and recommended upper intake limits for dietary supplement use.

Consumer use of hemp-derived products continues to rise, underscoring the need to establish evidence-based safety guidance. The present study sought to develop recommendations for oral upper intake limits of cannabidiol (CBD) isolate. Sufficiently robust and reliable data for this purpose were identified from published human clinical trials and guideline-compliant toxicity studies in animal models.

Benefit-risk of coffee consumption and all-cause mortality: A systematic review and disability adjusted life year analysis.

Background: Recommendations and guidance from scientific bodies do not provide clear messages about potential health risks or benefits of coffee consumption. Numerous studies have demonstrated inverse (beneficial) effects of coffee consumption for many adverse outcomes such as cancer and cardiovascular disease; fewer studies demonstrate risks. However, the risk-benefit relationship has not yet been fully assessed using quantitative metrics preferred by policy makers (disability-adjusted life years [DALYs]).

Impact of calcium nitrate supplementation on the oxygen-carrying capacity of lactating sows and their offspring.

Calcium nitrate supplementation has recently been suggested to provide potential benefits to sows and, in particular, their offspring when administered at a level of 1,200 ppm in feed shortly before farrowing through lactation. More specifically, nitrate supplementation has been suggested as one opportunity for improved placental and/or fetal blood flow and has been hypothesized in previous work to be important to the swine industry in light of the global trend toward larger litter sizes. The benefit is likely manifested through exposure to the nitrate moiety, but interestingly, nitrate has historically been considered a compound of concern for swine.

Review of potential risks associated with supplemental dietary exposure to nitrate-containing compounds in swine-a paradox in light of emerging benefits.

Calcium nitrate has been reported to benefit reproductive outcomes in sows and their offspring when administered via the feed (15 to 19 mg/kg-body weight [bw]/day) during the periparturient period. Traditionally, dietary nitrate had been considered a methemoglobinemia (MetHb) risk in swine. Similar hazard concerns have existed in humans, but a recent benefit/risk analysis established that nitrate levels associated with well-recognized health benefits outweigh potential risks.

Assessing the food safety risk of ochratoxin A in coffee: A toxicology-based approach to food safety planning.

Under the Food Safety Modernization Act (FSMA) and preventive controls (PCs) regulations, food manufacturers must consider whether PCs are needed for potential hazards present in food. The mycotoxin ochratoxin A (OTA) is considered a chemical hazard under FSMA. It is produced by several fungal species and can be present in various agricultural commodities, including coffee.

Use of acceptable daily intake (ADI) as a health-based benchmark in nutrition research studies that consider the safety of low-calorie sweeteners (LCS): a systematic map.

Background: It is well-recognized that consumers face many challenges in understanding and applying nutritional guidance for low-calorie sweeteners (LCS). Thus, this research aims to (1) assess how benchmarks for safe levels of consumption of LCS are utilized by researchers, and (2) understand how varying use of such benchmarks may contribute to challenges in understanding and applying nutritional guidance for LCS consumption.

Methods: A systematic mapping exercise was employed to characterize when and how acceptable daily intake (ADI) values are used as health-based benchmarks in nutrition research studies that consider the safety of LCS.

A Bibliometric Analysis of the Top 100 Cited Papers in Retinal Detachment.

Purpose: This work aimed to identify and analyze the most frequently cited articles in retinal detachment (RD).

Methods: Institute for Scientific Information's Web of Science index (Thomas Scientific) was used to identify the top 100 most cited articles on RD between 1900 and 2019. Data from the top 100 most cited articles that met inclusion criteria were analyzed based on title, citation frequency, authorship, institution, journal, year of publication, and country of origin.

Google Trends Data of Radiologists Who Accept Medicare: A Potential Tool for Predicting State Demand.

Purpose: To identify and analyze the demand for radiologists who accept Medicare per state from 2004 to 2009, as reflected by volume of Google searches, and to place such demand in context with other available data by state.

Methods: The number of radiologists who accept Medicare by state was divided by each state's population to achieve the radiologist density per 10,000 residents. Relative search volume (RSV) for the term "radiologist" was collected from Google Trends from 2004 to 2009.

Lack of potential carcinogenicity for steviol glycosides - Systematic evaluation and integration of mechanistic data into the totality of evidence.

Steviol glycosides are present in the leaves of the Stevia rebaudiana plant, have a sweet taste, and have been used as a sweetener for centuries. To build on previous authoritative safety assessments of steviol glycosides, a systematic assessment of mechanistic data related to key characteristics of carcinogens (KCCs) was conducted. Over 900 KCC-relevant endpoints from peer-reviewed literature and high-throughput screening data (ToxCast/Tox21) were identified across individual steviol glycosides and derivatives, metabolites, and whole leaf extracts.

Lack of potential carcinogenicity for acesulfame potassium - Systematic evaluation and integration of mechanistic data into the totality of the evidence.

The safety of low- and no-calorie sweeteners remains a topic of general interest. Substantial evidence exists demonstrating a lack of carcinogenicity of the no-calorie sweetener acesulfame potassium (Ace K). The objective of this evaluation was to conduct a systematic assessment of available mechanistic data using a framework that quantitatively integrates proposed key characteristics of carcinogens (KCCs) into the totality of the evidence.

Lack of potential carcinogenicity for sucralose - Systematic evaluation and integration of mechanistic data into the totality of the evidence.

Sucralose is widely used as a sugar substitute. Many studies and authoritative reviews have concluded that sucralose is non-carcinogenic, based primarily on animal cancer bioassays and genotoxicity data. To add to the body of knowledge on the potential carcinogenicity of sucralose, a systematic assessment of mechanistic data was conducted.

Lack of potential carcinogenicity for aspartame - Systematic evaluation and integration of mechanistic data into the totality of the evidence.

Despite repeated confirmation of aspartame safety in a variety of foods and beverages, there continues to be interest in researching the potential carcinogenic risk associated with its consumption. The objective of this evaluation was to conduct a systematic assessment of available mechanistic data using a framework for quantitatively integrating the key characteristics of carcinogens (KCCs). For aspartame, 1332 endpoints were appraised for quality and relevance and quantitatively integrated using an algorithm to determine the potential for individual KCC activity based on all available evidence, and subsequently assessed in the context of human and animal evidence streams.

Key Findings and Implications of a Recent Systematic Review of the Potential Adverse Effects of Caffeine Consumption in Healthy Adults, Pregnant Women, Adolescents, and Children.

In 2016⁻2017, we conducted and published a systematic review on caffeine safety that set out to determine whether conclusions that were presented in the heavily cited Health Canada assessment, remain supported by more recent data. To that end, we reviewed data from 380 studies published between June 2001 and June 2015, which were identified from an initial batch of over 5000 articles through a stringent search and evaluation process. In the current paper, we use plain language to summarize our process and findings, with the intent of sharing additional context for broader reach to the general public.

Benefit-risk analysis for foods (BRAFO): Evaluation of exposure to dietary nitrates.

Dietary nitrate has been associated with health benefits as well as potential risks, thus presenting a paradox for consumers and health professionals. To address the issue, we applied the Benefit-Risk Analysis for Foods (BRAFO) framework to evaluate dietary exposure to nitrate by considering how the risks and benefits might vary under the reference scenario of the acceptable daily intake (ADI) set forth by JECFA (3.7 mg/kg-day), or under an alternative scenario of a higher ADI (independently developed herein).

Systematic review of the potential adverse effects of caffeine consumption in healthy adults, pregnant women, adolescents, and children.

To date, one of the most heavily cited assessments of caffeine safety in the peer-reviewed literature is that issued by Health Canada (Nawrot et al., 2003). Since then, >10,000 papers have been published related to caffeine, including hundreds of reviews on specific human health effects; however, to date, none have compared the wide range of topics evaluated by Nawrot et al.

Caffeine: Friend or Foe?

The debate on the safety of and regulatory approaches for caffeine continues among various stakeholders and regulatory authorities. This decision-making process comes with significant challenges, particularly when considering the complexities of the available scientific data, making the formulation of clear science-based regulatory guidance more difficult. To allow for discussions of a number of key issues, the North American Branch of the International Life Sciences Institute (ILSI) convened a panel of subject matter experts for a caffeine-focused session entitled "Caffeine: Friend or Foe?," which was held during the 2015 ILSI Annual Meeting.

Lack of induction of micronuclei in human peripheral blood lymphocytes treated with hydroquinone.

Hydroquinone (HQ) has been reported to produce chromosomal effects in some in vivo and in vitro animal models. Its potential for inducing similar effects in human lymphocytes is less clear. The purpose of this study was to examine human lymphocytes treated with HQ for the presence of chromosomal anomalies, using an accepted assay for micronuclei.

Structural and numerical chromosomal aberrations in a metabolically competent human lymphoblast cell line (MCL-5).

MCL-5 cells are Epstein Barr virus-transformed human lymphoblasts which have been genetically engineered for use in mutagenicity testing. We have examined the modal chromosome number, karyotype and spontaneous micronucleus (MN) and sister chromatid exchange (SCE) frequencies of the cell line. Replicate experiments were conducted on two different shipments purchased from Gentest Corp.