-
Journal of Food Protection Apr 2023Allergens are one of the leading causes of food recalls in the US. The Food and Drug Administration (FDA) enforces requirements relating to major food allergens (MFAs)...
Allergens are one of the leading causes of food recalls in the US. The Food and Drug Administration (FDA) enforces requirements relating to major food allergens (MFAs) and gluten-free labeling to ensure food safety for allergic and celiac patients, respectively. Violative foods are subject to recalls. In this study, recall data for FDA-regulated foods were analyzed for fiscal years (FYs) 2013-2019 to identify trends and root causes associated with 1471 food allergen and gluten recalls. Of the 1471 recalls, 1415 recalls were due to MFAs, 34 recalls were due to gluten-free labeling violation and 23 recalls involved other allergens. Recalls due to MFAs overall increased during the study period with a peak incidence in FY 2017. MFA recall health hazard classifications were assessed as Class I (51.2%), Class II (45.5%), and Class III (3.3%). A majority of MFA recalls involved one allergen (78.8%). Milk was the most common MFA involved in MFA recalls (37.5%), followed by soy (22.5%) and tree nuts (21.6%). Almond, anchovy, and shrimp were the most common allergens recalled within the MFA groups of tree nuts, fish, and Crustacean shellfish, respectively. About 97% of MFA recalls involved one product category and among them, the category of 'bakery products, dough, bakery mixes and icings' ranked first (367 recalls), followed by the category of 'chocolate and cocoa products' (120 recalls). Labeling-associated errors accounted for 71.1% of MFA recalls with known root causes (914 out of 1286). It is important for the industry to develop and implement appropriate allergen controls to reduce the number of MFA recalls.
Topics: Animals; United States; Food Contamination; Glutens; United States Food and Drug Administration; Food Safety; Food Hypersensitivity; Allergens
PubMed: 36940660
DOI: 10.1016/j.jfp.2023.100069 -
Drug Metabolism and Pharmacokinetics 2011Toxicity has been estimated to be responsible for the attrition of approximately one-third of drug candidates and is a major contributor to the high cost of drug... (Review)
Review
Toxicity has been estimated to be responsible for the attrition of approximately one-third of drug candidates and is a major contributor to the high cost of drug development, particularly when not recognized until late in clinical trials or post-marketing. The causes of drug toxicity can be classified in several ways and include mechanism-based (on-target) toxicity, immune hypersensitivity, off-target toxicity, and bioactivation/covalent modification. In addition, idiosyncratic responses are rare but can be one of the most problematic issues; several hypotheses for these have been advanced. Although covalent binding of drugs to proteins was described almost 40 years ago, the significance to toxicity has been difficult to establish; recent literature in this field is considered. The development of more useful biomarkers and short-term assays for rapid screening of drug toxicity early in the drug discovery/development process is a major goal, and some progress has been made using "omics" approaches.
Topics: Animals; Biomarkers; Biotransformation; Chemical and Drug Induced Liver Injury; Cytochrome P-450 Enzyme System; Drug Discovery; Drug Evaluation, Preclinical; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Haptens; Humans; Liver; Models, Animal; Pharmaceutical Preparations; Protein Binding; Proteomics; Safety-Based Drug Withdrawals; Toxicogenetics
PubMed: 20978361
DOI: 10.2133/dmpk.dmpk-10-rv-062 -
Australian and New Zealand Journal of... Apr 2022To identify leading injury risk factors and jurisdictional differences in Australian and US child-related product safety regulatory responses to inform the development...
OBJECTIVE
To identify leading injury risk factors and jurisdictional differences in Australian and US child-related product safety regulatory responses to inform the development of Australian policy and reform priorities.
METHODS
The study established and evaluated a knowledge base of child-related product safety regulatory responses (recalls, bans, standards and warnings) made in Australia and the US over the period 2011-17 to identify risk factors and potential regulatory gaps.
RESULTS
The research identified 1,540 Australian and US child-related product safety regulatory responses with the most common response type being product safety recall, and the leading product hazards in responses being choking, fire, fall, strangulation and chemical hazards. Jurisdictional differences identified potential regulatory gaps in Australia related to chemical hazards and high-risk durable infant and toddler products, and some data deficiencies in Australian responses.
CONCLUSIONS
Priorities include the need to improve the prevention orientation of the Australian product safety framework, to create an intelligence platform to assess injury risks more precisely and to address regulatory gaps related to the use of toxic chemicals in children's products and high-risk durable infant and toddler products.
IMPLICATIONS FOR PUBLIC HEALTH
The study demonstrates the identification of policy and reform priorities for child product safety using a public health lens.
Topics: Accidental Falls; Australia; Family; Humans; Infant; Public Health; Risk Factors
PubMed: 35174934
DOI: 10.1111/1753-6405.13212 -
Journal of the American Veterinary... Nov 2010
Topics: Drug Industry; Drug Recalls; Legislation, Drug; Societies; United States; United States Food and Drug Administration; Veterinary Drugs; Veterinary Medicine
PubMed: 21073378
DOI: 10.2460/javma.237.10.1104 -
Journal of Food Protection Apr 2017The U.S. Department of Agriculture, Food Safety and Inspection Service maintains a recall case archive of meat and poultry product recalls from 1994 to the present. In...
The U.S. Department of Agriculture, Food Safety and Inspection Service maintains a recall case archive of meat and poultry product recalls from 1994 to the present. In this study, we collected all recall records from 1994 to 2015 and extracted the recall date, meat or poultry species implicated, reason for recall, recall class, and pounds of product recalled and recovered. Of a total of 1,515 records analyzed, the top three reasons for recall were contamination with Listeria, undeclared allergens, and Shiga toxin-producing Escherichia coli . Class I recalls (due to a hazard with a reasonable probability of causing adverse health consequences or death) represented 71% (1,075 of 1,515) of the total recalls. The amounts of product recalled and recovered per event were approximately lognormally distributed. The mean amount of product recalled and recovered was 6,800 and 1,000 lb (3,087 and 454 kg), respectively (standard deviation, 1.23 and 1.56 log lb, respectively). The total amount of product recalled in the 22-year evaluation period was 690 million lb (313 million kg), and the largest single recall involved 140 million lb (64 million kg) (21% of the total). In every data category subset, the largest recall represented >10% of the total product recalled in the set. The amount of product recovered was known for only 944 recalls. In 12% of those recalls (110 of 944), no product was recovered. In the remaining recalls, the median recovery was 29% of the product. The number of recalls per year was 24 to 150. Recall counts and amounts of product recalled over the 22-year evaluation period did not regularly increase by year, in contrast to the regular increase in U.S. meat and poultry production over the same time period. Overall, these data suggest that (i) meat and poultry recalls were heavily skewed toward class I recalls, suggesting recalls were focused on improving food safety, (ii) numbers of products and amounts of each product recalled were highly variable but did not increase over time, and (iii) the direct contribution of recalls to the food waste stream was associated with the largest recalls.
Topics: Animals; Consumer Product Safety; Food Contamination; Food Microbiology; Food Safety; Meat; Poultry Products; United States; United States Food and Drug Administration
PubMed: 28294687
DOI: 10.4315/0362-028X.JFP-16-388 -
Frontiers in Psychology 2017Improvisation is an articulated multidimensional activity based on an extemporaneous creative performance. Practicing improvisation, participants expand sophisticated... (Review)
Review
Improvisation is an articulated multidimensional activity based on an extemporaneous creative performance. Practicing improvisation, participants expand sophisticated skills such as sensory and perceptual encoding, memory storage and recall, motor control, and performance monitoring. Improvisation abilities have been developed following several methodologies mainly with a product-oriented perspective. A model framed under the socio-cultural theory of learning for designing didactic activities on processes instead of outcomes is presented in the current paper. The challenge is to overcome the mere instructional dimension of some practices of teaching improvisation by designing activities that stimulate self-regulated learning strategies in the students. In the article the present thesis is declined in three ways, concerning the following three possible areas of application: (1) high-level musical learning, (2) musical pedagogy with children, (3) general pedagogy. The applications in the music field focusing mainly on an expert's use of improvisation are discussed. The last section considers how these ideas should transcend music studies, presenting the benefits and the implications of improvisation activities for general learning. Moreover, the application of music education to the following cognitive processes are discussed: anticipation, use of repertoire, emotive communication, feedback and flow. These characteristics could be used to outline a pedagogical method for teaching music improvisation based on the development of reflection, reasoning, and meta-cognition.
PubMed: 28626441
DOI: 10.3389/fpsyg.2017.00911 -
The Journal of Nutrition Sep 2018Healthy food consumption patterns in early childhood support optimal growth and development and promote lifelong health.
BACKGROUND
Healthy food consumption patterns in early childhood support optimal growth and development and promote lifelong health.
OBJECTIVE
The objective of the Feeding Infants and Toddlers Study (FITS) 2016 is to provide updated information on food consumption patterns of children aged 0 to <4 y. This article focuses on several key aspects of the food consumption patterns of 2- and 3-y-olds and how those patterns differ between racial/ethnic groups.
METHODS
The FITS 2016 is a cross-sectional study in caregivers of children aged 0 to <4 y living in the United States. Dietary data were collected in a national random sample of children (n = 3235, of whom 600 were aged 24-47.9 mo) by using a 24-h dietary recall telephone survey with the primary caregiver of the child. Data from the recall were used to calculate the percentage of children consuming specific food groups on the day of the recall and energy from these foods (kilocalories per consumer). Differences in food patterns between racial/ethnic groups were analyzed by using ANOVA and t tests.
RESULTS
On the day of the 24-h dietary recall, 27% of 2- and 3-y-olds did not consume a distinct portion of vegetables. Fried potatoes were the most commonly consumed vegetable. Approximately 75% consumed a distinct portion of fruit and 45% consumed 100% fruit juice. Eighty-one percent of children consumed cow milk. Almost all (95%) consumed a grain product, and 59% consumed a whole grain-rich product. The majority of children (88%) consumed meat or another protein food. Nearly all (90%) consumed a dessert, sugar-sweetened beverage (SSB), or sweet; and 45% consumed an SSB. Thirty-six percent of children consumed a savory snack. There were some differences in food consumption patterns between racial/ethnic groups.
CONCLUSION
Findings from the FITS 2016 indicate that individual-, community-, and policy-level strategies are needed to improve the diets of young children in the United States.
Topics: Caregivers; Child Health; Child, Preschool; Cross-Sectional Studies; Diet; Diet Surveys; Ethnicity; Feeding Behavior; Female; Humans; Male; Mental Recall; Racial Groups; United States
PubMed: 29878237
DOI: 10.1093/jn/nxx053 -
Sensors (Basel, Switzerland) Nov 2022Sensing and remembering features in visual scenes are conditioned by visual attention and methods to guide it. This should be relevant in terms of product placement,... (Randomized Controlled Trial)
Randomized Controlled Trial
Sensing and remembering features in visual scenes are conditioned by visual attention and methods to guide it. This should be relevant in terms of product placement, which has become an important part of incorporating brands into different mass media formats with a commercial purpose. The approach can be challenging in 360° video, where an omnidirectional view enables consumers to choose different viewing perspectives, which may result in overlooking the brands. Accordingly, attention guidance methods should be applied. This study is the first to explore diegetic guidance methods as the only appropriate guiding method for an unobtrusive and unconscious nature of product placement. To test the effectiveness of three different diegetic guiding methods, a between-subject design was employed, where the participants were assigned randomly to one of four videos with the same scene but different guiding methods. The findings show and explain the discrepancy with studies on guiding attention in other contexts, as there were no significant differences between the guiding cues according to brand recall and brand recognition. The results also indicate a significant influence of brand familiarity on brand recall in 360° video. The article concludes by providing limitations, future research directions, and recommendations for audiovisual policy.
Topics: Humans; Recognition, Psychology; Mental Recall; Cues
PubMed: 36433406
DOI: 10.3390/s22228809 -
PloS One 2015Due to an ageing population and demographic changes worldwide, a higher prevalence of heart disease is forecasted, which causes an even higher demand for cardiac...
BACKGROUND
Due to an ageing population and demographic changes worldwide, a higher prevalence of heart disease is forecasted, which causes an even higher demand for cardiac implants in future. The increasing high incidence of clinical adverse events attributed especially to high-risk medical devices has led an advocated change from many stakeholders. This holds especially true for devices like cardiac implants, with their high-risk nature and high complication rates associated with considerable mortality, due to their frequent use in older populations with frequent co-morbidities. To ensure patients' safety, the objective of this study is to analyze different cardiac implants recall reasons and different recall systems, based on an overview of the recalls of cardiac implant medical devices in the last decade. On the basis of the results from this structured analysis, this study provides recommendations on how to avoid such recalls from a manufacturer perspective, as well as how to timely react to an adverse event from a post-surveillance system perspective.
METHODS AND FINDINGS
A systematic search of cardiac implant recalls information has been performed in the PubMed, ScienceDirect and Scopus databases, as well as data sources in regulatory authorities from 193 UN Member States. Data has been extracted for the years 2004-2014 with the following criteria applied: cardiac implant medical device recalls and reasons for recall, associated harm or risk to patients. From the data sources described above, eleven regulatory authorities and 103 recall reports have been included in this study. The largest cardiac implant categories include ICDs 40.8%, pacemakers 14.5% and stents 14.5%. Regarding the recall reasons, the majority of reports were related to device battery problems (33.0%) and incorrect therapy delivery (31.1%). From a total of 103 recall reports, five reported death and serious injuries. Our review highlights weaknesses in the current cardiac implant recall system, including data reporting and management issues and provides recommendations for the improvement of safety information and management.
CONCLUSION
Due to the mortality associated with the nature of cardiac implants, the traceability and transparency of safety hazards information is crucial. By a structured analysis of recall reasons and their efficient management, important knowledge is gained to inform an effective safety-reporting system for monitoring the safety of cardiac implanted patients, ideally by building up cardiac implant registries worldwide in the future.
Topics: Heart Valve Prosthesis; Heart, Artificial; Humans; Medical Device Recalls; Patient Safety; Prosthesis Failure
PubMed: 25962074
DOI: 10.1371/journal.pone.0125987 -
Nutricion Hospitalaria Jul 2020Intestinal failure (IF) is defined as a reduction in intestinal function below the minimum necessary for the absorption of nutrients, requiring intravenous...
Intestinal failure (IF) is defined as a reduction in intestinal function below the minimum necessary for the absorption of nutrients, requiring intravenous supplementation to maintain health and/or growth. The most common cause is short bowel syndrome (SBS). Approximately 50% of patients with SBS have IF and require parenteral support. Teduglutide is a human glucagon-like peptide-2 analogue (GLP-2) approved for the treatment of patients with SBS. Clinical trial results have proven its efficacy by reducing volume and days of administration of parenteral nutrition and fluid therapy. Few publications evaluate the effects on long-term bowel function in respondent patients after teduglutide suspension. A patient with type I SBS (terminal jejunostomy) due to multiple surgeries for Crohn's disease, who was treated with liraglutide for one year and sequential teduglutide for 21 months, is described. With the former, a reduction in the need for contribution and debit by jejunostomy was observed. The GLP-2 analogue achieved a greater reduction in the hydric disbalance that allowed the suspension of the nocturnal suerotherapy, with weight gain and maintenance of nutritional parameters; situation maintained two years after its suspension.
Topics: Crohn Disease; Fluid Therapy; Gastrointestinal Agents; Humans; Intestinal Diseases; Jejunostomy; Liraglutide; Male; Middle Aged; Parenteral Nutrition; Peptides; Product Recalls and Withdrawals; Short Bowel Syndrome
PubMed: 32406744
DOI: 10.20960/nh.03052