A Network-based Analysis of Ingredients Lists in Nutrient Profile Systems

It is well-established that diseases can be prevented or mitigated through dietary intervention, yet proper nutrition is one aspect consumers struggle to manage. Recent studies have shown that there are barriers to understanding the nutrition facts component of a food label which can be linked to dietary choices. In this work, we demonstrate reproducibility and replicability of a network-based method for automating the analysis of ingredients on a food product label en masse using the Open Food Facts Database and the USDA FoodData Central Branded Foods database in February 2020. Our results, which analyze the co-occurrence of 72,754 ingredients across show some consensus in labeling across FALCPA-regulated ingredients in food product labels across databases but highlight potential areas for discrepancy in consumer understanding and labeling practices for terms not subject to strict regulations. The key findings or contributions of this work include the provision of a reproducible method for quantifying the ingredients of packaged food in the United States across two nutritional profiling systems, and have identified 17 total ingredients that appear in the top 20 most co-occurring ingredients for both databases examined. We compare how of 8 FALCPA-regulated ingredients are represented in ingredients lists versus a common, but non-FALCPA regulated ingredient (corn), to demonstrate how one could examine differences between ingredient labeling between products. These findings suggest more research is needed in developing information systems to increase information available for consumers.

Characterization of different forms of kava (Piper methysticum) products by UPLC-MS/MS

There are several forms of kava (Piper methysticum) products available for human consumption, and many factors are known to influence their chemical compositions and therefore their pharmacological properties. Because of the increased popularity of kava intake, a rigorous characterization of their content diversity is prerequisite, particularly due to its known potential to cause hepatotoxicity. To understand the composition diversity of kavalactones and flavokavains in commercial kava products, we developed a UPLC-MS/MS-based analytical method for the quantification of six kavalactones (kavain, dihydrokavain, methysticin, dihydromethysticin, yangonin and desmethoxyyangonin) and two flavokavains (flavokavains A and B) and analyzed their contents in 28 different kava products in the form of capsules, tinctures, traditional aqueous suspensions and dried powders. Our results demonstrated a great variation in terms of the total and relative abundance of the analyzed kavalactones and flavokavains among the analyzed kava preparations. More importantly, the kavalactone abundance in the product label could differ up to 90% from our experimental measurements. Therefore, more rigorous and comprehensive quality control of kava products is required with respect to the content of individual kavalactones and flavokavains. Accurate content information is essential to understand the pharmacological properties and safety of different kava products.

The Effect of Label and Medication Package Insert Reading Habits of Parents on their Children’s Oral Dental Health

Objective: The aim of this study is to evaluate the relationship between packaged product label and medication package insert reading habits of parents and their children’s oral/dental health. Study design: A questionnaire including demographic characteristics and label/insert reading habits was filled by parents of 301 children who referred to the Pediatric Dentistry Department. The children were examined intraorally and dmft/DMFT and ICDAS II scores were recorded. The data were evaluated statistically. Results: Label and medication package insert reading were found in 71.4% and 88.4% of the parents, respectively. Label reading increased as the age of the child and the number of children in the family increased. Medical package insert reading increased as the mother’s education and SLS/paraben knowledge increased. Decrease of 1 point in ICDAS II resulted in the 1.410 times increase in the rate of medical package insert reading of the parents. Conclusion: It is concluded that improving the label and medical insert reading rate of the parents would be effective for providing better oral and dental health for their children.

O Risco da Utilização de Produtos Cosméticos Falsificados / The Risk of Using Counterfeit Cosmetic Products

Resumo: A indústria de cosméticos possui grande destaque na economia brasileira e mundial. Esse setor está crescendo em ritmo exponencial e no ano de 2018 faturou 109,7 bilhões de reais. O Brasil ocupa o quarto lugar no ranking de países que mais consomem produtos e serviços de beleza. Devido ao custo dos produtos comercializados por grandes empresas, uma parcela dos consumidores opta por comprar produtos falsificados disponíveis no mercado paralelo, expondo a sua saúde a riscos, uma vez que os produtos vendidos de forma ilegal não são fiscalizados pelas agências sanitárias e estes podem conter desde microrganismos patogênicos a produtos tóxicos. O presente estudo tem por objetivo realizar um levantamento bibliográfico sobre a segurança e os riscos associados a produtos cosméticos falsificados. Para isso foram analisadas publicações na literatura referentes ao tema proposto, com escolhas de artigos nos idiomas português, inglês e espanhol publicados em periódicos como Scielo, Google Acadêmico e PubMed entre os anos de 2005 a 2021. Foram encontrados relatos de presença de microrganismos patogênicos, metais pesados e possíveis reações adversas que os cosméticos falsificados podem causar. Os cosméticos falsificados representam grande risco para a saúde humana, uma vez que não possuem certificação e muitas das vezes o rótulo do produto não condiz com o que realmente é encontrado nos produtos. Abstract: The cosmetics industry has great prominence in the Brazilian and world economy. This sector is growing at an exponential rate and in 2018 it had revenues of 109.7 billion reais. Brazil occupies fourth place in the ranking of countries that consume the most beauty products and services. Due to the cost of products sold by large companies, a portion of consumers chooses to buy counterfeit products available on the parallel market, exposing their health to risks, since products sold illegally are not inspected by health agencies and these may contain from pathogenic microorganisms to toxic products. This study aims to carry out a literature review on the safety and risks associated with counterfeit cosmetic products. For this, publications in the literature referring to the proposed topic were analyzed, with choices of articles in Portuguese, English and Spanish published in journals such as Scielo, Academic Google and PubMed between the years 2005 to 2021. Reports of the presence of pathogenic microorganisms were found, heavy metals and possible adverse reactions that counterfeit cosmetics can cause. Counterfeit cosmetics pose a great risk to human health, since they do not have certification and often the product label does not match what is actually found on the products.

Regulatory restrictions on the use of valproate in girls and women of childbearing potential: status update

In 2019, some restrictions for use of valproic acid in women with reproductive potential by regulatory authorities and the original drug manufacturer based on the results of studies in real clinical practice were introduced. During 2019–2021, there were a further clinical data accumulation and labeling changes. The review presents a critical analysis of the changes in prescribing information and product label. There is a long lead time from the moment when safety data become known to the moment when changes are made to the medicinal product label and patient brochures. Some of the changes, including the need for high doses of folic acid to prevent neural tube defects, are debatable. Repealing the provision for mandatory archiving of informed consent forms for valproic acid use in girls and women raises legal risks. Improvements in pregnancy prevention programs and further research on the safety of valproic acid in real-world clinical settings are needed.

Assessment of artificial and natural sweeteners present in packaged non-alcoholic beverages (NABs) sold on the Singapore market

Background New Nutri-Grade labelling, aimed at reducing Singaporeans’ sugar consumption will be implemented for all pre-packaged non-alcoholic beverages (NABs) sold in retail outlets from end 2021 onwards. It is expected such labelling will have a major impact on sugar content of beverages, as well as the replacement of sugar with non-caloric alternatives. Methods This study used product label data obtained from in-store surveys to investigate sugar and sweetener composition of NABs present on the Singapore market. Using this data we calculated products prospective Nutri-Grade classification in order to compare the current market composition with relation to sugar and/or sweetener use. Results Over half of the NABs on market were sweetened with sugar (59%) and were associated with less healthy Nutri-Grades of ‘C’ and ‘D’. The use of natural sweeteners; Stevia and Monk fruit, remains low (6%). Conclusion With continuous efforts by the government in promoting public health nutrition, it is expected that there will be a greater usage of sugar substitutes among NABs in response to the upcoming implementation of Nutri-Grade and ever-fluctuating consumers’ demands. The data collected in this study provide a point estimate (July–September 2020) on market composition and use of both sugar and artificial sweeteners in beverages prior to integration of the mandatory labelling requirements.

Oseltamivir and acute hepatitis, reality association or coincidence?

Oseltamivir is an orally administered antiviral medication that selectively inhibits the influenza neuraminidase enzymes that are essential for viral replication and it is active against both influenza A and B viruses. Oseltamivir is indicated for therapy or post-exposure prevention of influenza A and B. Side effects are uncommon and include mild nausea, gastrointestinal upset, dizziness, and headache. Despite widespread use, oseltamivir has not been associated with clinically apparent liver injury; however, there is growing evidence of possible toxic liver involvement during oseltamivir therapy. To the best of our knowledge, this is the first reported case in Italy linking the development of acute hepatitis and oseltamivir therapy, in a patient suffering from influenza H1N1 infection. We also present a review of the literature on cases of oseltamivir hepatotoxicity, through the consultation of PubMed database, the bibliographical references of various articles and an extensive search using Google. In view of the analyzed results, we suggest that experts should carefully consider the need for inclusion of potential serious liver reactions be added to the oseltamivir product label.

Consumer attitudes towards the mountain product label: Implications for mountain development

To protect and promote the originality and authenticity of mountain foodstuffs, the European Union set Regulation No 1151/2012 to create the optional quality term “mountain product”. Our research aimed at exploring the attractiveness of the mountain product label for consumers, considering both attitude towards the label itself and purchase intentions. We propose a model to investigate relationships between four latent constructs — mountain attractiveness, mountain food attractiveness, attitude towards the mountain product label, and purchase intention — which have been tested, thus confirming the statistical relevance of the relationships. All 47 items selected for describing the latent constructs are suitable for this purpose. Ridge and LASSO results also show that 17 items of the first three constructs are relevant in explaining purchase intentions. Some contextual variables, such as age, income, geographical origin of consumers, and knowledge of mountain products and mountains for tourism purposes, can positively influence consumers’ behavior. These findings could support the design of mountain development strategies, in particular marketing actions for both the product and the territory.

Specific Prescribing Information for Geriatric Use in the 2019 Product Labeling for Novel New Drug Approvals

Objectives To review the availability of information specific to older people in the product labeling for novel US Food and Drug Administration drug approvals in 2019. Design Descriptive report. Methods Product labeling for the 48 novel new drugs approved by the US Food and Drug Administration in 2019 were analyzed for the presence of information specific to older people. The “Geriatric Use” section, Section 8.5 in the product labeling, was categorized based on the information available. Each product label was further searched using the terms “geriatric,” “elderly,” “old,” and “year.” Searches of the term “old” and “year” focused on information that mentioned adults 65 years of age or older. The sections of the product label that contained additional information related to older people was identified. Results Information was available in the “Geriatric Use” section (Section 8.5) for 46 of the 48 novel new drugs approved in 2019; 2 did not include a “Geriatric Use” section. Four product labels indicated that the drugs were not used in older people. One of the 2 medications whose labeling omitted the “Geriatric Use” section was also not indicated for use in older people. These labels were excluded from analysis.Of the remaining 42 drugs, there was insufficient numbers of patients 65 years of age and older to determine whether older patients responded differently than younger patients for 18 medications. Labeling for 15 medications indicated that there was no difference in safety and/or efficacy between younger and older persons. Product information for 6 medications indicated that the incidence of adverse events was higher for older people. The product label for 2 medications indicated that no dosage adjustment was required in older patients. One medication’s product labeling indicated that there were insufficient numbers of patients 65 years of age or older for 1 indication but that there was no difference in safety and/or efficacy for the medication’s second indication. Additional sections that referred to people 65 years of age and older included warnings and precautions, clinical trial experience, pharmacokinetics for special populations, and clinical studies. The “Geriatric Use” section of 1 product label referred to the dosage recommendations in patients with renal impairment. Conclusion Despite efforts to increase the enrollment of older people in clinical trials, 43% of the novel new drugs approved in 2019 lacked information on differences in response between older and younger populations because of insufficient numbers of study subjects. This paucity of information translates into therapeutic uncertainty regarding the safety and efficacy of these new medications in older people. An additional concern is that 14% of novel new drug labels indicated that older people are at greater risk for adverse events. Limited information specific to older people is available in other parts of the product labeling. More useful information related to older persons needs to be included in new drug labeling.