Naturally leading: a content analysis of terms, themes and word associations in Natural American Spirit advertising, 2000–2020

BackgroundNatural American Spirit (NAS) is a cigarette brand distinguished by supposed ‘natural’, ‘additive-free’ characteristics, marketing of which is tied to misperceptions of reduced harm. In 2017, NAS’s manufacturer agreed (with the Food and Drug Administration) to remove ‘natural’/‘additive-free’ from US marketing. Prior research has explored NAS marketing immediately post-agreement. This study sought to identify prominent post-agreement terms and themes and analyse how they had been used in pre-agreement ads.MethodsWe conducted a content analysis of NAS ads from 2000 to 2020 (N=176), documenting prominent pre-agreement and post-agreement terms/themes and examining how they are used in NAS ads. We coded for descriptors, themes, imagery and promotions, and extended prior research by analysing how leading post-agreement terms were used in conjunction and thematically associated with ‘additive-free’ and ‘natural’ before the agreement.ResultsResults indicated ‘tobacco and water’ and ‘Real. Simple. Different.’ increased post-agreement, as did environmental imagery. ‘Organic’ was prominent pre-agreement and post-agreement. The descriptors used most often in post-agreement ads almost always appeared in conjunction with (and were thematically linked to) ‘natural’ and ‘additive-free’ in pre-agreement ads.ConclusionsIn the years since the agreement, NAS ads have heavily relied on still-allowable descriptors that may invite reduced risk misperceptions. Notably, these descriptors were consistently used alongside the banned terminology before the agreement and presented as if affiliated conceptually, possibly prompting similar connotations. Findings indicate a continuing need for research into NAS advertising effects and a potential role for additional regulatory action.

Postmarketing safety of orphan drugs: a longitudinal analysis of the US Food and Drug Administration database between 1999 and 2018

Background Information about the specific regulatory environment of orphan drugs is scarce and inconsistent. Uncertainties surrounding the postmarketing long-term safety of orphan drugs remain. This study aimed to evaluate the labelling changes of orphan drugs and to identify postmarketing safety-associated approval factors. Methods This retrospective cohort study includes all drugs with orphan drug designation approved by the Center for Drug Evaluation and Research of the US Food and Drug Administration between 1999 and 2018. Main outcomes are safety-related labelling changes up to 31 December 2019. We defined any safety-related labelling changes as postmarketing safety events (PMSE). Safety-related withdrawals, suspensions, and boxed warnings were further categorised as severe postmarketing safety events (SPSE). Outcome measurements include frequencies of PMSE, SPSE, and association between approval factors and the occurrence of safety events. Results Amongst the 214 drugs identified with orphan drug designation (25.7% biologics), 83.6% were approved through at least one expedited programme, and 29.4% were approved with boxed warnings. During a median follow-up of 6.74 years since approval, 69.2% and 14.5% of the analysed orphan drugs had PMSE and SPSE, respectively. Safety-related withdrawal (0%, 0/214), suspended marketing (0.46%, 1/214) and new boxed warnings are uncommon (3.7%, 8/214). The safety-related labelling changes were more frequent in the drugs approved with boxed warnings [Incidence rate ratio (IRR): 1.95 (1.02–3.73)] and approved for long-term use [IRR: 2.76 (1.52–5.00)]. Conclusions and Relevance In this long-term postmarketing analysis, approximately 70% of FDA-approved orphan drugs had safety-related labelling changes although severe safety events were rare. While maintaining early access to orphan drugs, the drug regulatory body has taken timely regulatory action with postmarketing surveillance to ensure patient safety.

Las vacunas contra la COVID-19, ¿cuál es mejor?

Desde el comienzo de la pandemia por SARS-CoV-2 las vacunas se plantearon como una de las principales estrategias para hacerle frente, debido a esto se inició una carrera en el desarrollo de una vacuna contra la COVID-19. Dicho proceso implica el conocer al agente patógeno de interés, así como el proceso mediante el cual causa enfermedad. Durante el proceso de desarrollo se ponen a prueba las diferentes vacunas en múltiples escenarios pero solo un porcentaje pequeño logra finalizar las diversas etapas. Existen diversos tipos de vacunas, cada una tiene una forma diferente de transportar hacia dentro de la célula al antígeno, o a las partes de este, para inducir una respuesta inmune, y precisamente un dato sorprendente respecto a las vacunas contra COVID-19 es que se están desarrollando bajo una cantidad nunca antes vista de plataformas y tipos de vacunas. Actualmente se desarrollan más de 200 vacunas, pero solo 21 de ellas se encuentran en ensayos clínicos de fase III, cinco de las cuales han sido aprobadas por la COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), tan solo tres por la FDA (Food and Drug Administration) y tres por la EMA (European Medicines Agency). En el presente trabajo se evidencian los resultados de una revisión de la literatura publicada hasta el momento en la base de datos en línea PubMed y el motor de búsqueda Google Academico, todo con el objetivo que fue responder la pregunta ¿Cuál de las vacunas ya aprobadas contra la COVID-19 es la mejor opción?

Highlights on the Labels of Packaged Foods Sold in Jordanian Market from A Cross-Sectional Study

Jordan has adapted a strategy to prevent chronic diseases. Accordingly, Ministry of Health is looking for controlling food labeling particularly food fat, trans-fat, and caloric content. This study aimed to screen the food label of products that are sold in Jordanian market in terms of serving size, energy, macronutrient, fiber, total and added sugars, saturated and trans fat, cholesterol, dietary fiber, and micronutrient contents. A cross-sectional study was performed to screen the food label for the food products based on the standards of The United States Food and Drug Administration (FDA) regulations of 2016 and Jordan Food and Drug Administration (JFDA). Generally, food labels were not clear. The screened products were compliant with JFDA standards and not in compliance with some FDA standards. In addition, many products were found to be sources of added sugars, Na, and saturated fats. Stakeholders and legislators are called to focus on developing new laws, regulations, and polices for developing food label. Food manufacturers are needed to work hardly on developing informative, clear, easy-to-understand, and attractive food labels. The legislators of food label policies are called to look for ways to indicate the presence of high amounts of dietary risk factors such as sugars, added sugars, Na, saturated, and trans fats in packaged foods.