Product Warnings Research Articles

“É importante que não tome mais comprimidos do que lhe foi indicado”: estratégias linguísticas de desresponsabilização da indústria farmacêutica em folhetos informativos

Legally, pharmaceutical companies are responsible for any damage, injury or harm caused to the user by their products. However, the language present in product warnings (Dumas, 1990; Shuy, 1990; Tiersma, 2002) and in patient information leaflets (PIL) (van der Waarde, 2008; Hagemeyer & Coulthard, 2017) seem to protect manufacturers from possible litigation, transferring responsibility to the consumer or user. Therefore, using both a pragmatic and discoursive analysis approach, we aim to investigate which linguistic strategies in European Portuguese (EP) acquit pharmaceutical companies from holding liability for the users’ actions. The qualitative analysis of a corpus of 20 PIL in EP reveals that the use of passive voice, impersonal constructions, attenuation of directive acts, declarative sentences with imperative value and vague language represent intentional strategies for pharmaceutical companies to protect themselves from possible litigation. Additionally, the comprehensibility of the text is further compromised by grammatical inconsistencies, the constant calculation of inferences and the presence of technical terms, “medicalese”.

Toddler Milk Perceptions and Responses to Front-of-Package Claims and Product Warnings: A Qualitative Study of Caregivers of Toddlers.

Toddler milk products are ultraprocessed milk-based beverages promoted for children aged 9 through 36 months. They often contain added sugars, which may contribute to unhealthy dietary habits. Aggressive promotion of toddler milk, particularly to the Latinx population, has likely led to rapid rises in sales. The study aims were to qualitatively explore caregivers' experiences with, beliefs about, and attitudes toward toddler milk; to explore caregivers' reactions to health claims and product warnings on toddler milk packaging; and explore whether perceptions of toddler milk differ by Latinx ethnicity. Focus group discussions and in-depth interviews were conducted. Fifteen online in-depth interviews and 4 online focus groups with US caregivers of children aged 9 through 36 months who reported serving toddler milk to their children were conducted in2021. Audio files were transcribed, coded, and analyzed in NVivo. A thematic analysis with a hybrid analytical approach of deductive and inductive coding was conducted. Caregivers struggled to discern toddler milk from infant formula and perceived formula as a larger term that included toddler milk. Participants described offering toddler milk to their children for its convenience, nutritional profile, and perceived benefits tied to health claims present on the labels. Participants reported that health claims on toddler milk packaging attracted their attention; most participants did not express skepticism about the veracity of the claims. An "added sugar" warning increased understanding of the presence of added sugar in a toddler milk product. Latinx and non-Latinx participants largely reported similar perceptions, beliefs, and patterns of provision of toddler milk. Health claims may lead caregivers to perceive toddler milk as a nutritionally adequate product. Research is needed to investigate caregiver-directed interventions for informing caregivers about the distinction between infant formula and toddler milk.

Testing the Comprehensibility: Designing a Simplified Philippine Consumer Product Warnings

Testing the Comprehensibility: Designing a Simplified Philippine Consumer Product Warnings

Lexis and Syntax of Medicine Product Warnings in the Philippines

Lexis and Syntax of Medicine Product Warnings in the Philippines

LEXIS AND SYNTAX OF MEDICINE PRODUCT WARNINGS IN THE PHILIPPINES

In the Philippines, parents refused their children having an anti-measles and anti-dengue vaccines, which created a medical outbreak. This may not happen if product warnings have been given and explained to the parents. Indeed, product warnings are found to be in their optimal position in safeguarding the life of consumer-patients. This paper anatomizes the lexical features of medicine product warnings in the Philippines which are crucial in the response discourses. A range of linguistic frameworks were applied and significant findings were drawn. Gaps were identified on the use of noun abstractness, synthetic personalization, field continuum, adjectives, and adverbs. Such an investigation brought up the transparency of communicative features of medicine safety texts. In the end, linguistic components create a vital impact on the legal content adequacy of medicine product warnings, unfolding the vitalities of these messages in facilitating informed decision-making among consumer-patients.

Copycat and lookalike edible cannabis product packaging in the United States

BackgroundRecent media reports have highlighted copycat/lookalike cannabis edibles as a public health concern. No empirical papers have described this phenomenon. MethodsFrom May 2020-August 2021, we collected photos of cannabis products via an online survey of cannabis users and through personal contacts. Copycat/lookalike products are defined as those that use the same or similar brand name, logo, and/or imagery as an existing commercial non-cannabis counterpart (CNCC). We assessed each package for similarities with its CNCC with respect to brand name, product name, font, color, flavors, and brand/promotional characters. We examined cannabis content indicators including: THC content per package and serving, cannabis leaf symbol, product warnings, cannabis terms, cannabis motifs, activation time, and guidance on edible use. ResultsWe collected photos of 731 cannabis products; 267 (36%) were edibles of which 22 (8%) represented 13 unique copycat/lookalike products. Eight used exact brand/product names as existing CNCCs, and five used similar names. Packages copied or imitated a mean of 3.9 of six features and indicated cannabis content with a mean of 4.1 of eight features. Thirteen packages indicated a mean THC content of 459 mg/package. Four reported THC dose per serving, with a mean dose of 47.5 mg. ConclusionsOur content analysis highlights three key concerns. First, copycat/lookalike edibles subtly indicate cannabis content while using high fidelity replication or imitation of their CNCC. Second, THC content is high and there were multiple 10 mg THC doses in the equivalent of 1 serving of a CNCC. Third, these products may be attractive to children.

Drivers of purchase decisions for cannabis products among consumers in a legalized market: a qualitative study

BackgroundCannabis was legalized in Canada for non-medical use in 2018. The goal of legalization was to improve health and safety by creating access to regulated products, with accurate product labels and warnings and no risk of contamination. However, more than 2 years post-legalization, a large proportion of purchases are still suspected to be through unlicensed retailers. This study sought to identify the factors that influenced the purchase decisions of cannabis consumers in Newfoundland and Labrador (NL).MethodsSemi-structured focus groups and interviews were conducted in NL with individuals who were > 19 and had purchased cannabis within the last 12 months. All sessions were conducted virtually, audio-recorded, and transcribed. A thematic analysis was conducted, and two members of the research team coded the data using NVivo. A combination of deductive and inductive coding was carried out, themes from the literature were identified, and new themes from the transcripts were discovered. A final coding template of the data was agreed upon by the team through discussion and consensus.ResultsA total of 23 individuals (30% women) participated, with 83% coming from urban areas. While all cannabis product types were discussed, the conversation naturally focused on dried flower products. Participants discussed a variety of considerations when making purchase decisions categorized around five broad themes: 1) price, 2) quality, 3) packaging and warnings, 4) the source of the cannabis, and 5) social influences. The price difference between licensed and un-licensed sources was commonly discussed as a factor that influenced purchase decisions. Product quality characteristics (e.g. size, color, moisture content) and social influences were also considered in purchase decisions. Participants were generally indifferent to packaging and warning labels but expressed concern about the excessive packaging required for regulated products.ConclusionThis study explores the many attributes that influence purchase decisions for dried leaf cannabis. Understanding the drivers of purchase decisions can help inform policy reforms to make regulated cannabis products more appealing to consumers. Further research is needed to measure the effect of each attribute on cannabis purchase decisions.

Exploring responses to differing message content of pictorial alcohol warning labels

AbstractOne way of tackling hazardous alcohol consumption is introducing warning labels on alcohol products. This research explores three under‐researched message content areas in relation to alcohol warning labels: negative/positive framing of the message; use of signal words and qualifiers and type of information used in the message (qualitative or quantitative), across message themes that depict social or health consequences. A qualitative and exploratory approach was undertaken using five focus groups of UK undergraduate students followed by 15 semi‐structured interviews with UK adults. Discussions centred around responses to the alcohol warning labels that varied in message content characteristics. The students also created their own warning label designs based on what they believed would be useful for encouraging students to keep to low‐risk drinking guidelines. Findings across both samples revealed a preference for negatively (loss) framed health messages that elicit fear and use evidence‐based reasoning and statistics. The avoidance of signal words (e.g. ‘government warning’) and qualifiers (e.g. may cause) would likely make the messages more persuasive. Our findings contribute to understanding the influence of message content on consumer responses to alcohol warning labels. However, such message content characteristics are inherent in the design of many product warnings and our findings may apply to other contexts.

Waterpipe Tobacco Warnings: An Experimental Study Among a Nationally Representative Sample of US Young Adults.

Waterpipe tobacco (WT) smoking by young adults remains high and misperceptions are common. Product warnings can increase knowledge of harms and reduce use. The goal of this study was to test warning statements, including the FDA-required nicotine warning (prior to implementation), on young adults' thinking about harms of and discouragement from WT smoking. We conducted a between-subjects experiment in a nationally representative telephone survey of 1152 young adults aged 18-29. Participants were randomly assigned to hear one of five warning statements and reported how much, on a 4-point scale, the warning made them think about the harms and discouraged them from WT smoking. The sample was 36.8% female, 57.8% white, 20.2% Black, 24.1% Hispanic, with a mean age of 23.2 (SE = 0.25). Under half (43.5%) had ever smoked WT. There were significant differences among the statements on both thinking about harms (p < .0001) and discouragement (p < .0001). The FDA-required "nicotine" warning led to the lowest thinking about harms (M = 2.85, SE = 0.08) and was the least discouraging (M = 2.86, SE = 0.08), while the "100 cigarettes" warning resulted in the greatest thinking about harms (M = 3.62, SE = 0.05) and was the most discouraging (M = 3.56, SE = 0.06). The nicotine warning resulted in the lowest levels of thinking about harms and discouragement from WT smoking, suggesting limited impact. However, a warning focused on comparing smoke inhalation from WT smoking to cigarettes seems promising. Warnings should cover a broad range of WT health effects, and possibly comparisons to cigarettes. Findings also have implications for the content of international waterpipe warnings. This study indicates that the nicotine warning is the least effective at making young adults think about the harms of and discouraging WT smoking. The FDA and other countries should consider requiring warnings to cover a broader range of health harms, misperceptions, and possibly comparisons to cigarettes.

Youth Exposure to Warnings on Cigar, E-Cigarette, and Waterpipe Tobacco Packages

Studies of tobacco product warnings have focused primarily on the reach and effectiveness of cigarette warnings for adult smokers, whereas few observational studies have examined noncigarette tobacco product warnings among youth. High school students from the 2019 National Youth Tobacco Survey (n=10,094) reported the frequency of exposure to warnings on cigar, e-cigarette, and waterpipe tobacco packages and the perceived harm of occasionally using e-cigarettes and waterpipe tobacco. In 2020, results were analyzed for the entire sample and among subgroups, including never users, ever users, youth susceptible to using tobacco, and current users. Reported high exposure to warnings was highest for cigars (22.3%), followed by that for e-cigarettes (20.8%) and that for waterpipe tobacco (7.0%). Youth who were susceptible to using cigars (AOR=1.53, 95% CI=1.29, 1.82), who ever used cigars (AOR=4.32, 95% CI=3.57, 5.22), or who currently used cigars (AOR=8.90, 95% CI=6.95, 11.39) were more likely to report high exposure to cigar warnings than youth who never used cigars. Similar findings were observed for e-cigarette and waterpipe tobacco warnings. For youth who ever used e-cigarettes, high exposure to warnings was associated with higher odds of perceiving e-cigarettes as harmful for occasional product use (AOR=1.50, 95% CI=1.05, 2.15), and high exposure to waterpipe tobacco warnings was associated with higher odds of perceiving waterpipe tobacco as harmful (AOR=1.21, 95% CI=1.00, 1.45). Warnings on noncigarette tobacco products reach some youth at risk for using these products, but these warnings may need to be strengthened to further reduce their use.

Efficacy of Canadian health warning statements on caffeinated energy drinks: an experimental study among young Canadians.

The current study examined the efficacy of health warnings on caffeinated energy drinks (CEDs). Participants aged 12-24 years (n = 2040) completed an online survey where they were asked to recall any existing warning statements on CED products and were randomized to one of 29 experimental warning conditions. Regression models were fitted to examine differences between conditions in product appeal, perceived safety and message recall. Overall, fewer than 30% of participants were able to accurately describe an existing CED product warning. Experimental findings indicated that exposure to CEDs with warning labels resulted in greater recall. Warnings on the back of CED cans featuring large font, a border, and a 'caution' heading resulted in significantly greater recall (P < 0.05 for all). Front-of-package 'High source of caffeine' labels resulted in greater recall than a quantitative description (P < 0.001); caffeine labels generally elicited lower product appeal (P < 0.001) and perceived safety (P = 0.002) ratings vs. no caffeine labels, and the qualitative caffeine statement elicited lower perceived safety ratings than the quantitative statement (P = 0.02). Existing warning statements in Canada have low levels of awareness. Warnings on CEDs could be enhanced to increase the salience of messages, with greater impact from clear, descriptive, front-of-package 'High source of caffeine' labels.

Perceptions of U.S. and Canadian Cannabis Package Warnings Among U.S. Adults

BackgroundCannabis warning labels can communicate risks, but there is little research on warning perceptions and differences by product type. MethodsIn a 2019 online survey, 1,000 U.S. adults (500 cannabis users and 500 cannabis non-users who used tobacco) were randomly assigned to view no warning or one of four U.S. or Canadian warnings displayed on images of packaging for dried flower or edible cannabis. The warnings described cannabis risks related to psychosis, addiction, lack of FDA oversight, and impaired driving. We used linear regression to examine perceptions of warnings and product harm as a function of product type (dried or edible) and warning. We examined which warning participants selected as most effective for discouraging youth use and impaired driving. ResultsParticipants found the addiction warning (cannabis users: B = −1.04, p < 0.001; cannabis non-users: B = 1.17, p < 0.001) and psychosis warning (users: B = −0.65, p < 0.05; non-users: B = −0.71, p < 0.05) less believable than the driving warning but indicated that they learned more from the psychosis warning than the driving warning (users: B = 0.88, p < 0.01; non-users (B = 1.60, p < 0.001). Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05). The psychosis warning was most frequently selected as the best warning for discouraging youth use. ConclusionsWarnings have the potential to educate consumers and impact cannabis harm perceptions. Warnings have similar effects across product types, potentially eliminating the need for product type-specific warnings. The association of cannabis use with risk for psychosis, a topic addressed in Canadian warnings, could be a useful topic of focus in U.S. warnings.

The Harmful Consequences of Vaping

The vaping of nicotine products has overwhelmingly gained national attention as the new public health crisis. The use of electronic nicotine delivery systems and products such as electronic cigarettes, JUUL, pods, or vaporizers is now a worldwide multibillion dollar industry. Despite the notable gains decreasing harmful smoking behaviors of traditional cigarettes among youth, these public health initiatives have been significantly nullified by the indiscriminate exposure of these highly addictive products by nicotine manufacturers to the adolescent population. Although touted as a safer alternative to traditional tobacco smoking and an effective cessation method to quit traditional cigarette smoking, there are no definitive data, to date, substantiating that this is true. Currently, adolescents are the predominant population using electronic nicotine delivery systems and at the greatest risk to the negative effects of nicotine exposure (U.S. Department of Health & Human Services, 2016). The purpose of this article is to identify the health impact and potential dangers related to the vaping epidemic that conflict with teens' risk beliefs that vaping is harmless. To protect American youth, a comprehensive approach for harm reduction to this deadly problem is imperative, including product warnings and regulation, public media campaigns, economic and social strategies, and policy initiatives.

Evaluating the impacts of cannabis legalization: The International Cannabis Policy Study

An increasing number of jurisdictions have legalized non-medical cannabis use, including Canada in October 2018 and several US states starting in 2012. The policy measures implemented within these regulated markets differ with respect to product standards, labelling and warnings, public education, retail policies, marketing, and price/taxation. The International Cannabis Policy Study (ICPS) seeks to evaluate the impacts of these policy measures as well as the broader population-level impact of cannabis legalization using a quasi-experimental research design. The objective of this paper is to describe the ICPS conceptual framework, methods, and baseline estimates of cannabis use. The ICPS is a prospective cohort survey conducted with national samples of 16–65-year-olds in Canada and the US. Data are collected via an online survey using the Nielsen Consumer Insights Global Panel. Primary survey domains include: prevalence and patterns of cannabis use; purchasing and price; consumption and product types; commercial retail environment; problematic use and risk behaviours; cannabis knowledge and risk perceptions; and policy-relevant outcomes including exposure to health warnings, public educational campaigns, and advertising and promotion. The first annual wave was conducted in Aug-Oct 2018 with 27,169 respondents in three geographic ‘conditions’: Canada (n = 10,057), US states that had legalized non-medical cannabis (n = 7,398) and US states in which non-medical cannabis was prohibited (n = 9,714). The ICPS indicates substantial differences in cannabis use in jurisdictions with different regulatory frameworks for cannabis. Future waves of the study will examine changes over time in cannabis use and its effects associated with legalization in Canada and additional US states.

Tobacco Product Warnings in the Mist of Vaping

Warning labels have been mandated for cigarette packages under US federal law since the mid-1960s. While the nature and specificity of warnings has evolved, there is a long-standing skepticism about the effectiveness of textual warning labels, which has spurred the global use of pictorial warnings as a deterrent mechanism. Due to commercial speech challenges, the USFDA has delayed adoption of graphic cigarette labels, and the impact of pending, newly revised graphic warnings remains a matter of uncertainty. Like other matters of smoking abatement, public health anti-tobacco initiatives are compounded by the rapid increase in e-cigarette use where currently, mandatory warnings are tepid, mirroring both lack of knowledge and regulatory inertia. This paper explores the trajectory of cigarette warning labels, using the Public Health Cigarette Smoking Act of 1969 as a jumping off point for tracing the evolution of package warnings from their origin to the present. Particular consideration centers on how warning labels can be strengthened in the context of e-cigarettes through revisions to the current tobacco regulatory process.

Modern Theories of Product Warnings and European Product Liability Law

Scholars inside and outside Europe have recently argued that product liability law should recognise the sheer complexity of designing an adequate warning. In the US, for instance, it has been suggested that a plaintiff bringing a claim based on a defective warning should be required to prove which reasonable alternative warning would have prevented her from suffering harm. While much can be said in favour of a more refined approach to product warnings, these proposals are incompatible with many key characteristics of positive European product liability law as construed by the Court of Justice of the European Union. These scholars' recommendations invite us to reconsider some of the features of European product liability law and decide upon a direction for the future.

The Adolescent Label Impact Index in a Multicentric Observational Study. Have the Tobacco Advertisements an Impact on the Adolescents?

BackgroundPictorial warnings may contribute to lower attractiveness of smoking, particularly among adolescents. The present study compared the impact of two different label styles of tobacco product warnings (textual and pictorial) among adolescents in a new standardized way, using the Adolescent Label Impact Index (ALII).MethodsA school-based cross-sectional study was conducted. Adolescent aged 10–20 years completed an online questionnaire. The ALII score was used to assess the impact of only-textual (ALII-T) and pictorial advertisements (ALII-P).ResultsA total of 1,759 students (68.4% response-rate) declared that graphic warnings have a significant impact than textual ones (p < 0.05). The younger group, which has never smoked or just tried and believed in the harmful effects of tobacco, is associated with both scales of ALII scales (T and P) (p < 0.01). The socioeconomic status was associated with ALII-T (p < 0.01), but not ALII-P; female gender, smoker-peers, perception of the body weight are related to the ALII-P (p < 0.05) but not ALII-T.ConclusionsThe pictorial labels represent a policy of tobacco use control that has potential effects, in particular in reducing communication inequalities between socio-economic categories, reinforcing the knowledge about the damage of smoking, discouraging adolescents, especially the younger ones who do not have never smoked or have just tried to become smokers.Collaborative GroupSiriana Campioni, Department of Public Health and Infectious Disease, “Sapienza” University of RomeGabriele Castorina, Armando Platania, Specialization School of Hygiene and Preventive Medicine, Department “GF Ingrassia” Hygiene and Public Health, University of Catania, Italy;Ilenia Bellini, School of Specialization in Hygiene and Preventive Medicine, University of FlorenceOmar Enzo Santangelo, Specialization School of Hygiene and Preventive Medicine, Department of Sciences for Health Promotion and Mother and Child Care “Giuseppe D’Alessandro,” University of PalermoClara Ferrara, Department of Gynecology and Obstetrics Palermo Civic Hospital and National Center of Clinical Excellence (ARNAS Di Cristina-Benfratelli) Palermo, Italy.

Crying Wolf or Ever Vigilant: Do Wide-Ranging Product Warnings Increase or Decrease Sensitivity to Other Product Warnings?

Product safety warnings are pervasive in the marketplace. The frequency and, in some cases, content of such warnings has led some to speculate that the cumulative effects may undermine the efficacy of warnings in general—including that of different warnings for other products. According to the generalized desensitization hypothesis, numerous past warnings can cause consumers to react less strongly to safety warnings for other products subsequently encountered. In contrast, the literature on goal activation and compensatory consumer behavior suggests that any self-protective goals aroused by initial warnings can potentially generalize to increase awareness and safety precautions in other warning contexts, consistent with the generalized sensitization hypothesis. The authors tested both hypotheses by manipulating the number and strength of an initial set of product warnings and examining whether such exposure generalized to different product warnings. In support of the generalized sensitization prediction, prior warnings motivated appreciation of the risks communicated in a different warning context and increased relevant safety behaviors. These generalized sensitization effects were moderated by self-affirmation, supporting the prediction that they are driven by self-protective goals.

Use of Anti-Warnings to Falsely Reassure Downstream Users: An Asbestos Example

Product warnings are theoretically designed to reduce injuries associated with occupational, environmental, or consumer product exposures. Unfortunately, in an effort to protect sales, some companies have produced media and information to falsely reassure their customers about the risks associated with their products. These tactics have been termed "anti-warnings." We reviewed corporate documents uncovered in litigation alongside other historical publications to ascertain the types of anti-warnings used by Union Carbide Corporation (UCC) regarding their asbestos products. Our review finds that UCC went to great lengths to confuse their customers and make their particular asbestos product-which contained short-fiber, chrysotile asbestos-look safe. We discuss three primary communications methods UCC used: industry-produced publications, sales force direct communication with customers, and public speeches. These examples provide further insight into how corporations encourage uncertainty about the risks associated with their products. Understanding anti-warning methods is critical for the implementation of future policies that protect consumer, worker, and environmental health.

Unconvincing and ineffective: Young adult responses to current Australian alcohol product warnings

ObjectivePublic health literature suggests that alcohol warnings on products could be utilised to effectively communicate the risks of alcohol consumption. However, there is a lack of research regarding how consumers perceive such warnings. This qualitative study aimed to understand young adult drinkers’ perceptions of current voluntary Australian alcohol product warnings.MethodSix focus groups (n = 40) were conducted to examine impressions, reactions, and thoughts about current alcohol warnings on Australian products. Participants were alcohol‐consuming male and female (55%) university students from Victoria, Australia, aged 18–25-years (M = 20.54, SD = 2.17). Focus groups were video recorded, transcribed verbatim, and analysed thematically.ResultsThree broad themes emerged from the data: (1) participants’ lack of understanding of DrinkWise as an industry‐funded body; (2) a belief the warnings were too small, hard to find, vague, and conveyed weak messages; and (3) the current Australian warnings would not encourage them to change their drinking behaviour or to seek further information about the harms of alcohol.ConclusionsOur sample of current Australian young adults perceived the alcohol warning messages to be unconvincing and did not deter them from drinking to excess. These findings suggest that alcohol warnings need to be prominent on alcohol product labels, include images, and contain targeted messages.