Presence of unsafe chemical impurities, accelerated evaporation of alcohol, and lack of key labeling requirements are risks and concerns for some alcohol-based hand sanitizers and dispenser practices during the COVID-19 pandemic.

Alcohol-based hand sanitizers (ABHS) have been an important hand hygiene tool during the COVID-19 pandemic. Recently, ABHS from non-traditional drug manufacturers have entered the market, triggered by a lack of ABHS availability. Some of these ABHS contain high levels of chemical impurities that may be harmful with frequent exposure. Additionally, the use of refillable dispensers designed to accept ABHS from bulk containers allows for mixing and evaporation that may compromise ABHS integrity. To understand the risks associated with low quality ABHS and bulk refilling practices, we collected 77 ABHS samples sourced from community settings (restaurants, grocery stores, etc.) and 40 samples from a single school district. All samples were obtained from bulk refillable dispensers that were in use. Samples were analyzed for alcohol content, chemical impurities, aesthetic qualities, and presence of drug labeling information. Additionally, we performed laboratory-based experiments to determine the impact of dispenser design on alcohol evaporation rates. Over 70% of samples for which photos were available showed lack of essential labeling information, including missing "Drug Facts Labels". For ABHS samples acquired from community settings, nearly 14% of samples had visible impurities, and over 30% of samples had concentrations of acetal and acetaldehyde in excess of FDA interim limits. Subpotent ethanol concentrations were observed in 9.09% and 82.05% of samples from community settings and the school district, respectively, with the school district sample results being associated with dispenser misuse. Laboratory-based experiments show dispenser design significantly impacts the rate of ethanol evaporation of ABHS products, especially if stored in open refillable dispensers without an internal reservoir. This study demonstrates risks associated with use of inferior ABHS and bulk refilling practices. Regulatory agencies should issue guidance on best practices in community settings to ensure the integrity of ABHS as an essential public health tool to prevent the spread of COVID-19 and other transmissible diseases.

Health Warning Label Compliance for Smokeless Tobacco Products and Bidis in Five Indian States.

BACKGROUND: The burden of tobacco use In India is very high. To inform users of harm, India has a strong health warning label law that applies to all tobacco products. This study examines the extent of compliance of health warning labels on smokeless tobacco (SLT) and bidi products with the Indian law. METHODS: In 2017, a systematic protocol was used to collect unique SLT and bidi packages from five Indian states. To assess compliance, we used three indicators: location, label elements, and warning size. RESULTS: Only 1% of the 133 SLT products and none of the 32 bidi packs were compliant with all three compliance indicators. Other compliance-related issues included non-standardized packaging, incomplete health warning labels, poor printing quality, and old warning labels. CONCLUSION: There is very poor compliance with the health warning label law on bidi and SLT products. India needs to regularly monitor and address implementation to ensure that warning labels are effective.

Exploring the Point-of-Sale Among Vape Shops Across the United States: Audits Integrating a Mystery Shopper Approach.

INTRODUCTION: Vape shops represent prominent, unique retailers, subject to Food and Drug Administration (FDA) regulation in the United States. AIMS AND METHODS: This study assessed compliance of US vape shop retail marketing strategies with new regulations (eg, required age verification, prohibited free samples) and pre-implementation conditions for other regulations (eg, health warning labels on all nicotine products, required disclosures of e-liquid contents). RESULTS: 95.0% of shops displayed minimum-age signage; however, mystery shoppers were asked for age verification at 35.6% upon entry and at 23.4% upon purchase. Although 85.5% of shops had some evidence of implementing FDA health warnings, 29.1% had signage indicating prohibited health claims, 16.3% offered free e-liquid samples, 27.4% had signage with cartoon imagery, and 33.3% were within two blocks of schools. All shops sold open-system devices, 64.8% sold closed-system devices, 68.2% sold their own brand of e-liquids, 42.5% sold e-liquids containing cannabidiol, 83.2% offered price promotions of some kind, and 89.9% had signage for product and price promotions. CONCLUSIONS: Results indicated that most shops complied with some implementation of FDA health warnings and with free sampling bans and minimum-age signage. Other findings indicated concerns related to underage access, health claims, promotional strategies, and cannabidiol product offerings, which call for further FDA and state regulatory/enforcement efforts.

The Unintended Consequences of Adverse Event Information on Medicines' Risks and Label Content.

Patients and prescribers need to be aware of adverse drug events to minimize the risk of their occurrence and the severity with which they appear. However, numerous studies show that being informed about adverse events can increase the possibility of suffering from them. Patients tend to overestimate the likelihood of experiencing the adverse events included in the label, and this can contribute to worsening the negative expectations which are at the root of the nocebo effect. In fact, patients can become anxious after reading the undesirable effects section of the leaflet and, in addition to suffering from the nocebo effect, might not take a drug they could benefit from due to the fear of experiencing adverse events. In addition, patients' attention can focus towards non-specific symptoms of daily living that can be misattributed to the drug and included in the labelling. This article proposes a number of suggestions to reduce the abovementioned unintended effects associated with labelling, namely, an increased focus on the excess risk of experiencing adverse events rather than crude incidence, using attribute framing to help patients to better understand the risk of experiencing adverse events, dividing the undesirable effect section of the leaflet into subsections according to the level of evidence supporting causal relationships and, finally, restricting the addition of non-specific adverse events that are also symptoms of daily living to only those where there is enough evidence to show they have been caused by the drug. More studies on how to minimize the nocebo effect induced by adverse event information should be performed, and these should be done in collaboration with health authorities, to reach a shared consensus on how to better present adverse event information in the label.

Visual Attention to the Use of #ad versus #sponsored on e-Cigarette Influencer Posts on Social Media: A Randomized Experiment.

Youth and young adults are the largest consumers of social media content. Individuals with large followers are paid to share social media content using specific products for compensation. This type of activity is considered commercial sponsorship and requires a disclosure in order to comply with Federal Trade Commission regulations. Between July and August 2019, youth and young adult (ages 16-24; n = 200) participants were recruited into an eye-tracking laboratory to view their native Instagram feed on a mobile device where a set of posts from e-cigarette influencers were inserted with one of the two potential labeling strategies: #ad and #sponsored. Participants spent an average of 6.6 seconds viewing e-cigarette influencer posts. Youth and young adults spent 3.1 seconds on the area labeled #ad, compared to 2.2 seconds on the area of interest labeled #sponsored (p = .03). After accounting for age, current tobacco use, and dependence, #ad drew 0.93 seconds more than #sponsored on influencer posts (p = .02). Both labeling strategies drew visual attention to Instagram e-cigarette influencer posts, with nearly 1 second more attention paid to the presence of #ad. Labeling commercially sponsored content on social media is a viable strategy to attract the attention of youth and young adults.

Are over-the-counter fish oil supplements safe, effective and accurate with labelling? Analysis of 10 New Zealand fish oil supplements.

AIM: Fish oil supplements are regulated in New Zealand under the Dietary Supplement Regulations (Section 42, Food Act 1981) and therefore are not subject to the same level of scrutiny and regulations as medicines. We investigated accuracy of labelling, stated health benefits of fish oil supplements sold in New Zealand, and risks relating to possible mercury content. METHOD: The amounts of omega-3 fatty acids contained per capsule were determined by an independent laboratory using gas chromatography on 10 of the most popular over-the-counter fish oil supplements sold in New Zealand and were compared with amounts stated on product labels. Information on doses recommended to achieve a specific health benefit were taken from the 10 labels as well as the company websites. These recommended doses were compared with published recommended doses identified as being effective in those health areas stipulated on the labels, based on either systematic reviews, meta-analyses and/or consensus statements. Mercury was analysed by an independent laboratory using inductively coupled plasma mass spectrometry. RESULTS: The actual amounts of EPA and DHA per capsule in 90% of the over-the-counter fish oil supplements analysed were within 10% of the amount stated on the product labels. Only one product was greater than 10% below the stated dose on the label. All products suggested benefit across heart, brain and joint health and all but two products stated a range of capsules required to achieve that health benefit (eg, 2-6 capsules). Based on the maximum number of capsules recommended (which ranged from 3-6 capsules), only three products would likely confer the dose identified as optimal for achieving a health benefit across all three health areas. Only two products recommended doses that would likely confer a health benefit both at the minimum and maximum number of capsules. More products would likely benefit brain and heart health than joint health. Mercury was not detected in any sample. CONCLUSIONS: It is reassuring that the doses of 90% of the products were accurate and that mercury was not detected in any sample; however, less than a third of the supplements would likely confer all the health benefits stated, even at the highest recommended daily doses. This paper has highlighted the ongoing challenges associated with the regulation of "health claims" associated with dietary supplements in New Zealand. Indeed, the literature on health effects is contradictory at best. Clearer definitions of the types of health statements that can be made and the research necessary to support them requires regulatory clarification.

Reactions to Standardized Cigarette Packs With Varying Structural Designs, and the Association With Smoking Susceptibility: A Postimplementation Cross-Sectional Survey With Never-Smoking Adolescents in Scotland.

INTRODUCTION: From May 20, 2017, cigarettes in the United Kingdom must be sold in standardized (plain) packaging. We explore postimplementation reactions to standardized cigarette packaging among never-smokers in Scotland, whether reactions vary in relation to permitted variations in pack structure, and whether reactions are associated with susceptibility. AIMS AND METHODS: A cross-sectional survey with 12-17-year-old never-smokers (n = 507) in Scotland, conducted November 2017-November 2018. Participants were shown one "regular" standardized cigarette pack (flip-top lid and straight-edged pack, similar to designs in Australia) and three standardized packs with varied pack structures (beveled-edges, slim pack, and shoulder box), which are permitted postimplementation in the United Kingdom. Participants rated each pack on eight five-point reaction measures (eg, attractiveness). Participants also indicated which pack, if any, they would choose. Smoking susceptibility was the outcome. RESULTS: The mean reaction scores for all four packs were mostly negative, however the shoulder box was consistently rated less negatively than the regular, slim, or beveled-edge packs. Most participants (87%) said they would not select any of the four packs, although susceptible participants were more likely to select one than nonsusceptible participants (25% vs. 7%; χ 2 = 29.70; p < .001). For all four packs, not finding them off-putting was associated with susceptibility (Adjusted Odds Ratio range: 2.73-3.69), albeit only a minority of adolescents did not find each pack off-putting. CONCLUSIONS: Adolescents have negative reactions to the standardized cigarette packs implemented in the United Kingdom, albeit permitted variations in structure can reduce the extent of negativity. Most reactions to standardized packaging had no association with susceptibility. IMPLICATIONS: We provide the first empirical evidence that adolescents find the standardized cigarette packs implemented in the United Kingdom unappealing and that most pack reactions have no association with susceptibility among never-smokers, with the exception of the minority who did not think that they would put them off smoking. This suggests that the legislation is achieving one of its primary aims, to reduce the appeal of packaging. That permitted variations in pack structure (eg, shoulder boxes) somewhat reduce negative reactions suggests that the United Kingdom, and other countries introducing similar legislation, should ensure that all aspects of pack design are fully standardized.

Content versus Label Claims in Cannabidiol (CBD)-Containing Products Obtained from Commercial Outlets in the State of Mississippi.

Products containing cannabidiol (CBD) are now available throughout the United States, but their quality is oftentimes questionable. The CBD and Δ9-tetrahydrocannabinol (THC) content of 25 commercially available hemp oil products, obtained throughout the state of Mississippi, was determined via gas chromatography/flame ionization detection (GC/FID). These products were also analyzed for the presence of synthetic cannabinoids using full scan gas chromatography/mass spectrometry (GC/MS). Analytical findings were compared to label claims for CBD content. Product label claims for CBD ranged from no claim to 500 mg per serving; however, marked variability was observed between actual CBD content and claimed quantities. Of the 25 products, only three were within ±20% of label claim. Fifteen were well below the stated claim for CBD; two exceed claims in excess of 50%; and 5 made no claims. In addition, THC content for three products exceeded the 0.3% legal limit. Furthermore, four products-primarily marketed for vaping-were adulterated with synthetic cannabinoids. From this small, but diverse, sampling of hemp-derived merchandise, it appears that most product label claims do not accurately reflect actual CBD content and are fraudulent in that regard. Moreover, products that exceed legal THC levels may jeopardize a consumer's employment status (i.e. failed "drug test"), while those adulterated with synthetic cannabinoids may subject them to serious adverse health effects. These findings argue strongly for further development of current good manufacturing practices for CBD-containing products and their stringent enforcement.

Regulating hearing aid compatibility of cell phones: results from a national survey.

Accessibility of telecommunication technologies by people who are deaf or hard of hearing has been a critical issue since the invention of the telephone. As both telephone and hearing-aid technologies have evolved, finding compatible solutions has been an ongoing challenge. This paper uses the findings of a longitudinal study to examine the impact of Federal hearing-aid compatibility (HAC) regulations in resolving this problem. The study ran concurrently with the phase-in of Federal Communications Commission regulations requiring that mobile handset manufacturers and wireless service providers make available minimum numbers of cell phones with shielding to reduce electromagnetic interference when cell phones are positioned close to a hearing aid user's ear. These regulations also require package labeling and printed information to assist buyers in selecting a hearing-aid compatible phone. The survey presented here focused on changes in satisfaction with sound quality and ease of finding a hearing-aid compatible mobile handset. Data analysis suggests that the regulations have had limited success, and problems persist for consumers in locating a hearing aid compatible phone. The FCC has requested input on more stringent hearing-aid compatibility requirements; study findings suggest that these changes are not likely to remedy the problem.

Communicating the relative health risks of E-cigarettes: An online experimental study exploring the effects of a comparative health message versus the EU nicotine addiction warnings on smokers' and non-smokers' risk perceptions and behavioural intentions.

INTRODUCTION: This study investigated the effects of the European Union Tobacco Products Directive [EU-TPD] Article 20 E-cigarette (EC) health warnings ("This product contains nicotine which is a highly addictive substance. [It is not recommended for non-smokers.]") and a comparative harm message ("Use of this product is much less harmful than smoking" [COMP]) on smokers' and non-smokers' perceptions and behavioural intentions. METHODS: 2495 UK residents (1283 smokers and 1212 non-smokers) self-reported perceived harm, addictiveness, EC effectiveness, social acceptability, and intentions to purchase and use EC, and in smokers, intentions to quit and intentions to use EC in future quit attempts. These were measured before and after exposure to EC images containing either the TPD, COMP, TPD + COMP or no message. RESULTS: Non-smokers had higher harm, addictiveness and lower social acceptability perceptions. TPD presence increased, whilst COMP decreased, harm and addictiveness perceptions in both groups. For smokers only, harm perceptions were lower following exposure to COMP alone vs. no message. For non-smokers the TPD increased harm perceptions vs. no message. There were no effects on social acceptability, EC effectiveness or use intentions. In smokers only, purchase and quit intentions were higher following exposure to the COMP alone. CONCLUSION: TPD messages may be effective smoking prevention tools, although the COMP message was more effective in reducing harm perceptions and increasing use intentions in smokers. That COMP did not increase use intentions in non-smokers suggest that such exposures may potentially act as an effective harm reduction tool without resulting in increased uptake among non-smokers.

The Federal Trade Commission's mandated Four Loko labeling fails to facilitate accurate estimation of alcohol content by college students.

BACKGROUND: Four Loko, the leading supersized alcopop brand, is a pre-mixed alcoholic beverage containing up to 5.5 standard alcoholic drinks in a can. In 2013, the Federal Trade Commission (FTC) mandated the addition to Four Loko cans of a label indicating its alcohol content in standard drinks, presented as "alcohol per serving" and "servings per container." OBJECTIVE: The current study investigated whether college students accurately estimate the alcohol content in cans of Four Loko bearing the FTC mandated labels. METHOD: Undergraduate student drinkers (n = 833; 51.6% women) in three states (Florida, Montana, and Virginia) were provided an empty Watermelon Four Loko can and asked to determine the number of standard drinks it contained, using 12-ounce regular beer (Budweiser) equivalents. In Florida and Virginia, Watermelon Four Loko contains 4.70 standard alcoholic drinks; in Montana, it contains 3.13. RESULTS: More than 60% of Florida students and more than 70% of Virginia students underestimated Four Loko's alcohol content by one or more standard drinks, compared to 45% of Montana students. Multivariable logistic regression analysis found the following variables were associated with greater odds of underestimating Four Loko's alcohol content by one or more standard alcoholic drinks: being female (AOR = 2.2), having never seen nor heard of Four Loko (AOR = 1.9), and residing in Florida (AOR = 1.7) or Virginia (AOR = 2.8) versus Montana. CONCLUSIONS: Students were far less likely to underestimate alcohol content for 8% alcohol-by-volume (abv) cans compared to those with higher alcohol concentrations. Thus, policies restricting supersized alcopops' abv may help consumers better estimate their alcohol content.

The Effectiveness of Cigarette Pack Health Warning Labels with Religious Messages in an Urban Setting in Indonesia: A Cross-Sectional Study.

This study sought to assess the effectiveness of religious cigarette health warning labels (HWLs) in Indonesia, a country with a high public health burden from tobacco use. The study tested different religious and nonreligious messages related to suicide, secondhand smoke (SHS) and gangrene. Participants were smokers and non-smokers from Surabaya, Indonesia (n = 817). Participants rated each HWL for its effectiveness on a scale of 1 to 10 (1 = "not at all", 10 = "extremely") with respect to 10 items. Nonreligious HWLs were marginally superior for SHS and suicide while religious HWLs were marginally superior for gangrene. Given the close rating scores between religious and nonreligious HWLs, they were functionally equal in effectiveness. With proper assessment of potential unintended consequences, the implementation of religious HWLs could be considered for a proportion of HWLs.

Adolescent Attention to Disgust Visuals in Cigarette Graphic Warning Labels.

PURPOSE: Adolescents are often a target audience for disgust-eliciting antismoking messages, including graphic warning labels (GWLs) on cigarette packages. Yet, few studies have examined how adolescents attend and respond to disgust imagery frequently depicted in these messages. METHODS: A within-subjects eye-tracking experiment with middle school youth (N = 436) examined attention for GWLs that feature disgust versus nondisgust images. Hypotheses were based on emotion theory and previous findings with adult participants. This study also tested whether living with a smoker moderated effects of attention on negative emotions and risk beliefs. RESULTS: Participants paid similar levels of attention to warnings with disgust visuals as they did warnings with nondisgust visuals, accounting for other differences in the warnings. The presence of a disgust visual drew greater attention to the warning image and reduced attention for the warning text. These viewing patterns were similar for youth who live with a smoker and those who do not. Attention to disgust imagery was the only attentional factor to predict negative emotional reactions, and this relationship was driven by results observed among youth who live with a smoker. Attention to neither image nor text predicted risk beliefs. CONCLUSIONS: GWLs with disgust imagery do not trigger more or less attention to the overall warnings but do influence allocation of attention to images over text. Future work should confirm whether attention to disgust imagery itself is important for triggering negative emotional responses, particularly with youth for whom the message is more personally relevant.

Graphic Warning Labels Affect Hypothetical Cigarette Purchasing Behavior among Smokers Living with HIV.

Cigarette pack graphic warning labels (GWLs) are associated with increased knowledge of tobacco-related harms; scant research has evaluated their effects on behavior among vulnerable populations. We used a behavioral economic approach to measure the effects of GWLs and price on hypothetical cigarette purchasing behavior among HIV-positive smokers. Participants (n = 222) completed a cigarette valuation task by making hypothetical choices between GWL cigarette packs at a fixed price ($7.00) and text-only warning label cigarette packs at increasing prices ($3.50 to $14.00; $0.25 increments). More than one-quarter (28.8%) of participants paid more to avoid GWLs. The remaining participants' purchasing decisions appear to have been driven by price: 69.8% of participants chose the cheaper pack. Across all participants, overall monetary choice value observed for GWL cigarette packs (mean = $7.75) was greater than if choice was driven exclusively by price ($7.00). Most (87.4%) preferred the text-only warning label when GWL and text-only cigarette packs were equally priced. Correlation analysis indicated GWL pack preference was associated with agreement with statements that GWLs would stop individuals from having a cigarette or facilitate thoughts about quitting. These data suggest that GWLs may influence some HIV-positive smokers in such a way that they are willing to pay more to avoid seeing GWLs.

Patient-Reported Outcomes in Orphan Drug Labels Approved by the US Food and Drug Administration.

OBJECTIVES: In recent years, there has been increasing recognition of the need to assess treatment benefit from the patient's perspective. The extent of patient-reported outcome (PRO) data included in labeling for rare disease treatment is largely unknown. The objective of this study was to review trends over time for PRO-based labeling granted by the US Food and Drug Administration (FDA) for orphan drugs. STUDY DESIGN: Review of FDA package inserts. METHODS: Products included in this analysis were all new molecular entities (NMEs) and biologic license applications (BLAs) with orphan designations approved by the FDA from 2002 through 2017. For identified products, package inserts were reviewed to determine the number and type of PRO claim(s) granted, endpoint status, and PRO measure named. Two trends were analyzed: (1) over all years 2002 to 2017 and (2) 2002 to 2017 stratified into 3 periods (before draft FDA PRO guidance [2006], between draft and final guidance release, and after final guidance [2009] release. RESULTS: A total of 156 NMEs and BLAs with orphan designations were approved between 2002 and 2017. Of these, 13 products (8.3%) had PRO-based labeling, and 7 of 13 were symptom-related. The percent of orphan drugs approved with PRO-based labeling between 2002 and 2005, 2006 and 2008, and 2009 and 2017 was 0, 10.5, and 9.9, respectively. CONCLUSIONS: In FDA-approved labeling for orphan therapies, PRO measures used as primary and secondary endpoints increased after draft FDA PRO guidance release but remained relatively low thereafter. It is important to understand barriers to PRO measure use to ensure that treatments capture perspectives of patients with rare diseases.

Emotional salience of the image component facilitates recall of the text of cigarette warning labels.

Background: Graphic warning labels (GWLs) on cigarette packages, that combine textual warnings with emotionally salient images depicting the adverse health consequences of smoking, have been adopted in most European countries. In the US, the courts deemed the evidence justifying the inclusion of emotionally salient images in GWLs insufficient and put the implementation on hold. We conducted a controlled experimental study examining the effect of emotional salience of GWL's images on the recall of their text component. Methods: Seventy-three non-treatment-seeking daily smokers received cigarette packs carrying GWLs for a period of 4 weeks. Participants were randomly assigned to receive packs with GWLs previously rated as eliciting high or low level of emotional reaction (ER). The two conditions differed in respect to images but used the same textual warning statements. Participants' recognition of GWL images and statements were tested separately at baseline and again after the 4-week repetitive exposure. Results: Textual warning statements were recognized more accurately when paired with high ER images than when paired with low ER images, both at baseline and after daily exposure to GWLs over a 4-week period. Conclusion: The results suggest that emotional salience of GWLs facilitates cognitive processing of the textual warnings, resulting in better remembering of the information about the health hazards of smoking. Thus, high emotional salience of the pictorial component of GWLs is essential for their overall effectiveness.

Graphic health warnings on tobacco packets and containers: compliance status in Bangladesh.

OBJECTIVE: This study describes and analyses compliance with tobacco product graphic health warning (GHW) legislation introduced in Bangladesh in March 2016. METHODS: A survey based on a structured questionnaire was conducted in April 2016 (immediately following the law coming into force), and 8 months later in November 2016, in eight divisional cities in Bangladesh. Five stores from three categories of retailers of combustible and smokeless tobacco products were surveyed, providing a total of 120 completed questionnaires. The study investigated a range of measures including the image and text of GHW, their ratio and colour use, and prescribed rotation. FINDINGS: Warning labels for 3312 tobacco items were assessed. In April 2016, 75% of tobacco products surveyed did not have GHWs. In November 2016, 19% were still found to not have the prescribed warnings. Even among products which did include GHW, there was significant non-compliance with the full range of requirements, in both survey periods. Compliance was highest for cigarette packets and lowest among smokeless tobacco products. In addition, awareness among tobacco retailers about the range of GHW requirements was low. CONCLUSION: Effective implementation of GHW labels in low-income and middle-income countries requires awareness-raising among key stakeholders, combined with focused monitoring and compliance strategies. This should take into account different product categories and manufacturers, as well as measures targeted at retailers.

All Aboard Meal Train: Can Child-Friendly Menu Labeling Promote Healthier Choices in Hospitals?

OBJECTIVE: To evaluate patient meal orders and consumption with a revised menu design that includes child-friendly labeling. STUDY DESIGN: A randomized controlled trial among hospitalized children was performed over a 1-month period comparing the control menu layout and the intervention menu. The intervention menu contained the same choices but was labeled to encourage healthy eating. Children on a specialized diet, receiving parenteral nutrition, or age <2 years were excluded. RESULTS: A total of 163 patients (81 males) were included, with a mean age of 9.9 ± 5.1 year, and a mean weight z-score of -0.08 ± 1.3. Children receiving the intervention ordered more "green-light" healthy choices and fewer "red-light" items, with 0.65 lower odds of selecting a red-light item (95% CI, 0.55-0.76) and 1.75 higher odds of selecting a green-light item (95% CI, 1.49-2.04), both at the first meal, but with effects waning over time. There were trends toward increased intake of fruits and vegetables and decreased intake of "foods to limit", but no impact on the consumption of sugar-sweetened beverages. Both intervention and control group consumed their meals in equal proportions. CONCLUSIONS: The combination of menu labeling techniques targeted to children in the inpatient hospital setting was an effective short-term tool for increasing the intake of healthier foods, although the effect of labeling waned over time. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02692001.

Which type of tobacco product warning imagery is more effective and sustainable over time? A longitudinal assessment of smokers in Canada, Australia and Mexico.

OBJECTIVE: This study examined smokers' responses to pictorial health warnings (PHWs) with different types of imagery under natural exposure conditions. METHODS: Adult smokers from online panels in Canada (n=2357), Australia (n=1671) and Mexico (n=2537) were surveyed every 4 months from 2012 to 2013. Participants were shown PHWs on packs in their respective countries and asked about: (1) noticing PHWs; (2) negative affects towards PHWs; (3) believability of PHWs; (4) PHW-stimulated discussions; and (5) quit motivation due to PHWs. Country-specific generalised estimating equation models regressed these outcomes on time (ie, survey wave), PHW imagery type (ie, symbolic representations of risk, suffering from smoking and graphic depictions of bodily harm) and interactions between them. RESULTS: In all countries, PHW responses did not significantly change over time, except for increased noticing PHWs in Canada and Mexico, increased negative affect in Australia and decreased negative affect in Mexico. For all outcomes, symbolic PHWs were rated lower than suffering and graphic PHWs in Canada (the only country with symbolic PHWs). Graphic PHWs were rated higher than suffering PHWs for negative affect (all countries), discussions (Canada) and quit motivation (Australia). Suffering PHWs were rated higher than graphic PHWs for noticing PHWs (Canada), believability (all countries), discussions (AustraliaandMexico) and quit motivation (Mexico). Changes in noticing, believability and discussions varied somewhat by imagery type across countries. CONCLUSIONS: The different PHW imagery appears to have different pathways of influence on adult smokers. Reactions to specific PHWs are similar over 1-2 years, suggesting that wear-out of PHW effects is due to decreased attention rather than the diminishing effectiveness of content.