Label Accuracy of Legal Oral Cannabis Oil Products in Ontario, Canada.

This case series compares amounts of tetrahydrocannabinol and cannabidiol reported on product labels vs levels found in laboratory testing in legal oral cannabis oil products in Ontario, Canada.

Examining labelling guidelines for AI-based software as a medical device: A review and analysis of dermatology mobile applications in Australia.

In recent years, there has been a surge in the development of AI-based Software as a Medical Device (SaMD), particularly in visual specialties such as dermatology. In Australia, the Therapeutic Goods Administration (TGA) regulates AI-based SaMD to ensure its safe use. Proper labelling of these devices is crucial to ensure that healthcare professionals and the general public understand how to use them and interpret results accurately. However, guidelines for labelling AI-based SaMD in dermatology are lacking, which may result in products failing to provide essential information about algorithm development and performance metrics. This review examines existing labelling guidelines for AI-based SaMD across visual medical specialties, with a specific focus on dermatology. Common recommendations for labelling are identified and applied to currently available dermatology AI-based SaMD mobile applications to determine usage of these labels. Of the 21 AI-based SaMD mobile applications identified, none fully comply with common labelling recommendations. Results highlight the need for standardized labelling guidelines. Ensuring transparency and accessibility of information is essential for the safe integration of AI into health care and preventing potential risks associated with inaccurate clinical decisions.

Warning Labels as a Public Health Intervention: Effects and Challenges for Tobacco, Cannabis, and Opioid Medications.

Warning labels help consumers understand product risks, enabling informed decisions. Since the 1966 introduction of cigarette warning labels in the United States, research has determined the most effective message content (health effects information) and format (brand-free packaging with pictures). However, new challenges have emerged. This article reviews the current state of tobacco warning labels in the United States, where legal battles have stalled pictorial cigarette warnings and new products such as electronic cigarettes and synthetic nicotine products pose unknown health risks. This article describes the emerging research on cannabis warnings; as more places legalize recreational cannabis, they are adopting lessons from tobacco warnings. However, its uncertain legal status and widespread underestimation of harms impede strict warning standards. The article also reviews opioid medication warning labels, suggesting that lessons from tobacco could help in the development of effective and culturally appropriate FDA-compliant opioid warning labels that promote safe medication use and increased co-dispensing of naloxone.

Chemical analysis of fresh and aged Australian e-cigarette liquids.

OBJECTIVES: To assess the chemical composition of electronic cigarette liquids (e-liquids) sold in Australia, in both their fresh and aged forms. DESIGN, SETTING: Gas chromatography-mass spectrometry analysis of commercial e-liquids sold in Australia (online and physical stores). MAIN OUTCOME MEASURES: Chemical composition of 65 Australian e-liquids - excipients/solvents, flavouring chemicals, other known e-liquid constituents (including nicotine), and polycyclic aromatic hydrocarbons - before and after an accelerated ageing process that simulated the effects of vaping. RESULTS: The measured levels of propylene glycol and glycerol often diverged from those recorded on the e-liquid label. All e-liquids contained one or more potentially harmful chemicals, including benzaldehyde, menthol, trans-cinnamaldehyde, and polycyclic aromatic hydrocarbons. Nicotine or nicotyrine were detected in a small proportion of e-liquids at extremely low concentrations. CONCLUSIONS: Australian e-liquids contain a wide variety of chemicals for which information on inhalation toxicity is not available. Further analyses are required to assess the potential long term effects of e-cigarette use on health.

Sunscreen Secondary Claims: Market Differentiation or Market Confusion?

This chapter is focused on those products that are sold primarily as sun protection products and considers the additional claims made for these that are intended to differentiate and imply additional benefits. It is essentially an overview, as each claim would require an individual chapter to deal with in detail. We do not consider products with another intended primary use, such as moisturizer or colour comments, which are, in themselves "secondary sunscreens," defined specifically in Australia [AS/NZS 2604:2012 Sunscreen products - Evaluation and classification] or Canada. Primarily, the chapter serves as a reference guide. An argument is presented for the potential negative impact on the credibility of the whole product category brought about by the marketing strategy of attempting to segment on the basis of either criticism of competitor products and/or targeting niche groups of consumers. The European Union (EU) Regulation 655/2013 [Commission Regulation (EU) No 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products] states 6 criteria for representation of products. These are Legal Compliance, Truthfulness, Evidential Support, Honesty, Fairness and Informed Decision Making. More specifically to sunscreens, the EU Synthesis Document makes recommendation on efficacy and related claims [European Union Synthesis Document - Commission recommendation on the efficacy of sunscreen products and claims related thereto]. This chapter does not consider or test these criteria but does include a table of claims and suggested ways to substantiate these.

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.

Tobacco Industry Fingerprints on Delaying Implementation of Pictorial Health Warnings in the Western Pacific.

OBJECTIVE: This case series describes tobacco industry tactics and strategies used to interfere, derail, delay, and weaken the development of effective health warning regulations in Malaysia, Cambodia, the Philippines, and Hong Kong. METHODS: A historical review of official reports, news articles, and gray literature was undertaken to identify tobacco industry tactics and strategies to hamper government efforts in implementing stronger pictorial health warning regulations in four Asian jurisdictions (Cambodia, Hong Kong, Malaysia, and the Philippines). RESULTS: Nineteen countries/jurisdictions in the WHO Western Pacific region currently require pictorial health warnings on cigarette packs, including some of the world's largest, in line with the WHO Framework Convention on Tobacco Control Article 11 Guidelines. In the four jurisdictions examined, tobacco industry interference consisted of lobbying and misinformation of high-level government officers and policy-makers, distributing industry-friendly legislative drafts, taking government to court, challenging government timelines for law implementation, and mobilizing third parties. Strong political leadership and strategic advocacy enabled governments to successfully overcome this industry interference. CONCLUSION: The tobacco industry uses similar tactics in different jurisdictions to derail, delay, and weaken the implementation of effective health warning policies. Identifying and learning from international experiences can help anticipate and defeat such challenges.

Health and Economic Impact of Health Warnings and Plain Tobacco Packaging in Seven Latin American Countries: Results of a Simulation Model.

INTRODUCTION: The burden of disease attributable to tobacco use in Latin America is very high. Our objective was to evaluate the 10-year potential impact of current legislation related to cigarette packaging and warnings and expected effects of moving to a higher level of strategies implementing cigarette plain packaging on health and cost outcomes in Argentina, Bolivia, Brazil, Chile, Colombia, Mexico, and Peru, using a microsimulation model. AIMS AND METHODS: We used a probabilistic state-transition microsimulation model, considering natural history, costs, and quality of life losses associated with main tobacco-related diseases. We followed up individuals in hypothetical cohorts and calculated health outcomes annually to obtain aggregated long-term population health outcomes and costs. We performed a literature review to estimate effects and analyzed studies and information from ministries, relevant organizations, and national surveys. We calibrated the model comparing the predicted disease-specific mortality rates with local statistics. RESULTS: Current graphic warnings already in place in each country could avert, during 10 years, 69 369 deaths and 638 295 disease events, adding 1.2 million years of healthy life and saving USD 5.3 billion in the seven countries. If these countries implemented plain packaging strategies, additional 155 857 premature deaths and 4 133 858 events could be averted, adding 4.1 million healthy years of life and saving USD 13.6 billion in direct health care expenses of diseases attributable to smoking. CONCLUSIONS: Latin American countries should not delay the implementation of this strategy that will alleviate part of the enormous health and financial burden that tobacco poses on their economies and health care systems. IMPLICATIONS: Tobacco smoking is the single most preventable and premature mortality cause in the world. The Framework Convention on Tobacco Control, supported by the World Health Organization, introduced a package of evidence-based measures for tobacco control. This study adds evidence on the potential health effects and savings of implementing cigarette plain packaging in countries representing almost 80% of the Latin American population; findings are valuable resources for policy makers in the region.

Baseline Assessment of Alcohol-Related Knowledge of and Support for Alcohol Warning Labels Among Alcohol Consumers in Northern Canada and Associations With Key Sociodemographic Characteristics.

OBJECTIVE: Evidence-informed alcohol warning labels (AWLs) are a promising, well-targeted strategy to increase consumer awareness of health risks. We assessed consumers' baseline knowledge of alcohol-related cancer risk, standard drinks, and low-risk drinking guidelines as well as levels of support for AWLs. We further assessed associations with sociodemographic factors. METHOD: Forming part of a larger study testing new evidence-informed AWLs in a northern Canadian territory compared with a neighboring territory, baseline surveys were completed among liquor store patrons systematically selected in both sites. Chi-square and multivariable logistic regression analyses were performed to assess outcomes. RESULTS: In total, 836 liquor store patrons (47.8% female) completed baseline surveys across both sites. Overall, there was low knowledge of alcohol-related cancer risk (24.5%), limited ability to calculate a standard drink (29.5%), and low knowledge of daily (49.5%) and weekly (48.2%) low-risk drinking guideline limits. There was moderate support for AWLs with a health warning (55.9%) and standard drink information (51.4%), and lower support for low-risk drinking guideline labels (38.7%). No sociodemographic characteristics were associated with cancer knowledge. Identifying as female and having adequate health literacy were associated with support for all three AWLs; high alcohol use was associated with not supporting standard drink (adjusted odds ratio = 0.60, 95% CI [0.40, 0.88]) and low-risk drinking guideline (adjusted odds ratio = 0.57, 95% CI [0.38, 0.87]) labels. CONCLUSIONS: Few consumers in this study had key alcohol-related health knowledge; however, there was moderate support for AWLs as a tool to raise awareness. Implementation of information-based interventions such as evidence-informed AWLs with health messages including alcohol-related cancer risk, standard drink information, and national drinking guidelines is warranted.

Testing Alcohol Labels as a Tool to Communicate Cancer Risk to Drinkers: A Real-World Quasi-Experimental Study.

OBJECTIVE: This study tested the initial and continued effects of cancer warning labels on drinkers' recall and knowledge that alcohol can cause cancer. METHOD: A quasi-experiment was conducted to examine changes in the intervention versus comparison site for three outcomes: unprompted and prompted recall of the cancer warning, and knowledge that alcohol can cause cancer. The intervention site applied cancer warning labels to alcohol containers in its liquor store for 1 month, and the two liquor stores in the comparison site did not apply cancer labels. In total, 2,049 unique cohort participants (1,056 male) were recruited at liquor stores in the intervention and comparison sites to participate in surveys 4 months before labels were applied and 2 and 6 months after the cancer label was halted because of alcohol industry interference. Generalized estimating equations tested differences in outcomes between sites over time adjusting for socio-demographics and other covariates. RESULTS: Two months after the cancer label, unprompted (+24.2% vs. +0.6%; adjusted odds ratio [AOR] = 32.7, 95% CI [5.4, 197.7]) and prompted (+35.7% vs. +4.1%; AOR = 6.2, 95% CI [3.6, 10.9]) recall increased to a greater extent in the intervention versus comparison site. There was a 10% greater increase in knowledge (+12.1% vs. +11.6%; AOR = 1.1, 95% CI [0.7, 1.5]) 2 months after the cancer label in the intervention versus comparison site. Similar results were found 6 months after the cancer label for all three outcomes. CONCLUSIONS: In a real-world setting, cancer warning labels get noticed and increase knowledge that alcohol can cause cancer. Additional cancer label intervention studies are required that are not compromised by industry interference.

Examining the Impact of Alcohol Labels on Awareness and Knowledge of National Drinking Guidelines: A Real-World Study in Yukon, Canada.

OBJECTIVE: Alcohol labels are one strategy for communicating health information to consumers. This study tested the extent to which consumers recalled alcohol labels with national drinking guidelines and examined the impact of labels on awareness and knowledge of the guidelines. METHOD: A quasi-experimental study was conducted in two jurisdictions in northern Canada examining the impact of labels on the following outcomes: unprompted and prompted recall of the drinking guideline label message, awareness of the drinking guidelines, and knowledge of the daily and weekly recommended drink limits. The intervention site applied labels with national drinking guidelines, a cancer warning, and standard drink information to alcohol containers in its liquor store, whereas the comparison site did not apply these labels. In total, 2,049 cohort participants in both sites were recruited to complete surveys before and at two time points after the intervention. Changes in outcomes were examined using generalized estimating equations. RESULTS: After the intervention, unprompted and prompted recall of the drinking guideline label message increased more in the intervention versus comparison site (adjusted odds ratio [AOR] = 10.8, 95% CI [0.9, 127.6]; AOR = 7.0, 95% CI [3.3, 14.9], respectively). Awareness of the drinking guidelines increased 2.9 times more in the intervention versus comparison site (AOR = 2.9, 95% CI [2.0, 4.3]). In addition, knowledge of the daily and weekly drink limits increased 1.5 and 1.4 times more in the intervention versus comparison site, respectively (daily: AOR = 1.5, 95% CI [1.0, 2.1]; weekly: AOR = 1.4, 95% CI [1.0, 2.0]). CONCLUSIONS: Enhanced alcohol labels get noticed and may be an effective population-level strategy for increasing awareness and knowledge of national drinking guidelines.

News Media and the Influence of the Alcohol Industry: An Analysis of Media Coverage of Alcohol Warning Labels With a Cancer Message in Canada and Ireland.

OBJECTIVE: Media coverage of alcohol-related policy measures can influence public debate and is often more aligned with interests of the alcohol industry than public health. The purpose of this study was to examine the framing of news coverage of alcohol warning label (AWL) initiatives that included a cancer message on alcohol containers in two different countries. Policy contexts and industry perspectives were also evaluated. METHOD: We identified and systematically reviewed news articles published between 2017-2019 covering an AWL academic study in Yukon, Canada, and labeling provisions in a Public Health (Alcohol) Bill in Ireland. Both included a cancer message. News stories were coded for media type and topic slant; inclusion of alcohol industry perspectives was examined using content analysis. RESULTS: Overall, 68.4% of media articles covering the Yukon Study (n = 38) and 18.9% covering the Ireland Bill (n = 37) were supportive of AWLs with a cancer message. The majority of articles in both sites presented alcohol industry perspectives (Yukon, 65.8%; Ireland, 86.5%), and industry arguments opposing AWLs were similar across both contexts. In articles with statements from industry representatives, the label message was frequently disputed by distorting or denying the evidence that alcohol causes cancer (n = 33/43). CONCLUSIONS: News coverage of AWLs with a cancer message was more supportive in Canada than Ireland, where alcohol industry perspectives were consistently foregrounded. Industry arguments opposing the cancer label bore similarities across contexts, often distorting or denying the evidence. Increasing awareness of industry messaging strategies may generate more critical coverage of industry lobbying activities and increase public support for alcohol policies.

Cancer Warning Labels on Alcohol Containers: A Consumer's Right to Know, a Government's Responsibility to Inform, and an Industry's Power to Thwart.

OBJECTIVE: Although the World Health Organization (WHO) declared alcohol a Class 1 carcinogen 30 years ago, few governments have communicated this fact to the public. We illustrate how alcohol industry groups seek to keep their customers in the dark about alcohol-related cancer risks. In Canada, a federally funded scientific study examining the introduction of cancer warning labels on containers was shut down following industry interference. We show that the industry complaints about the study had no legal merit. Of 47 WHO member countries with alcohol warning labels, only South Korea requires cancer warnings on alcohol containers. However, industry complaints, supported by sympathetic governments, helped weaken the warning labels' implementation. Ireland has legislated for cancer warnings but faces continuing legal opposition expressed through regional and global bodies. Cancer societies and the public health community have failed to counter industry pressures to minimize consumer awareness of alcohol's cancer risks. Placing cancer warnings on alcohol containers could make a pivotal difference in motivating both drinkers to consume less and regulators to introduce more effective policies to reduce the serious harms of alcohol consumption.

Improving Knowledge that Alcohol Can Cause Cancer is Associated with Consumer Support for Alcohol Policies: Findings from a Real-World Alcohol Labelling Study.

Knowledge that alcohol can cause cancer is low in Canada. Alcohol labels are one strategy for communicating alcohol-related harms, including cancer. Extending existing research observing an association between knowledge of the alcohol-cancer link and support for alcohol policies, this study examined whether increases in individual-level knowledge that alcohol is a carcinogen following an alcohol labelling intervention are associated with support for alcohol polices. Cancer warning labels were applied to alcohol containers at the intervention site, and the comparison site did not apply cancer labels. Pre-post surveys were conducted among liquor store patrons at both sites before and two-and six-months after the intervention was stopped due to alcohol industry interference. Limiting the data to participants that completed surveys both before and two-months after the cancer label stopped, logistic regression was used to examine the association between increases in knowledge and support for policies. Support for pricing and availability policies was low overall; however, increases in individual-level knowledge of the alcohol-cancer link was associated with higher levels of support for pricing policies, specifically, setting a minimum unit price per standard drink of alcohol (OR = 1.86, 95% CI: 1.11-3.12). Improving knowledge that alcohol can cause cancer using labels may increase support for alcohol policies. International Registered Report Identifier (IRRID): RR2-10.2196/16320.

An Experimental Study of Nicotine Warning Statements in E-cigarette Tweets.

INTRODUCTION: It is unclear whether warnings on electronic cigarette (e-cigarette) advertisements required by the US Food and Drug Administration (FDA) will apply to social media. Given the key role of social media in marketing e-cigarettes, we seek to inform FDA decision making by exploring how warnings on various tweet content influence perceived healthiness, nicotine harm, likelihood to try e-cigarettes, and warning recall. METHODS: In this 2 × 4 between-subjects experiment participants viewed a tweet from a fictitious e-cigarette brand. Four tweet content versions (e-cigarette product, e-cigarette use, e-cigarette in social context, unrelated content) were crossed with two warning versions (absent, present). Adult e-cigarette users (N = 994) were recruited via social media ads to complete a survey and randomized to view one of eight tweets. Multivariable regressions explored effects of tweet content and warning on perceived healthiness, perceived harm, and likelihood to try e-cigarettes, and tweet content on warning recall. Covariates were tobacco and social media use and demographics. RESULTS: Tweets with warnings elicited more negative health perceptions of the e-cigarette brand than tweets without warnings (p < .05). Tweets featuring e-cigarette products (p < .05) or use (p < .001) elicited higher warning recall than tweets featuring unrelated content. CONCLUSIONS: This is the first study to examine warning effects on perceptions of e-cigarette social media marketing. Warnings led to more negative e-cigarette health perceptions, but no effect on perceived nicotine harm or likelihood to try e-cigarettes. There were differences in warning recall by tweet content. Research should explore how varying warning content (text, size, placement) on tweets from e-cigarette brands influences health risk perceptions. IMPLICATIONS: FDA's 2016 ruling requires warnings on advertisements for nicotine-containing e-cigarettes, but does not specify whether this applies to social media. This study is the first to examine how e-cigarette warnings in tweets influence perceived healthiness and harm of e-cigarettes, which is important because e-cigarette brands are voluntarily including warnings on Twitter and Instagram. Warnings influenced perceived healthiness of the e-cigarette brand, but not perceived nicotine harm or likelihood to try e-cigarettes. We also saw higher recall of warning statements for tweets featuring e-cigarettes. Findings suggest that expanding warning requirements to e-cigarette social media marketing warrants further exploration and FDA consideration.

Optimizing Warnings on E-Cigarette Advertisements.

INTRODUCTION: We examined the effect of visual optimizations on warning text recall. METHODS: We used Amazon's Mechanical Turk to recruit 1854 young adult (18-34 years) electronic cigarette (e-cigarette) users or susceptible nonusers. We conducted a between-subjects 3 × 2 × 2 experiment to examine the influence of color (black text on white background [BW] vs. black on yellow [BY] vs. yellow on black [YB]), shape (rectangle vs. novel), and signal word (presence vs. absence of the word "warning"). We randomized participants to view one of 12 warnings on a fictional e-cigarette advertisement. We coded open-ended recall responses into three categories: (1) recalled nothing, (2) recalled something, (3) recalled the concept. We examined main effects on warning text recall using multinomial regression. We examined differences in attention, perceived message effectiveness, and appeal. RESULTS: Those exposed to BW or BY warnings were more likely than those exposed to YB to recall something (AOR = 1.6, AOR = 1.5, respectively) or the concept (OR = 1.4, BW). Those exposed to novel shape (44.7% novel vs. 37.9% rectangle; p = .003) or color (44.5% BY vs. 41.9% YB vs. 37.5% BW; p = .04) warnings were more likely to report attention to the warning. In aided recall, those exposed to the signal word were more likely than those not exposed to select the correct response (64.0% vs. 31.3%; p < .0001). We did not find differences for message effectiveness or appeal. CONCLUSIONS: Visual optimizations such as color may influence warning text recall and should be considered for new warnings. Research should continue exploring variations for advertisement warnings to maximize attention to warning text. IMPLICATIONS: This study examines the impact of visual optimizations on recall of the US Food and Drug Administration-mandated e-cigarette advertisement warning text. We found that color might influence warning text recall, but we did not find effects for shape or signal word. It is possible the newly mandated e-cigarette advertisement warnings, which are required to occupy at least 20% of the advertisement, are currently novel enough to attract attention. Future research should examine optimizations following implementation of the new advertisement warnings.

The impact of textual and pictorial warnings on tumbac (waterpipe tobacco) boxes on the motivation and intention to quit waterpipe smoking in Lebanon: a cross-sectional study.

Few published studies have examined the impact of waterpipe tobacco pictorial health warnings worldwide but none of these papers assessed the motivation and intention to quit among Lebanese waterpipe smokers. To examine factors associated with the motivation and intention to quit waterpipe smoking (WS) in Lebanon, particularly the impact of textual vs. pictorial warnings on tumbac boxes. A cross-sectional study was conducted between January and May 2018, involving 520 participants. Having smokers at work (OR = 0.92) and increasing number of waterpipes per week (ORa = 0.94) were associated with decreased motivation to quit WS. Thinking that shocking images on tumbac packages would have more effect than textual warnings (ORa = 2.96) and those who would change the tumbac if the company decides to change the look of the box with shocking images about health damage (ORa = 1.98) were significantly associated with increased motivation to quit WS. Having a high motivation (ORa = 2.61), thinking that using shocking images on tumbac boxes can have more effect than textual warnings (ORa = 2.12), those who stopped smoking because of the warnings (ORa = 2.62), those who would choose pictorial warnings alone (ORa = 2.11), and both pictorial and textual warnings (ORa = 3.41) on tumbac packages were associated with higher intention to quit WS in two months. Pictorial and textual warnings on tumbac packs were associated with higher intention and motivation to stop WS. Public health education programs for this purpose seem warranted.