High levels of food processing can have detrimental health effects independent of nutrient content. Experts and advocates have proposed adding information about food processing status to front-of-package labeling schemes, which currently exclusively focus on nutrient content. How consumers would perceive \"ultraprocessed\" labels has not yet been examined. To address this gap, we conducted a within-subjects online experiment with a convenience sample of 600 US adults. Participants viewed a product under three labeling conditions (control, \"ultraprocessed\" label, and \"ultraprocessed\" plus \"high in sugar\" label) in random order for a single product. The \"ultraprocessed\" label led participants to report thinking more about the risks of eating the product and discouraging them from wanting to buy the product more than the control, despite not grabbing more attention than the control. The \"ultraprocessed\" plus \"high in sugar\" labels grabbed more attention, led participants to think more about the risks of eating the product, and discouraged them from wanting to buy the product more than the \"ultraprocessed\" label alone. \"Ultraprocessed\" labels may constitute promising messages that could work in tandem with nutrient labels, and further research should examine how they would influence consumers\' actual intentions and behaviors.

Obesity is a growing global health concern associated with high comorbidity rates, leading to an increasing number of patients who are obese requiring medication. However, clinical trials often exclude or under-represent individuals who are obese, creating the need for a methodology to adjust labeling to ensure safe and effective dosing for all patients. To address this, we developed a 2-part decision tree framework to prioritize drugs for dedicated pharmacokinetic studies in obese subjects. Leveraging current drug knowledge and modeling techniques, the decision tree system predicts expected exposure changes and recommends labeling strategies, allowing stakeholders to prioritize resources toward the drugs most in need. In a case study evaluating 30 drugs from literature across different therapeutic areas, our first decision tree predicted the expected direction of exposure change accurately in 73% of cases. We conclude that this decision tree system offers a valuable tool to advance research in obesity pharmacology and personalize drug development for patients who are obese, ensuring safe and effective medication.

Plain packaging and graphic warning labels are two regulatory strategies that may impact cigarette risk beliefs and reduce consumption, but data are needed to better understand how smokers respond to such regulations.
Adult, daily, Marlboro non-menthol smokers (Red [n = 141] or Gold [n = 43]) completed a mixed factorial randomized trial. Participants smoked their usual cigarettes during baseline (5-days) and were randomized to receive cigarette packs with a warning label manipulation (graphic vs. text-only). Within each warning label condition, participants completed three within-subjects pack color manipulations (red, gold, plain), each lasting 15 days. Participants were blinded to the fact that all packs contained their usual cigarettes. Mixed-effects models examined between- and within-subject differences on risk beliefs, product perceptions, and smoking behavior.
Warning type and package color did not impact cigarette consumption or subjective ratings. However, use increased in all conditions (2.59-3.59 cigarettes per day) relative to baseline. While smokers largely held correct risk beliefs at baseline (Mean = 6.02, SE = 0.17, Range:0-8), the cumulative number of incorrect or uncertain cigarette risk beliefs increased from baseline in all pack color manipulations in the text (IRR range = 1.70-2.16) and graphic (IRR range = 1.31-1.70) warning conditions. Across all pack color periods, those in the graphic (vs. text) warning condition had reduced odds of reporting their study cigarettes as \'safer\' than regular cigarettes (OR range = 0.22-0.32).
Pack color modification may increase uncertainty about several key cigarette risk beliefs, though graphic warnings may attenuate these effects. Regulatory agencies could consider supporting policy changes with information campaigns to maximize public knowledge.
November 25, 2014; Registration number: NCT02301351.

Cigarette pack inserts with messages on cessation benefits and advice are a promising labeling policy that may help promote smoking cessation.
To assess insert effects, with and without accompanying pictorial health warning labels(HWLs), on hypothesized psychosocial and behavioral outcomes.
We conducted a 2 × 2 between-subject randomized trial (inserts with efficacy messages vs. no inserts; large pictorial HWLs vs. small text HWLs), with 367 adults who smoked at least 10 cigarettes a day. Participants received a 14-day supply of their preferred cigarettes with packs modified to reflect their experimental condition. Over 2 weeks, we surveyed participants approximately 4-5 times a day during their smoking sessions, querying feelings about smoking, level of worry about harms from smoking, self-efficacy to cut down on cigarettes, self-efficacy to quit, hopefulness about quitting, and motivation to quit. Each evening, participants reported their perceived susceptibility to smoking harms and, for the last 24 hr, their frequency of thinking about smoking harms and cessation benefits, conversations about smoking cessation or harms, and foregoing or stubbing out cigarettes before they finished smoking. Mixed-effects ordinal and logistic models were estimated to evaluate differences between groups.
Participants whose packs included inserts were more likely than those whose packs did not include inserts to report foregoing or stubbing out of cigarettes (OR = 2.39, 95% CI = 1.36, 4.20). Otherwise, no statistically significant associations were found between labeling conditions and outcomes.
This study provides some evidence, albeit limited, that pack inserts with efficacy messages can promote behaviors that predict smoking cessation attempts.
Cigarette pack inserts (small leaflets inside packs) with messages about quitting benefits and tips to quit may promote smoking cessation. We randomly assigned 367 adult smokers to one of four groups: control group with small health warning labels (HWLs) on the side of packs; inserts with cessation messages and small HWLs; large picture HWLs showing health effects from smoking; inserts and large picture HWLs. Participants received a 14-day supply of their preferred cigarettes in packs that reflected their assigned group. Over 2 weeks, we surveyed participants 4–5 times a day during times when they smoked, asking their feelings about smoking and smoking-related harms, confidence to reduce cigarettes and quit, hopefulness about quitting, and motivation to quit. Each evening, participants reported on the prior 24 hr: how often they thought about smoking harms and cessation benefits; conversations about smoking cessation or harms; and foregoing or stubbing out cigarettes before they finished smoking. People whose packs had inserts (with or without picture HWLs) were more likely than those whose packs did not include inserts (control group or picture HWLs only) to report foregoing or stubbing out of cigarettes. This study provides some evidence that inserts with cessation messages may promote smoking cessation.

Meat consumption has been linked to adverse health consequences, worsening climate change, and the risk of pandemics. Meat is however a popular food product and dissuading people from consuming meat has proven difficult. Outside the realm of meat consumption, previous research has shown that pictorial warning labels are effective at curbing tobacco smoking and reducing the consumption of sugary drinks and alcohol. The present research extends this work to hypothetical meat meal selection, using an online decision-making task to test whether people\'s meal choices can be influenced by pictorial warning labels focused on the health, climate, or pandemic risks associated with consuming meat. Setting quotas for age and gender to approximate a UK nationally representative sample, a total of n = 1001 adult meat consumers (aged 18+) were randomised into one of four experimental groups: health pictorial warning label, climate pictorial warning label, pandemic pictorial warning label, or control (no warning label present). All warning labels reduced the proportion of meat meals selected significantly compared to the control group, with reductions ranging from -7.4% to -10%. There were no statistically significant differences in meat meal selection between the different types of warning labels. We discuss implications for future research, policy, and practice.

The US Food and Drug Administration (FDA) regulatory process often involves several reviewers who focus on sets of information related to their respective areas of review. Accordingly, manufacturers that provide submission packages to regulatory agencies are instructed to organize the contents using a structure that enables the information to be easily allocated, retrieved, and reviewed. However, this practice is not always followed correctly; as such, some documents are not well structured, with similar information spreading across different sections, hindering the efficient access and review of all of the relevant data as a whole. To improve this common situation, we evaluated an artificial intelligence (AI)-based natural language processing (NLP) methodology, called Bidirectional Encoder Representations from Transformers (BERT), to automatically classify free-text information into standardized sections, supporting a holistic review of drug safety and efficacy. Specifically, FDA labeling documents were used in this study as a proof of concept, where the labeling section structure defined by the Physician Label Rule (PLR) was used to classify labels in the development of the model. The model was subsequently evaluated on texts from both well-structured labeling documents (i.e., PLR-based labeling) and less- or differently structured documents (i.e., non-PLR and Summary of Product Characteristic [SmPC] labeling.) In the training process, the model yielded 96% and 88% accuracy for binary and multiclass tasks, respectively. The testing accuracies observed for the PLR, non-PLR, and SmPC testing data sets for the binary model were 95%, 88%, and 88%, and for the multiclass model were 82%, 73%, and 68%, respectively. Our study demonstrated that automatically classifying free texts into standardized sections with AI language models could be an advanced regulatory science approach for supporting the review process by effectively processing unformatted documents.

While many countries require prominent pictorial health warning labels (PHWLs) on the outside of cigarette packs to communicate the harms of smoking, there is evidence that cigarette pack inserts that contain efficacy messages may enhance the effectiveness of PHWLs. The US Food and Drug Administration (FDA) has regulatory authority to communicate with smokers through inserts. While current labeling regulations do not require inclusion of inserts, the FDA could implement them in the future. This study assesses US smokers\' perceptions of cigarette package inserts at the conclusion of a two-week randomized trial on cigarette labeling where half of participants were exposed to insert messages (two response-efficacy messages and two self-efficacy messages) in their packs. Participants (n = 359) completed a 30- to 60-min interview with both quantitative and qualitative assessments, including measures of recall and perceived message effectiveness (PME) for specific inserts. Correlates of recall and PME were estimated using mixed-effects regression models. Qualitative responses to PME items were analyzed using thematic analysis. Response-efficacy messages had higher PME and recall than self-efficacy messages. People had diverse responses to the inserts, including that they were positive, thought-provoking, and helpful. Reactions to and perceptions of the inserts indicate potential benefits of integrating efficacy messages into labeling policies.

This study compares the impact of pictorial health warning labels (HWLs) and their placements on waterpipe parts (device, tobacco and charcoal packages) on health communication outcomes between waterpipe smokers and nonsmokers in Lebanon. An online randomized crossover experimental study was conducted among young adults (n = 403, August 2021) who observed three conditions of HWLs: pictorial HWLs on the tobacco package, pictorial HWLs on all waterpipe\'s parts and text-only HWL on the tobacco package in random order. Participants completed post-exposure assessments of health communication outcomes after each image. Using linear mixed models, we examined the differences in the effect of HWL conditions on several outcomes (i.e. warning reactions) between waterpipe smokers and nonsmokers, controlling for confounders (i.e. age, sex). Nonsmokers reported greater attention (β = 0.54 [95% confidence interval: 0.25-0.82]), cognitive elaboration (0.31 [0.05-0.58]) and social interaction (0.41 [0.18-0.65]) for pictorial HWLs on the tobacco packages than text-only compared with smokers. Pictorial HWLs on three parts versus one part elicited higher cognitive reactions and perceived message effectiveness in nonsmokers compared with waterpipe smokers. These findings provide valuable information for policymakers about the potential of implementing HWLs specific to waterpipes to prevent their use among young adults and limit tobacco-related morbidity and mortality in Lebanon.

Tobacco consumption is associated with nearly 30 000 deaths annually in Nigeria alongside other adverse health and economic effects. Our objective was to estimate the health and economic implications of the current cigarette labeling policies (text-only HWs); new health warnings policies in the country (adding graphic health warnings with up to 60% coverage), and plain packaging policy as recommended by the World Health Organization.
We used a probabilistic state-transition individual microsimulation model, considering natural history, healthcare costs, and quality-of-life losses associated with main tobacco-attributable diseases; and the potential effects of packaging and labeling policies. We used three scenarios: (1) text-only health warnings (HWs) covering 50% of the pack, (2) introduction of graphic HWs of 50% (and later increasing to 80%) of the pack, and (3) plain packaging with HWs covering 80% of the pack.
A total of 748 deaths are averted in the current situation; 7478 and 14 208 deaths can be averted with the new policy and with plain packaging, respectively. The number of cardiac, cerebrovascular, and cancer events that could be averted by adopting text and graphic HWs are 3093, 5093, and 1346, respectively; increasing to 5876, 9676, and 2557, respectively, with plain packaging. Up to 251 794 years were lost because of early deaths and disability, and ₦144.6 billion (USD 469 million) in health costs could be saved with HWs covering 50% to 80% of the pack over 10 years. With plain packaging and graphic HWs covering 80% of the package 478,408 years and ₦274.7 billion (USD 895 million) would be saved.
The new cigarette labeling policy in Nigeria may yield significant health and economic benefits over 10 years. Moving the current policy to plain packaging can significantly improve these benefits.
The new cigarette labeling policy that Nigeria is implementing should aim to achieve 100% compliance with its current regulation and the logical next step: Plain packaging with large warnings. The present study adds evidence of the potential health effects and cost savings of these levels of implementation, which is valuable for local policymakers.

Background: Manufacturers of Puff Bar electronic cigarettes (e-cigarettes) and Fre nicotine pouches claim that their products contain synthetic nicotine. The packages for Puff Bar and Fre have modified versions of the warning labels required by the Food and Drug Administration (FDA) for tobacco products, which specify that Puff Bar and Fre products contain \"tobacco free\" or \"non-tobacco\" nicotine, respectively. We evaluated whether exposure to these \"tobacco free\" warning labels was associated with differing perceptions about the products. Method: N = 239 young adult men who were enrolled in a cohort study completed a short online experiment. Participants were randomly assigned to view either packages of Puff Bar and Fre nicotine pouches with the standard FDA warning or packages with the standard FDA warning + the tobacco free descriptor. We compared harm and addictiveness perceptions and products\' perceived substitutability for cigarettes and smokeless tobacco (SLT) by exposure to a \"tobacco free\" warning. Results: Viewing a Puff Bar package with a \"tobacco free\" warning label was associated with increased perceived substitutability of the product for cigarettes and smokeless tobacco (p\'s<.05). Viewing a Fre package with a \"non-tobacco\" warning label was associated with thinking the product was less harmful than SLT (p<.01). Conclusions: \"Tobacco free\" descriptors in warning labels for e-cigarettes and nicotine pouches affect young adults\' perceptions of the products. To date, it is unclear whether the FDA will continue to permit \"tobacco free\" descriptors in warning labels. As e-cigarettes and nicotine pouches are increasingly marketed with \"tobacco free\" language, urgent action is needed.