Product Labeling

This white paper reframes food labels as instruments of governance rather than neutral tools of consumer information. Drawing on the history of U.S. food labeling policy, especially the FDA’s shift from food standards of identity to nutrition disclosure and the later rise of the Nutrition Facts panel, it argues that labels govern through four channels: steering consumer choice, inducing producer reformulation, creating and policing market categories, and making firms accountable to standardized public reference points. The paper applies this historical framework to contemporary policy debates over front-of-package nutrition labeling, date-label reform, ultra-processed foods, sustainability and “clean label” claims, and the migration of “Facts”-style transparency labels into other sectors. The central argument is that labeling can standardize markets, discipline marketing claims, and reshape products, but it cannot substitute for enforcement, institutional trust, or structural food policy. The paper proposes a “labeling-plus-capacity” framework: policymakers should pair labeling reforms with funded enforcement, realistic evaluation of consumer interpretation and market effects, attention to institutional trust, and candor about when labeling is the wrong tool for the policy problem at hand.

This study offers an exploratory evaluation of the labeling and packaging characteristics of extra virgin olive oils (EVOO) available in Montevideo and its metropolitan area, in the context of expanding local production and growing demand for healthy products. In 2022, a cross-sectional survey was conducted in 18 retail establishments (15 small supermarkets and 3 large chains). Data from 131 EVOO products were systematically entered into the Food Label Information Program for Latin America (FLIP-LAC). The variables examined included packaging material, country of origin, and nutritional and quality information declared on the label. All products complied with the minimum requirements of national regulations. However, only 15% declared free acidity and less than 6% included complementary quality indicators such as peroxide index or UV absorbance. Nutritional claims were scarce: only 6% reported vitamin E content. Packaging practices generally favored preservation, with opaque glass predominating (74%) and more than 90% using non-transparent materials. Differences were observed according to origin: European oils dominated the market and included more sensory descriptors; Argentine oils showed a greater tendency to declare quality indicators, and Uruguayan oils more frequently reported olive variety and uses in culinary preparations. These findings suggest that labeling strategies reflect diverse regulatory frameworks, production capacities, and consumer expectations.

This study examined how digital financial inclusion affects the profitability of female entrepreneurs in Ondo State, Nigeria. This study employed descriptive survey design method and structured copies of questionnaire validated by academic experts in the field of entrepreneurship. Informal businesses owned by female entrepreneurs in Ondo State were purposively selected including, tailoring, interior decoration, catering, petty traders, and agric-related businesses. The study's sample size of 385 was attained by Cochran formular because the total number of the businesses was unknown because a lot of the businesses were not formally registere). Regression analysis with the aid of SPSS v25.0 was used to analyse the effect of access and usage of digital financial services including, Mobile Phones, Point of Sales (PoS), Internet, and Debit Cards on profitability of the female entrepreneurs. Findings revealed that access to mobile phones had the highest value of 42.8%. Similarly, all the variables showed positive and significant effects on profitability of female entrepreneurs, particularly in informal businesses. In conclusion, digital financial inclusion improves profitability. The study recommends the need for digital literacy and creation of supporting environment for internet connectivity.

There is a broad agreement that patient-reported outcome (PRO) assessment in health care should proceed from a strong conceptual basis, with rationales clearly articulated in advance concerning what is to be measured and how this is to be accomplished. The representation of the patient's perspective has been part of clinical trials for some time; but the formalization of, and broader emphasis on PROs has become increasingly important with the release of the draft guidance for industry on patient-reported outcomes. In response, we address the challenges in constructing the conceptual foundations for PRO assessment to support drug product labeling claims submitted to regulatory agencies worldwide. After discussing what constitutes a PRO concept and an adequate basis for framing a PRO assessment, we examine the consequences of choosing PRO instruments without reference to a well-established conceptual framework for measurement. Then we illustrate through a hypothetical example the important interplay between the sponsor's proposed product claim, the corresponding conceptual model that depicts hypotheses involving the PRO concept(s) in the claim, and the resulting conceptual framework(s) for measurement to guide instrument selection and psychometric analyses. We discuss how these conceptual issues may vary or evolve over time depending on the phase of product development. As the science of PRO measurement continues to develop and experience accumulates, a consensus may emerge on how best to articulate the conceptual basis of PRO measurement for purposes of product labeling and regulation. In the meantime, one point is imminently clear: in regulatory decisions expected to affect not only the quantity but the quality of life, it is imperative to incorporate the patient's own perspective on the illness experience and the effects of therapy.

to address the growing need for standardization of terminology and labeling for cellular therapy products as a result of increasing international transfer of these products. This paper presents new standards for terminology and labeling. These standards have been developed through a consultative process and are supported by key professional and accreditation bodies. By using these standards, together with the unique donation identification numbers and international product reference tables provided by the International Society of Blood Transfusion (ISBT) 128 Standard, consistency and traceability can be assured at the global level. A companion paper provides guidance on the implementation of the ISBT 128 system.

Many ionizable drugs are developed and marketed as salt forms. However, there are no clear US regulatory guidelines on drug strength labeling for salts. The strengths of some drugs are expressed as salts and some as free acids/bases. This study surveyed the top 200 US drugs to assess the common practice in industry. The top 200 drugs prescribed in the United States were included in this survey. The drugs containing active pharmaceutical ingredient (API) salts were selected for analysis. Generic or combination products with redundant API salts were excluded. The package insert of each selected drug was reviewed, and the information on drug strength expression was extracted and categorized. Out of the top 200 drugs, 59 unique API salts were identified. The drug strengths were expressed as salts for 32 drugs (54%) and as free acids/bases for 27 drugs (46%). The survey results revealed the inconsistent practice among the industries regarding the drug strength expression for salts. Non-harmonized labeling practice can lead to confusions, potential calculation/dosing errors, and complications in labeling new products. The authors recommend the US Food and Drug Administration to standardize the labeling format for salts and preferably express the drug strengths based on the free acid/base forms.

After a brief foray on the concept of organizational culture and on the research in this area, our work relates to how the project was organised featuring COMOR exploratory research activities, research that aims to identify the greatest possible number of elements, sides ...

Introduction-Existing measures of tobacco marketing and messaging exposure are limited, relying on recall, recognition, or proxy measures. This study aimed to determine the feasibility and reliability of a mobile application for the measurement of tobacco and e-cigarette marketing and message exposure using ecological momentary assessment (EMA). Methods-Young adults from Austin, TX (n=181, ages 18-29) were instructed to use a mobile application to record all sightings of marketing or social media related to tobacco (including ecigarettes) in real-time for 28 days (Event EMAs). Tobacco product use and recall of message encounters were assessed daily using an app-initiated EMA (Daily EMAs). Results-The mobile app was a feasible and acceptable method to measure exposure to tobacco messages. The majority of messages (45.0%) were seen on the Internet, and many were usergenerated. Thirty-day recall of messages at baseline was poorly correlated with messages reported via Event EMA during the study period; however, the correlation between post-study 30-day recall and Event EMA was much stronger (r=0.603 for industry-sponsored messages, r=0.599 for usergenerated messages). Correlations between Daily EMAs and 30-day recall of message exposure

Existing measures of tobacco marketing and messaging exposure are limited, relying on recall, recognition, or proxy measures. This study aimed to determine the feasibility and reliability of a mobile application for the measurement of tobacco and e-cigarette marketing and message exposure using ecological momentary assessment (EMA). Young adults from Austin, TX (n=181, ages 18-29) were instructed to use a mobile application to record all sightings of marketing or social media related to tobacco (including e-cigarettes) in real-time for 28days (Event EMAs). Tobacco product use and recall of message encounters were assessed daily using an app-initiated EMA (Daily EMAs). The mobile app was a feasible and acceptable method to measure exposure to tobacco messages. The majority of messages (45.0%) were seen on the Internet, and many were user-generated. Thirty-day recall of messages at baseline was poorly correlated with messages reported via Event EMA during the study period; however, th...

A study was carried out using four measures of effectiveness to compare product warnings that are consistent with the American National Standards Institute Product Safety Signs and Labels standard (ANSI Z535.4) to warnings that are not consistent with the standard. Inconsistent warnings were based on the format of existing product warnings. Two warnings, consistent and inconsistent, for each of ten different products were evaluated: cooking oil, trampoline, paint, dresser, airbag, seat belt, tire, sports utility vehicle, reclining seat and swimming pool. The four effectiveness criteria were judgments of noticeability, likelihood to read, understandability and likelihood of complying. Participants were 176 students with varied majors from five different universities. Results indicated higher levels of judged effectiveness for the warnings that were consistent with the ANSI standard. The differences were statistically significant for all four effectiveness measures for all ten product...

The processed foods and beverages consumption has caused, in Mexican population, an overweight and obesity rates increase, and with it, the development of chronic diseases such as diabetes or hypertension, among others. The Mexican government has implemented measures such as the modification of the Official Mexican Standard NOM-051-SCFI/SSA1-2010, which proposes the application of a frontal labeling that includes a warning about the content excess of harmful ingredients for health. Countries such as Chile, Peru, Costa Rica and Brazil have implemented similar measures in order to eradicate chronic diseases that have developed over the years, such as the excessive increase in diabetes mellitus, morbid obesity and hypertension in adults and, mainly, in children, thanks to eating habits and excessive consumption of foods rich in fats, sugars or sodium, among others. In Mexico, with this new front labeling, it is expected to reduce the cases of chronic non-communicable diseases and, in t...

At its most elemental, patient-reported outcomes (PRO) assessment involves asking the patients questions and evaluating their answers. Instrument developers need to be clear about what they want to know, from whom they want to know it and why, whether what they learned is credible, and whether they can interpret what they learned in the context of the research objectives. Because credible instrument development is neither inexpensive nor technically trivial, researchers must first determine that no available measure meets their research objectives. We suggest that the tasks of either reviewing current instruments or developing new ones originate from the same basic premise: PRO assessment requires a well-articulated conceptual framework. Once defined in the context of the research objectives, the conceptual framework needs to be adapted to the population of interest. We discuss how qualitative methods enrich the conceptual framework and facilitate the technical measurement tasks of item development, testing, and reduction. We recognize that PRO assessment stands at a technological crossroads with the increasingly frequent application of "modern" psychometric methods and discuss how innovations such as item banks and computer-adaptive testing will influence PRO instrument development. Although items are the essential building blocks for instruments, scales are the primary unit of analysis for PRO assessment, and we discuss methods for scoring and combining them. Finally, PRO assessment is meaningless if the key figure chooses not to cooperate. We consider how respondent burden influences the quality of PRO assessment.

Background In Australia, introduction of pictorial health warnings on cigarette packets was supported by a televised media campaign highlighting illnesses featured in two of the warning labelsdgangrene and mouth cancer. Methods Two studies examined whether the warnings and the television advertisements complemented one another. Population telephone surveys of two cross-sections of adult smokers measured changes in top-of-mind awareness of smoking-related health effects from before (2005; n¼587) to after the pack warnings were introduced (2006; n¼583). A second study assessed cognitive and emotional responses and intentions to quit after smokers watched one of the campaign advertisements, comparing outcomes of those with and without prior pack warning exposure. Results Between 2005 and 2006, the proportion of smokers aware that gangrene is caused by smoking increased by 11.2 percentage points (OR¼23.47, p¼0.000), and awareness of the link between smoking and mouth cancer increased by 6.6 percentage points (OR¼2.00, p¼0.006). In contrast, awareness of throat cancer decreased by 4.3 percentage points, and this illness was mentioned in the pack warnings but not the advertisements. In multivariate analyses, smokers who had prior exposure to the warnings were significantly more likely to report positive responses to the advertisements and stronger post-exposure quitting intentions. Conclusions Television advertisements and pictorial health warnings on cigarette packets may operate in a complementary manner to positively influence awareness of the health consequences of smoking and motivation to quit. Jurisdictions implementing pictorial warnings should consider the benefits of supportive mass media campaigns to increase the depth, meaning and personal relevance of the warnings.

In Australia, introduction of pictorial health warnings on cigarette packets was supported by a televised media campaign highlighting illnesses featured in two of the warning labels--gangrene and mouth cancer. Two studies examined whether the warnings and the television advertisements complemented one another. Population telephone surveys of two cross-sections of adult smokers measured changes in top-of-mind awareness of smoking-related health effects from before (2005; n=587) to after the pack warnings were introduced (2006; n=583). A second study assessed cognitive and emotional responses and intentions to quit after smokers watched one of the campaign advertisements, comparing outcomes of those with and without prior pack warning exposure. Between 2005 and 2006, the proportion of smokers aware that gangrene is caused by smoking increased by 11.2 percentage points (OR=23.47, p=0.000), and awareness of the link between smoking and mouth cancer increased by 6.6 percentage points (OR...

Oklahoma 12. System of Signs: A related set of signs that form an entity with singular purpose. The sign's individual parts have a connection to the system. 13. Warning: forceful, cautionary advice, advance notice or "event that indicates a possible or impending danger, problem, or other unpleasant situation" (New Oxford American Dictionary, 2007). 14. Warning Label: something affixed to or printed directly onto an object, providing cautionary information of "a possible or impending danger, problem, or other unpleasant situation" (New Oxford American Dictionary, 2007). 15. Warning Sign: a cautionary object whose presence indicates "a possible or impending danger, problem, or other unpleasant situation" (New Oxford American Dictionary, 2007). 16. Wayfinding: the use of objects, graphics, signs, and/or audible methods to communicate location and help people navigate in physical space toward a specific destination . Warning Signs: Avoiding Consumer Debt Can a system of visual signs be developed to persuade consumers to become wary of their debt?

This paper aims at analyzing the way of action of the Romanian entrepreneurs in the context of the COVID 19 pandemic, their reactions and ways of adapting to the current market. The research is a qualitative one conducted on a group of 10 entrepreneurs.

In this paper, the authors have analysed the influence of the Covid-19 pandemic on air transport services in Romania and implicitly on the customers of these companies. The research is a quantitative study conducted on a sample of 408 respondents.

IntroductIon: Tobacco is the prime and most perilous killer of humanity probably since its discovery. From all its caretakers in farms to stakeholders and mainly its users suffer from multiple health hazards the ultimate outcome of which is premature miserable death. Almost one million annual deaths from tobacco-related diseases occur in India, the world's second-largest consumer of tobacco, where about one-third of adults use some form of tobacco. According to the Million Death Study, Smoking alone causes 10% of all deaths. [1] One in five of all adult male deaths and one in twenty of all adult female deaths in middle age are due to smoking. In India, around 34.3% of youths are exposed to passive smoking at home. Among Daily tobacco users, 60.2% consumed tobacco within half an hour of waking up. [2] In India, beedi smoking is the most popular form of tobacco smoking, followed by cigarette smoking. Paan with tobacco is the major chewing form of tobacco. Dry tobacco-areca nut preparations such as paan masala, gutka, and mawa are also popular and highly addictive. Indian Parliament passed the Cigarette and Other Tobacco Products (prohibition of Advertisement and Regulation of Trade and Commerce, production, supply, and Distribution) Bill, 2003. One of the key provisions under this act is health warnings in both written and pictorial form. Health warnings on tobacco packages are among the most widespread policy initiatives implemented to raise awareness of the health risks of tobacco as well as to encourage consumers to Background: Tobacco use continues to be the leading global cause of preventable deaths, killing nearly 6 million people worldwide each year. Tobacco control must be given high priority by scaling up tobacco control measures. In India under the Control of Tobacco Product Act, it is mandatory to keep the warning labels over all kinds of tobacco products to minimize the use of tobacco. Objectives: To determine whether tobacco packages with graphic warning labels or text-only warning labels had a stronger impact on addicting behavior. Materials and Methods: A cross-sectional study was carried out among the group of people using tobacco in any form. A total of 776 tobacco users were enrolled in the study. Results: The mean age of tobacco users was 41.4 years. Out of the total of 776 tobacco users, 561 (72.3%) had noticed warning signals over the tobacco products. Among those who had noticed warning labels, 64.4% became aware about health effects and 66% had thought to quit tobacco. Tobacco users of the young age group (15-45) were more aware regarding warning labels. Females were less aware. As the level of education increases the number of tobacco users who tried to quit or reduce the daily quantity of tobacco intake also increases. Conclusions: The positive impact of warning labels has been seen among the tobacco users who have noticed them. Not all tobacco users were aware regarding the presence of warning labels as per the findings of the present study.

To test the effect of exposure to the US Food and Drug Administration's proposed graphic images with text warning statements for cigarette packages on implicit and explicit attitudes towards smoking. A two-session web-based study was conducted with 2192 young adults 18-25-years-old. During session one, demographics, smoking behaviour, and baseline implicit and explicit attitudes were assessed. Session two, completed on average 18 days later, contained random assignment to viewing one of three sets of cigarette packages, graphic images with text warnings, text warnings only, or current US Surgeon General's text warnings. Participants then completed post-exposure measures of implicit and explicit attitudes. ANCOVAs tested the effect of condition on the outcomes, controlling for baseline attitudes. Smokers who viewed packages with graphic images plus text warnings demonstrated more negative implicit attitudes compared to smokers in the other conditions (p = .004). For the entir...

Food safety is a public health issue of paramount importance. In this regard, blockchain has emerged as a promising technology that allows users to effectively and efficiently record the origin and flow of products and eliminate or reduce harmful food fraud. Consumers can benefit from this development by receiving up-to-date and verifiable information about the origins and delivery routes of their purchases. Drawing on signaling theory and the results of two experimental studies with 151 and 152 participants, respectively, we investigate how the use of blockchain to trace food products impacts consumers' perception of product quality as a mediating variable and subsequently their purchase intention. Our framework further considers brand familiarity as a moderating variable. The findings from the two experiments show that blockchain labels as a signaling mechanism in food supply chains help to strengthen consumers' perceived quality of food products, which, in turn, increases their purchase intention. This effect is more pronounced for less familiar brands, which is valuable information for managers who want to build a brand's reputation. From an academic perspective, we highlight the applicability of signaling theory to identify blockchain-based traceability systems as important drivers of perceived product quality and consequently purchase intention.

College of Obstetrician Gynecologists (ACOG), American Medical Association (AMA), Biotechnology Industry Organization (BIO), GS1 Healthcare US, Association of Immunization Managers (AIM), and the American Medical Informatics Association (AMIA). Searches were performed using a combination of keywords, which included vaccine, immunization, barcode, health care, practice, pediatric, obstetric-gynecology (ob-gyn), internal medicine, family physician, public health clinic, time-motion, economic, safety, medical errors, record keeping, electronic health records, health information technology, immunization information system, and data. We excluded articles that were not in the English language and those that were specific to developing health care systems (e.g., we included references from Australia but not from sub-Saharan Africa). References for these sources were catalogued using EndNote X4 software.

To the Editor, The accidental ingestion of cleaning substances (CS), also called "corrosive substances, " may lead to severe tissue injury, based on the type, content, quantity of CS, and exposure time (1-3). Accidental ingestion of CS that was stored in food or drink bottles in easily accessible places is common, especially in children under 5 years of age. We performed an in vitro study to examine the contents of commercially available labeled and unlabeled CS. Samples from 20 labeled or unlabeled CS, including bleach (n=9) and detergents (n=11) were collected. The pH values, sodium hydroxide (NaOH) level, and hydrochloric acid (HCl) level were measured in each sample (4 mL; mM). NaOH and HCl levels were measured by titrating the samples with solutions of a known concentration. The pH values were measured by pH meter (HI 2211 pH/ORP meter, Hanna Instruments, GmbH, Kehl, Germany). The results are listed in Table . Three of the bleaches were labeled with appropriate stickers, whereas 6 were unlabeled. The pH value of all the bleaches

Objective-This study aimed to determine the most effective content of pictorial health warning labels (HWLs) and whether educational attainment moderates these effects. Methods-Field experiments were conducted with 529 adult smokers and 530 young adults (258 nonsmokers; 271 smokers), wherein participants reported responses to different HWLs printed on cigarette packages. One experiment involved manipulating textual form (testimonial narrative vs didactic) and the other involved manipulating imagery type (diseased organs vs human suffering). Results-Tests of mean ratings and rankings indicated that HWLs with didactic textual forms had equivalent or significantly higher credibility, relevance, and impact than HWLs with testimonial forms. Results from mixed-effects models confirmed these results. However, responses differed by participant educational attainment: didactic forms were consistently rated higher than testimonials among participants with higher education, whereas the difference between didactic and testimonial narrative forms was weaker or not statistically significant among participants with lower education. In the second experiment, with textual content held constant, greater credibility, relevance and impact was found for graphic imagery of diseased organs than imagery of human suffering. HWLs with didactic textual forms appear to work better than with testimonial narratives. Future research should determine which pictorial HWL content has the greatest real-world impact among consumers from disadvantaged groups, including assessment of how HWL content should change to maintain its impact as tobacco control environments strengthen and consumer awareness of smoking-related risks increases.