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.

Label Accuracy of Weight Loss Dietary Supplements Marketed Online With Military Discounts.

Importance: Dietary supplements for weight loss, among the most popular supplement products on the market, are promoted not only for losing weight and shedding fat, but also for added benefits of energy and performance, all packed into 1 capsule with multiple combinations of ingredients. Fraudulent marketing of weight loss supplements, some with exaggerated claims, some that are potentially dangerous, and some that contain illegal ingredients, is ever present, especially through online sources, where multiple manufacturers target service members by offering military discounts. Objectives: To examine whether select dietary supplements marketed online for weight loss from companies advertising military discounts are accurately labeled according to the Supplement Facts listed ingredients, whether they contain any ingredients prohibited for use in the military, and to qualitatively describe the products' label claims. Design, Setting, and Participants: In this case series, 30 dietary supplement products marketed for weight loss were selected and purchased in June 2023 from 12 online companies advertising military discounts. Data were analyzed from July to August 2023. Main Outcomes and Measures: Liquid chromatography-mass spectrometry was used to verify whether products were accurately labeled according to the Supplement Facts listed ingredients and whether they contained any substances on the DoD Prohibited Dietary Supplement Ingredients List. A separate analysis was conducted to describe product label claims by using the Operation Supplement Safety (OPSS) Risk Assessment Scorecard. Results: Of the 30 products tested, analysis showed that 25 had inaccurate labels. Of these, 24 had ingredients listed on the label that were not detected (misbranded); 7 had hidden components not present on the label, some of which would be considered adulterated; and 10 had substances on the DoD Prohibited Dietary Supplement Ingredients List either on or hidden from the label. All products were rated as risky when applying the OPSS Scorecard. Conclusions and Relevance: In this case series study, the majority of products had inaccurate labels. Some were misbranded, others would be considered adulterated with ingredients not allowed in dietary supplements, and some contained ingredients prohibited for use in the military.

Minimum labelling requirements for dermatology artificial intelligence-based Software as Medical Device (SaMD): A consensus statement.

BACKGROUND/OBJECTIVES: Artificial intelligence (AI) holds remarkable potential to improve care delivery in dermatology. End users (health professionals and general public) of AI-based Software as Medical Devices (SaMD) require relevant labelling information to ensure that these devices can be used appropriately. Currently, there are no clear minimum labelling requirements for dermatology AI-based SaMDs. METHODS: Common labelling recommendations for AI-based SaMD identified in a recent literature review were evaluated by an Australian expert panel in digital health and dermatology via a modified Delphi consensus process. A nine-point Likert scale was used to indicate importance of 10 items, and voting was conducted to determine the specific characteristics to include for some items. Consensus was achieved when more than 75% of the experts agreed that inclusion of information was necessary. RESULTS: There was robust consensus supporting inclusion of all proposed items as minimum labelling requirements; indication for use, intended user, training and test data sets, algorithm design, image processing techniques, clinical validation, performance metrics, limitations, updates and adverse events. Nearly all suggested characteristics of the labelling items received endorsement, except for some characteristics related to performance metrics. Moreover, there was consensus that uniform labelling criteria should apply across all AI categories and risk classes set out by the Therapeutic Goods Administration. CONCLUSIONS: This study provides critical evidence for setting labelling standards by the Therapeutic Goods Administration to safeguard patients, health professionals, consumers, industry, and regulatory bodies from AI-based dermatology SaMDs that do not currently provide adequate information about how they were developed and tested.

Should we depend on reference intervals from manufacturer package inserts? Comparing TSH and FT4 reference intervals from four manufacturers with results from modern indirect methods and the direct method.

OBJECTIVES: Correct interpretation of thyroid function tests relies on correct reference intervals (RIs) for thyroid-stimulating hormone (TSH) and free thyroxine (FT4). ISO15189 mandates periodic verification of RIs, but laboratories struggle with cost-effective approaches. We investigated whether indirect methods (utilizing historical laboratory data) could replace the direct approach (utilizing healthy reference individuals) and compared results with manufacturer-provided RIs for TSH and FT4. METHODS: We collected historical data (2008-2022) from 13 Dutch laboratories to re-establish RIs by employing indirect methods, TMC (for TSH) and refineR (for FT4). Laboratories used common automated platforms (Roche, Abbott, Beckman or Siemens). Indirect RIs (IRIs) were determined per laboratory per year and clustered per manufacturer (>1.000.000 data points per manufacturer). Direct RIs (DRIs) were established in 125 healthy individuals per platform. RESULTS: TSH IRIs remained robust over the years for all manufacturers. FT4 IRIs proved robust for three manufacturers (Roche, Beckman and Siemens), but the IRI upper reference limit (URL) of Abbott showed a decrease of 2 pmol/L from 2015. Comparison of the IRIs and DRIs for TSH and FT4 showed close agreement using adequate age-stratification. Manufacturer-provided RIs, notably Abbott, Roche and Beckman exhibited inappropriate URLs (overall difference of 0.5-1.0 µIU/mL) for TSH. For FT4, the URLs provided by Roche, Abbott and Siemens were overestimated by 1.5-3.5 pmol/L. CONCLUSIONS: These results underscore the importance of RI verification as manufacturer-provided RIs are often incorrect and RIs may not be robust. Indirect methods offer cost-effective alternatives for laboratory-specific or platform-specific verification of RIs.

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.

Determining the geographical origin and cultivation methods of Shanghai special rice using NIR and IRMS.

Songjiang CPB rice (cultivated by a 'combination of planting and breeding') and Chongming NCFP rice (cultivated by using 'no chemical fertilizers and pesticides') are two high quality special rice products developed for Shanghai urban agriculture. Protecting these products from geographical origin mislabeling or cultivation method fraud are very important. To verify the origin of Songjiang and Chongming rice and discriminate their cultivation methods (CPB or N (non) CPB, NCFP or chemical fertilizers and pesticides (CFP)), NIR and IRMS methods combined with chemometrics were developed. Results showed complete separation of Songjiang and Chongming rice from other geographic origins using NIR combined with PLSDA and LVQNN; CPB and NCPB Songjiang rice could be completely identified using NIR or IRMS, while the optimal identification accuracy rate of NCFP from CFP in Chongming rice was 87.5%. It provided a rapid and robust method to identify the origin and cultivation methods of Shanghai special rice.

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.

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.

Strategies to identify and prevent penicillin allergy mislabeling and appropriately de-label patients.

Taking a good drug allergy history is critical, followed by removing the "penicillin-allergic" label in certain low-risk patients and referring for testing those at high risk.

Regulation of Sun Protection Products in the EU.

Unlike more "traditional" cosmetic products, sunscreens do not sit inertly on the skin, providing a simple decorative effect. Their recognized and important contribution to public health has led many regions in the world to treat them as drugs or special cosmetics. Against the trend at that time, in 1976, the EU legislator already took a conscious decision to treat and regulate sunscreens as fast-moving consumer products. Since then, the EU Cosmetics Directive/Regulation balances the need for strict safety and efficacy requirements, with need for rapid innovation and easy consumer availability. Whilst the EU Regulation considers that "all cosmetic products are equal," sunscreens are clearly "more equal." In several areas of the legislation, specific requirements or guidance for sunscreen products have been introduced over the years. Whilst staying in the overall spirit of the legislation, these requirements take into account the specificity of sunscreens with regard to ingredient safety (positive list for UV filters), product safety assessment (photostability, deliberate exposure to UV light), minimum efficacy (UVA/UVB), efficacy testing (standardized test methods) and labelling (clear use instructions, non-misleading information to consumers). The article presents the history of the EU Cosmetics Regulation, its main requirements, where applicable, and specific considerations relating to sunscreens are highlighted and explained.

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.

Alcohol Labeling Regulations and Industry Compliance in Nigeria: Evidence to Guide Policy Implementation.

OBJECTIVE: Alcohol labeling raises consumers' awareness of a product's composition and the risks associated with alcohol consumption. We identified mandatory elements and health warnings in alcohol regulations in Nigeria and evaluated selected product labels on alcoholic beverages produced in Nigeria to determine their compliance with the requirements. METHOD: A descriptive case study was used. Labeling requirements were extracted from two alcohol regulations and one related document retrieved from the website of the National Agency for Food and Drug Administration and Control (NAFDAC). The information on the product labels of 59 selected beers and spirit drinks produced in Nigeria was assessed based on six mandatory elements: list of ingredients, allergens, nutritional information, percentage of alcohol by volume (ABV), "drink responsibly" statement, and age restrictions. Five health warnings were also assessed: standard drinks per container, drinking guidelines, link to an alcohol education website, a "drinking during pregnancy" logo/text, and drink driving logo/text. RESULTS: Different regulations exist for beer and spirit drinks in Nigeria. Health warnings are not mandatory on labels of alcoholic beverages. No single product label included all six mandatory elements. Four mandatory elements--list of ingredients, ABV, drink responsibly statement, and age restrictions--were present on 61% of the product labels examined. CONCLUSIONS: The alcohol labeling regulations in Nigeria fall short of the World Health Organization labeling recommendations. The alcohol industry does not fully comply with labeling requirements in Nigeria. Enhanced labeling inclusive of health warnings should be mandatory as a strategy to create awareness of alcohol-related risks while monitoring industry-labeling practices to ensure compliance.

A cross-industry collaboration to assess if acute oral toxicity (Q)SAR models are fit-for-purpose for GHS classification and labelling.

This study assesses whether currently available acute oral toxicity (AOT) in silico models, provided by the widely employed Leadscope software, are fit-for-purpose for categorization and labelling of chemicals. As part of this study, a large data set of proprietary and marketed compounds from multiple companies (pharmaceutical, plant protection products, and other chemical industries) was assembled to assess the models' performance. The absolute percentage of correct or more conservative predictions, based on a comparison of experimental and predicted GHS categories, was approximately 95%, after excluding a small percentage of inconclusive (indeterminate or out of domain) predictions. Since the frequency distribution across the experimental categories is skewed towards low toxicity chemicals, a balanced assessment was also performed. Across all compounds which could be assigned to a well-defined experimental category, the average percentage of correct or more conservative predictions was around 80%. These results indicate the potential for reliable and broad application of these models across different industrial sectors. This manuscript describes the evaluation of these models, highlights the importance of an expert review, and provides guidance on the use of AOT models to fulfill testing requirements, GHS classification/labelling, and transportation needs.

Current Challenges in Labelling for Generic Medicinal Products: Company Core Data Sheet (CCDS) Development and Maintenance.

Labelling of pharmaceutical products plays a vital role in the safe and effective use of approved medicinal products. This information may be provided to end-users including patients and/or prescribers, and it needs to be made available in multiple formats including printed forms (patient information leaflets, pack inserts, etc.) or web portals of the product, based on national authority guidelines. The Company Core Data Sheet (CCDS) serves as a key document representing the pharmaceutical company's position on the product and is used as a reference document for national labels. Content from national labels may differ from the CCDS for different reasons including implementation of national authority requirements in the serving market and findings from local markets. In the current article, we discuss the process, challenges and key concepts in creating and maintaining CCDS documents for generic products. We highlight key parameters that are worthy of process improvement in generic products' CCDS updates. In addition, we argue that labelling harmonisation across multiple regions, especially safety section-related information, plays a key role in promoting end-user safety and would help communicate risks. We also strongly believe that the topic is worthy of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) consideration, and propose that this is the key area that requires standardisation and harmonisation.

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.