Implied Claims in Drug Advertising: A Review of Recent Literature and Regulatory Actions.

Federal agencies and self-regulatory bodies help to ensure prescription and nonprescription drug promotion contains accurate information; however, false or misleading claims may cause people to have inaccurate perceptions of a drug and inhibit their ability to make informed decisions. We conducted a systematic review assessing evidence from 2012-2021 on how consumers and healthcare providers (HCPs) interpret claims made indirectly or through inference (implied or implicit claims) as well as synthesizing prescription and nonprescription drug advertising claims that have been the subject of regulatory actions from 2017-2021. Our search identified 16 studies from the peer-reviewed literature and 26 letters or case reports issued by the Food and Drug Administration (FDA) or National Advertising Division (NAD). Results from peer-reviewed studies suggest that implied claims can result in inferences that may not be warranted by the material facts about the drug. Perceptions of a drug's efficacy and, to a lesser extent, risk, are influenced by implied and explicitly false claims in prescription drug promotion. Claims related to implied superiority and overstatement of efficacy were the most prevalent claims flagged for review and examined in the literature. These types of claims were also the subject of many of the compliance actions by the FDA and case reports from the NAD. More research is needed to understand how people interpret varying types of implied claims and the impact of such claims on key outcomes. From a policy standpoint, understanding how people interpret implied claims can inform how the FDA approaches these claims in the marketplace.

Determining an Appropriate Sample Size for Qualitative Interviews to Achieve True and Near Code Saturation: Secondary Analysis of Data.

BACKGROUND: In-depth interviews are a common method of qualitative data collection, providing rich data on individuals' perceptions and behaviors that would be challenging to collect with quantitative methods. Researchers typically need to decide on sample size a priori. Although studies have assessed when saturation has been achieved, there is no agreement on the minimum number of interviews needed to achieve saturation. To date, most research on saturation has been based on in-person data collection. During the COVID-19 pandemic, web-based data collection became increasingly common, as traditional in-person data collection was possible. Researchers continue to use web-based data collection methods post the COVID-19 emergency, making it important to assess whether findings around saturation differ for in-person versus web-based interviews. OBJECTIVE: We aimed to identify the number of web-based interviews needed to achieve true code saturation or near code saturation. METHODS: The analyses for this study were based on data from 5 Food and Drug Administration-funded studies conducted through web-based platforms with patients with underlying medical conditions or with health care providers who provide primary or specialty care to patients. We extracted code- and interview-specific data and examined the data summaries to determine when true saturation or near saturation was reached. RESULTS: The sample size used in the 5 studies ranged from 30 to 70 interviews. True saturation was reached after 91% to 100% (n=30-67) of planned interviews, whereas near saturation was reached after 33% to 60% (n=15-23) of planned interviews. Studies that relied heavily on deductive coding and studies that had a more structured interview guide reached both true saturation and near saturation sooner. We also examined the types of codes applied after near saturation had been reached. In 4 of the 5 studies, most of these codes represented previously established core concepts or themes. Codes representing newly identified concepts, other or miscellaneous responses (eg, "in general"), uncertainty or confusion (eg, "don't know"), or categorization for analysis (eg, correct as compared with incorrect) were less commonly applied after near saturation had been reached. CONCLUSIONS: This study provides support that near saturation may be a sufficient measure to target and that conducting additional interviews after that point may result in diminishing returns. Factors to consider in determining how many interviews to conduct include the structure and type of questions included in the interview guide, the coding structure, and the population under study. Studies with less structured interview guides, studies that rely heavily on inductive coding and analytic techniques, and studies that include populations that may be less knowledgeable about the topics discussed may require a larger sample size to reach an acceptable level of saturation. Our findings also build on previous studies looking at saturation for in-person data collection conducted at a small number of sites.

Military Eligibility for the Supplemental Nutrition Assistance Program: Simulating the Exemption of the Basic Allowance for Housing from Gross Income.

BACKGROUND: Twenty-four percent of active-duty service member households experienced food insecurity in 2020; however, limited data have suggested that few participate in the Supplemental Nutrition Assistance Program (SNAP). A potential reason for low SNAP participation among active-duty military households is that the basic allowance for housing (BAH) is considered countable income for SNAP eligibility determination. OBJECTIVES: This study explores how many more service members' households, referred to as "SNAP units" (that is, a group of individuals who live together and regularly buy food and prepare meals together), would become eligible for SNAP benefits if the BAH is excluded from countable income in deciding eligibility. METHODS: This study used 2016-2020 American Community Survey 5-y estimates to construct a sample of active-duty military households combined with data on military pay and allowances to simulate changes to SNAP eligibility and poverty status with a BAH exemption as well as impacts on federal spending on SNAP. RESULTS: Eligibility for SNAP among military SNAP units increases from 0.4% to 1.5% (263% increase) if a service member's BAH was exempted from their gross income. The increase was driven by SNAP units whose highest-ranking service member was from the noncommissioned officer ranks without dependents. As more military SNAP units became eligible and chose to participate, annual SNAP disbursements (that is, amount of funds spent on SNAP) for the whole program increased by up to 1.3%, compared with FY16-20 SNAP disbursements. With an increase in SNAP participation, the poverty rate among military SNAP units decreases from 8.7% to 1.4% (83.9% decrease). CONCLUSIONS: Exempting service members' BAH from their gross income would likely increase SNAP eligibility and participation among military households and, in turn, reduce poverty.

Survey of Afterschool Programs Suggests Most Offer Fruit and Vegetables Daily.

INTRODUCTION: Most children underconsume fruit and vegetables. This study estimated the frequency and quality of fruit and vegetables offered during snack in US afterschool programs and examined program-level factors associated with offering them, including awareness and use of the National AfterSchool Association Healthy Eating and Physical Activity standards. METHODS: We conducted descriptive analyses and regression modeling by using data collected from 684 National AfterSchool Association members and their colleagues via a 2015 online survey. RESULTS: At the previous snack, 63% of respondents offered fruit, a vegetable, or both, with 42% offering only fruit, 18% offering fruit and vegetables, and 3% offering only vegetables. The quality of the items offered showed that most respondents selected the healthiest options, such as fresh fruit and vegetables. Controlling for other factors, we found that factors independently associated with offering fruit, vegetables, or both were membership in the National AfterSchool Association, using the standards for menu planning, and training staff members in healthy eating more than once a year. Programs run by school districts were less likely to offer fruit than programs run by other organizations. CONCLUSION: Membership in the National AfterSchool Association and use of its Healthy Eating and Physical Activity standards are associated with offering fruit and vegetables during snack at afterschool programs staffed by National AfterSchool Association members and their colleagues across the United States. With over a third of sites surveyed offering neither a fruit nor a vegetable at the previous snack, additional implementation of the standards is still needed.

Consumers' Perceptions of Edible Marijuana Products for Recreational Use: Likes, Dislikes, and Reasons for Use.

BACKGROUND: Edible marijuana products have become extremely popular in states that have legalized marijuana for recreational use. OBJECTIVES: The goal of this research was to provide a better understanding of consumer perceptions of edible marijuana products, including why they prefer edibles relative to other forms of marijuana (e.g., smoking) and their concerns regarding the consumption of edibles. METHODS: We conducted eight focus groups (four groups in Denver, Colorado, and four groups in Seattle, Washington) in February 2016 with 62 adult consumers of edibles. Focus group transcripts were coded in QSR NVivo 10.0 qualitative analysis software, and coding reports identified trends across participants. RESULTS: Most participants preferred edibles to smoking marijuana because there is no smell from smoke and no secondhand smoke. Other reasons participants like edibles included convenience, discreetness, longer-lasting highs, less intense highs, and edibles' ability to aid in relaxation and reduce anxiety more so than smoking marijuana. Concerns and dislikes about edibles included delayed effects, unexpected highs, the unpredictability of the high, and inconsistency of distribution of marijuana in the product. No participants in either location mentioned harmful health effects from consuming edibles as a concern. Conclusions/Importance: The present study was qualitative in nature and provides a good starting point for further research to quantify through surveys how consumers understand and use edibles. Such information will help guide policy makers and regulators as they establish regulations for edibles. Also, such research can help inform educational campaigns on proper use of edibles for recreational purposes.

Detecting bad actors in value-based payment models.

The U.S. federal government is spending billions of dollars to test a multitude of new approaches to pay for healthcare. Unintended consequences are a major consideration in the testing of these value-based payment (VBP) models. Since participation is generally voluntary, any unintended consequences may be magnified as VBP models move beyond the early testing phase. In this paper, we propose a straightforward unsupervised outlier detection approach based on ranked percentage changes to identify participants (e.g., healthcare providers) whose behavior may represent an unintended consequence of a VBP model. The only data requirements are repeated measurements of at least one relevant variable over time. The approach is generalizable to all types of VBP models and participants and can be used to address undesired behavior early in the model and ultimately help avoid undesired behavior in scaled-up programs. We describe our approach, demonstrate how it can be applied with hypothetical data, and simulate how efficiently it detects participants who are truly bad actors. In our hypothetical case study, the approach correctly identifies a bad actor in the first period in 86% of simulations and by the second period in 96% of simulations. The trade-off is that 9% of honest participants are mistakenly identified as bad actors by the second period. We suggest several ways for researchers to mitigate the rate or consequences of these false positives. Researchers and policymakers can customize and use our approach to appropriately guard VBP models against undesired behavior, even if only by one participant. Supplementary Information: The online version contains supplementary material available at 10.1007/s10742-021-00253-9.

Farm-to-school education grants reach low-income children and encourage them to learn about fruits and vegetables.

For children from low-income families, school meals are a significant portion of daily caloric intake and hence an opportunity to address food insecurity. For a variety of reasons, including children not eating school meals, participation in the National School Lunch Program remains below eligibility. Many states have pursued legislation to institutionalize programs such as farm to school that aim to improve the quality of school meals and acceptance of healthy foods (fruits and vegetables) to address the interconnected problems of food insecurity, hunger, and diet-related diseases. Oregon established its Farm to School Education Grant Program to increase knowledge of and preference for fruits and vegetables among children in low-income school districts. This article outlines the reach of the education grants and examines their influence on children's food choices and behaviors related to fruits and vegetables. We analyzed Oregon Department of Education Farm to School Baseline and Progress Reports from school year 2015-2016 and conducted interviews with education grantees. We conducted descriptive analyses for quantitative data. For qualitative data, we coded repeated concepts and identified themes using grounded theory approach. Education grants reached more than 20,000 students in 30 districts, including 25 low-income districts. The most reported activities were nutrition and food-based lessons, school gardens, and farm field trips. Thematic results included students eating fruits and vegetables, trying new foods because of gardens, and learning about growing produce. Oregon's Farm to School Education Grant Program reached the targeted low-income students, encouraged districts to implement educational activities, and allowed low-income children to learn about produce. Education is a core element of farm-to-school success and can help achieve the behavior change in youth needed for increased acceptance of school meals, better health outcomes, and improved food security.

Consumer use and understanding of labelling information on edible marijuana products sold for recreational use in the states of Colorado and Washington.

BACKGROUND: In 2014, the states of Colorado and Washington began allowing retail sales of marijuana for recreational use. The regulatory agencies in these states have implemented specific labelling requirements for edible marijuana products sold for recreational use to help address concerns such as delayed activation time, accidental ingestion, and proper dosing. METHODS: We conducted 12 focus groups with 94 adult consumers and nonconsumers of edibles in Denver and Seattle to collect information on their use and understanding of labelling information on edible marijuana products sold for recreational use. Specifically, we asked participants about the usefulness, attractiveness, ease of comprehension, relevancy, and acceptability of the label information. RESULTS: Some focus group participants look for and read specific information, such as the potency profile and serving size statement, but do not read or were unfamiliar with other labelling features. The focus groups revealed that participants have some concerns about the current labelling of edibles. In particular, participants were concerned that there is too much information on the labels so consumers may not read the label, there is no obvious indication that the product contains marijuana (e.g., a Universal Symbol), and the information on consumption advice is not clear. Participants in both locations suggested that education in a variety of formats, such as web- and video-based education, would be useful in informing consumers about the possible risks of edibles. CONCLUSION: The focus group findings suggest that improvements are needed in the labelling of edibles to prevent unintentional ingestion among adult nonusers and help ensure proper dosing and safe consumption among adult users. These findings, along with lessons learned from Colorado and Washington, can help inform the labelling of edibles as additional states allow the sale of edibles for recreational use.

How four U.S. states are regulating recreational marijuana edibles.

BACKGROUND: Sales of edible marijuana products have been strong in Colorado and Washington State since the legalization of recreational marijuana. Initially, these states did not have comprehensive labelling or packaging requirements in place. In response to increases in marijuana-related emergency room visits and poison control centre calls, additional regulations were implemented. Currently, Alaska, Colorado, Oregon, and Washington each have passed into law various labelling and packaging requirements for edibles. METHODS: This article presents the primary legal research findings of relevant statutes and regulations for edibles in Alaska, Colorado, Oregon, and Washington. These laws were identified by using Boolean terms and connectors searches in these states' legal databases in LexisNexis. RESULTS: Alaska, Colorado, Oregon, and Washington vary greatly in how they regulate labelling and packaging. Colorado, Oregon and Washington require a Universal Symbol to be affixed to edibles, but only Oregon and Washington require that the use of pesticides be disclosed on the label. Only Colorado and Oregon require that the packaging for edibles bear a Nutrition Facts Panel on the label. Δ9-Tetrahydracannabinol (THC) in a single serving or single edible product as Alaska and Oregon. All four states prohibit the manufacture or packaging of edibles that appeal to youth. CONCLUSION: State laws governing recreational marijuana edibles have evolved since the first recreational edible products were available for sale. Alaska, Colorado, Oregon, and Washington now require edible product labels to disclose a variety of product information, including risk factors associated with consumption. However, there still remain concerns about the regulatory gaps that exist in each of these states, inherent difficulties in enforcing laws around the labelling, packaging, and manufacturing of edibles, and the outstanding question of whether these edible laws are actually informing consumers and keeping the public safe.