Legal Action Against Health Claims on Foods and Beverages Marketed to Youth

The prevalence of obesity among US children raises numerous health concerns. One pathway to reduce childhood obesity is by decreasing energy intake through the ingestion of fewer calories. Yet, food and beverage manufacturers often promote energy-dense items for children via varied health claims.Deceptive health claims are prohibited, and may be addressed through litigation or governmental regulatory efforts. While the amount of legal action against these potentially deceptive claims has increased, no comprehensive assessment has been conducted.This article, which analyzes litigation and governmental regulatory activities, considers key factors that may influence decisions to take legal action against potentially deceptive health claims on foods and beverages, including scientific support, forum selection, selection of plaintiffs, and potential public health impact.During the last 3 decades, the prevalence of obesity among US children has increased.1 Today, one third of youths are overweight or obese, and 17% are obese.2 Childhood obesity raises numerous health concerns, including greater likelihood of cardiovascular disease risk factors, presence of pre-diabetic indicators, and psychosocial issues.3–5 Obese children are more likely to become overweight or obese adults, with attendant risks for cardiovascular disease, metabolic challenges, and certain cancers.6–9Decreasing energy intake through the ingestion of fewer calories represents one pathway to reduce childhood obesity.10 Yet, companies that advertise foods and beverages often promote energy-dense items for children (i.e., items high in sugar, fat, or calories, such as sugar-sweetened beverages or certain breakfast cereals).11,12 This may be particularly confusing for parents seeking nutritious choices for their children, since some companies use health-related claims to promote energy-dense products (e.g., “good source of vitamin C”).13By law, however, “deceptive” claims are prohibited.14 A deceptive claim is one that: (1) is likely to mislead consumers when viewed by those acting reasonably under the circumstances; and (2) contains a message directly tied to a consumer’s purchasing decision.15 Federal regulatory authority for health claims is shared by the US Food and Drug Administration (FDA), for food labeling, and the Federal Trade Commission (FTC), for food advertising.16 In addition, state attorneys general, other state-level regulators, and private individuals may take legal action against potentially deceptive health claims.17Although federal agencies such as the FDA and FTC may use varied administrative tools to address allegedly deceptive health claims on foods and beverages, litigation brought by federal or state governments or private individuals may also encourage food and beverage manufacturers to limit their risk. This litigation often relies on federal or state consumer protection or false advertising laws, which require that consumers receive product information that is truthful and not misleading. In response to threatened litigation, or to avoid future litigation, manufacturers may voluntarily remove deceptive health claims from their products.18,19Although several analyses have examined specific claims that received regulatory attention,20,21 no comprehensive assessment of these actions has been conducted. We conducted a comprehensive review of federal, state, and private litigation and governmental regulatory activities regarding potentially deceptive health claims on foods and beverages marketed to children. We identify trends in these legal actions and discuss lessons learned for policymakers, practitioners, and other stakeholders seeking to limit the untruthful or misleading marketing of foods and beverages to children.     

Survival and mortality among users and non-users of hydroxyurea with sickle cell disease

OBJECTIVE:

to estimate survival, mortality and cause of death among users or not of hydroxyurea with sickle cell disease.

METHOD:

cohort study with retrospective data collection, from 1980 to 2010 of patients receiving inpatient treatment in two Brazilian public hospitals. The survival probability was determined using the Kaplan-Meier estimator, survival calculations (SPSS version 10.0), comparison between survival curves, using the log rank method. The level of significance was p=0.05.

RESULTS:

of 63 patients, 87% had sickle cell anemia, with 39 using hydroxyurea, with a mean time of use of the drug of 20.0±10.0 years and a mean dose of 17.37±5.4 to 20.94±7.2 mg/kg/day, raising the fetal hemoglobin. In the comparison between those using hydroxyurea and those not, the survival curve was greater among the users (p=0.014). A total of 10 deaths occurred, with a mean age of 28.1 years old, and with Acute Respiratory Failure as the main cause.

CONCLUSION:

the survival curve is greater among the users of hydroxyurea. The results indicate the importance of the nurse incorporating therapeutic advances of hydroxyurea in her care actions.     

Adverse Birth Outcomes in Colorado: Assessing the Impact of a Statewide Initiative to Prevent Unintended Pregnancy

Objectives. We assessed whether living in counties with Title X clinics and increased use of long-acting reversible contraception (LARC) in Colorado are associated with decreased risk of adverse birth outcomes.Methods. We linked Title X clinic counties to the Colorado birth data set by using the mother’s county of residence. We compared low birth weight (LBW) and preterm birth (PTB) in 2008 and 2012, in counties with and without Title X clinics. We compared the relationship between LARC use and the incidence of LBW or PTB in 2012 for women living in counties with Title X clinics.Results. For women living in counties with Title X clinics, the odds of PTB were significantly lower in 2012 compared with 2008 (odds ratio = 0.85; 95% confidence interval = 0.81, 0.89; interaction P = .02). For women living in Title X clinic counties in 2012, a higher proportion of LARC use (> 12.4%) was significantly associated with decreased risk of PTB (P = .02) compared with a low proportion of LARC use (≤ 4.96%).Conclusions. Improved access to family planning services and increased use of LARC are associated with lower risk of PTB.Unintended pregnancy is a significant public health issue in the United States. According to the most recent published estimates, 51% of pregnancies in the United States were unintended, and 60% of unintended pregnancies resulted in a live birth.1 Unintended pregnancies are associated with increased risk of adverse pregnancy outcomes, such as preterm birth (PTB) and delivery of low–birth weight (LBW) infants.2–8 In a large systematic review, Shah et al. reported increased odds of PTB (odds ratio [OR] = 1.31; 95% confidence interval [CI] = 1.09, 1.58) and LBW (OR = 1.36; 95% CI = 1.25, 1.48) among unintended pregnancies ending in live birth compared with intended pregnancies.2 The link between unintended pregnancy and poor birth outcomes is likely multifaceted, and may be associated with maternal socioeconomic risk factors, inadequate prenatal care, and preconceptual and prenatal maternal behavioral risk factors such as smoking and alcohol use.9–11 As part of the national effort to improve overall public health, increasing the proportion of pregnancies that are intended and decreasing the rates of PTB and LBW deliveries are all objectives of the Healthy People 2020 initiative.12In 2008, 37% of live births in Colorado resulted from unintended pregnancies according to the Pregnancy Risk Assessment Monitoring System.13 To address this issue, the Colorado Initiative to Reduce Unintended Pregnancy (Colorado Initiative) was developed and enacted in 2009 with the generous support of an anonymous donor.14 As part of the effort, the Colorado Family Planning Initiative was implemented through the Colorado Department of Public Health and Environment. Two of the primary goals of the initiative were (1) increasing the number of women accessing family planning services and (2) increasing the adoption of long-acting reversible contraceptive (LARC) methods such as intrauterine devices and contraceptive implants.14 Long-acting reversible contraceptive methods are safe and highly effective forms of contraception that have been shown to reduce rates of unintended pregnancy.15–18To help achieve these objectives, the Colorado Initiative provided funding to 28 Title X–funded agencies across the state of Colorado from 2009 to 2013, serving 37 of 64 Colorado counties. Those 37 counties were home to 95% of the state’s low-income population (defined as individuals with incomes at or below 150% of the federal poverty level).14 The locations of Colorado Title X clinics are shown in Figure 1. This distribution of resources in Colorado is important, in light of the known disparities of unintended pregnancy rates for women on the basis of socioeconomic status, age, race/ethnicity, and level of education.1Open in a separate windowFIGURE 1—Counties and locations of Title X clinics: Colorado, 2008 and 2012.The funding for the Colorado Initiative specifically supported the provision of intrauterine devices and contraceptive implants to women seeking care at Title X clinics, training for providers and staff on the counseling and provision of LARC methods, and technical assistance to Title X agencies related to increasing the use of these methods.14 Many of the Title X clinics across the state successfully executed the primary objectives of the Colorado Initiative, resulting in a rise in the total number of clients accessing family planning services per year from 46 201 to 64 148 and the proportion of women choosing LARC methods out of all women using contraception at Title X clinics from 0.8% to 8.6% from 2008 to 2012 (G. Klinger, Colorado Department of Public Health and Environment, e-mail communication, April 1, 2014).Although LARC use is on the rise in the United States, there is little in the published literature demonstrating an association between the use of LARC methods and rates of adverse birth outcomes.19 Given the scale of the Colorado Initiative, there is a unique opportunity to evaluate this possible association. As a result of improved use of family planning services in general and LARC use in particular, we hypothesized the following: (1) there will be a significant decrease in LBW and PTB in Colorado from 2008 to 2012; (2) for women living in Colorado counties in 2012 compared with 2008, LBW and PTB will differ by whether there is a Title X clinic in that woman’s county of residence; and (3) for women living in Colorado counties with Title X clinics in 2012, there will be a significant inverse association between LARC use at Title X clinics and LBW and PTB.     

Aplasia cutis congenita: a conservative approach of a case with large,extensive skin,and underlying skull defect

Aplasia cutis congenita is a disease in which skin, bone, and dura mater can be absent. In majority of the cases it affects the scalp. We report a baby girl born at term with a large scalp and skull defect measuring 9 × 10 cm. Conservative treatment led to complete epithelization.     

Occupational therapy with people with depression: Using nominal group technique to collate clinician opinion

Aims. This aim of this study was to obtain a consensus from clinicians regarding occupational therapy for people with depression, for the assessments and practices they use that are not currently supported by research evidence directly related to functional performance. The study also aimed to discover how many of these assessments and practices were currently supported by research evidence. Methods. Following a previously reported systematic review of assessments and practices used in occupational therapy for people with depression, a modified nominal group technique was used to discover which assessments and practices occupational therapists currently utilize. Three online surveys gathered initial data on therapeutic options (survey 1), which were then ranked (survey 2) and re-ranked (survey 3) to gain the final consensus. Twelve therapists completed the first survey, whilst 10 clinicians completed both the second and third surveys. Major findings. Only 30% of the assessments and practices identified by the clinicians were supported by research evidence. A consensus was obtained on a total of 35 other assessments and interventions. These included both occupational-therapy-specific and generic assessments and interventions. Principle conclusion. Very few of the assessments and interventions identified were supported by research evidence directly related to functional performance. While a large number of options were generated, the majority of these were not occupational therapy specific.     

Noise pollution and annoyance: An urban soundscapes study

Since 1972, the World Health Organization (WHO) has declared noise as a pollutant. Over the last decades, the quality of the urban environment has attracted the interest of researchers due to the growing urban sprawl, especially in developing countries. The objective of this study was to evaluate the effects of noise exposure in six urban soundscapes: Areas with high and low levels of noise in scenarios of leisure, work, and home. Cross-sectional study. The study was conducted in two steps: Evaluation of noise levels, with the development of noise maps, and health related inquiries. 180 individuals were interviewed, being 60 in each scenario, divided into 30 exposed to high level of noise and 30 to low level. Chi-Square test and Ordered Logistic Regression Model (P < 0,005). 70% of the interviewees reported noticing some source of noise in the selected scenarios and it was observed an association between exposure and perception of some source of noise (P < 0.001). 41.7% of the interviewees reported some degree of annoyance, being that this was associated with exposure (P < 0.001). There was also an association between exposure in different scenarios and reports of poor quality of sleep (P < 0.001). In the scenarios of work and home, the chance of reporting annoyance increased when compared with the scenario of leisure. We conclude that the use of this sort of assessment may clarify the relationship between urban noise exposure and health.