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BACKGROUND: Consumption of sugar-sweetened beverages, including fruit drinks (i.e., fruit-flavored drinks containing added sugar), contributes to childhood obesity. OBJECTIVES: We aimed to examine whether nutrition-related claims on fruit drinks influence purchasing among parents and lead to misperceptions of healthfulness. METHODS: We conducted an experiment in a virtual convenience store with 2219 parents of children ages 1–5 y. Parents were randomly assigned to view fruit drinks displaying 1 of 3 claims (“No artificial sweeteners,” “100% Vitamin C,” and “100% All Natural”) or no claim (i.e., control group). Parents selected among each of 2 drinks for their young child: 1) a fruit drink or 100% juice (primary outcome), and 2) a fruit drink or water. RESULTS: When choosing between a fruit drink and 100% juice, 45% of parents who viewed the fruit drink with the “No artificial sweeteners” claim, 51% who viewed the “100% Vitamin C” claim, and 54% who viewed the “100% All Natural” claim selected the fruit drink, compared with 32% in the no-claim control group (all P 0.05). CONCLUSIONS: Nutrition-related claims led parents to choose less healthy beverages for their children and misled them about the healthfulness of fruit drinks. Labeling regulations could mitigate misleading marketing of fruit drinks. This trial was registered at clinicaltrials.gov as NCT04381481.

Allergen avoidance is critical for those with immunoglobulin E-mediated food allergy, but can only be successful with accurate product information. Although the Food and Drug Administration maintains the Center for Food Safety and Nutrition Adverse Event Reporting System to collect adverse event (AE) reports related to foods, there is substantial underreporting, and information regarding product labeling issues is limited.The purpose of this study was to describe allergic reactions associated with accidental oral exposure to sesame and the role of product labeling.A questionnaire was developed and disseminated to online communities focused on sesame allergy. The questionnaire included questions on clinical characteristics, treatments, outcomes, and labeling issues.A total of 360 clinical reactions related to sesame were reviewed in 327 individuals. Anaphylaxis occurred in 68.9% of reactions. Hospitalization occurred in 47.8% of events and epinephrine was administered in 36.4% of cases. Events involving a packaged food product occurred in 67.5% of AEs with only 43.8% of these using the term "sesame." An alternative name was noted in 46.0% of products that did not include "sesame" on labeling, most of which was "tahini."We determined considerable sesame food allergy morbidity, in part owing to inconsistent allergen labeling. Our findings support the development of a more rapid process for the Food and Drug Administration to update the major allergen list and formulation of an improved system for reporting AEs related to foods.

Added-sugar consumption in the U.S. exceeds recommended limits. Policymakers are considering requiring restaurants to use menu warning labels to indicate items high in added sugar. We sought to determine whether icon-only and icon-plus-text added-sugar menu labels were (1) perceived as more effective at potentially reducing consumption of items high in added sugar and (2) increased knowledge of menu items' added-sugar content relative to control labels, and if effects differed by label design. A national sample of U.S. adults (n=1327) participated in an online randomized experiment. Participants viewed menu items with either a control label, 1 of 6 icon-only labels, or 1 of 18 icon-plus-text labels with 3 text variations. For their assigned label, participants provided ratings of perceived message effectiveness (a validated scale of a message's potential to change behavior). Participants were also asked to classify menu items by their added-sugar content. The icon-only and icon-plus-text labels were perceived as more effective than the control label (means: 3.7 and 3.7 vs. 3.1, respectively, on a 5-point scale; p&nbsp

ImportanceFruit drinks are widely consumed by young children, and many parents mistakenly believe that these drinks are healthy, potentially due to front-of-package claims and imagery. Research is needed on the influence of this marketing and how labeling regulations could change behavior.ObjectiveTo assess the effects of a front-of-package 100% vitamin C claim, fruit imagery, percentage juice and teaspoons of added sugar disclosures, and high–added sugar warnings on parents’ choices, knowledge, and perceptions of beverages.Design, Setting, and ParticipantsThis randomized clinical trial was conducted May to July 2021 as a single-exposure (no follow-up) online survey of primary caregivers of children ages 0 to 5 years throughout the US.InterventionsParticipants were shown no–, low–, and high–added sugar beverages and asked to choose 1 for their child. Participants were randomized to see high–added sugar beverages with 1 of 7 front-of-package conditions: (1) claim and imagery (control); (2) no claim; (3) no imagery; (4) no claim or imagery; (5) claim, imagery, and percentage juice disclosure; (6) claim, imagery, and warning; or (7) claim, imagery, warning, and teaspoons of added sugar disclosure.Main Outcomes and MeasuresPrimary outcomes were type of beverage chosen (eg, high–added sugar beverage) and resulting calories and added sugar (in grams). Secondary outcomes were fruit drink knowledge (added sugar and percent juice) and perceptions.ResultsThere were 5005 participants included in the final analysis (mean [SD] age, 31.5 [8.3] years; 3587 female participants [71.7%]), including 714 participants in group 1, 717 participants in group 2, 710 participants in group 3, 717 participants in group 4, 708 participants in group 5, 729 participants in group 6, and 710 participants in group 7. Compared with participants in the control group, who had a mean (standard error [SE]) of 9.4 (0.5) g of added sugar and 81.9 (1.6) kcal in chosen beverages, only participants who saw warnings with teaspoons of added sugar disclosures had significantly reduced added sugar (−1.3 g; 95% CI, −2.6 to −0.1 g [−14.2%; 95% CI, −26.7% to −1.8%]; P = .04) and calories (−5.3 kcal; 95% CI, −9.8 to −0.9 kcal [−6.5%; 95% CI, −11.8% to −1.3%]; P = .02) in selected beverages. In warning conditions (ie, 6 and 7) compared with the control group (mean [SE] 41.0% [1.8%]), the proportion of participants choosing high–added sugar beverages was significantly reduced, by 5.5 percentage points (95% CI, 0.5 to 10.5 percentage points [13.4%; 95% CI, 1.2% to 25.6%]; P = .03) and 6.4 percentage points (95% CI, 1.4 to 11.4 percentage points [15.6%; 95% CI, 3.3% to 27.8%]; P = .01), respectively. The no claim or imagery condition (4) significantly reduced the proportion of parents choosing high–added sugar beverages (−7.6 percentage points; 95% CI, −12.6 to −2.6 percentage points [−18.4%; 95% CI, −30.6% to −6.3%]; P = .003). Percentage juice disclosures did not affect beverage choice.Conclusions and RelevanceThese findings suggest that added sugar warnings and prohibitions of front-of-package claims and imagery may reduce parents’ purchases of high–added sugar beverages for their young children but that percentage juice disclosures may not change behavior.Trial RegistrationClinicalTrials.gov Identifier: NCT04811690

Young children regularly consume sugary fruit drinks, in part because parents may falsely believe they are healthful due to front-of-package (FOP) claims and imagery. The goal of this study was to assess: 1) the prevalence of FOP claims/imagery on fruit-flavored beverages purchased by U.S. households with 0-5-year-olds, and 2) proportional differences in beverages purchased with FOP claims/imagery across household demographic groups. A content analysis of FOP claims/imagery (e.g., nutrient claims, fruit imagery) on beverages (n = 1365) purchased by households with 0-5-year-olds was conducted by linking beverage sales with FOP marketing data. Results were merged with purchasing data from a nationally representative sample of households (FoodAPS), and survey-weighted logistic regression was used to assess differences in the proportions of 100% juices and fruit drinks with specific FOP claims/imagery purchased by household race/ethnicity, income, and SNAP/WIC participation. The most common claims on fruit-flavored beverages included nutrient claims (fruit drinks: 73%; 100% juices: 68%; flavored waters: 95%), which most commonly highlighted vitamin C (35-41% across beverage categories) and the absence of sugar (31-48%). Most beverages also contained implied-natural claims (fruit drinks: 60%; 100% juices: 64%; flavored waters: 95%) and natural imagery (fruit drinks: 97%; 100% juices: 96%; flavored waters: 73%). A large proportion of fruit drinks and 100% juices purchased by households across all demographic groups contained FOP claims and imagery, with a few minor differences between racial/ethnic groups. In conclusion, most fruit drinks, 100% juices, and flavored waters purchased by households with 0-5-year-olds contained FOP claims and imagery that may lead consumers to believe the beverages are healthy and natural. FDA regulations should ensure parents are not misled by this marketing.

Sarah Sorscher, Azza AbuDagga, Sammy Almashat, Michael A Carome, Sidney M Wolfe Health Research Group, Public Citizen, Washington, DC, USA Purpose: The Food and Drug Administration (FDA) permits investigators to withhold active interventions from human subjects randomly assigned to control groups in clinical trials. The scope of this practice in trials for life-threatening diseases is unknown. We assessed the frequency and characteristics of trials providing control group subjects with active interventions versus those providing only placebos to control group subjects in trials supporting FDA approvals of new drugs for nine life-threatening diseases. Materials and methods: We reviewed the FDA’s database of approved drug products and identified all new approvals from 2006 to 2011 for drugs or biological products indicated for asthma, bipolar disorder, chronic obstructive pulmonary disease (COPD), diabetes mellitus, hypertension, osteoporosis, Parkinson’s disease, partial seizures, and schizophrenia. Then, we identified all trials described in FDA medical review documents for these approvals and abstracted information on trial characteristics and the interventions provided to control group subjects. Results: Of 508 included trials, 201 (39.6%) were placebo-only-controlled, meaning subjects in at least one control group did not receive an active intervention, and 307 (60.4%) were active-controlled, meaning subjects in all control groups received an active intervention. The total recorded enrollments in control groups provided with placebos only and in control groups provided with active interventions were 19,361 and 93,093 subjects, respectively. The proportion of placebo-only-controlled trials varied across diseases (P