Currently, in the United States, there is no comprehensive surveillance system to collect data on food allergies; however, prevalence and severity data are critical to quantify the burden of food allergies, develop evidence-based control measures, detect emerging issues, and monitor trends. To address this gap, we conducted a literature search, and expert interviews to identify surveillance systems and datasets that could be used to estimate the prevalence and severity of food allergies in the United States overall and for specific foods. Inclusion and exclusion criteria were developed and used to screen each data source. Selected articles were evaluated according to quality parameters to identify the most appropriate studies. Most studies estimated the prevalence of food allergies in children, investigated multiple foods, and used surveys to collect self-reported data. Despite the high quality, robust study designs, and comprehensive survey instruments that currently exist, the studies identified do not provide sufficiently recent data to estimate the current burden of food allergies in the country. Studies lack consistencies across the years making the analysis of trends over time a challenge. National surveys conducted by Northwestern University in 2009/2010 and 2015/2016 represented the best available data; however, these data are likely outdated and are limited in assessing temporal food allergy trends. Data to accurately estimate the current prevalence and severity of food allergies and related trends are lacking. U.S. public health agencies should explore the development of a comprehensive surveillance program to address this gap and help inform evidence-based policies in food allergy management and prevention.

Objective. To characterize adverse event (AE) cases received by the US Food and Drug Administration (FDA) reportedly involving cannabinoid hemp products (CHPs). Methods. We searched the FDA Adverse Event Reporting System and Center for Food Safety and Applied Nutrition Adverse Event Reporting System for cases reported directly to the FDA from 2019-2023 involving CHPs, which are defined as products containing 1 or more of the following: cannabidiol, delta-8 tetrahydrocannabinol, and emerging cannabinoids (i.e., other intoxicating cannabinoids often synthesized from hemp-derived cannabidiol). We abstracted and summarized information on reporting trends, consumer demographics, reporter information, product information, and AEs. Results. We identified 610 AE cases reportedly involving CHPs containing 1 or more of the following: delta-8 tetrahydrocannabinol (n=355), cannabidiol (n=253), and emerging cannabinoids (n=36). Multiple trends and safety issues were identified, including an annual increase in the number of cases involving intoxicating cannabinoids since 2021, potential quality issues, and the occurrence of fatalities and pediatric exposures. Conclusions. Our findings emphasize the importance of monitoring AE cases received by the FDA involving CHPs as part of a comprehensive surveillance strategy to identify trends and safety issues with these products. ( AmJ Public Health. 2024;114(S8):S664-S672. https://doi.org/10.2105/AJPH.2024.307712)

As the most commonly consumed dietary supplement, how multivitamin use associates with risk of mortality remains inconclusive. Methods: We used data from three cohort studies to examine the association of time-varying multivitamin use with risk of mortality. We also emulated a target trial to estimate the association by applying the parametric g-formula. Results: Of 241,068 eligible participants (mean age at baseline: 50 for NHS, 37 for NHSII, and 53 for HPFS), there were 44,415 deaths over 30-years of follow up. Compared to non-users, the pooled age-adjusted harzard ratio (HR) of mortality was 0.92 (95% CI: 0.89, 0.94) and 0.89 (95% CI: 0.88, 0.91) for users who used <1 and ≥1 pill/day, respectively. These results were attenuated after multivariable adjustment (0.97 [0.95, 1.00] and 0.98 [0.96, 0.99], respectively), and the inverse association was primarily due to lower risk of CVD mortality ( table 1 ). In the emulated target trial, the estimated 30-y all-cause mortality under a multivitamin intervention was slightly lower than no intervention ( table 2 ). Conclusions: Multivitamin use may relate to a small reduction in mortality among middle-aged adults.

Importance: Consumption of energy drinks has increased drastically in recent years, particularly among young people. It is unknown whether intake of energy drinks is associated with health during pregnancy.Objective: To examine associations of energy drink intake before and during pregnancy with risk of adverse pregnancy outcomes (APOs).Design, setting, and participants: This prospective cohort study included data from women enrolled in the Nurses' Health Study 3 (NHS3) between June 1, 2010, and September 27, 2021, and the Growing Up Today Study (GUTS) who reported 1 or more singleton pregnancy from January 1, 2011, to June 1, 2019. Data were analyzed from October 1, 2021, to September 28, 2023.Exposure: Intake of energy drinks, assessed by food frequency questionnaire.Main outcomes and measures: The main outcomes were self-reported APOs, including pregnancy loss, gestational diabetes, gestational hypertension, preeclampsia, or preterm birth, and a composite APO, defined as development of any of the APOs. Risk of APOs was compared between consumers and nonconsumers of energy drinks.Results: This study included 7304 pregnancies in 4736 participants with information on prepregnancy energy drink intake and 4559 pregnancies in 4559 participants with information on energy drink intake during pregnancy. There were 1691 GUTS participants (mean [SD] age, 25.7 [2.9] years) and 3045 NHS3 participants (mean [SD] age, 30.2 [4.1] years). At baseline, 230 GUTS participants (14%) and 283 NHS3 participants (9%) reported any intake of energy drinks. While no associations were found for pregnancy loss (odds ratio [OR], 0.89; 95% CI, 0.71-1.11), preterm birth (OR, 1.07; 95% CI, 0.71-1.61), gestational diabetes (OR, 0.89; 95% CI, 0.58-1.35), preeclampsia (OR, 0.73; 95% CI, 0.41-1.30), or the composite APO (OR, 1.05; 95% CI, 0.87-1.26), prepregnancy energy drink use was associated with a higher risk of gestational hypertension (OR, 1.60; 95% CI, 1.12-2.29). A significant interaction was found between age and energy drink intake in relation to hypertensive disorders (P = .02 for interaction for gestational hypertension; P = .04 for interaction for any hypertensive disorders), with stronger associations for participants above the median age. No associations of energy drink intake during pregnancy with any of the APOs were found in NHS3 (eg, any APO: OR, 0.86; 95% CI, 0.41-1.79).Conclusions and relevance: In this study, energy drink intake before pregnancy was associated with an elevated risk of gestational hypertension. Given the low prevalence of energy drink intake and low consumption levels among users, the results should be interpreted cautiously.

This multiagency report developed by the Interagency Collaboration for Genomics for Food and Feed Safety provides an overview of the use of and transition to whole genome sequencing (WGS) technology for detection and characterization of pathogens transmitted commonly by food and for identification of their sources. We describe foodbome pathogen analysis, investigation, and harmonization efforts among the following federal agencies: National Institutes of Health; Department of Health and Human Services, Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA); and the U.S. Department of Agriculture, Food Safety and Inspection Service, Agricultural Research Service, and Animal and Plant Health Inspection Service. We describe single nucleotide polymorphism, core-genome, and whole genome tnultilocus sequence typing data analysis methods as used in the PulseNet (CDC) and GenomeTrakr (FDA) networks, underscoring the complementary nature of the results for linking genetically related foodbome pathogens during outbreak investigations while allowing flexibility to meet the specific needs of Interagency Collaboration partners. We highlight how we apply WGS to pathogen characterization (virulence and antimicrobial resistance profiles) and source attribution efforts and increase transparency by making the sequences and other data publicly available through the National Center for Biotechnology Information. We also highlight the impact of current trends in the use of culture-independent diagnostic tests for human diagnostic testing on analytical approaches related to food safety and what is next for the use of WGS in the area of food safety.

AbstractObjective:Energy drinks are consumed for a variety of reasons, including to boost mental alertness and energy. We assessed associations between demographic factors and various high-risky behaviours with energy drink consumption as they may be linked to adverse health events.Design:We conducted cross-sectional analysis including basic descriptive and multivariable-adjusted logistic regression analyses to characterise demographic and behavioural factors (including diet quality, binge drinking and illicit drug use, among others obtained via questionnaires) in relation to energy drink consumption.Setting:We used data from two large US-based cohorts.Participants:46 390 participants from Nurses’ Health Study 3 (NHS3, n 37 302; ages 16–31) and Growing Up Today Study (GUTS, n 9088, ages 20–55).Results:Of the 46 390 participants, 13·2 % reported consuming ≥ 1 energy drink every month. Several risky behaviours were associated with energy drink use, including illegal drug use (pooled OR, pOR: 1·45, 95 % CI: 1·16, 1·81), marijuana use (pOR: 1·49, 95 % CI: 1·28, 1·73), smoking (pOR: 1·88. 95 % CI: 1·55, 2·29), tanning bed use (pOR: 2·31, 95 % CI: 1·96, 2·72) and binge drinking (pOR: 2·53, 95 % CI: 2·09, 3·07). Other factors, such as high BMI, e-cigarette use and poor diet quality were found to be significantly associated with higher energy drink consumption (P values < 0·001).Conclusions:Our findings show that energy drink consumption and high-risk behaviours may be related, which could potentially serve as not only as a talking point for providers to address in outreach and communications with patients, but also a warning sign for medical and other health practitioners.

Purpose Obesity prevalence has reached an all-time high in the US, affecting >40% of the population. This study’s objective was to evaluate associations between demographics and self-reported calorie knowledge and self-perceived confidence in calorie knowledge (“calorie confidence”). The relationships between body mass index (BMI) and calorie knowledge and confidence were also explored. Methods We analyzed data from participants (n = 2171) in the crosssectional, nationally representative 2019 FDA Food Safety and Nutrition Survey using logistic regression to estimate adjusted odds ratios (AORs) and confidence intervals (95% CIs) for associations between BMI and calorie knowledge (correct/incorrect), calorie confidence (confident/not confident), and demographic characteristics, and the Wald chi square test to evaluate relationships between BMI and both calorie knowledge and confidence. Results Many of the same subgroups were more likely than others to report lack of calorie knowledge and lack of confidence in knowing the typical daily calorie intake needed to maintain a healthy weight [respective AORs (95% CIs): age (years), >60 vs 51-60, 1.7 (1.1-2.5), and 1.4 (1.0-2.0); sex, male vs female, 1.7 (1.3-2.3), and 1.7 (1.3-2.1); race/ethnicity, non-Hispanic Black vs non-Hispanic white, 3.4 (2.1-5.5), and 2.4 (1.6-3.8); education, ≤high school vs college grad, 1.5 (1.0- 2.3), and 1.9 (1.3-2.7)]. BMI was significantly correlated with calorie confidence ( P = .047), such that those reporting less confidence were more likely overweight or obese [underweight/healthy (BMI < 25): 29%, overweight (25 ≤ BMI < 30): 34%, obese (BMI ≥ 30): 37%]. Conclusion In certain demographic subgroups associations between calorie knowledge and confidence differed. Tailored education and outreach for these groups may help to address these disparities.

Foodborne illnesses are a substantial and largely preventable public health problem; before 2020 the incidence of most infections transmitted commonly through food had not declined for many years. To evaluate progress toward prevention of foodborne illnesses in the United States, the Foodborne Diseases Active Surveillance Network (FoodNet) of CDC's Emerging Infections Program monitors the incidence of laboratory-diagnosed infections caused by eight pathogens transmitted commonly through food reported by 10 U.S. sites.* FoodNet is a collaboration among CDC, 10 state health departments, the U.S. Department of Agriculture's Food Safety and Inspection Service (USDA-FSIS), and the Food and Drug Administration. This report summarizes preliminary 2020 data and describes changes in incidence with those during 2017-2019. During 2020, observed incidences of infections caused by enteric pathogens decreased 26% compared with 2017-2019; infections associated with international travel decreased markedly. The extent to which these reductions reflect actual decreases in illness or decreases in case detection is unknown. On March 13, 2020, the United States declared a national emergency in response to the COVID-19 pandemic. After the declaration, state and local officials implemented stay-at-home orders, restaurant closures, school and child care center closures, and other public health interventions to slow the spread of SARS-CoV-2, the virus that causes COVID-19 (1). Federal travel restrictions were declared (1). These widespread interventions as well as other changes to daily life and hygiene behaviors, including increased handwashing, have likely changed exposures to foodborne pathogens. Other factors, such as changes in health care delivery, health care-seeking behaviors, and laboratory testing practices, might have decreased the detection of enteric infections. As the pandemic continues, surveillance of illness combined with data from other sources might help to elucidate the factors that led to the large changes in 2020; this understanding could lead to improved strategies to prevent illness. To reduce the incidence of these infections concerted efforts are needed, from farm to processing plant to restaurants and homes. Consumers can reduce their risk of foodborne illness by following safe food-handling and preparation recommendations.

FDA's Menu Labeling Final Rule requires covered establishments provide calorie information on menus or menu boards, among other requirements. This study describes correlates of noticing and using menu calorie information in a nationally representative sample of U.S. adults before implementation of the Final Rule in May 2018. Data from the 2018 National Cancer Institute Health Information National Trends Survey was used to assess noticing menu calorie information, using menu calorie information to change menu ordering behavior, and knowledge of daily calorie needs. Regression analysis of weighted data tested associations between individual characteristics and noticing and using menu calorie information. Nearly half of adults (44%) reported noticing menu calorie information. Women, younger individuals, those who seek health information, individuals with a BMI ≥ 30, and those with higher education or higher income were more likely to report noticing menu calorie information. Among adults who reported noticing menu calorie information, three-quarters responded by ordering less (e.g., fewer calories), which equates to about one-third of the population. About 36% of women and 42% of men lacked calorie knowledge. Men with, versus without, calorie knowledge were twice as likely to report noticing menu calorie information (adjusted OR 2.23 95% CI 1.51, 3.29). Findings suggest behavioral response to menu calorie information varies and most individuals who notice the information respond by ordering less in ways that could reduce caloric intake. Future analyses could compare noticing and using menu calorie information before and after menu labeling implementation to assess the effect of policy on population behaviors.

Foodborne illness source attribution is foundational to a risk-based food safety system. We describe a method for attributing US foodborne illnesses caused by nontyphoidal Salmonella enterica, Escherichia coli O157, Listeria monocytogenes, and Campylobacter to 17 food categories using statistical modeling of outbreak data. This method adjusts for epidemiologic factors associated with outbreak size, down-weights older outbreaks, and estimates credibility intervals. On the basis of 952 reported outbreaks and 32,802 illnesses during 1998-2012, we attribute 77% of foodborne Salmonella illnesses to 7 food categories (seeded vegetables, eggs, chicken, other produce, pork, beef, and fruits), 82% of E. coli O157 illnesses to beef and vegetable row crops, 81% of L. monocytogenes illnesses to fruits and dairy, and 74% of Campylobacter illnesses to dairy and chicken. However, because Campylobacter outbreaks probably overrepresent dairy as a source of nonoutbreak campylobacteriosis, we caution against using these Campylobacter attribution estimates without further adjustment.

To evaluate progress toward prevention of enteric illnesses, the Foodborne Diseases Active Surveillance Network (FoodNet) of CDC's Emerging Infections Program monitors the incidence of laboratory-diagnosed infections caused by eight pathogens transmitted commonly through food at 10 U.S. sites.* This report summarizes preliminary 2019 data and describes changes in incidence compared with that during 2016-2018. The incidence of enteric infections caused by these eight pathogens reported by FoodNet sites in 2019 continued to increase or remained unchanged, indicating progress in controlling major foodborne pathogens in the United States has stalled. Campylobacter and Salmonella caused the largest proportion of illnesses; trends in incidence varied by Salmonella serotype. Widespread adoption of whole genome sequencing (WGS) of bacteria has improved the ability to identify outbreaks, emerging strains, and sources of pathogens. To maximize the potential of WGS to link illnesses to particular sources, testing of isolates by clinical and public health laboratories is needed. Reductions in Salmonella serotype Typhimurium suggest that targeted interventions (e.g., vaccinating chickens and other food animals) might decrease human infections. Reducing contamination during food production, processing, and preparation will require more widespread implementation of known prevention measures and of new strategies that target particular pathogens and serotypes.

BACKGROUND:The association of body mass index (BMI) and waist circumference (WC) with risk of Guillain-Barré syndrome (GBS) has been inconsistent in previous studies.METHODS:We examined the associations of BMI and WC in relation to risk of GBS among 252,980 participants from the Nurses' Health Study (NHS), NHS-II, and the Health Professional Follow-up Study (HPFS). BMI and WC were assessed by self-reported questionnaire, and GBS cases were self-reported.RESULTS:We documented 328 incident GBS cases during a total of 5,422,788 person years of follow-up. Compared to participants with BMI<25kg/m2, the multivariate pooled hazard ratio (HR) of GBS was 1.34 (95% CI: 1.04, 1.73) for overweight participants (25kg/m2≤BMI<30 kg/m2), and 1.68 (95% CI: 1.21, 2.35) for obese participants (BMI≥30 kg/m2) (P for trend = 0.001). Compared to participants with normal WC (<35 inches for women and <40 inches for men), the HR of GBS was 1.55 (95% CI: 1.10, 2.18) for participants with high WC (≥35 inches for women, and ≥40 inches for men). The positive associations of BMI and WC with risk of GBS were attenuated to null after mutually adjusting for BMI and WC. Joint analysis showed that the HR was 1.84 (95% CI: 1.27, 2.66) for participants with high WC and BMI≥25 kg/m2 in comparison to participants with normal WC and BMI<25kg/m2.CONCLUSION:These data from large cohorts showed that higher BMI and WC jointly were associated with higher risk of GBS. Our study highlighted the importance of maintaining a normal body weight and waist circumference in prevention of GBS.

FDA developed the interim reference level (IRL) for lead of 3 μg/day in children and 12.5 μg/day in women of childbearing age (WOCBA) to better protect the fetus from lead toxicity. These IRLs correspond to a blood lead level (BLL) of 0.5 μg/dL in both populations. The current investigation was performed to determine if the IRL for WOCBA should apply to the general population of adults. A literature review of epidemiological studies was conducted to determine whether a BLL of 0.5 μg/dL is associated with adverse effects in adults. Some studies reported adverse effects over a wide range of BLLs that included 0.5 μg/dL adding uncertainty to conclusions about effects at 0.5 μg/dL; however, no studies clearly identified this BLL as an adverse effect level. Results also showed that the previously developed PTTDI for adults of 75 μg/day lead may not be health protective, supporting use of a lower reference value for lead toxicity in this population group. Use of the 12.5 μg/day IRL as a benchmark for dietary lead intake is one way FDA will ensure that dietary lead intake in adults is reduced.

This study assessed energy drink consumption and high-risk behaviors, including alcohol and drug use, cross-sectionally among participants in three cohort studies—the Nurses' Health Study 3 (NHS 3), the Growing Up Today Study (GUTS) and GUTS2. Questionnaires, including validated food-frequency questionnaires (FFQs), collected participant demographics, risky behavior, and energy drink consumption data. [The specific question used for energy drink intake read as follows: "Do you drink energy drinks, e.g., Red Bull, Rock Star, Monster (8 oz. can)?" for NHS3, 2010–2019; GUTS, 2011; and GUTS2, 2011.] Following descriptive analysis, multivariable-adjusted logistic regression estimated associations between energy drink consumption and odds of risky behaviors, including pooled odds-ratios (pORs) across all cohorts. Of the 46,390 participants this study assessed, ∼13% reported energy drink consumption at least monthly. Risky behaviors associated with energy drink consumption included smoking [pOR: 1.88 (95% CI 1.55–2.29)], having higher body mass index [pORs: 1.31 (95% CI 1.11–1.53) for overweight (25–30 kg/m2) and 1.67 (95% CI 1.34–2.08) for obesity (≥30 kg/m2) compared to <25 kg/m2, respectively], insufficient sleep [pOR: 1.29 (95% CI 1.11–1.50) for <7 hours compared to 7–9 hours], tanning bed use [pOR: 2.31 (95% CI 1.96–2.72)], binge drinking [pOR: 2.53 (95% CI 2.09–3.07)], marijuana use [pOR: 1.49 (95% CI 1.28–1.73)], and use of any illegal drugs (other than marijuana) [pOR: 1.45 (95% CI 1.16–1.81)]. Demographic factors associated with consumption of energy drinks included higher education, which was associated with lower odds of energy drink consumption [pORs: 0.71 (95% CI 0.56–0.91) for bachelor's degree and 0.55 (95% CI 0.40–0.74) for master's degree, compared to no bachelor's degree, respectively], and race/ethnicity [pOR: 4.43 (95% CI: 2.41–8.15) comparing African Americans to non-Hispanic white]. Both within and across the cohorts, risky behaviors were associated with higher odds of energy drink consumption. This study was funded via FDA contracts and NIH grants.

AbstractObjective:To describe and compare caffeinated energy drink adverse event (AE) report/exposure call data from the US Food and Drug Administration Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System (CAERS) and the American Association of Poison Control Centers’ National Poison Data System (NPDS).Design:Cross-sectional.Setting:Data were evaluated from US-based CAERS reports and NPDS exposure calls, including report/exposure call year, age, sex, location, single v. multiple product consumption, outcome, symptom, intentionality (NPDS only), report type, product name (CAERS only).Participants:The analysis defined participants (cases) by the number of caffeinated energy drink products indicated in each AE report or exposure call. Single product cases included 357 from CAERS and 12 822 from NPDS; multiple product cases included 153 from CAERS and 931 from NPDS.Results:CAERS v. NPDS single product cases were older and more frequently indicated serious symptoms. Multiple v. single product consumers were older in both. In CAERS, unlike NPDS, most multiple product consumers were female. CAERS single v. multiple product reports cited higher proportions of life-threatening events, but less often indicated hospitalization and serious events. NPDS multiple v. single product cases involved fewer ≤5-year-olds and were more often intentional.Conclusions:Despite limitations, both data sources contribute to post-market surveillance and improve understanding of public health concerns.

Background: To facilitate swallowing of medications and promote patient adherence to medical treatment, the U.S. Food and Drug Administration (FDA) has provided voluntary guidance regarding the size of generic drug tablets and capsules (1). The FDA recommends that generic products not exceed 17 mm in a single dimension. If a branded product already exceeds 17 mm, then the generic product should be no larger. No tablets or capsules should exceed 22 mm. Currently, similar guidelines do not exist for dietary supplements; however, these products have been implicated in swallowing problems, particularly among adults aged 65 years and older (2). Objective: To identify and characterize dietary supplementassociated swallowing problems in relation to pill size by using 10 years of data from adverse event reports submitted to the FDA Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS). Methods and Findings: The CAERS database contains reports to the FDA about adverse events and product complaints regarding foods, dietary supplements, and cosmetics (3). The Dietary Supplement and Nonprescription Drug Consumer Protection Act (effective date for compliance, 22 December 2007) requires manufacturers, packers, and distributors of dietary supplements to report serious adverse events to CAERS; health care professionals, consumers, and other members of the public may submit reports voluntarily (3). We used MedDRA (Medical Dictionary for Regulatory Activities) terminology to identify dietary supplement reports submitted to CAERS from 1 January 2006 through 31 December 2015 that involved swallowing problems (such as choking and dysphagia). We extracted sex, age, product, and adverse event outcomes and excluded 442 reports implicating either multiple supplement products or nonsolid oral formulations (such as liquids or powders). We categorized products on the basis of their ingredients or common reasons for use (2). We measured pill (that is, tablet or capsule) sizes for the 10 most commonly identified dietary supplements. Of 20791 adverse event reports submitted to CAERS regarding dietary supplements in 2006 to 2015, 3962 (19.1%) indicated swallowing problems. These reports most commonly involved females (85.6%)(Table 1) and represented 25.4% of all CAERS reports among females. Of the 64.5% of swallowing problem reports that included age data, 76.8% involved adults aged 65 years or older. Table 1. Adverse Event Reports to the FDA Involving Dietary Supplement Swallowing Problems, 20062015* Choking was the most frequently reported swallowing problem (86.0%), followed by foreign body trauma (7.8%). According to a CAERS medical reviewer assessment, 14.3% of swallowing problem reports cited serious adverse events, including 3 deaths attributed to supplement-induced airway obstruction or aspiration. Most reports of swallowing difficulty (72.9%) involved multivitamins; 17.3% involved calcium supplements. The 10 most commonly reported dietary supplements accounted for 3026 (76.4%) of swallowing problems (Table 2) and had a weighted mean pill length, width, and height of 19.3 mm, 9.8 mm, and 7.8 mm, respectively. Swallowing complications from these 10 products accounted for a proportional reporting ratio of 12.7, indicating that the ratio of reports of swallowing problems to those of all problems was 12.7 times higher for these 10 products than for other dietary supplements. Seven of the 10 products, accounting for 64.5% of all swallowing problem reports, were multivitamins marketed to older adults or calcium supplements. A single multivitamin product marketed to older women was involved in 40.6% of swallowing problem reports. Table 2. Pill Sizes of 10 Dietary Supplement Products Commonly Identified in Adverse Event Reports to the FDA Involving Swallowing Problems, 20062015* Discussion: Most reports of swallowing complications from dietary supplements involve multivitamins or calcium supplements. Multivitamins are used by up to 35% and calcium supplements by up to 24% of older adults (5), who have higher rates of dysphagia and other swallowing issues than younger persons (1). The 10 products most commonly identified in reports of swallowing complications all exceed 17 mm in length. One way to prevent swallowing problems is to modify dosage form characteristics (for example, produce smaller dosage forms or add coatings). Another approach is to educate patients to speak with their pharmacists or physicians about ways to address swallowing difficulties. This study had limitations. Data regarding frequency of use for specific products were not available, CAERS reports may not represent the U.S. population overall, swallowing problems may be underreported, and completeness of reports may vary. Therefore, patient-specific risk factors for choking could not be fully assessed. In addition, pill sizes may have changed during or after the study period. Nevertheless, these data identify a specific harmchokingthat may be preventable, particularly in older adults who regularly consume dietary supplements.

Letters19 November 2019Swallowing Problems and Dietary Supplements: Data From U.S. Food and Drug Administration Adverse Event Reports, 2006–2015Cecile Punzalan, MD, MPH, Daniel S. Budnitz, MD, MPH, Stuart J. Chirtel, MStat, MSc, Andrew I. Geller, MD, Olivia E. Jones, MPH, Robert P. Mozersky, DO, and Beverly Wolpert, PhD, MSCecile Punzalan, MD, MPHU.S. Food and Drug Administration, College Park, Maryland (C.P., S.J.C., O.E.J., R.P.M., B.W.), Daniel S. Budnitz, MD, MPHCenters for Disease Control and Prevention, Atlanta, Georgia (D.S.B., A.I.G.), Stuart J. Chirtel, MStat, MScU.S. Food and Drug Administration, College Park, Maryland (C.P., S.J.C., O.E.J., R.P.M., B.W.), Andrew I. Geller, MDCenters for Disease Control and Prevention, Atlanta, Georgia (D.S.B., A.I.G.), Olivia E. Jones, MPHU.S. Food and Drug Administration, College Park, Maryland (C.P., S.J.C., O.E.J., R.P.M., B.W.), Robert P. Mozersky, DOU.S. Food and Drug Administration, College Park, Maryland (C.P., S.J.C., O.E.J., R.P.M., B.W.), and Beverly Wolpert, PhD, MSU.S. Food and Drug Administration, College Park, Maryland (C.P., S.J.C., O.E.J., R.P.M., B.W.)Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M19-0947 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Background: To facilitate swallowing of medications and promote patient adherence to medical treatment, the U.S. Food and Drug Administration (FDA) has provided voluntary guidance regarding the size of generic drug tablets and capsules (1). The FDA recommends that generic products not exceed 17 mm in a single dimension. If a branded product already exceeds 17 mm, then the generic product should be no larger. No tablets or capsules should exceed 22 mm. Currently, similar guidelines do not exist for dietary supplements; however, these products have been implicated in swallowing problems, particularly among adults aged 65 years and older (2).Objective: ...References1. U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Guidance Document. Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules. June 2015. Accessed at www.fda.gov/downloads/drugs/guidances/ucm377938.pdf on 31 May 2019. Google Scholar2. Geller AI, Shehab N, Weidle NJ, et al. Emergency department visits for adverse events related to dietary supplements. N Engl J Med. 2015;373:1531-40. [PMID: 26465986] doi:10.1056/NEJMsa1504267 CrossrefMedlineGoogle Scholar3. U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition. CFSAN Adverse Event Reporting System (CAERS). Accessed at www.fda.gov/food/complianceenforcement/ucm494015.htm on 31 May 2019. Google Scholar4. Dietary Supplement Health and Education Act of 1994. Pub L 103-417, 108 Stat 4325 (1994). Accessed at www.congress.gov/bill/103rd-congress/senate-bill/784 on 5 August 2019. Google Scholar5. Qato DM, Wilder J, Schumm LP, et al. Changes in prescription and over-the-counter medication and dietary supplement use among older adults in the United States, 2005 vs 2011. JAMA Intern Med. 2016;176:473-82. [PMID: 26998708] doi:10.1001/jamainternmed.2015.8581 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: U.S. Food and Drug Administration, College Park, Maryland (C.P., S.J.C., O.E.J., R.P.M., B.W.)Centers for Disease Control and Prevention, Atlanta, Georgia (D.S.B., A.I.G.)Disclaimer: The findings and conclusions in this study are those of the authors and do not necessarily represent the official position of the FDA, the U.S. Centers for Disease Control and Prevention, or the U.S. Department of Health and Human Services.Acknowledgment: The authors thank William R. Mindak, BS, formerly of the FDA and now head of Mindak Professional Services, Springfield, Virginia, for his assistance in measuring the pill samples. Mr. Mindak was not compensated for his assistance. The authors also thank Travis Canida, BS, and John Ihrie, MStat, MSPS,Indiana University School of Medicine of the Center for Food Safety and Applied Nutrition FDA Biostatistics and Bioinformatics Staff for estimating the proportional reporting ratios.Disclosures: Authors have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M19-0947.>Reproducible Research Statement: Study protocol: Available from Dr. Punzalan (e-mail, Cecile.[email protected]hhs.gov). Statistical code: Available from Dr. Punzalan, Mr. Chirtel (e-mail, Stuart.[email protected]hhs.gov), or Mr. Canida (e-mail, Travis.[email protected]hhs.gov). Data set: Available with legally required redactions at www.fda.gov/food/compliance-enforcement-food/cfsan-adverse-event-reporting-system-caers. 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Consistency, Viscosity, Texture, and Application of the International Dysphagia Diet Standardization Initiative (IDDSI) FrameworkOsteoporosis: evidence for vitamin D and calcium in older peoplePreventing Lethal Prostate Cancer with Diet, Supplements, and Rx: Heart Healthy Continues to Be Prostate Healthy and "First Do No Harm" Part IIMultivitamin pill aspiration leading to hemorrhagic bronchial necrosis 19 November 2019Volume 171, Issue 10Page: 771-773KeywordsAdverse eventsCalciumDysphagiaElderlyFoodFood and Drug AdministrationNutritionSafetySerious adverse eventsSwallowing ePublished: 20 August 2019 Issue Published: 19 November 2019 PDF downloadLoading ...

Water from the Hickey Run Tributary of the Anacostia River is being collected quarterly (beginning August 2018) and analyzed to create high-resolution baseline taxonomic profiles of microbiota associated with this important aquatic ecosystem, which has a long history of exposure to residential and commercial effluents from Washington, DC. These United States National Arboretum Microbial Observatory data are available under NCBI BioProject number PRJNA498951.