scholarly journals Use of Flavored E-Cigarettes and the Type of E-Cigarette Devices Used among Adults and Youth in the US—Results from Wave 3 of the Population Assessment of Tobacco and Health Study (2015–2016)

2019 ◽  
Vol 16 (16) ◽  
pp. 2991 ◽  
Author(s):  
Liane M. Schneller ◽  
Maansi Bansal-Travers ◽  
Maciej L. Goniewicz ◽  
Scott McIntosh ◽  
Deborah Ossip ◽  
...  
Keyword(s):  
United States ◽  
Smoking Cessation ◽  
Drug Administration ◽  
Smoking Status ◽  
Food And Drug Administration ◽  
The United States ◽  
Health Study ◽  
Population Assessment ◽  
The Us

The United States (U.S.) Food and Drug Administration has expressed concern about flavored e-cigarettes (e.g., JUUL brand) because they are appealing to youth who may be unaware that the product is addictive. The Population Assessment of Tobacco and Health Study Wave 3 provided data on flavor categories, type of e-cigarette product, and smoking status among past 30-day youth and adult e-cigarette users in the US. Most past 30-day youth and adult users reported using only one flavor category, with fruit (53% youth, 31% adult) being the most commonly reported category. Adults were far more likely to report using tobacco flavor alone, compared to any other individual flavor category or flavor category combinations (OR: 21.08, 95%CI: 5.92, 75.12). Whereas, youth were more likely to report using multiple flavor categories (OR: 2.03, 95%CI: 1.55, 2.65), with the most reported pairing being fruit and candy (36%). The variety of flavors on the market appeals to consumers of all ages. Although most past 30-day e-cigarette users reported only one flavor category, non-tobacco flavors were far more common among youth. Differences in flavor preferences among adult versus youth vapers may have implications for the role of flavors in both the initiation of youth vaping and adult vaping for smoking cessation.

scholarly journals US Food and Drug Administration Approval of Whole Slide Imaging for Primary Diagnosis: A Key Milestone Is Reached and New Questions Are Raised

2018 ◽  
Vol 142 (11) ◽  
pp. 1383-1387 ◽  
Author(s):  
Andrew J. Evans ◽  
Thomas W. Bauer ◽  
Marilyn M. Bui ◽  
Toby C. Cornish ◽  
Helena Duncan ◽  
...  
Keyword(s):  
United States ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Digital Pathology ◽  
The United States ◽  
Primary Diagnosis ◽  
Clinical Applications ◽  
Whole Slide Imaging ◽  
The Us ◽  
Available Information

April 12, 2017 marked a significant day in the evolution of digital pathology in the United States, when the US Food and Drug Administration announced its approval of the Philips IntelliSite Pathology Solution for primary diagnosis in surgical pathology. Although this event is expected to facilitate more widespread adoption of whole slide imaging for clinical applications in the United States, it also raises a number of questions as to the means by which pathologists might choose to incorporate this technology into their clinical practice. This article from the College of American Pathologists Digital Pathology Committee reviews frequently asked questions on this topic and provides answers based on currently available information.

Allegron and aventyl - nortriptyline

1963 ◽  
Vol 1 (15) ◽  
pp. 57-58
Keyword(s):  
United States ◽  
Drug Administration ◽  
Wide Spectrum ◽  
Food And Drug Administration ◽  
The United States ◽  
Methyl Group ◽  
The Us ◽  
Drug Promotion ◽  
Depressant Drug

Nortriptyline, a new anti-depressant drug, has just been launched simultaneously as a “potent multi-phasic psychotrope, highly predictable in action” (Allegron - Dista), and as a “wide spectrum mood enhancer” (Aventyl - Lilly). Connoisseurs of drug promotion will note that Dista is a subsidiary of Lilly. Nortriptyline has not so far been marketed in the United States, where it was discovered; it has not yet been approved by the US Food and Drug Administration. Chemically the drug closely resembles amitriptyline, differing from it by only one methyl group.

scholarly journals Low-Calorie Sweetened Beverages and Cardiometabolic Health: A Science Advisory From the American Heart Association

Circulation ◽  
2018 ◽  
Vol 138 (9) ◽  
Author(s):  
Rachel K. Johnson ◽  
Alice H. Lichtenstein ◽  
Cheryl A.M. Anderson ◽  
Jo Ann Carson ◽  
Jean-Pierre Després ◽  
...  
Keyword(s):  
United States ◽  
Drug Administration ◽  
High Intensity ◽  
Food And Drug Administration ◽  
The United States ◽  
Cardiometabolic Health ◽  
Low Calorie ◽  
Writing Group ◽  
Sweetened Beverages ◽  
The Us

In the United States, 32% of beverages consumed by adults and 19% of beverages consumed by children in 2007 to 2010 contained low-calorie sweeteners (LCSs). Among all foods and beverages containing LCSs, beverages represent the largest proportion of LCS consumption worldwide. The term LCS includes the 6 high-intensity sweeteners currently approved by the US Food and Drug Administration and 2 additional high-intensity sweeteners for which the US Food and Drug Administration has issued no objection letters. Because of a lack of data on specific LCSs, this advisory does not distinguish among these LCSs. Furthermore, the advisory does not address foods sweetened with LCSs. This advisory reviews evidence from observational studies and clinical trials assessing the cardiometabolic outcomes of LCS beverages. It summarizes the positions of government agencies and other health organizations on LCS beverages and identifies research needs on the effects of LCS beverages on energy balance and cardiometabolic health. The use of LCS beverages may be an effective strategy to help control energy intake and promote weight loss. Nonetheless, there is a dearth of evidence on the potential adverse effects of LCS beverages relative to potential benefits. On the basis of the available evidence, the writing group concluded that, at this time, it is prudent to advise against prolonged consumption of LCS beverages by children. (Although water is the optimal beverage choice, children with diabetes mellitus who consume a balanced diet and closely monitor their blood glucose may be able to prevent excessive glucose excursions by substituting LCS beverages for sugar-sweetened beverages [SSBs] when needed.) For adults who are habitually high consumers of SSBs, the writing group concluded that LCS beverages may be a useful replacement strategy to reduce intake of SSBs. This approach may be particularly helpful for persons who are habituated to a sweet-tasting beverage and for whom water, at least initially, is an undesirable option. Encouragingly, self-reported consumption of both SSBs and LCS beverages has been declining in the United States, suggesting that it is feasible to reduce SSB intake without necessarily substituting LCS beverages for SSBs. Thus, the use of other alternatives to SSBs, with a focus on water (plain, carbonated, and unsweetened flavored), should be encouraged.

Role of the U.S. Food and Drug Administration in the Regulatory Management of Human Listeriosis in the United States

2008 ◽  
Vol 71 (6) ◽  
pp. 1277-1286 ◽  
Author(s):  
KARL C. KLONTZ ◽  
PATRICK V. McCARTHY ◽  
ATIN R. DATTA ◽  
JUDY O. LEE ◽  
DAVID W. K. ACHESON ◽  
...  
Keyword(s):  
United States ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
The United States ◽  
Demographic Trends ◽  
The Past ◽  
Compliance Programs ◽  
Regulatory Management ◽  
The U.S

From 1986 to 2006, the incidence of listeriosis in the United States dropped from approximately seven to three cases per million population, a reduction that most likely reflects the joint efforts of industry, government, consumers, and academia. Herein, we describe the U.S. Food and Drug Administration (FDA) strategy over the past three decades to combat listeriosis. Specifically, we discuss early actions taken to address outbreaks during the 1980s, policy decisions regarding the presence of Listeria monocytogenes in FDA-regulated foods, FDA compliance programs with L. monocytogenes components, enforcement actions to remove L. monocytogenes–contaminated products from the market (i.e., recalls) or to prevent entry of such products into the market (i.e., import detentions and refusals), research milestones, outreach and education efforts, and selected special projects. Evolving demographic trends in the United States may pose a challenge to further reduction of the incidence of listeriosis.

scholarly journals Use of Electronic Cigarettes to Aid Long-Term Smoking Cessation in the United States: Prospective Evidence From the PATH Cohort Study

2020 ◽  
Vol 189 (12) ◽  
pp. 1529-1537 ◽  
Author(s):  
Ruifeng Chen ◽  
John P Pierce ◽  
Eric C Leas ◽  
Martha M White ◽  
Sheila Kealey ◽  
...  
Keyword(s):  
United States ◽  
Smoking Cessation ◽  
Electronic Cigarettes ◽  
Smoking Status ◽  
The United States ◽  
Health Study ◽  
Propensity Score Methods ◽  
Continuous Abstinence ◽  
Nationally Representative

Abstract Electronic cigarettes (e-cigarettes) are the preferred smoking-cessation aid in the United States; however, there is little evidence regarding long-term effectiveness among those who use them. We used the Population Assessment of Tobacco and Health Study to compare long-term abstinence between matched US smokers who tried to quit with and without use of e-cigarettes as a cessation aid. We identified a nationally representative cohort of 2,535 adult US smokers in 2014–2015 (baseline assessment), who, in 2015–2016 (exposure assessment), reported a past-year attempt to quit and the cessation aids used, and reported smoking status in 2016–2017 (outcome assessment; self-reported ≥12 months continuous abstinence). We used propensity-score methods to match each e-cigarette user with similar nonusers. Among US smokers who used e-cigarettes to help quit, 12.9% (95% confidence interval (CI): 9.1%, 16.7%) successfully attained long-term abstinence. However, there was no difference compared with matched non–e-cigarette users (cigarette abstinence difference: 2%; 95% CI: −3%, 7%). Furthermore, fewer e-cigarette users were abstinent from nicotine products in the long term (nicotine abstinence difference: −4%; 95% CI: −7%, −1%); approximately two-thirds of e-cigarette users who successfully quit smoking continued to use e-cigarettes. These results suggest e-cigarettes may not be an effective cessation aid for adult smokers and, instead, may contribute to continuing nicotine dependence.

The ABCs of the FDA: A Primer on the Role of the United States Food and Drug Administration in Medical Device Approvals and IR Research

2015 ◽  
Vol 26 (9) ◽  
pp. 1324-1330 ◽  
Author(s):  
Ashley Adamovich ◽  
Susie Park ◽  
Gary P. Siskin ◽  
Meridith J. Englander ◽  
Kenneth D. Mandato ◽  
...  
Keyword(s):  
United States ◽  
Medical Device ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
The United States ◽  
United States Food ◽  
States Food

scholarly journals Regulatory Considerations for Hemodiafiltration in the United States

2018 ◽  
Vol 13 (9) ◽  
pp. 1444-1449 ◽  
Author(s):  
Richard A. Ward ◽  
Jörg Vienken ◽  
Douglas M. Silverstein ◽  
Stephen Ash ◽  
Bernard Canaud
Keyword(s):  
United States ◽  
Drug Administration ◽  
Large Scale ◽  
Food And Drug Administration ◽  
The United States ◽  
Management Process ◽  
High Flux ◽  
Clinical Use ◽  
The Us ◽  
Testing Protocols

Online hemodiafiltration provides greater removal of higher molecular weight uremic retention solutes than conventional high-flux hemodialysis. However, online hemodiafiltration is used sparsely in the United States in part because of a paucity of delivery systems cleared for clinical use by the US Food and Drug Administration. Although a pathway for regulatory approval exists in the United States, concerns remain, particularly regarding online production of the large volumes of sterile, nonpyrogenic substitution fluid infused directly into the bloodstream to maintain fluid balance. Clearly defined testing protocols, acceptable to Food and Drug Administration, will be useful to show that an online hemodiafiltration system is capable of routinely achieving a sterility assurance level of 10−6 and nonpyrogenic levels of endotoxin. Large-scale clinical experience has shown that systems providing this level of performance when combined with certain design features, such as redundancy, and an appropriate quality management process can routinely and safely produce substitution fluid for online hemodiafiltration.

Thalidomide

2018 ◽  
Author(s):  
Joshua M. Sharfstein
Keyword(s):  
United States ◽  
Drug Administration ◽  
Birth Defects ◽  
Food And Drug Administration ◽  
The United States ◽  
Close Call ◽  
The U.S

In 1962, the United States found itself transfixed by a crisis involving the medication thalidomide. Marketed widely in Europe for a variety of ailments, including nausea during pregnancy, thalidomide turned out to be a severe teratogen, causing thousands of severe birth defects in Germany alone. Yet as a result of diligence by the U.S. Food and Drug Administration (FDA), thalidomide was never approved for marketing in the United States.). When the close call came to light, Congress responded by granting the agency new authority, including the unprecedented power to require medications to be proven effective before sale. A key to turning tragedy into progress was the decision to highlight the central role of the FDA reviewer Dr. Frances Oldham Kelsey in protecting the nation.

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