Children’s Fruit “Juice” Drinks and FDA Regulations: Opportunities to Increase Transparency and Support Public Health

2020 ◽  
Vol 110 (6) ◽  
pp. 871-880 ◽  
Author(s):  
Jennifer L. Pomeranz ◽  
Jennifer L. Harris
Keyword(s):  
Public Health ◽  
Vitamin C ◽  
Drug Administration ◽  
Fruit Juice ◽  
Food And Drug Administration ◽  
Federal Law ◽  
Added Sugar ◽  
Labeling Regulations ◽  
Wide Range ◽  
Fda Regulations

Objectives. To compare children’s drink products that contain or purport to contain juice and evaluate labels in light of US Food and Drug Administration (FDA) regulations. Methods. In 2019, we analyzed federal law for drinks that contain or purport to contain juice by using LexisNexis and FDA’s Web site, identified top-selling children’s “juice” drinks in fruit punch flavors, gathered labels in store and online, and extracted data from the principal display and information panels. Results. FDA regulations permit a wide range of names, claims, and fruit vignettes on drinks that contain or purport to contain juice, reflecting the product’s flavor and not necessarily its ingredients. We identified 39 brands of children’s drinks, including 100% juice (n = 7), diluted juices (n = 11), juice drinks (n = 8), fruit-flavored drinks (n = 8), and flavored waters (n = 5), with nonuniform statements of identity; vitamin C and low-sugar claims; and fruit vignettes representing 19 fruits. Many products contained added sugar and nonnutritive sweeteners but little to no juice. Conclusions. Principal display panels rendered it difficult to differentiate among product types, identify those with added sweeteners, and distinguish healthier products. Revised labeling regulations are warranted to support public health.

HIV

2018 ◽  
Author(s):  
Joshua M. Sharfstein
Keyword(s):  
Public Health ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Research Process ◽  
National Institutes Of Health ◽  
Health Agencies ◽  
Act Up ◽  
The U.S

The emergence of AIDS in the early 1980s caused a profound crisis for federal health agencies, particularly the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA). Activists in ACT UP, charging that these agencies were failing patients with AIDS, initiated a series of escalating protests. NIH officials, led by Dr. Anthony Fauci, began to talk with the advocates and make major changes in the research process. However, over at the FDA, a protest involving the arrest of hundreds of AIDS activists undermined the agency’s public health image. Eventually, under a new commissioner, the FDA earned back the trust of activists.

The U.S. Food and Drug Administration’s Complex Innovative Trial Design Pilot Meeting Program: Progress to date

2021 ◽  
pp. 174077452110505
Author(s):  
Dionne Price ◽  
John Scott
Keyword(s):  
Public Health ◽  
Drug Administration ◽  
Trial Design ◽  
Drug Evaluation ◽  
Food And Drug Administration ◽  
Medical Product ◽  
Global Public Health ◽  
Multiple Sources ◽  
Meeting Program ◽  
The U.S

Background The Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research of the U.S. Food and Drug Administration have been leaders in advancing science to protect and promote public health by ensuring that safe and effective drugs and biological products are available to those who need them. Recently, new therapeutic discoveries, increased understanding of disease mechanisms, the need for innovation to optimally use resources, and global public health crises have led to an evolving drug development landscape. As a result, the U.S. Food and Drug Administration and medical product developers are faced with unique challenges and opportunities. The U.S. Food and Drug Administration is proactively meeting the challenges of this evolving landscape through various efforts, including the Complex Innovative Trial Design Pilot Meeting Program. Our focus, here, will be on the pilot meeting program. Methods The U.S. Food and Drug Administration has defined a process to facilitate the implementation of the Complex Innovative Trial Design Pilot Meeting Program. The process is transparent and outlines the steps and timeline for submission, review, and meetings. Results Five submitted meeting requests have been selected for participation in the Complex Innovative Trial Design Pilot Meeting Program. Conclusion The pilot meeting program has been successful in further educating stakeholders on the potential uses of complex innovative designs in trials intended to provide substantial evidence of effectiveness. The selected submissions, thus far, have all utilized a Bayesian framework. The reasons for the use of Bayesian approaches may be due to the flexibility provided, the ability to incorporate multiple sources of evidence, and a desire to better understand the U.S. Food and Drug Administration perspective on such approaches. We are confident the pilot meeting program will have continued success and impact the collective goal of bringing safe and effective medical products to patients.

Drug Repurposing in Neurological Disorders: Implications for Neurotherapy in Traumatic Brain Injury

2020 ◽  
pp. 107385842096107
Author(s):  
Zaynab Shakkour ◽  
Karl John Habashy ◽  
Moussa Berro ◽  
Samira Takkoush ◽  
Samar Abdelhady ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Drug Administration ◽  
Neurological Disorders ◽  
De Novo ◽  
Food And Drug Administration ◽  
Drug Repurposing ◽  
Adverse Outcomes ◽  
Minimal Risk ◽  
Wide Range

Traumatic brain injury (TBI) remains a significant leading cause of death and disability among adults and children globally. To date, there are no Food and Drug Administration–approved drugs that can substantially attenuate the sequelae of TBI. The innumerable challenges faced by the conventional de novo discovery of new pharmacological agents led to the emergence of alternative paradigm, which is drug repurposing. Repurposing of existing drugs with well-characterized mechanisms of action and human safety profiles is believed to be a promising strategy for novel drug use. Compared to the conventional discovery pathways, drug repurposing is less costly, relatively rapid, and poses minimal risk of the adverse outcomes to study on participants. In recent years, drug repurposing has covered a wide range of neurodegenerative diseases and neurological disorders including brain injury. This review highlights the advances in drug repurposing and presents some of the promising candidate drugs for potential TBI treatment along with their possible mechanisms of neuroprotection. Edaravone, glyburide, ceftriaxone, levetiracetam, and progesterone have been selected due to their potential role as putative TBI neurotherapeutic agents. These drugs are Food and Drug Administration–approved for purposes other than brain injuries; however, preclinical and clinical studies have shown their efficacy in ameliorating the various detrimental outcomes of TBI.

The Statistics of Nutrition Sampling and Analysis

1974 ◽  
Vol 57 (5) ◽  
pp. 1181-1189
Author(s):  
Howard R Roberts
Keyword(s):  
Drug Administration ◽  
Natural Variation ◽  
Food And Drug Administration ◽  
Nutrient Content ◽  
Nutrition Labeling ◽  
Critical Importance ◽  
Analytical Methodology ◽  
Labeling Regulations ◽  
Analytical Variation

Abstract It is widely recognized that there is natural variation in the nutrient content of food products. When one attempts to measure nutrient levels, another source of variation becomes apparent—that inherent in the measurement process itself. Analytical variation is, of course, apparent when different methods are used but can also occur with the same method because of differences among laboratories and/or analysts. Both in its own right and more especially with regard to evaluating compliance with labeling regulations, method variability is of critical importance. In order to appreciate the role of analytical methodology, the nutrition labeling regulations and the procedures by which the Food and Drug Administration will assess compliance must first be thoroughly understood. This paper is directed toward that understanding.

Pharmacy and Tobacco

1997 ◽  
Vol 31 (10) ◽  
pp. 1253-1256
Author(s):  
Martha M Rumore
Keyword(s):  
Smoking Cessation ◽  
Young People ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Morbidity And Mortality ◽  
Tobacco Products ◽  
The Future ◽  
The Impact ◽  
Fda Regulations

With the recognition that smoking begins in youth and that tobacco products are readily available to those under 18 years of age, new Food and Drug Administration (FDA) regulations restrict the sale, distribution, promotion, and advertising of cigarettes to minors. The objective is to decrease the use of tobacco by young people and consequently reduce the future morbidity and mortality from tobacco. Pharmacists currently have three choices with regard to the sale of tobacco in pharmacies: display and sell tobacco products, refuse to sell tobacco products, or make tobacco products available but counsel on smoking cessation. Each choice, as well as the impact of the new FDA regulations on pharmacy, is discussed.

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