Histamine Fish Poisoning and Histamine Production by Raoultella ornithinolytica in Milkfish Surimi

2020 ◽  
Vol 83 (5) ◽  
pp. 874-880 ◽  
Author(s):  
CHIU-CHU HWANG ◽  
HSIEN-FENG KUNG ◽  
YI-CHEN LEE ◽  
SHENG-YUN WEN ◽  
PEI-YU CHEN ◽  
...  
Keyword(s):  
Drug Administration ◽  
Bacterial Growth ◽  
Food And Drug Administration ◽  
Potential Hazard ◽  
Bacterial Strains ◽  
Histamine Production ◽  
Fish Poisoning ◽  
Southern Taiwan ◽  
The U.S ◽  
Kaohsiung City

ABSTRACT In April 2017, an outbreak of histamine fish poisoning causing illness in nine victims associated with consumption of milkfish surimi products (fish ball) occurred in Kaohsiung City, southern Taiwan. Of the two suspected frozen milkfish surimi samples, one sample contained 91.06 mg/100 g of histamine, levels that are greater than the potential hazard action level (50 mg/100 g) in most illness cases. Moreover, 28 frozen milkfish surimi samples from retail stores were collected and tested to determine the occurrence of histamine. One (3.6%) of 28 commercial surimi samples had histamine levels greater than the U.S. Food and Drug Administration (FDA) guideline for decomposition of 5 mg/100 g for scombroid fish and/or products. Thirteen histamine-producing bacterial strains isolated from suspected and commercial surimi samples were identified as prolific histamine formers, able to produce 98.4 to 121.8 mg/100 mL of histamine in Trypticase soy broth supplemented with 1.0% l-histidine. In addition, milkfish surimi was inoculated with Raoultella ornithinolytica at 5.0 log CFU/g and stored at 4, 15, 25, and 37°C to investigate bacterial growth and formation of histamine. The histamine contents quickly increased to more than 50 mg/100 g in samples stored at 37 and 25°C within 12 and 24 h, respectively, as well those stored at 15°C within 96 h. To our knowledge, this is the first report in Taiwan to demonstrate that milkfish surimi products could cause histamine intoxication. HIGHLIGHTS

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.

Evaluation of Orphan Products by the U.S. Food and Drug Administration

1992 ◽  
Vol 8 (4) ◽  
pp. 647-657 ◽  
Author(s):  
Marlene E. Haffner ◽  
John V. Kelsey
Keyword(s):  
Drug Administration ◽  
Rare Diseases ◽  
Food And Drug Administration ◽  
Orphan Drugs ◽  
Marketing Approval ◽  
Drug Products ◽  
Governmental Agencies ◽  
Number Of Patients ◽  
Life Threatening ◽  
The U.S

AbstractOrphan drug products generally are used in treating or preventing rare diseases. The small number of patients available for study may create special problems in the evaluation of these products. This paper examines some of the special problems that are associated with the design and implementation of studies to evaluate the safety and efficacy of orphan drugs. The U.S. Food and Drug Administration (FDA) has not established special criteria for evaluating orphan drugs per se, but the FDA has been flexible in evaluating drug products that present special problems, especially when these products are for treatment of serious of life-threatening illnesses. The FDA and other U.S. governmental agencies also have taken steps to promote the development and availability of drugs for rare diseases, including making these products available to patients who are in need, even before the drugs have full FDA marketing approval.

scholarly journals Engineering Analysis of Cost to Protect Workers from Diacetyl Exposure and the Economic Benefit of Noncompliance

2018 ◽  
Vol 35 (2) ◽  
Author(s):  
Drew Peake ◽  
Greg Hait
Keyword(s):  
At Risk ◽  
Drug Administration ◽  
Economic Benefit ◽  
Food And Drug Administration ◽  
Engineering Analysis ◽  
Regulatory Standard ◽  
Substitute Products ◽  
The U.S

Large commercial bakeries use artificial butter flavor (containing diacetyl) in its recipes, and have for more than 40 years. In 2012, a health-based exposure threshold was published for diacetyl by the American Conference of Governmental Industrial Hygienists (ACGIH). Bakery managers typically knew what was necessary to protect workers from exposure. However, for a variety of reasons, most did little to control exposure: The Food and Drug Administration said diacetyl was generally recognized as safe; substitute products had not been demonstrated as less harmful; and no regulatory standard had been established. This study develops the costs that would have been necessary to protect workers, using the U.S. EPA model (known as BEN) to calculate the economic benefit of noncompliance, and offers a characterization of the profit incentive to place workers at risk.

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