scholarly journals Standard Reference Materials for Analysis of Dietary Supplements

2008 ◽  
Vol 91 (6) ◽  
pp. 1298-1302 ◽  
Author(s):  
Katherine E Sharpless ◽  
David L Duewer
Keyword(s):  
Quality Control ◽  
Dietary Supplements ◽  
Method Validation ◽  
Drug Administration ◽  
Reference Materials ◽  
Food And Drug Administration ◽  
Standard Reference Materials ◽  
Quality Control Materials ◽  
The U.S

Abstract National Institute of Standards and Technology (NIST), in collaboration with the National Institutes of HealthOffice of Dietary Supplements and the U.S. Food and Drug Administration, is producing Standard Reference Materials (SRMs) for dietary supplements. These and other natural-matrix SRMs should be used in method validation, characterization of in-house quality control materials, and to establish traceability.

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.

scholarly journals Development of the Analytical Methods and Reference Materials Program for Dietary Supplements at The National Institutes of Health

2004 ◽  
Vol 87 (1) ◽  
pp. 162-165 ◽  
Author(s):  
Leila G Saldanha ◽  
Joseph M Betz ◽  
Paul M Coates
Keyword(s):  
Quality Control ◽  
Dietary Supplements ◽  
Reference Materials ◽  
Analytical Methods ◽  
Research Agenda ◽  
Control Unit ◽  
Lessons Learned ◽  
National Institutes Of Health ◽  
Good Manufacturing Practices ◽  
The U.S

Abstract The need for validated analytical methods and reference materials to identify and measure constituents in dietary supplements is essential. Such methods allow for the documentation that products meet manufacturer's specifications and contain what their labels declare. In March 2003, the U.S. Food and Drug Administration issued a proposed rule that would establish specific current good manufacturing practices for dietary supplements. This proposed rule requires that companies create a quality control unit to set specifications and ensure compliance with these specifications using scientifically valid procedures. This report provides insights and lessons learned from 3 meetings the Office of Dietary Supplements (ODS) at the National Institutes of Health helped organize. These meetings were structured to (1) educate individuals about the importance and need for validated analytical methods and reference materials to identify and quantify constituents of dietary supplements; (2) identify resources required to fulfill this need; and (3) serve as a platform to obtain input from interested parties to help frame the research agenda for the Dietary Supplements Methods and Reference Materials Program within ODS. Stakeholder's opinions and views expressed at these 3 meetings are outlined in this report.

Characterization of Listeria monocytogenes Recovered from Imported Cheese Contributed to the National PulseNet Database by the U.S. Food and Drug Administration from 2001 to 2008

2010 ◽  
Vol 73 (8) ◽  
pp. 1511-1514 ◽  
Author(s):  
BABGALEH B. TIMBO ◽  
CHRISTINE KEYS ◽  
KARL KLONTZ
Keyword(s):  
Listeria Monocytogenes ◽  
Drug Administration ◽  
Genetic Relatedness ◽  
Tracking System ◽  
Food And Drug Administration ◽  
The United States ◽  
Surveillance Network ◽  
Imported Foods ◽  
The U.S

Imported foods must meet the same U.S. Food and Drug Administration (FDA) standards as domestic foods. The FDA determines whether an imported food is in compliance with the Federal Food, Drug, and Cosmetic Act. Pursuant to its regulatory activities, the FDA conducts compliance surveillance on imported foods offered for entry into the U.S. commerce. The National PulseNet Database is the molecular surveillance network for foodborne infections and is widely used to provide real-time subtyping support to epidemiologic investigations of foodborne diseases. FDA laboratories use pulsed-field gel electrophoresis to subtype foodborne pathogens recovered from imported foods and submit the molecular patterns to the National PulseNet Database at the Centers for Disease Control and Prevention. There were 60 isolates of Listeria monocytogenes in the FDA Field Accomplishment and Compliance Tracking System from 2001 to 2008 due to cheese imported from the following countries: Mexico (n = 21 isolates), Italy (19), Israel (9), Portugal (5), Colombia (3), Greece (2), and Spain (1). We observed genetic diversity of L. monocytogenes isolates and genetic relatedness among strains recovered from imported cheese products coming to the United States from different countries. Consistent characterization of L. monocytogenes isolates recovered from imported cheeses, accompanied by epidemiologic investigations to ascertain human illness associated with these strains, could be helpful in the control of listeriosis acquired from imported cheeses.

Preparation and Characterization of Three New NBS Fly Ash Standard Reference Materials

1985 ◽  
Vol 65 ◽  
Author(s):  
Howard M. Kanare
Keyword(s):  
Fly Ash ◽  
Reference Materials ◽  
Chemical Elements ◽  
Standard Reference Materials ◽  
Physical Analysis ◽  
National Bureau ◽  
Loss On Ignition ◽  
New Methods ◽  
The U.S

Three new fly ash standard reference materials (SRM's) have been produced by CTL under contract with the U.S. National Bureau of Standards (NBS). Each unit of the SRM's consists of approximately ten grams of well-blended fly ash hermetically sealed in a glass vial. Twenty-thousand vials of each SRM were produced. The SRM's will be certified for major and minor chemical elements, loss on ignition, and for the percentage residue on the No. 325 standard sieve. The SRM's are suitable for use in developing new methods of chemical and physical analysis, for checking the performance of instruments and analysts, and for research into the composition and properties of fly ash.

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.

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