The FDA Grand Rounds is webcast every other month to highlight cutting-edge research underway across the Agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities. The 45-minute presentation is followed by questions from the audience.
Thursday, September 8, 2016
12:00 to 1:00 p.m., Eastern Standard Time (EST)
Rapid Screening of Dietary Supplements for Undeclared Ingredients
Connie M. Ruzicka, PhD
FDA Center for Drug Evaluation and Research
Division of Pharmaceutical Analysis, St. Louis, MO
About the Presentation
The growing availability and use of dietary supplements among consumers has been accompanied by an increased frequency of adulteration of these products with undeclared pharmaceutical substances and unapproved ingredients.
The presence of these adulterated products in the marketplace is a worldwide problem and their consumption poses health risks to consumers. In response, FDA has developed a program to evaluate rapid screening tools to be used in assessing the quality and safety of imported dietary supplements.
One of the techniques that FDA’s Center for Drug Evaluation and Research has developed for the program is ion mobility spectrometry (IMS), a rapid, reliable screening tool that requires minimal sample preparation and produces results in less than a minute. FDA is currently exploring the use of IMS instruments at U.S. ports of entry to test products labeled as dietary supplements that are suspected of containing undeclared Active Pharmaceutical Ingredients (APIs) or unapproved new dietary ingredients.
This presentation will describe the development of IMS screening methods for product quality surveillance. It will also discuss FDA efforts to deploy the IMS instruments in the field for on-site testing. IMS screening can quickly identify violative products and assist FDA in removing these products from the marketplace. FDA can also issue alerts and bulletins in a timely manner to warn consumers of potential hazards associated with the consumption of adulterated supplements.
About the Presenter
Dr. Connie Gryniewicz-Ruzicka is a Research Chemist in FDA’s Center for Drug Evaluation and Research. An analytical chemist by training, she has more than 10 years’ experience developing methods and using a variety of instrumentation to study the authentication and quality of pharmaceutical products. Dr. Ruzicka’s research focuses on applying rapid screening technologies to problems in regulatory pharmaceutical analysis. In particular, her research involves the application of ion mobility spectrometry and Raman spectroscopy to identify misbranded, substandard, or adulterated pharmaceutical products and dietary supplements.
Non-FDA Attendees: To register for CE credit and access the webcast remotely click here .
FDA Attendees: Must register through the Scientific Professional Development Calendar or FDA Notices.
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