Registration is filling fast for the Sept. 8, 2016, FDA Grand Rounds. From 12-1 p.m., Dr. Connie Ruzicka of FDA's Center for Drug Evaluation and Research will present on Rapid Screening of Dietary Supplements for Undeclared Ingredients for which participants can receive continuing education (CE) credit. To register for CE credit and access the live webcast visit the FDA website.
The presentation will focus on the growing availability and use of dietary supplements among consumers, which 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.