GRAS Associates, LLC provides technical regulatory consulting services associated with foods that are regulated by the US Food and Drug Administration (FDA). We specialize in the safety review of food ingredients which may be considered to be “Generally Recognized as Safe” or GRAS.
The services that we provide respond to the expanding industry needs to access capable scientists who can provide timely safety evaluations that are grounded in sound science. A team of highly skilled toxicologists, biochemists, and regulatory scientists work together to provide the expertise that the law requires in order to make GRAS determinations. We also generate New Dietary Ingredient submissions on behalf of clients, and we prepare Food Contact Notifications for clients who have interest in food processing materials, food packaging materials, or other food contact articles.
More detailed information on GRAS Associates and our team can be found on our website at www.gras-associates.com.
Upon completion of his graduate training in chemistry from The Ohio State University and subsequent post-doctoral research in bio-inorganic chemistry, Dr. McQuate started his scientific regulatory career within FDA’s Office of Food Additive Safety in Washington, DC. He subsequently served in technical management positions with The Dial Company and the National Soft Drink Association where he addressed high visibility food ingredient safety issues including non-nutritive sweeteners, such as aspartame. He later served in academic administration with Oregon State University and the University of Oregon while functioning as an independent consultant prior to co-founding GRAS Associates, LLC.
Overview of Presentation
Use of stevia in the United States as a dietary supplement was first authorized by the US Food and Drug Administration (FDA) in 1995, but incorporating high purity stevia-derived sweetener products into formulated or processed foods was not authorized in the US until 2008. By 2008, the safety documentation for high purity rebaudioside A and steviol glycosides was sufficient to fulfill the FDA requirements for “reasonable certainty of no harm under the intended conditions of use,” and this resulted in selected high purity stevia-derived sweeteners being designated as Generally Recognized as Safe (GRAS). GRAS status was conferred on these high purity materials by appropriately qualified independent Expert Panels. In December 2008, FDA announced its agreement that GRAS status was appropriate for these highly purified products.
The FDA regulatory process for food ingredients that resulted in the availability of high purity steviol glycosides for incorporation into formulated foods in the US will be discussed. Appropriate consideration will be given to the most recent scientific studies and safety documentation that support the GRAS status. The pharmacokinetics and toxicology of the subject sweeteners, along with chemical composition and purity issues, will be considered, along with anticipated dietary intake estimates, in affirming the GRAS status of these natural sweeteners.
Stevia World 2009 Shanghai Speaker
Day 1 – Thursday, May 14
10:10 Attaining Regulatory Authorizations for Stevia-Derived Sweetener Food Uses in the United States
Stevia World 2009 in Shanghai is a showcase of the who’s who in Stevia sector, including top stevia growers, refiners, traders, key stevia organisations, government officials, scientists and investors who will highlight Upcoming opportunities, Pinpoints Regulatory Challenges & Shares Market Updates. To find more about Stevia World in Shanghai from May 14 to 15, 2009, please visit http://www.steviaworldforum.com