LAS VEGAS—Calling GRAS ingredients “key instruments in the advancement of food technology and food safety,” Gavin P. Thompson, Ph.D., principal consultant, ENVIRON International Corp., spoke in-depth during a presentation at SupplySide West about the impact of various regulatory, scientific, social, political and market forces on the status of GRAS ingredients and the GRAS determination process.
In the U.S., one regulatory force of note is the imminent implementation of section 912 of the FDA Amendments Act of 2007, which will create section 301(II) of the Food, Drug and Cosmetic Act (FDCA). This new regulation “prohibits use of a substance in a food or supplement—if the substance has been subjected to substantial clinical testing that is publicly available,” Thompson said. “If broadly interpreted by the FDA, this new section of the FDCA may impact food ingredients for which clinical evidence of efficacy is publicly available, and could inhibit the generation and publication of important safety data on new ingredients.”
Scientific forces shaping the future of GRAS ingredients relate to intake and safety assessments. “Safety assessments to support GRAS determinations have become more sophisticated, specialized and complex,” Thompson said. “They require an accurate estimate of intakes, and background intakes may not be characterized.”