In a blog post published on August 18, 2016 by the non-profit organization Environmental Defense Fund’s (EDF) + Business portal, Tom Neltner comments on the ‘generally recognized as safe’ (GRAS) rule that food companies in the U.S. can use to declare food additives as safe without review by the U.S. Food and Drug Administration (FDA). EDF recommends retailers and food manufacturers to submit all ingredients for FDA safety review, particularly those additives considered GRAS. However, notifying the FDA of GRAS substances is voluntary and many companies worry that FDA review is slow and may delay product marketing and sales. Neltner explains that the FDA “allows the use and marketing of a self-certified GRAS substance while a review is under way.” The FDA aims to complete reviews within 270 days and according to an in-house performance report the agency manages to finalize reviews timely. Further, Neltner notes that in most cases the FDA concludes that the GRAS safety declaration is adequate and issues a ‘no question letter’ for the given additive. Also, “when companies are unable or unwilling to answer FDA’s questions, they can ask FDA to ‘cease to evaluate’ the submission,” Neltner explains. In conclusion, Neltner stresses the importance that “GRAS safety determinations are made properly,” meaning that the FDA is notified of them and can review them. Otherwise, the FDA does not know what chemicals are present in food and cannot ensure that food is safe.
Tom Neltner (August 18, 2016). “For FDA reviews of ‘generally recognized as safe’ ingredients, time is not an issue.” EDF + Business