Navigating the U.S. Food Additive Regulatory Program

Abstract

The Food Additives Amendment of 1958 is the foundation for the U.S. food additive regulatory program, which oversees most substances added to food. This article is a comprehensive review of the program, including original analysis of pre-and postmarket safety standards for various categories and subcategories of substances and their uses; assigning the more than 10000 substances currently allowed in human food to those categories; and analyzing the U.S. Food and Drug Administration's (FDA) review of more than 1900 petitions and notifications received from 1990 to 2010. Overall, federal agencies made approximately 40% of the 6000 safety decisions allowing substances in human food. These decisions allowed an estimated 66% of the substances currently believed to be used in food. Manufacturers and a trade association made the remaining decisions without FDA review by concluding that the substances were generally recognized as safe (GRAS). Robust premarket safety decisions are critical since FDA has limited resources to monitor potentially significant scientific developments and changing uses of a substance after it enters commerce and only has access to published data or data submitted to it. In the late 1990s, FDA moved from promulgating rules for its decisions for food contact and GRAS substances to reviewing manufacturer safety decisions and posting the results of the review on the agency's website. This shift appears to have encouraged manufacturers to submit their decisions to FDA for review but has limited public opportunity to provide input.

Position of the Academy of Nutrition and Dietetics: Use of Nutritive and Nonnutritive Sweeteners

“…In 1973, FDA initiated a GRAS affirmation process, which encouraged manufacturers to submit their GRAS determinations to the agency for review. In 1997, FDA replaced the affirmation process with a GRAS notification process (14). Manufacturers may determine that use of a substance is GRAS and will notify FDA of that conclusion.…”

“…Common food ingredients that were used before 1958 were listed as GRAS and not included in the definition of a food additive (14), which is "any substance, the intended use of which results or may be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food" (15).…”

Review of the regulation and safety assessment of food substances in various countries and jurisdictions

“…Secondly, as USFDA notification of the GRAS determination is voluntary, there is no publicly available list of the uses of substances that have been “self-determined” to be GRAS and thus no opportunity for public scrutiny of safety decisions. A recent review by Neltner et al (2011) provides further discussion of the US food additive regulatory programme. For a summary of the regulations pertaining to direct food additives, see Table 12.…”

Food packaging and migration of food contact materials: will epidemiologists rise to the neotoxic challenge?

“…Third, the total number of known chemical substances intentionally used in FCMs exceeds 400029 30; in addition, FCMs also contain an unknown number of polymerisation by-products, impurities and breakdown compounds7 31—collectively known as non-intentionally added substances (NIAS). Improvements in analytical chemistry have led to the constant reduction of detection limits, thereby disclosing the migration of NIAS into food 7 32 33…”