FDA Removes 7 Synthetic Flavoring Substances from Food Additives List

The FDA is amending its food additive regulations in response to two food additive petitions, to no longer allow for the use of a total of 7 synthetic flavoring substances and flavor enhancers (adjuvants). The FDA determined that the data presented in one of the petitions submitted to the FDA by Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Consumers Union, Environmental Defense Fund, Environmental Working Group, Improving Kids’ Environment, Natural Resources Defense Council, WE ACT for Environmental Justice, and Mr. James Huff show that 6 of these synthetic substances caused cancer in laboratory animals under the conditions of the studies. The seventh synthetic flavor is being de-listed because it is no longer used by industry.The 6 flavoring substances include synthetically-derived benzophenone, ethyl acrylate, eugenyl methyl ether (methyl eugenol), myrcene, pulegone, and pyridine. These substances are being removed from the food additive regulations under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (section 409(c)(3) of the FD&C Act). This clause, enacted in 1958, requires that the FDA cannot find as safe; i.e., cannot approve, the use of any food additive that has been found to induce cancer in humans or animals at any dose.