On April 15, 2015 four U.S.-based non-governmental organizations (NGOs) filed an 80-page regulatory comment to the U.S. Food and Drug Administration (FDA), as they consider the process for determining what substances are generally recognized as safe (“GRAS”) to be illegal. The GRAS designation means that a substance added to food is considered safe by experts and, as a result, is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements. The NGOs (Center for Science in the Public Interest, Consumers Union, Environmental Working Group and Natural Resources Defense Council) believe that the current process violates the 1958 law that requires the FDA oversight of whether ingredients are safe before they can be used in food. “The GRAS loophole gives industry the upper hand,” says Maricel Maffini, co-author of a 2014 report from the Natural Resources Defense Council on problems with the GRAS system (FPF reported). If the FDA asks for additional or more current toxicology or exposure data, a company has the possibility to withdraw its GRAS notice, effectively leaving the agency in the dark, Maffini adds. According to the NGOs, GRAS designations must not be used for novel chemical ingredients or for high risk substances. Moreover, GRAS notifications should not be based on unpublished studies and should be made by experts without a conflict of interest. The FDA shall also make the GRAS notifications mandatory and public, not voluntary and secret, the groups say.

On April 14, 2015 the Center for Public Integrity (CPI), a non-profit investigative journalism organization, reported on the GRAS system. Further, on April 15, 2015 CPI highlighted how the food industry repeatedly turns to the same group of scientists to evaluate the safety of food additives. Several of these scientists have even done similar work for the tobacco industry, CPI’s investigation revealed.

Read more

Center for Science in the Public Interest (April 15, 2015). “FDA food ingredient approval process violates law, says CSPI.

Center for Science in the Public Interest (April 15, 2015). “Regulatory comment to U.S. FDA.(pdf)

Center for Public Integrity (April 14, 2015). “Why the FDA doesn’t really know what’s in your food.

Center for Public Integrity (April 15, 2015). “Food safety scientists have ties to Big Tobacco.