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On October 9, 2018, the U.S. Food and Drug Administration (FDA) issued a final rule revoking authorization for seven synthetic flavorings and adjuvants as food additives. Notably, FDA’s rigorous scientific analysis determined that these additives do not pose a risk to public health under the conditions of their intended use.
The agency acknowledges that these flavorings and adjuvants are used in very small amounts and their use results in very low levels of exposures and low risk. Nonetheless, in light of the animal data showing carcinogenicity, the agency concluded it had to withdraw their authorization as food additives as a matter of law under the Delaney clause. FDA intends to enforce the Rule’s requirements only on products manufactured after October 9, 2020, containing one or more of the six synthetic flavoring substances.
Authored by Martin Hahn, Xin Tao & Mary Lancaster.