USFDA to Prohibit Use of 7 Artificial Food Flavors

October 26, 2018

3 Min Read
USFDA to Prohibit Use of 7 Artificial Food Flavors

The U.S. Food and Drug Administration revealed plans this month to prohibit the use of seven artificial flavoring additives after a number of organizations petitioned the regulator with data showing that six of the substances caused cancer in lab animals. An additional flavor additive is being banned because it is no longer in use. 

On Oct. 5, the agency announced that it would remove synthetically-derived benzophenone, ethyl acrylate, eugenyl metyl ether (methyl eugenol), mycrene, pulegone, and pyridine from the food additive regulations within the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 409(c)(3) of the act, known as the Dalaney Clause, stipulates that the FDA cannot allow the use of any food additive that is known to cause cancer in humans or animals in any amount. 

Petitions were received from the 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 Environment Council, WE ACT for Environmental Justice, and an individual, James Huff, that provided evidence of the six substances’ cancer-causing properties in laboratory animals. 

While the removal of the additives indicates that the petitioners’ data on the additives is valid, the FDA said that its own analysis of the substances revealed that they do not pose much of a risk to the public. 

“The synthetic flavoring substances that are the subject of the petition are typically used in food available in the U.S. marketplace in very small amounts and their use results in very low levels of exposures and low risk,” the agency wrote in a constituent update statement. “While the FDA’s recent exposure assessment of these substances does not indicate that they pose a risk to public health under the conditions of their intended use, the petitioners provided evidence that these substances caused cancer in animals who were exposed to much higher doses. As such, the FDA is only revoking the listing of these six synthetic flavorings as a matter of law.”

As a result of the changes, the FDA will also ban the use of benzophenone as a plasticizer in rubber goods that make repeated contact with foods. In addition to the six cancer-causing artificial substances, the FDA is also removing styrene from its food additive regulations because most food companies no longer use the additive. 

Food companies will have 24 months after the regulation change is published in the Federal Register to select replacement ingredients and reformulate products.

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