FDA Amends Food Additive Regulations to No Longer Allow Use of 7 Substances

The Agency is removing the additives due to data demonstrating that the substances induce cancer in animals
The Agency is removing the additives due to data demonstrating that the substances induce cancer in animals

The Food and Drug Administration (FDA) is removing 6 synthetic flavoring substances typically used in foods available in the US marketplace from the Food Additives List. The 6 substances include benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine. A seventh synthetic flavoring substance, styrene, was also listed for removal in the petition but the Agency considered this a moot point as its use has already been "permanently and completely" abandoned.

The petition was submitted by a number of non-profit organizations including the Center for Science in the Public Interest and the Breast Cancer Fund. The rule will become effective on October 9, 2018 – the date it is published in the Federal Register. The Agency will accept objections and requests for hearings up to 30 days after this date.

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Despite FDA analysis indicating that these substances do not pose a risk to public health under the conditions of their intended use, the Agency is removing the additives due to data provided by the petitioners demonstrating that the additives induce cancer in laboratory animals. Under the Delaney Clause, the FDA cannot approve the use of any food additive that has been found to induce cancer in humans or animals at any dose.

The petitioners also asked the FDA to establish a "zero tolerance" policy for these additives, however, the second request was not granted as it does not fall within the statutory scope of a food additive petition.

For more information visit federalregister.gov.