FDA Petition to Ban Cancer-Inducing Solvents

On January 17, 2024, the Food and Drug Administration (FDA) announced the filing of a food additive petition on behalf of the Environmental Defense Fund and others, requesting that the food additive regulations be amended to eliminate four specific solvents. The food additive petition was filed on December 21, 2023. Comments are due March 11, 2024. 

Content of the food additive petition 

The petition seeks to eliminate the solvents benzene, trichloroethene, ethylene dichloride, and methylene chloride under the procedures for amending or repealing a food additive regulation in § 171.130 (21 CFR 171.130). The petitioners allege that these substances are not safe under the Delaney Clause because they have been found to induce cancer in humans and animals. 

According to the Delaney Clause, no food additive may be considered safe if it is found to cause cancer in humans or animals when consumed, or if it is found to cause cancer in humans or animals after studies appropriate for determining the safety of food additives. The petitioners have argued that 21 CFR 25.32(m), which refers to actions intended to restrict, or reduce the use of a substance in food, food packaging, or cosmetics, clearly excludes this action. 

Further details can be found here.  

Electronic Submissions 

 Electronic comments may be submitted as follows:  

• Submit either electronic or written comments on the filing notice by March 11, 2024. 

• Late, untimely filed comments will not be considered. The electronic filing system at https:// www.regulations.gov. will accept comments until 11:59 p.m. Eastern Time at the end of March 11, 2024. Comments received by mail/hand delivery/courier (for written/ paper submissions) will be considered timely if they are received on or before that date.