RE Docket No. FDA-2023-F-5684Docket No. FDA-2023-C-5679

The other requests that FDA amend the color additive regulations to remove approvals for the three of these four solvents appearing in the color additive regulations: ethylene dichloride, methylene chloride, and TCE. [...] Under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, no food or color additive shall be considered safe, “if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal.”1 In 2018, FDA recognized its obligations under the Delaney Clause in its. [...] Benzene3 and TCE4 are each classified as “known to be a human carcinogen” and ethylene dichloride5 and methylene chloride6 are each classified as “reasonably anticipated to be a human carcinogen” in the Report on Carcinogens published by the United States National Toxicology Program. [...] FDA has stated that, “Benzene is a known human carcinogen that causes leukemia and other blood disorders” in an alert to drug manufacturers.15 Based on government-sponsored cancer studies in animals, FDA proposed to prohibit TCE in food in 1977.16 In 1989, FDA prohibited use of methylene chloride in cosmetic products due to cancer risk.17 FDA assessed the risk associated with the use of methylene. [...] Circuit held that Congress barred the FDA from employing a de minimis exception to the Delaney Clause,19 and FDA acknowledged this in 2018 in the context of other chemicals violating the Delaney Clause, stating: The Delaney Clause limits FDA’s discretion to determine the safety of food additives, in that it prevents FDA from finding a food additive to be safe if it has been found to induce cancer.