How the 62-year old Delaney Clause continues to thwart science: Case study of the flavor substance β-myrcene.

How the 62-year old Delaney Clause continues to thwart science: Case study of the flavor substance β-myrcene. Regul Toxicol Pharmacol. 2020 Jun 06;:104708 Authors: Felter SP, Llewelyn C, Navarro L, Zhang X Abstract The Delaney Clause is a provision of the 1958 Food Additive Amendment to the Food, Drug and Cosmetic Act of 1938 which stipulates that if a substance is found by the Food and Drug Administration to be carcinogenic in any species of animal or in humans, then it cannot be used as a food additive. This paper presents a case study of β-myrcene, one of seven synthetic substances that was challenged under the Delaney Clause, ultimately resulting in revocation of its regulatory approval as a food additive despite a lack of safety concern. While it is listed as a synthetic flavor in 21 CFR 172.515, β-myrcene is also a substance naturally occurring in a number of dietary plants. The exposure level to naturally-occurring β-myrcene is orders of magnitude higher (estimated to be 16,500 times greater) than the exposure via β-myrcene added to food as a flavoring substance. The National Toxicology Program conducted genotoxicity testing (negative), a 13-week range-finding study, and a two-year cancer bioassay in B6C3F1 mice and F344/N rats. An increase in liver tumors was seen in male mice and kidney tumors in male rats, ultimately resulting in β-myrcene being classified by IARC as a Class 2B carcinogen and being listed on Californi...
Source: Regulatory Toxicology and Pharmacology : RTP - Category: Toxicology Authors: Tags: Regul Toxicol Pharmacol Source Type: research