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

Regulatory Toxicology and Pharmacology : RTP
Susan P FelterXiaoling Zhang

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 California Propositi...Continue Reading

Citations

Feb 9, 2021·Regulatory Toxicology and Pharmacology : RTP·Susan P FelterChad Thompson
Jan 16, 2021·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Michael SchmiechThomas Simmet
Aug 6, 2021·Frontiers in Nutrition·Shelini SurendranMichael Heinrich

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