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

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 ß-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, ß-myrcene is also a substance naturally occurring in a number of dietary plants. The exposure level to naturally-occurring ß-myrcene is orders of magnitude higher (estimated to be 16,500 times greater) than the exposure via ß-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 ß-myrcene being classified by IARC as a Class 2B carcinogen and being listed on California Proposition 65; in contrast, ß-myrcene is not classified as a carcinogen by any other regulatory authority. The doses administered in the NTP bioassay were five-six orders of magnitude higher than human exposures, and the FDA concluded after a thorough evaluation that there was no safety concern associated with the use of ß-myrcene as a flavor substance at the current use level. The Delaney Clause, however, does not consider the exposure potential or the human health relevance of effects observed in animals. The lack of options available to the US FDA led to the 2018 decision to remove ß-myrcene from the list of approved food additives. This revocation has contributed to the ongoing erosion of trust in regulatory agencies (and industry), which has both economic implications for food manufacturers and consumers alike, and implications for consumer perception of safety of the US food supply. It is time for us to reconsider the rationale behind any legislation that relies on classification alone, and whether there is, in fact, a reason to still classify nongenotoxic carcinogens at all.

Effect of Isolated Scenting Process on the Aroma Quality of Osmanthus Longjing Tea.

Scenting is an important process for the formation of aroma quality in floral Longjing tea. There are differences in the aroma quality of osmanthus Longjing teas processed by different scenting processes. The efficient isolated scenting method was employed to process a new product of osmanthus Longjing tea in this study, and this was compared with the traditional scenting method. The volatile compounds of osmanthus Longjing tea were analyzed by a GC-MS instrument. In addition, the effects of scenting time and osmanthus consumption on the aroma quality of Longjing tea were studied. The results indicated that there were 67 kinds of volatile compounds in the osmanthus Longjing tea produced by the isolated scenting process (O-ISP), osmanthus Longjing tea produced by the traditional scenting process (O-TSP), and raw Longjing tea embryo (R), including alcohols, ketones, esters, aldehydes, olefins, acids, furans, and other aroma compounds. The proportions of alcohol compounds, ester compounds, aldehyde compounds, and ketone compounds in O-ISP were higher than in O-TSP and R. When the osmanthus consumption was increased, the relative contents of volatile aroma compounds gradually increased, which included the contents of trans-3,7-linalool oxide II, dehydrolinalool, linalool oxide III (furan type), linalool oxide IV (furan type), 2,6-Dimethyl cyclohexanol, isophytol, geraniol, 1-octene-3-alcohol, cis-2-pentenol, trans-3-hexenol, ß-violet alcohol, 1-pentanol, benzyl alcohol, trans-p-2-menthene-1-alcohol, nerol, hexanol, terpineol, 6-epoxy-ß-ionone, 4,2-butanone, 2,3-octanedione, methyl stearate, cis-3-hexenyl wasobutyrate, and dihydroanemone lactone. When the scenting time was increased, the relative contents of aroma compounds gradually increased, which included the contents of 2-phenylethanol, trans-3,7-linalool oxide I, trans-3,7-linalool oxide II, dehydrolinalool, isophytol, geraniol, trans-3-hexenol, ß-ionol, benzyl alcohol, trans-p-2-menthene-1-ol, nerol, hexanol, terpineol, dihydroß-ionone, α-ionone, and ß-ionone,6,10. The isolated scenting process could achieve better aroma quality in terms of the floral fragrance, refreshing fragrance, and tender fragrance than the traditional scenting process. The isolated scenting process was suitable for processing osmanthus Longjing tea with high aroma quality. This study was hoped to provide a theoretical base for the formation mechanism and control of quality of osmanthus Longjing tea.

An Approach to Flavor Chemical Thermal Degradation Analysis.

Toxicological evaluations of flavor chemicals for use in inhalation products that utilize heat for aerosol generation are complicated because of the potential effect heat may have on the flavor chemical. The objective was to develop a thermal degradation technique to screen flavor chemicals as part of a toxicological testing program for their potential use in ENDS formulations. Based upon published data for acetaldehyde, acrolein, and glycidol from ENDS products (common thermal degradants of propylene glycol and glycerin), the pyrolizer temperature was adjusted until a similar ratio of acetaldehyde, acrolein, and glycidol was obtained from a 60/40 ratio (v/v) of glycerin/propylene glycol via GC/MS analysis. For each of 90 flavor chemicals, quantitative measurements of acetaldehyde, acrolein, and glycidol, in addition to semiquantitative non-targeted analysis tentatively identifying chemicals from thermal degradation, were obtained. Twenty flavor chemicals transferred at greater than 99% intact, another 26 transferred at greater than 95% intact, and another 15 flavor chemicals transferred at greater than 90% intact. Most flavor chemicals resulted in fewer than 10-12 tentatively identified thermal degradants. The practical approach to the thermal degradation of flavor chemicals provided useful information as part of the toxicological evaluation of flavor chemicals for potential use in ENDS formulations.

Roles of sulfur-containing compounds in fermented beverages with 2-furfurylthiol as a case example.

Aroma is a critical component of the flavor and quality of beverages. Among the volatile chemicals responsible for fragrance perception, sulfur compounds are unique odorants due to their extremely low odor threshold. Although trace amounts of sulfur compounds can enhance the flavor profile of beverages, they can lead to off-odors. Sulfur compounds can be formed via Maillard reaction and microbial metabolism, imparting coffee aroma and altering the flavor of beverages. In order to increase the understanding of sulfur compounds in the field of food flavor, 2-furfurylthiol (FFT) was chosen as a representative to discuss the current status of their generation, sensory impact, enrichment, analytical methods, formation mechanisms, aroma deterioration, and aroma regulation. FFT is comprehensively reviewed, and the main beverages of interest are typically baijiu, beer, wine, and coffee. Challenges and recommendations for FFT are also discussed, including analytical methods and mechanisms of formation, interactions between FFT and other compounds, and the development of specific materials to extend the duration of aroma after release.