title: Caramel color in soft drinks and exposure to 4-methylimidazole: a quantitative risk assessment.
abstract: Caramel color is added to many widely-consumed beverages as a colorant. Consumers of these beverages can be exposed to 4-methylimidazole (4-MEI), a potential carcinogen formed during its manufacture. California's Proposition 65 law requires that beverages containing 4-MEI concentrations corresponding to exposures that pose excess cancer risks > 1 case per 100,000 exposed persons (29 μg 4-MEI/day) carry warning labels. Using ultrahigh-performance liquid chromatography-tandem mass spectrometry, we assessed 4-MEI concentrations in 12 beverages purchased in California and a geographically distant metropolitan area (New York) in which warning labels are not required. In addition, we characterized beverage consumption by age and race/ethnicity (using weighted means calculated from logistic regressions) and assessed 4-MEI exposure and resulting cancer risks and US population cancer burdens attributable to beverage consumption. Data on beverage consumption were obtained from the National Health and Nutrition Examination Survey, dose-response data for 4-MEI were obtained from the California Environmental Protection Agency Office of Environmental Health Hazards Assessment, and data on population characteristics were obtained from the U.S. Census Bureau. Of the 12 beverages, Malta Goya had the highest 4-MEI concentration (915.8 to 963.3μg/L), lifetime average daily dose (LADD - 8.04x10-3 mg/kgBW-day), lifetime excess cancer risk (1.93x10-4) and burden (5,011 cancer cases in the U.S. population over 70 years); Coca-Cola had the lowest value of each (4-MEI: 9.5 to 11.7μg/L; LADD: 1.01x10-4 mg/kgBW-day; risk: 1.92x10-6; and burden: 76 cases). 4-MEI concentrations varied considerably by soda and state/area of purchase, but were generally consistent across lots of the same beverage purchased in the same state/area. Routine consumption of certain beverages can result in 4-MEI exposures > 29 μg/day. State regulatory standards appear to have been effective in reducing exposure to carcinogens in some beverages. Federal regulation of 4-MEI in caramel color may be appropriate.
authors.affiliation: Johns Hopkins Center for a Livable Future, Johns Hopkins University, Baltimore, Maryland, United States of America; Department of Environmental Health Sciences, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United States of America.
authors.forename: Tyler J S
authors.initials: TJ
authors.lastname: Smith
authors.affiliation: Johns Hopkins Center for a Livable Future, Johns Hopkins University, Baltimore, Maryland, United States of America; Department of Health Policy and Management, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United States of America.
authors.forename: Julia A
authors.initials: JA
authors.lastname: Wolfson
authors.affiliation: Food Safety and Sustainability Center, Consumer Reports, Yonkers, New York, United States of America.
authors.forename: Ding
authors.initials: D
authors.lastname: Jiao
authors.affiliation: Johns Hopkins Center for a Livable Future, Johns Hopkins University, Baltimore, Maryland, United States of America; Food Safety and Sustainability Center, Consumer Reports, Yonkers, New York, United States of America.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Crupain
authors.affiliation: Food Safety and Sustainability Center, Consumer Reports, Yonkers, New York, United States of America.
authors.forename: Urvashi
authors.initials: U
authors.lastname: Rangan
authors.affiliation: Maryland Institute for Applied Environmental Health, University of Maryland School of Public Health, College Park, Maryland, United States of America.
authors.forename: Amir
authors.initials: A
authors.lastname: Sapkota
authors.affiliation: Department of Health Policy and Management, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United States of America.
authors.forename: Sara N
authors.initials: SN
authors.lastname: Bleich
authors.affiliation: Johns Hopkins Center for a Livable Future, Johns Hopkins University, Baltimore, Maryland, United States of America; Department of Environmental Health Sciences, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United States of America; Department of Health Policy and Management, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United States of America; Risk Sciences and Public Policy Institute, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United States of America.
authors.forename: Keeve E
authors.initials: KE
authors.lastname: Nachman
mesh_terms: D000328:Adult; D000368:Aged; D001628:Beverages / Q000009:adverse effects; D002241:Carbohydrates / Q000009:adverse effects*; D002253:Carbonated Beverages; D002273:Carcinogens / Q000633:toxicity; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000633:toxicity*; D008297:Male; D008875:Middle Aged; D009749:Nutrition Surveys; D018570:Risk Assessment / Q000379:methods*; D014481:United States
chemical_list: D002241:Carbohydrates; D002273:Carcinogens; D007093:Imidazoles; C569050:caramel coloring; C023439:4-methylimidazole