U.S. Food and Drug Administration (FDA) researchers recently presented dietary exposure assessments for 4-methylimidazole (4-MEI) at the 248th American Chemical Society (ACS) National Meeting held August 10-14, 2014, in San Francisco. Contributing to FDA’s review of available toxicological data for 4-MEI found in Class III and IV Caramel colors produced using ammonium compounds, the scientists analyzed 4-MEI levels of caramel-containing foods and beverages using liquid chromatography-tandem mass spectrometry, then relied on intake data from the National Health and Nutrition Examination Survey (NHANES) to estimate dietary exposure levels for the following U.S. population groups: (i) “the U.S. population aged 2 years or more”; (ii) “infants (< 1 year old)”; (iii) “children aged 1 year”; (iv) “children aged 2-5 years”; (v) “children aged 6-12 years”; and (vi) “teenage boys aged 12-18 years.” According to the presentation poster, the caramel-containing food categories contributing more than 1 percent “to the cumulative dietary exposure to 4-MEI…
Tag Archives caramel color/4-MEI
Food and Drug Administration (FDA) representatives are slated to present findings of the agency’s analysis of more than 200 foods containing Class III and Class IV caramels for 4-methylimidazole (4-MEI), a chemical byproduct of manufacturing processes, during the American Chemical Society National Meeting & Exposition, August 10-14, 2014, in San Francisco, California. According to the session abstract, FDA’s analysis estimated dietary exposure to 4-MEI for six U.S. populations: infants younger than age 1; 1-year-olds; children ages 2 and older; children ages 2 to 5; children ages 6 to 12; and teenage boys ages 12 to 18. Consumer Reports has urged the agency to set standards for 4-MEI in foods and called on manufacturers to disclose the types of caramel color in their products so that consumers can avoid 4-MEI. The compound was added to California’s Proposition 65 list of substances known to the state to cause cancer in 2011 based…
A federal court in the Southern District of California has transferred to the Northern District a lawsuit filed in January 2014 against Pepsico, Inc., alleging that its products violate the state’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop. 65) because they contain 4 methylimidazole (4-MEI), a chemical included on the Prop. 65 list of substances known to the state to cause cancer, and the company has not provided appropriate consumer warnings. Riva v. Pepsico, Inc., No. 14-0340 (S.D. Cal., order entered April 30, 2014). Eight similar federal lawsuits against Pepsico were filed either in the Northern District or transferred there and are scheduled for a May 29, 2014, case management conference. Finding that transfer to the Northern District would promote the efficient use of judicial resources, the court granted the defendant’s motion. The plaintiffs had argued that under the first-to-file rule, all of the cases should have been…
Following up its testing of soft drinks for the caramel-coloring ingredient 4-methylimidazole (4-MEI) by testing for its presence in pancake syrups, Consumer Reports tested several products, including pure maple syrup which had just 0.7 micrograms in a one-quarter cup serving, and found relatively low levels in light of the amount of syrup generally consumed in the United States. Still, because 4 percent of children between the ages of 1 and 5 consume pancake syrup daily, Consumer Reports claims “the [cancer] risk would be 10 times higher than negligible, or one excess case of cancer in 100,000 people who ate that amount daily over a lifetime, that’s the point where risk becomes significant.” Because some syrups tested had little 4-MEI, Consumer Reports concludes that manufacturers that use caramel color can minimize the 4-MEI levels in their products and will urge the U.S. Food and Drug Administration “to set standards for 4-MEI in…
A California resident has filed a putative statewide class action against PepsiCo, Inc., alleging that the company “touts Pepsi One as follows—‘Full Flavor and One Calorie are now living in complete harmony inside Pepsi One—the drink that unites the taste of regular cola with all the things you like about diet cola’"—without disclosing that it contains the caramel-coloring chemical 4-methylimidazole (4-MEI), identified by the state as a carcinogen under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). Ree v. PepsiCo, Inc., No. 14-0328 (C.D. Cal., filed March 4, 2014). According to the complaint, the absence of the disclosure “was a material and substantial factor which influenced [the plaintiff’s] decision to purchase Pepsi One. In fact, Plaintiff would not have purchased the Product had she known that it contained 4-MEI well in excess of Proposition 65 guidelines.” The plaintiff includes information from a Consumer Reports article about…
A Connecticut-based law firm has filed Proposition 65 (Prop. 65) lawsuits against three companies that make food extracts and flavorings, alleging that they fail to disclose the presence of 4-Methylimidazole (4-MEI), a substance known to California to cause cancer. Leeman v. Adams Extract & Spice Co., LLC, No. 13-529493; Leeman v. McCormick & Co., Inc., No. 13-529494; Leeman v. Farmer Bros. Co., No. 13 529495 (Cal. Super. Ct., San Francisco Cty., filed March 13, 2013). Named plaintiff Whitney Leeman claims to hold a doctorate in environmental engineering and seeks “to promote awareness of exposures to toxic chemicals in products sold in California.” She provided 60-day notices of violation to the companies in December 2012 concerning their alleged failure to warn consumers about 4-MEI exposure. The products specifically named in the complaints are Adams’ “Extract Maple Imitation Maple Flavor,” McCormick’s “Culinary Imitation Maple Flavor” and “Culinary Caramel Color,” and Farmer’s “Sierra Brand…
Industry interests that lost their challenge to the listing of 4-MEI as a chemical known to California to cause cancer have abandoned the appeal they filed before the Third District Court of Appeals in February 2012. Cal. League of Food Processors v. OEHHA, No. C070406 (Cal. Ct. App., case complete August 15, 2012). Additional information about the challenge and trial court decision appears in Issues 420 and 429 of this Update. California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) added the chemical, commonly found in foods such as soy sauce, roasted coffee and the caramel coloring added to colas and beer, to the Proposition 65 (Prop. 65) list in January 2011.
The United Kingdom’s (UK’s) Children’s Food Campaign (CFC) has reportedly urged the Ministry of Health to prohibit use of the chemical 4-Methylimidazole (4-MEI), a byproduct of fermentation often found in soy sauce, roasted coffee and the caramel coloring added to colas and beer. In January 2012, California EPA’s Office of Environmental Health Hazard Assessment adopted a no significant risk level for 4 MEI, with Proposition 65 cancer warnings unnecessary for exposures at or below 29 micrograms per day. The development was covered in Issue 424 of this Update. According to news sources, CFC’s effort was prompted by test results indicating that colas sold in Britain contain 135 micrograms of 4-MEI per can. Malcolm Clark, CFC campaign coordinator, asserts that only caramel colorings “free of known cancer-causing chemicals” should be used worldwide. See Daily Mail, June 25, 2012.
After the Center for Science in the Public Interest (CSPI) informed Food and Drug Administration (FDA) Commissioner Margaret Hamburg that laboratory analyses of soft drinks revealed high levels of 4-methylimidazole (4-MEI) in certain caramel colored beverages, the major soft drink manufacturers reported that they were changing the way they manufacture the caramel coloring to address the issue. California added 4-MEI to its list of chemicals known to the state to cause cancer (Prop. 65), and the companies had already apparently reformulated products sold there to avoid the need for a Prop. 65 cancer exposure warning. The changes will be expanded throughout the national market even though an FDA spokesperson reportedly indicated in response to CSPI’s claims that a person would have drink in excess of 1,000 cans of soda a day to achieve the levels to which rats were exposed in studies purportedly showing an association with cancer. The American…
According to a news source, the industry interests that lost their challenge to the listing of 4-MEI as a chemical known to California to cause cancer have filed an appeal in the Third District Court of Appeals. Cal. League of Food Processors v. OEHHA, No. C070406 (Cal. Ct. App., 3rd Dist., appeal filed February 10, 2012). The chemical is commonly found in foods such as soy sauce, roasted coffee and the caramel coloring added to colas and beer. California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) added the chemical to the Proposition 65 (Prop. 65) list in January 2011, and a California Superior Court rejected the challenge filed by the California League of Food Processors, American Beverage Association, Grocery Manufacturers Association, and National Coffee Association in November. Additional information about the court’s ruling appears in Issue 420 of this Update. The plaintiffs reportedly argue that appellate intervention is needed “before…
