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Is Caramel Coloring Carcinogenic? FDA Tests Soft Drinks

That well-known dark caramel coloring of sodas like Coke and Pepsi could be toxic.

Most soft drink companies won’t give away their secret recipes, but the one ingredient you will consistently see on the back of soda cans is caramel coloring. Now the U.S. Food & Drug Administration has announced that it will be performing tests to determine how safe caramel coloring really is for consumption, prompting the protestations of the American Beverage Association, whose brands like Coca Cola, Pepsi, and even many beers most often use caramel coloring. “There is no reason why consumers need to be exposed to this avoidable and unnecessary risk that can stem from coloring food and beverages brown," Consumer Reports' Dr. Urvashi Rangan, a toxicologist and lead investigator on the study, told the Huffington Post.

The reason for the sudden change, according to the Huffington Post, is that recent reports found varying levels of the impurity 4-methylimidazole in the caramel coloring of 12 different brands of soda. The FDA is studying the toxicity of this impurity to see if it may be a carcinogen, because carcinogenic links have been seen in rodent test studies. The impurity is particularly prevalent in PepsiCo products.

“Our beverages are safe,” a representative from the American Beverage Association told The Daily Meal. “The FDA has noted that a consumer ‘would have to drink more than a thousand cans of soda in a day to match the doses administered in studies that showed links to cancer in rodents.’"

Studies thus far have been inconclusive.

Joanna Fantozzi is on Twitter! Follow her here.

What Not to Eat: Avoid Foods with Caramel Coloring

Caramel coloring is made by heating a sugar compound (usually high-dextrose corn syrup), often together with ammonium compounds, acids, or alkalis. It is the most widely used (by weight) coloring added to foods and beverages, with hues ranging from tannish-yellow to black, depending on the concentration and the food. Caramel coloring may be used to simulate the appearance of cocoa in baked goods, make meats and gravies look more attractive, and darken soft drinks and beer. Caramel coloring, when produced with ammonia, contains the contaminants 2-methylimidazole and 4-methylimidazole.

In 2007, studies by the U.S. National Toxicology Program found that those two contaminants cause cancer in male and female mice and possibly in female rats. In 2011, the International Agency for Research on Cancer, a division of the World Health Organization, agreed that 2- and 4-methylimidazole are “possibly carcinogenic to humans.”

After that, the State of California’s Environmental Protection Agency listed 2-methylimidazole and 4-methylimidazole as carcinogens under the state’s Proposition 65. Businesses are required to provide a “clear and reasonable” warning before knowingly and intentionally exposing anyone to a chemical on the list, unless exposure is low enough to pose no significant risk. California defines a “no significant risk level” for carcinogens as the amount that would result in no more than one excess cancer case in 100,000 people exposed to the chemical over a 70-year lifetime. California warned that as of January 7, 2012, widely consumed products, such as soft drinks, that contained more than 29 micrograms of 4-methylimidazole per serving would have to bear a warning notice.

In March 2012, when the Center for Science in the Public Interest published the results of a study that found levels up to 150 micrograms of 4-methylimidazole per can of Coca-Cola and Pepsi-Cola purchased in Washington, DC, the soft-drink giants announced that they had reduced the contaminant to below California’s threshold for action in products distributed in California. They said they would market the less-contaminated products throughout the country, which Coca-Cola did in 2013 and PepsiCo was expected to do by 2014. However, according to recent testing, levels of 4-methylimidazole are still high in Pepsi products.

The FDA has a guideline that is 10 times stricter than California’s for regulating substances that are contaminated with cancer-causing chemicals. CSPI’s analysis of a Coca-Cola purchased in 2012 in California found just 4 micrograms of 4-MI per 12 ounces. Even that much lower level might exceed the FDA’s guideline of 1 cancer per million consumers.

It is worth avoiding or drinking less colas and other ammonia-caramel-colored beverages not only because of risk from 4-methylimidazole, but because the drinks contain about 10 teaspoons of added sugars per 12 ounces, and that promotes obesity and tooth decay. Soy sauces, baked goods, and other foods that contain ammoniated caramel coloring are much less of a problem because the amounts consumed are small.

Other relevant links:

• An infographic on the FDA’s food additive approval process. See: Not So Safe: How the FDA Lets Food Safety Slip Through the Holes

Artificial Caramel Coloring in Soft Drinks Linked to Cancer, FDA Petitioned

The Center for Science in the Public Interest (CSPI) has submitted another blow to the soda industry in a petition with the FDA to ban ingredients commonly known as "caramel coloring" found in many sodas and snack food items due to the increased risk of cancer caused by these colorants.

Caramel coloring is far different from actual caramel, according to CSPI, who has said that the chemicals made during the caramel color process are "considered to pose cancer threats to humans," and they call for banning all caramel colorings. In a letter to Margaret Hamburg, FDA Commissioner, CSPI stated that "the American public should not be exposed to any cancer risk whatsoever as a result of consuming such chemicals, especially when they serve a non-essential, cosmetic purpose."

A process of reacting sugars with ammonia and sulfites in high pressure and high temperature environments creates caramel colors and also causes a chemical reaction resulting in 2-methylimidazole (2-MI) and 4-methylimidazole (4-MI). Both 2-MI and 4-MI were tested in government studies and shown to cause several types of cancers including lung, liver, thyroid and leukemia in lab animals.

Popular soda brands currently contain about 200 micrograms of 4-MI per 20-ounce bottle, but California&aposs Proposition 65 may potentially include 4-MI to the list of "chemicals known to the state to cause cancer." Foods and beverages containing more than specific levels of identified chemicals would be required to carry warning labels and reduce the levels of 4-MI in products, with the maximum level for 4-MI limited to 16 micrograms per person per day (from any one product).

Coloring used in some sodas poses cancer risk to consumers, study suggests

Public health researchers looking at U.S. soda drinking habits warn that many people may be regularly exposing themselves to a potentially cancer-causing byproduct of the caramel coloring used in some types of soda.

Caramel color is a common ingredient in colas and other dark soft drinks, and a possible human carcinogen𔃌-methylimidazole (4-MEI)—is formed during the manufacture of some kinds of the coloring. Analysis of soda consumption data show that between 44 and 58 percent of people over the age of 6 typically have at least one can of soda per day.

Building on an analysis of 4-MEI concentrations in 12 different soft drinks first published by Consumer Reports in 2014, researchers led by a team at the Johns Hopkins Center for a Livable Future estimated exposure to 4-MEI from caramel-colored soft drinks and modeled the potential cancer burden related to routine soft drink consumption levels in the U.S.

"Soft drink consumers are being exposed to an avoidable and unnecessary cancer risk from an ingredient that is being added to these beverages simply for aesthetic purposes," says Keeve Nachman, senior author of the study, director of the Food Production and Public Health Program at the center, and an assistant professor at the Johns Hopkins Bloomberg School of Public Health. "This unnecessary exposure poses a threat to public health and raises questions about the continued use of caramel coloring in soda."

While there's currently no federal limit for 4-MEI in food or beverages, Consumer Reports petitioned the Food and Drug Administration to set limits for the potential carcinogen last year. It also shared the findings with the California attorney general's office, which enforces the state's Proposition 65 law aimed at reducing consumers' exposure to toxic chemicals. Under this state law, any food or beverage sold in the state that exposes consumers to more than 29 micrograms of 4-MEI per day requires a health-warning label.

In 2013 and early 2014, Consumer Reports partnered with the Center for a Livable Future to analyze 4-MEI concentrations of 110 soft drink samples purchased from retail stores in California and the New York metropolitan area. The analysis found by far the highest concentration in Malta Goya, a non-alcoholic malt beverage that is popular in Caribbean nations. Samples of Pepsi One, Diet Pepsi, and Pepsi also scored above the 29 microgram per can/bottle level in some instances. Coke, Diet Coke, Coke Zero, and Dr. Pepper scored well below the 29 microgram threshold in two tests Sprite was shown to contain no significant levels of 4-MEI.

The more recent study pairs those results with population beverage consumption data from the National Health and Nutrition Examination Survey in order to estimate the population risks and cancer burden associated with 4-MEI exposures through soda. While the 2014 study of the 110 samples of soda brands was not large enough to recommend one brand over another or draw conclusions about specific brands, results indicated that levels of 4-MEI could vary substantially across samples, even for the same type of beverage. "For example, for diet colas, certain samples had higher or more variable levels of the compound, while other samples had very low concentrations," says Tyler Smith, lead author of the study and a program officer with the Center for a Livable Future.

"This new analysis underscores our belief that people consume significant amounts of soda that unnecessarily elevate their risk of cancer over the course of a lifetime," says Urvashi Rangan, executive director for Consumer Reports' Food Safety and Sustainability Center. "We believe beverage makers and the government should take the steps needed to protect public health. California has already taken an important step by setting a threshold for prompting Prop 65 labeling based on daily 4-MEI exposure from a food or beverage, such as a soda. This study sought to answer a critical question: How much soda do American consumers drink on average?"

CSPI Asks FDA to Ban Caramel Colorings

The Center for Science in the Public Interest (CSPI) has asked the FDA to ban two types of caramel coloring used as food additives. Some types of caramel coloring have been shown to cause cancer in laboratory animals.

Caramel coloring is one of the most commonly used food additives and is found in most kinds of commercially produced food, such as bread, beer, chocolate, liquor, potato chips, fruit preserves, ice cream, and soft drinks.

What Is Caramel Coloring?

Caramel coloring is a food additive produced by heating a carbohydrate (usually in some form of sugar) and combining it with acids, alkalis, or salts. The Maillard reaction that chefs and home cooks rely on to produce the browning that flavors recipes so well is a precursor to the commercial caramelization process.

Commercial processes continue heating the coloring to very high temperatures and under high pressure until it is stable. The heat and chemicals used to produce caramel coloring sterilize it and bacteria will not live in it unless it is diluted.

Caramel coloring tastes like burnt sugar. Other flavorings must be used to mask its flavor. It’s mainly used as a coloring and as an emulsifier to keep ingredients from separating.

Caramel Coloring Classification

Caramel coloring as a food additive is made in four ways:

  • I – no ammonium or sulfite compounds are used
  • II – no ammonium compounds are used, but sulfite compounds are used
  • III – ammonium compounds are used, but no sulfite compounds are used
  • IV – both sulfite and ammonium compounds are used

The two caramel colorings produced with ammonia (III and IV) form 2-methylimidazole and 4-methylimidazole, both of which cause lung, liver, or thryoid cancer or leukemia in laboratory mice and rats. It is these two caramel colorings that the CSPI has asked the FDA to ban.

California and Caramel Coloring

California has already started a labeling requirement for the caramel colorings III and IV. A hearing will be held on March 10. If the labeling is approved, soft drinks and many other foods in California would be labeled with a cancer warning.

The California League of Food Processors, the American Beverage Association, the Grocery Manufacturers Association, and the National Coffee Association are suing the state of California to prevent the labeling requirement.

Avoiding Caramel Coloring

Caramel coloring is used in so many foods, it’s nearly impossible to come home from the grocery store without it. Even many “natural” foods contain it. Limiting consumption of unnecessary foods (those containing “empty calories”, such as soft drinks) and increasing intake of whole foods, like fresh produce, is the best way to reduce caramel coloring intake.


4-MEI Analyses

Table 1 presents the mean and maximum 4-MEI concentrations (μg/L) in beverages, by brand, beverage, and location. There was wide variability in mean and maximum 4-MEI concentrations among the beverages, with the highest concentrations for all locations in Malta Goya (mean: 945.5μg/L maximum: 1104μg/L) and the lowest concentrations for all locations in Diet Coke (mean: 9.8μg/L maximum: 10.4μg/L) (Table 1). Details of quality control analyses are in S1 File.

For most combinations of beverages and locations, there was little variability between the mean and maximum 4-MEI concentrations (< 20% variation for 19 out of 24 beverage and location combinations). More notable variability was observed in Dr. Snap Regular (76% variability between mean and maximum New York area samples) and the three Pepsi beverages (50–90% for New York area samples, depending on the beverage, and 36% for California samples of Diet Pepsi). When results for the five combinations with variability > 20% are stratified by month of purchase, however, variability in 4-MEI concentrations declined markedly within beverage over time. For example, in Diet Pepsi samples from California, variability declined from 25% in samples purchased between April and July to 7% in samples purchased in December.

There were significant differences in mean 4-MEI concentrations of samples purchased in California and the New York metropolitan area for Dr. Snap Regular (p = 0.03), Pepsi (p = 0.02), Diet Pepsi (p = 0.02), and Pepsi One (p<0.001). Cross-location variability diminished substantially for these same beverages measured in December 2013, reflecting declines in 4-MEI concentrations in samples purchased in New York (Table 2).

NHANES Analyses

Table 3 shows the distribution of consumption of beverages on a typical day, by life stage. Persons reporting consumption of soft drinks overall varied considerably across the life course with 30.1% of children aged 3 to <6, 57.1% of young adults aged 16 to <21, and 34.9% of older adults aged 65 to 70 consuming any soft drinks. The percent of the population who consume each soft drink type varied as well with colas being the most popular and root beer and pepper colas being the least popular. For each soft drink type, the trend across the life course was similar with consumption highest among adolescents and young adults.

Table 3 shows the distributions (5 th , 50 th and 95 th percentiles) of the volume of each beverage consumed. Among drinkers of each beverage, the volume (mL) consumed differed by life stage and by soft drink type. Adolescents and young adults consumed the most of any soft drink compared to young children and older adults (e.g. 16 to <21 year olds consumed 550.1 mL—1070.3 mL of any soda compared to 457.4mL-864.4mL consumed by 45 to <65 year olds). This trend differed by beverage type. Consumption of cola and root beer among drinkers was relatively consistent across the life course (with the exception of children aged 3–11), whereas older adults who drank diet-cola drank more of it than adolescents (396.0 mL- 1006.3mL among 45 to <65 year olds compared to 290.0mL—505.1mL among 11 to <16 year olds).

Exposure, Risk, and Burden

Table 4 presents the results of the population exposure and risk assessments for 11 beverages (Sprite was dropped from the risk analysis, per above). In general, these results followed the same pattern as the results of the 4-MEI analyses: under average exposure conditions, the highest LADDs were associated with Malta Goya (7.64x10 –3 to 8.04x10 –3 mg/kgBW-day), the three Pepsi beverages (6.31x10 –4 to 4.24x10 –3 mg/kgBW-day, depending on beverage and location), and Dr. Snap Regular (2.53x10 –4 to 7.92x10 –4 mg/kgBW-day, depending on location). The lowest LADDs were associated with the Coca-Cola beverages (8.02x10 –5 to 1.01x10 –4 mg/kgBW-day, depending on beverage and location). A similar pattern was observed under high exposure conditions. 4-MEI exposure associated with the Pepsi beverages and Dr. Snap Regular was higher in the New York area than in California.

Both cancer risk and cancer burden mirrored the results of the exposure assessment: Malta Goya was associated with the highest risk (1.83x10 –4 to 1.93x10 –4 , depending on location) and burden (4,764 to 5,011 excess lifetime cancer cases over 70 years), followed by the three Pepsi beverages (risk: 1.52x10 –5 to 1.02x10 –4 , depending on beverage and location burden: 628 to 4,014 cases), and Dr. Snap Regular (risk: 6.07x10 –6 to 1.9x10 –5 , depending on location burden: 84 to 263 cases). While the three Coca-Cola beverages posed the lowest risk (1.92x10 –6 to 2.42x10 –6 , depending on location) and generally these beverages were associated with lower burdens (76 to 167 cases), Dr. Pepper from all locations and from California and the New York area was associated with a lower burden (78 to 81 cases) than Coca-Cola beverages from some locations. It is important to note that risks and associated burdens were driven both by varying 4-MEI concentrations in beverages and by varying consumption rates for the different beverages. Cancer risks and burdens for adults by race/ethnicity are presented in Table D in S1 File.

Questions & Answers About 4-MEI

4-methylimidazole (4-MEI) is a chemical compound that forms as a byproduct at low levels in some foods and beverages during the normal cooking process. For example, 4-MEI may form when coffee beans are roasted and when meats are roasted or grilled. 4-MEI also forms during the manufacturing of certain types of caramel coloring (known as Class III and Class IV caramel coloring). Class III and Class IV caramel coloring are the most commonly used food color additives by volume.

Is there a risk from eating foods that contain 4-MEI?

Based on current science, the FDA has no reason to believe that there are any immediate or short-term health risks presented by 4-MEI at the levels expected in food.

What about studies that show 4-MEI to be a carcinogen?

In 2007, the National Toxicology Program (NTP) issued reports summarizing the results of toxicological testing conducted on 4-MEI in rats and mice. A 2-year study in rats was inconclusive regarding carcinogenicity, but a 2-year mouse study showed an increased incidence of certain lung tumors. These NTP studies were conducted in rodents at levels of 4-MEI that far exceed current estimates of human exposure to 4-MEI from the consumption of food with or without the addition of Class III or Class IV caramel coloring.

Has 4-MEI been shown to cause other toxic effects?

In March 2020, NTP published the results of a multi-generation reproductive and developmental study on 4-MEI in rats. These types of toxicity studies are conducted to determine if exposure to a substance is associated with changes in reproduction, fertility, and development in the rats’ offspring. This study showed reproductive and developmental effects in male and female rats at the levels tested, however, the doses used in the study were similar to those used in the earlier carcinogenicity studies and similarly far exceed current estimates of human exposure to 4-MEI from foods.

Does the FDA require manufacturers to disclose whether food products contain Class III and Class IV caramel coloring?

No. The FDA’s regulations require that the labels of food containing non-certified color additives, such as caramel coloring, declare the color additives in the ingredients statement either by name or with a general term such as “artificial color” or “color added” unless otherwise indicated. There is no requirement in FDA’s regulations that the ingredient statement on the label of foods that contain Class III or Class IV caramel coloring list the color additive by name or type. It is therefore not possible, unless voluntarily disclosed, to know based on the label if a food contains Class III or IV caramel coloring. Foods that have “caramel coloring” on a food label do not necessarily contain 4-MEI, because the term “caramel coloring” may be used to describe any class of caramel coloring. Class I and Class II caramel coloring do not contain 4-MEI.

What is the FDA doing about the presence of 4-MEI in caramel coloring?

To ensure that the use of Class III and Class IV caramel coloring in food continues to be safe, the FDA is currently reviewing all available data on the safety of 4-MEI. In 2018, the FDA published an assessment of potential consumer exposure to 4-MEI from the use of Class III and Class IV caramel coloring in food products.

The FDA’s current review, along with this exposure assessment, will help the FDA determine what, if any, regulatory action needs to be taken. Such actions could include setting a limit on the amount of 4-MEI that can be present in Class III and IV caramel coloring. However, in the interim, the FDA is not recommending that consumers change their diets because of concerns about 4-MEI.

Can 4-MEI be eliminated from food products?

Eliminating 4-MEI in food is not feasible because it is formed during normal cooking processes. However, there are examples of manufacturers of Class III and IV caramel coloring who have taken steps to reduce the levels of 4-MEI in their products.

Caramel coloring chemical linked to cancer found in "too high" levels in some colas

Consumer Reports is warning the caramel coloring that gives cola its brown hue may be dangerous in the levels its found in some popular soft drinks.

&ldquoThere&rsquos no reason why consumers should be exposed to an avoidable and unnecessary risk that can stem from coloring food brown,&rdquo toxicologist Dr. Urvashi Rangan, executive director of Consumer Reports&rsquo Food Safety & Sustainability Center, said in a statement.

Researchers at the magazine tested dozens of cans and bottles from a variety of popular brands looking for levels of the artificial chemical used for coloring, 4-methylimidazole (4-MeI).

Previous studies of 4-MeI have found long-term exposure to the chemical caused lung cancer in mice, according to the California Office of Environmental Health Hazard Assessment. That prompted the state to add 4-MeI to its list of potentially toxic chemicals under Proposition 65, which requires warning labels on products containing concerning levels of the chemical -- in this case 29 micrograms of 4-MeI per can or bottle.

Consumer Reports tested 81 cans of soda purchased between April and September 2013 from New York and California metropolitan areas. The researchers tested another 29 samples from the same areas for products that initial tests showed exceeded the 29-microgram amount of 4-MeI.

On all tests, Pepsi One and Malta Goya sodas contained levels of 4-MeI higher than 29 micrograms, and the products purchased in Calif. did not have the warning labels.

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Results on Pepsi One ranged from 39.5 micrograms of 4-MeI to 195.3 micrograms of the chemical. Malta Goya contained a whopping 307.5 to 352.5 micrograms depending on the test date and purchase location.

For samples tested in California, Consumer Reports said it notified the state&rsquos attorney general to investigate to see whether Prop 65 was violated.

Initial tests of regular Pepsi found 24.8 micrograms and 174.4. micrograms of 4-MeI in cans sold in Calif. and N.Y. respectively. The next round of testing found 29.1 micrograms and 32.4 micrograms of 4-MeI in those states. Diet Pepsi tests showed similar results.

Whole Foods' 365 Everyday Value Dr. Snap soda contained 55.9 micrograms of 4-MeI in initial N.Y. tests, but dropped to 9.9 micrograms in the next testing phase.

&ldquoThe fact that we found lower amounts of 4-MeI in our last round of tests suggests that some manufacturers may be taking steps to reduce levels, which would be a step in the right direction,&rdquo Rangan said.

Coca-Cola, Coke Zero and Diet Coke&rsquos initial tests showed around or below 4 micrograms of 4-MeI in samples. A &W Root Beer contained 24.2 micrograms of 4-MeI in California and around 22 micrograms from New York cans, which also did not violate the law.

But Rangan says manufacturers have choices to pick alternatives that contain lower levels of the chemical.

&ldquoIt&rsquos possible to get more than 29 micrograms of 4-MeI in one can of some of the drinks we tested,&rdquo said Rangan. &ldquoAnd even if your choice of soft drink contains half that amount, many people have more than one can per day.&rdquo

The magazine called on the Food and Drug Administration to set federal limits for 4-MeI in foods, and to require manufacturers to list the chemical on ingredient labels. Now, the labels only have to state &ldquoartificial color&rdquo or &ldquocaramel color.&rdquo

In response to the study, the FDA told the Associated Press it is conducting new safety studies on the products containing 4-MeI, but noted it&rsquos been studied for decades. The agency said it has no reason to believe its unsafe.

"These efforts will inform the FDA's safety analysis and will help the agency determine what, if any, regulatory action needs to be taken," agency spokeswoman Juli Putnam told AP.

PepsiCo said it is "extremely concerned" about the new Consumer Reports study and believes it is factually incorrect, spokesperson Aurora Gonzalez told AP.

"All of Pepsi's products are below the threshold set in California and all are in full compliance with the law," she said.

Recently, other consumer watchdog groups have raised concerns about the caramel coloring chemical found in colas. The Center for Environmental Health conducted tests of Pepsi products in July, and announced researchers found high levels of the possible carcinogen.

In March 2012, the Center for Science in the Public Interest (CSPI) raised concerns in a new report, estimating about 15,000 cancers could be caused by the levels of 4-MeI currently found in drinks.

Shortly after, Coca Cola announced it would be switching to a low-4MeI formula, while still maintaining the product has always been safe.

Dr Oz: What Does “All Natural” Really Mean?

Dr. Urvashi Rangan says that Consumer Reports is asking the FDA to set a limit for 4-MEI and to require manufacturers disclose to consumers what type of caramel color is in the products they are buying. She also says they want the FDA to prohibit products labeled as “natural” from containing caramel color. For example, the soft drink Dr. Snap claims to be “all natural” and containing “nothing artificial”, yet there is caramel color (an artificial ingredient) listed on the label.

Sodas with caramel color contain potential carcinogen, report says

Nearly half of Americans drink soda daily, an average of two-and-a-half glasses a day. Much of it contains caramel color -- two types of which can contain a potentially carcinogenic by-product.

"There is a risk in there that consumers should be informed about," said Urvashi Rangan, PhD, with Consumer Reports.

Consumer Reports recently tested 110 samples of soft drinks bought in the New York area and California, including iced tea, root beer, colas, and a non-alcoholic malt drink. The chemical, 4-MEI -- which a government study found caused cancer in mice -- showed up at varying levels across all brands tested that contained caramel coloring.

"Some sodas were actually fairly low in their levels of 4-MEI, whereas some soft drinks were extremely high," said Rangan.

The highest levels of 4-MEI Consumer Reports found were in Malta Goya and in Pepsi One. All the Coca Cola samples were far lower.

"The limitation in this study is a very small sample size, so we can't really draw conclusions about any one given brand," said Rangan.

However, Consumer Reports says people should know if the caramel color they are drinking contains a potential carcinogen. Two types don't, but the label simply says caramel color or artificial color, so you don't know the type you're getting.

"Consumers who want to avoid this hazard should avoid caramel color in sodas altogether," said Rangan. Check the labels on other types of foods too, including barbecue sauce, syrups, bread and beer.

There are currently no federal limits on 4-MEI in food products, but Consumer Reports is calling on the Food and Drug Administration to set limits and to require more explicit labeling.

Consumer Reports told PepsiCo and Goya about its findings. Goya says it is looking into the matter. PepsiCo says its products sold in California meet that state's regulations for 4-MEI and it is voluntarily applying those same standards to the rest of the country within the next month.

The FDA's current position is that 4-MEI does not pose a risk to consumers. Consumer Reports says it plans on turning over its findings to the FDA. The consensus held by many in the scientific community is this chemical doesn't currently pose a health hazard at the levels humans are likeliest to be exposed.