400 representative products tested for 4-mei levels

FDA to conduct more tests, but has “no reason to believe” that 4-mei from caramel colors poses health risks at current intake levels

By Elaine Watson contact

- Last updated on GMT

4-MEI is a chemical impurity that may form at low levels in the manufacture of Class III and IV caramels
4-MEI is a chemical impurity that may form at low levels in the manufacture of Class III and IV caramels

Related tags: World health organization, Soft drink

UPDATED Aug 22: The FDA has conducted new tests to determine exposure to 4-mei (4-Methylimidazole) via consumption of products containing caramel colors III and IV, and plans more to assess exposure from other sources such as brewed coffee and roasted meats. But for now, it says it still has “no reason to believe” that 4-mei from caramel colors poses a health risk at current intake levels.

4-mei - an impurity generated in the production of some caramel colors produced using ammonium compounds - hit the headlines again in January​ after Consumer Reports published test results showing what it claimed to be “concerning​” levels of 4-mei in soft drinks and called on the FDA to set federal limits well below those enshrined in California’s Proposition 65 list.  

The FDA agreed to conduct new tests, but said at the time that it had no reason to believe that 4-mei from caramel colors posed a health risk (click HERE​). Speaking to FoodNavigator-USA on August 15 after presenting a poster at the American Chemical Society annual meeting, the agency reiterated its earlier comment: "We have no reason to believe that at current levels it poses a health concern."

FDA is currently evaluating the carcinogenic potential of 4-mei

However, tests and analysis are ongoing and stakeholders should not try to pre-judge the agency's response to citizen's petitions on 4-mei, said a spokesperson on August 22:

"FDA presented its refined exposure assessment in a poster session at the American Chemical Society meeting in San Francisco, California.   FDA will use these 4-mei exposure estimates in conjunction with review of the available toxicological data for 4-mei in order to address the citizen petitions before the Agency.  

"The World Health Organization’s  International Agency for Research on Cancer (IARC) evaluated 4-mei and determined it to be a Group 2B,  possibly carcinogenic to humans.   FDA is currently evaluating the carcinogenic potential of 4-mei.  These efforts will inform the FDA’s safety analysis, and will help the agency determine what, if any, regulatory action needs to be taken."

Intakes of 4-mei from carbonated soft drinks have fallen recently owing to wider adoption of low-4-mei caramel color variants

In its poster, the FDA said 400 representative products had recently been sent to a contract laboratory to assess 4-mei levels, while it had also done testing in-house.

The results were then correlated with dietary intake data from the National Health and Nutrition Examination Survey (NHANES) to determine estimated exposure levels.

cola-istock-Timur Suleymanov
The European Food Safety Authority (EFSA) said in 2012 that exposure estimates for 4-mei from caramel colors in Europe did not exceed the acceptable daily intakes (ADIs) for any population group.

As expected, when it came to 4-mei levels from caramel colors, colas were the biggest contributors, although levels have come down recently as more players have switched to using low 4-mei caramel colors, said the FDA.

“FDA will use the 4-mei exposure estimates in conjunction with review of the available toxicological data for 4-mei in order to address the citizen petitions before the Agency."

A 2011 petition urged the FDA to ban class III & IV caramel colors, while a 2014 petition asked it to set a maximum threshold level for 4-mei in caramel colors, identify caramel color classes on ingredients lists and bar products made with caramel colors from making ‘natural’ claims.

Click HERE ​to download the FDA's poster presentation on 4-mei.

4-mei exposure data from the FDA
Data from a poster presented by the FDA at the American Chemical Society annual meeting this month

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