Prop 65, 4-MeI and how many cans of cola you'd need to drink a day to match what those mice were consuming...
Negative PR surrounding a substance called 4-Methylimidazole (4-MeI), a trace element created naturally in the heat processing of everything from roasted coffee, chocolate and baked goods to Class III and IV caramel color - has caused a few sleepless nights for DDW.
4-MeI first hit the headlines a few years ago when Californian regulators proposed adding it to the Proposition 65 list of compounds that may require a warning label alerting shoppers that they contain 'known carcinogens'.
The eventual ruling - which came into force in 2012 - required warnings on all products sold in California containing levels above a 'safe harbor' amount of 29 micrograms a day.
Meanwhile, in early 2011, the Center for Science in the Public Interest (CSPI) upped the ante by petitioning the FDA to ban caramel colorings containing 4-MeI, which executive director Michael Jacobson claimed "may be causing hundreds or thousands of cancers in the American population".
In reality, says DDW CEO Ted Nixon, to consume the amounts of 4-MeI used in the controversial rodent studies that prompted the media storm in the first place, you'd have to consume more than a thousand cans of soda a day - for life.
(And the 1,000 can figure was provided by the FDA, which along with EFSA, Health Canada and all other major regulatory agencies, has concluded that 4-MeI levels in sodas are safe, he points out.)
The Prop 65 decision was based on two inconclusive and contradictory studies
However, DDW has worked hard to formulate products with substantially reduced levels of 4-MeI to meet Prop 65 standards, despite the fact that there is no evidence that the regular variety poses any health risk, he says.
"We actually started looking at 4-MeI more than 30 years ago and kept levels down to below 250ppm."
But the ultra-low levels that meet Prop 65 standards come at a price, he says. For a start, the less MeI, the more color you have to use, while the lower you go (25ppm or lower) you can meet stability challenges, he says.
"The Prop 65 decision was based on two inconclusive and contradictory studies — one in rats, after they were fed large amounts of 4-MeI, showed a reduction of tumors, while the same study in mice showed an increase in lung tumors."