"In kids, the total dosage effect tends to be greater," Vorhees said. "I actually think there are people that get these high exposures."
Banned bromine returns
Based on data from the early studies, the FDA yanked brominated vegetable oil from its Generally Recognized as Safe (GRAS) list for flavor additives in 1970, said Douglas Karas, a spokesman for the FDA. BVO bounced back after studies from an industry group from 1971 to 1974 demonstrated a level of safety.
The Flavor Extract Manufacturers’ Association petitioned the FDA to get BVO back in fruit-flavored beverages, this time as a stabilizer, which is its role today. After evaluating the petition and other data, the FDA in 1977 approved the interim use of BVO at 15 ppm in fruit-flavored beverages, pending the outcome of additional studies.
"This decision was based on the highest No Observed Effect Levels from the existing safety studies and the estimated daily intake," Karas said in an email. "Although there were doses that showed adverse effects in the animal studies, there also were lower doses in which there were no adverse effects observed."
As a condition of interim approval, the industry group submitted additional safety studies to the FDA.
The FDA determined that a two-year feeding study in pigs established a no-effect level of 1,200 ppm. A two-year feeding study in beagle dogs also was conducted. Although there were concerns about quality control with that particular study, Karas said, no cardiovascular effects were observed in the dogs fed BVO at levels as high as 3,600 ppm for two years. After an independent audit of the data to address the quality concerns, the FDA decided to allow BVO in fruit-flavored beverages.
"The findings from these studies supported the safety of BVO in beverages at a level of 15 ppm in fruit-flavored beverages," Karas said. "Its use as a flame retardant does not preclude its use as a food ingredient so long as the food use is safe."
More than 30 years later, brominated vegetable oil's approval status is still listed as interim. Changing the status would be costly and "is not a public health priority for the agency at this time," Karas said.
Michael Jacobson, executive director of the Center for Science in the Public Interest, was involved with the petition to remove BVO from the "safe" list in 1970. He said it's time for the FDA to make a decision, one way or the other.
"Is it harmful at the amounts consumed? Probably not," Jacobson said. "But it would be nice if the FDA did a thorough review of the literature and finalized an approval or a ban."
A safer switch?
BVO has seeped into Europe, mostly forbidden territory for this additive, according to an analysis of imported sodas presented at an international symposium on halogenated persistent organic pollutants in 2010.
"We found products with no label although BVO was present in the soda," said Vetter, lead author of the study.
He said soda makers in North America could easily replace BVO with alternatives such as hydrocolloids – chemicals that are used in many sodas in Europe. Natural hydrocolloids form small droplets on water into which non-water soluble compounds can be stored and stabilized for as long as necessary. They are almost exclusively natural products, Vetter said.
Barnes, of the Dr. Pepper Snapple Group, said that BVO and hydrocolloids "do not provide the same functionality and cannot be substituted for one another."
Vetter disagreed, saying that countries in Europe and elsewhere have used natural hydrocolloids for decades in the soda brands that rely on BVO in North America.