The Food and Drug Administration (FDA) told this publication changing the interim approval status of BVO would require an “expenditure of the FDA’s limited resources” and is not a “public health priority for the agency at this time.”
The synthetic chemical is used in sodas to keep the flavouring mixed into the drink and prevent it floating to the surface; BVO is derived from soybean or corn and can be found in brands including Moutain Dew and Fanta orange but Coca-Cola and Pepsi do not contain the substance, according to US media.
However, BVO is patented as a flame retardant for plastics and is banned in food throughout Europe and Japan.
Dr Walter Vetter, professor of food chemistry at Hohenheim University, headed a German study 'Polybrominated Flame Retardants Used in our Children's Soft Drinks' (2010) analysing samples of imported sodas from North America, and will continue work later this year.
He said: “Such testing should be performed for reasons of consumer protection. The consumer has the right to know. In my view, the best solution would be a voluntary ban [on BVO] by the industry”.
The FDA limits the use of BVO, found in 10% of US sodas, to 15 parts per million (ppm), but the chemical is still on the agency’s interim approval list.
Vetter said: “According to our understanding of the situation, this was only an interim level, which since then has never been controlled. We also think that there are newer and better toxicity tests available today compared to the 1960s and early 1970s.”
A 1997 study from Dr Zane Horowitz, now medical director of the Oregon Poison Center, into Excessive Cola Consumption found that a person who “daily consumed 2-4 L BVO-containing soft drink suffered from severe bromism and his serum bromide was at 3180 mg/L (39.8 mmol/L).
He added: “The toxic symptoms were headache, fatigue, ataxia, and memory loss which progressed over 30 days. The patient continued to deteriorate, until he was no longer able to walk…subsequent hemodialysis dramatically cleared his clinical condition, and reduced his serum bromide levels.”
Status change not a priority for FDA
A FDA spokesman said: “Regarding its interim status any change in the interim status of BVO would require an expenditure of [the] FDA’s limited resources, which is not a public health priority for the agency at this time.”
The FDA removed BVO from its Generally Recognized as Safe (GRAS) list for flavour additives in 1970 but approved it in 1977 as a stabiliser in fruit-flavoured beverages after further study findings.
He added: “[The] FDA issued an interim food additive regulation to provide for the interim use of BVO at a level not to exceed 15ppm in fruit-flavoured beverages pending the outcome of additional studies.
“Those studies were submitted. FDA determined that a 2-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, no cardiotoxicity was observed in the dogs fed BVO at levels as high as 3,600 ppm for two years.
“The findings from these studies supported the safety of BVO in beverages at a level of 15 ppm in fruit-flavoured beverages,” he added.
EU hydrocolloid substitute
The EU alternative is hydrocolloids, which form small droplets on water into which non-water soluble compounds can be stored and stabilised.
Vetter added: “Hydrocolloids are used for the same technological reason as BVO. In Europe they are used because they are considered safe in contrast to BVO.
“There are adequate substitutes available: the products containing BVO in North America are sold in Europe without BVO. Aside from this solution, there should be a toxicological evaluation.”
Christopher Gindlesperger, director of communications at the American Beverage Association (ABA) said: “It is a safe ingredient approved by the FDA, which is used in some citrus-based beverages.
"Importantly, consumers can rest assured that our products are safe and our industry adheres to all government regulations.”
Vetter et al.'s (2010) study: The Polybrominated Flame Retardants Used in Our Childrens’ Soft Drinks can be found here.