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FDA: Brominated vegetable oil (BVO), is safe, so removing its interim status is ‘not a priority’

By Elaine WATSON , 29-Jan-2013
Last updated the 29-Jan-2013 at 14:36 GMT

While brominated vegetable oil (BVO) has been sitting on a list of food additives “permitted on an interim basis pending further study” for decades, it is not in ‘regulatory limbo’ and is safe to use in fruit-flavored beverages, insists the Food and Drug Administration (FDA).

Its comments came after PepsiCo unveiled plans to remove BVO from Gatorade and replace it with sucrose acetate isobutyrate, owing to some consumers’ “negative perceptions”.

However, it insists BVO is safe and is not removing the offending substance from other products including Mountain Dew or Amp.

Coca-Cola, which uses BVO in Powerade and Fanta Orange, is equally confident about BVO's safety.

CSPI: It’s crazy that the FDA has let BVO linger in the food supply on an interim basis for 42 years

Typically made from soybean or corn oil combined with bromine, BVO keeps flavor oils in suspension

PepsiCo’s move was welcomed by the Center for Science in the Public Interest (CSPI), which regards BVO as “poorly tested and possibly dangerous” and claims it is “crazy” that the FDA has let it “linger in the food supply on an interim basis for 42 years”.

However, an FDA spokeswoman told FoodNavigator-USA that the only reason the agency has not embarked on rule-making to remove BVO’s ‘interim’ status is because it believes it is safe and has other more immediate priorities.

She added: “FDA is not conducting any studies into BVO at this time. Regarding its interim status in 21 CFR 180.30 , FDA prioritizes its rule-making in a risk-based manner to maximize its resources to protect public health.

“BVO is considered safe by FDA for use as a flavoring adjuvant in fruit-flavored beverages based on several long-term animal studies that were conducted on this substance, and as such commencing rulemaking to remove the interim status is not a priority for the agency at this time.”

Saccharin, mannitol and acrylonitrile copolymers are also on the ‘interim’ list of permitted food additives

The CSPI says 'sensitive, modern studies are urgently needed to better understand the risk, especially at the lower levels typically consumed by large numbers of children'. However, the FDA says it is safe for use in fruit-flavored beverages at 15ppm for use as a flavoring adjuvant in fruit-flavored beverages 'based on several long-term animal studies'

A stabilizer/emulsifier that keeps fat-soluble citrus flavors suspended in soft drinks, BVO is approved for use in North America and Latin America, but not in Europe, Japan or India.

It was removed from the FDA’s list of generally recognized as safe (GRAS) substances in January 1970 following a Canadian study on rats (Munro et al. 1969) showing cardiotoxicity at high doses, confirmed the spokeswoman.

However, it was permitted for use at a maximum level of 15 ppm in fruit-flavored beverages six months later following a food additive petition submitted by the Flavor Extract Manufacturer’s Association (FEMA).

It has since been sitting on a list of four food additives ‘permitted on an interim basis pending further study’ along with saccharin, mannitol and Acrylonitrile copolymers.

FDA: The totality of evidence supports the safe use of BVO in fruit-flavored beverages at 15ppm

She added: “In May 1970, FDA accepted for review a petition submitted by FEMA... After evaluating all of the available data, FDA issued a food additive regulation on July 20, 1970, to provide for the interim use of BVO at a level not to exceed 15ppm in fruit-flavored beverages, pending the outcome of additional studies. 

“This decision was based on the existing safety studies and the estimated daily intake… FEMA made several submissions to FDA during 1971-1974.  FDA reviewed the studies submitted by FEMA and determined that the totality of evidence supported the safe use of BVO in fruit-flavored beverages at 15ppm, with about a 100-fold margin of safety. 

“Reviews of these studies were completed in 1981. 21 CFR 180.30 has remained in interim status because the FDA prioritizes its rulemaking in a risk-based manner to maximize its resources to protect public health.”

CSPI: After 42 years, you'd think the FDA might have found time to seriously reevaluate this ingredient

While this was fair enough, the CSPI's Michael Jacobson told us, "After 42 years, you'd think the FDA might have found time to seriously reevaluate this ingredient and finalize its regulatory status."

As regards the safety studies, he said: "The longest published study we've seen is four months. Late last year, we submitted a Freedom of Information Act request to obtain any other studies that the FDA might have."

He added: "FDA is not charged with conducting studies, but it could require manufacturers to conduct studies...and, depending on the results, either affirm the substance's safety at the levels used, reduce the levels used, or ban the substance."

As for PepsiCo, he said: "Pepsi did the right thing by eliminating BVO from one major product.  It should [now] do the same for Mountain Dew and any other products it makes that contain it."

Gatorade: ‘We can assure you that Mountain Dew is safe

Gatorade senior director, communications Molly Carter denied that the reformulation was prompted by a Change.org petition filed by student Sarah Kavanagh last November that garnered more than 200,000 signatures, and said R&D experts “began working on an alternative ingredient… more than a year ago”.

Reformulated products will hit shelves in the next few months, she said.

“BVO is [still] used in Mountain Dew and Amp.  We are only announcing a change on Gatorade.  However, we take consumer safety and product integrity seriously and we can assure you that Mountain Dew is safe.”

Coca-Cola: The FDA has said that studies support the safety of BVO in soft drinks at the permitted levels

A Coca-Cola spokesman said: “We use BVO, which is permitted for use by the FDA, in a few of our beverages. Where it is used, it is listed as an ingredient on the label.  BVO improves the stability of our products, preventing some ingredients from separating.

“The FDA has said that studies support the safety of BVO in soft drinks at the permitted levels.”

Asked whether Coca Cola was considering reformulating any of its products to replace BVO, he said: “I am not able provide any more detail at this time.”

Click here to get Sarah Kavanagh’s reaction to PepsiCo’s move.

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