The U.S. Food and Drug Administration (FDA) is revoking the regulation authorizing the use of brominated vegetable oil (BVO) in food. Brominated vegetable oil (BVO) is a vegetable oil that is modified with bromine and has been used as a flavoring oil stabilizer and emulsifier since the 1920s and is primarily used in citrus-flavored soft drinks. The agency concluded that the intended use of BVO in food is no longer considered safe after the results of studies conducted in collaboration with the National Institutes of Health (NIH) found the potential for adverse health effects in humans.
In 1970, FDA removed BVO from the codified list of generally recognized as safe (GRAS) substances and established an interim food additive regulation, later codified at 21 CFR 180.30. The initial authorization was for a 3-year basis and then expanded indefinitely to
allow completion of subsequent safety studies. In 2014, FDA determined the existing data on BVO did not provide evidence of a health threat but that there were deficiencies in the existing studies and many studies did not clearly establish safe levels of chronic use. In 2022, the National Center for Toxicological Research published new rodent safety studies that confirmed dietary exposure to BVO results in bioaccumulation of bromine and toxic effects on the thyroid, a gland that produces hormones that play a key role in regulating blood pressure, body temperature, heart rate, metabolism, and the reaction of the body to other hormones.
My Personal Experience
When I was a kid (the middle of the last century), I was fond of Nesbit Orange Drink or
orange soda (see image of bottle, other renditions had a white label and a different shaped bottle). Nesbitt was great, but it had a problem with separation of the citrus flavor, which were hydrophobic in nature (limonene, citral, etc.) – terpenes that are not soluble in the acidic (due to carbonation) aqueous matrix of the soda and you would often get Nesbitt with thin layer of the organic flavor floating at the top of the bottle.
This organic flavor layer was VERY STRONG tasting, so your only option was to shake the bottle to disperse the organic layer, but this was a disadvantageous option because of the carbonation. I went home more than once with a large orange stain on my T-shirt. This separation was a problem for the beverage companies until brominated vegetable oil was used
nearly universally in terpene-flavored beverages. I believe Mountain Dew was the last company to use BVO widely and was banned in some countries as a result. As you can imagine, when the subject of potential toxicity of BVO came up a few decades ago, there was much moaning and gnashing of teeth that the loss of BVO might mean large business losses to the natural flavors and fruit extracts industry.
Bioaccumulation
As noted above, NTP found there was bioaccumulation of bromine, which should not have been a surprise to anyone, as bromine/bromide compounds, although used as sedatives, anticonvulsants and even to suppress sexual arousal among prisoners, were used until relatively recently1, were discovered to produce “bromisim” a condition with a myriad of neurological effects. Bromine is not unique in its bioaccumulation as many minerals accumulate in the body including strontium. Organics also accumulate including organo-chlorines and organo-fluorenes.
Now to the point of this all. When working on the safety of any substance, whether a new substance for a GRAS or FAP or a contamination, it is important to assure the regulator that the substance is excreted and does not bioaccumulate in the body.
George A. Burdock, Ph.D.
Diplomate, American Board of Toxicology
Fellow, Academy of Toxicological Sciences
Fellow, American College of Nutrition
President, Burdock Group
859 Outer Road
Orlando, FL 32814
PH 407.802.1400 x168
FX 407.802.1405
“If you think compliance is expensive, try non-compliance” – Paul McNulty, Former U.S. Deputy Attorney General
1 Bromo Seltzer was not banned until 1975