Brominated Vegetable Oil: Why the FDA Finally Revoked Its Approval

Some food additive stories are about genuine scientific ambiguity. BVO’s story is different. It’s more about regulatory inertia than scientific uncertainty.

The additive spent over 60 years on an “interim” approved list, waiting for a complete safety review that never came. By the time FDA finished that review in 2024, it found enough evidence of harm to revoke authorization entirely.

Here’s what happened, and what BVO actually was.

What BVO Is and Why Drinks Needed It

Brominated vegetable oil is exactly what the name says: vegetable oil (typically soybean or corn oil) that has been chemically modified by adding bromine atoms to the triglyceride molecules.

The purpose is physics, not chemistry.

Flavor compounds used in citrus-flavored drinks are often dissolved in vegetable oil before being added to the beverage. These oil droplets are less dense than water. Without intervention, they float to the surface. The drink separates and looks unappealing.

Adding bromine atoms to the vegetable oil increases its density. Brominated oil is heavy enough to stay suspended throughout the drink, creating the evenly cloudy, orange-juice-like appearance that beverage companies want. You see a uniform orange drink instead of clear soda with an oily layer on top.

BVO also works as an emulsifier of sorts, helping keep the oil-water mixture stable in an acidic environment. Citrus-flavored beverages are acidic, and that acidity can destabilize other emulsifiers.

For decades, it appeared in Mountain Dew, some citrus-flavored Gatorade products, some flavored sodas, and certain sports drinks. It was never in a wide range of foods. This was primarily a beverage additive.

The Problem With Bromine

Bromine accumulates.

Unlike many food components that are metabolized and excreted efficiently, bromine from BVO can deposit in body fat and fatty tissues, building up over time with repeated exposure. This property is called bioaccumulation.

The other problem: bromine is a halogen, and the body’s thyroid uses another halogen, iodine, as a key building block for thyroid hormones. Elevated bromine levels can compete with iodine for thyroid uptake, potentially interfering with thyroid function.

Case reports in medical literature have documented bromine toxicity from excessive BVO consumption. These cases typically involved people drinking very large quantities of BVO-containing beverages over extended periods, not typical consumption. Symptoms included skin lesions, headaches, memory problems, and fatigue.

Those case reports don’t represent typical exposure. But they provided a clear biological mechanism and a documented pathway to harm.

The “Interim” Status Problem

FDA’s approved food additive list has two categories: substances that went through full formal review and received permanent approval, and substances on the “interim” list. Interim status was created to handle substances in use before the 1958 Food Additives Amendment that needed more review before receiving permanent approval.

BVO went on the interim list in 1958. The plan was to complete a full safety review. That review took 66 years.

During that time, BVO was technically legal but without permanent approval. It sat in regulatory limbo. Meanwhile, several states and federal agencies periodically raised concerns, and other countries banned it.

The EU banned BVO. Japan banned it. India banned it. Canada banned it. The US kept it on the interim list.

The FDA Safety Review and 2024 Ban

FDA conducted a new safety study on BVO using rat models, looking specifically at thyroid function and bromine accumulation. The results showed that BVO at levels comparable to consumption from heavily BVO-containing beverage diets caused thyroid effects.

The FDA announced its findings and issued a proposed rule to revoke BVO’s interim food additive status. The final rule was published July 3, 2024, with an effective date giving manufacturers until August 2, 2025 to remove BVO from products.

The agency’s language was straightforward: the available evidence shows BVO is not safe at current use levels. That’s the threshold for revocation under food additive law.

What Replaced It

The beverage industry had largely anticipated this outcome. Several major manufacturers removed BVO years before the ban.

PepsiCo removed BVO from Mountain Dew in 2020. Other brands had already reformulated.

The replacements that have become standard are:

Glycerol ester of wood rosin (GEWOR): derived from wood rosin, it functions similarly to BVO in weighting flavor oils and stabilizing beverage emulsions. It’s considered safe at current use levels.

Sucrose acetate isobutyrate (SAIB): another weighting agent approved for beverages. Also considered safe at current use levels and already widely used.

Neither replacement has raised concerns comparable to BVO. The reformulation has been largely invisible to consumers.

What This Story Shows About Regulatory Gaps

BVO is a useful case study in the gaps that exist in food additive regulation.

The GRAS system, with its interim categories and self-determination provisions, allowed a substance to stay in the food supply for decades past the point when a full safety review should have completed. The companies selling BVO-containing products faced no pressure to fund that review, and FDA’s resources for reviewing existing additives were limited.

The 2024 revocation is the outcome the system eventually reached. But it took six decades and the persistent pressure of international bans and growing scientific literature to get there.

The lesson: “currently approved” and “formally reviewed as safe under modern standards” are not the same thing. BVO illustrated that gap more clearly than most.