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What you need to know about the FDA’s proposed ban of brominated vegetable oil

The US Food and Drug Administration has announced a proposal to revoke the nationwide regulation authorizing the use of brominated vegetable oil, or BVO, in food.

After a review of evidence, “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,” the FDA said in a November 2 statement.

What exactly is BVO, what is it used for, and what kinds of foods contain it? What is the evidence for revoking its authorization? And what about another food additive, red dye No. 3? California has already passed legislation to ban it, along with BVO and two other food additives. How worried should people be about products that contain BVO and red dye No. 3, and are there steps they could be taking to reduce any risks?

To help us with these questions, I spoke with our CNN Wellness medical expert, Dr. Leana Wen. Wen is an emergency physician and professor of health policy and management at the George Washington University Milken Institute School of Public Health. She previously was Baltimore’s health commissioner.

What is brominated vegetable oil, or BVO? What is it used for, and what kinds of foods contain it?

Dr. Leana Wen: BVO is a vegetable oil that is modified with the chemical compound bromine. It is currently allowed to be used in small amounts in the production of citrus-flavored drinks, specifically to keep the citrus flavoring from separating and floating to the top of these beverages.

This additive has been around since the 1920s. In 1970, the FDA responded to concerns over potential safety issues and removed it from its “generally recognized as safe” list, also known as GRAS. However, since federal regulators did not believe there was enough data to revoke its authorization altogether, the FDA took an intermediate step: It limited its use to a reduced level and for the specific use as an emulsifier in fruit-flavored beverages.

Brominated vegetable oil is used in small amounts in some citrus-flavored drinks to keep the citrus flavoring from separating and floating to the top of the beverage.Tom_Young67/E+/Getty Images/FILE

Some major companies have since taken voluntary steps to remove BVO from their ingredient list. In 2013, PepsiCo announced that it would remove BVO from Gatorade, and in 2014, Coca-Coca and PepsiCo said they intended to remove BVO from all their beverages. It’s banned in Europe and Japan but is still allowed in the US and is found primarily in smaller store-brand soft drinks.

What is the evidence that suggests its authorization should be revoked? 

Wen: Questions about BVO’s safety have been raised for decades. This includes a 1976 study that found consumption of BVO by pigs damaged their hearts, kidneys, livers and testicles. A more recent study, published in 2022 and specifically cited by the FDA in its recent decision, found that rats given BVO had accumulations of BVO’s derivatives in their heart, liver and fat. Moreover, this study, done in collaboration with the National Institutes of Health, found that BVO led to changes in the thyroid, with thyroid cells growing larger and increasing the production of the thyroid-stimulating hormone.

BVO is among the four products that California has already banned. How does the FDA announcement affect what’s happening in California?

Wen: The legislation in California was signed into law in October by Gov. Gavin Newsom. It would prohibit the manufacture, sale or distribution of foods in California that contain BVO as well as red dye No. 3, potassium bromate and propylparaben.

This legislation goes into effect in 2027 and would only affect California. The FDA revoking authorization of BVO would have a nationwide effect. The FDA has said that it is reviewing red dye No. 3 and that “a decision from the FDA is forthcoming.”

What can you tell us about red dye No. 3 and the studies linking it to health risks?

Wen: The FDA actually banned the use of red dye No. 3 over two decades ago for use in cosmetics after its use was shown to be associated with cancer in rats. Another study, published in 2012, provided more evidence for a cancer association in animals. Several studies have also linked consumption of this dye to hyperactivity and other behavioral challenges in children. The use of red dye No. 3 is severely restricted in other countries including those in the European Union; however, it remains allowed for use in food and drinks in the US, including in quite a few candies.

Since these products are not yet banned in the US, should people worry about products that contain BVO and red dye No. 3? Are there steps they should be taking to reduce risk?

Wen: I think it’s very good that we have a rigorous regulatory agency in the FDA that is constantly evaluating the safety of consumer products. When new evidence emerges, the FDA scientists review the data and revise guidelines accordingly. Moreover, the FDA is responsive to comments from the public, including advocacy organizations that are often very proactive about examining potential risks.

My takeaway from the studies is that how much and how often you drink matters. If someone drinks one soda at a barbecue that happens to contain BVO, that’s not a big deal. However, if someone is drinking a soda a day, every day, they should be careful and check out the ingredients.

As for red dye No. 3, it’s currently in so many foods that it may be difficult to avoid everything altogether for most people. Parents with children who have hyperactivity or who are particularly sensitive to hyperactivity and behavioral conditions should check food and medication ingredient labels. In food, red dye No. 3 is often listed as “FD&C Red #3” and in medicines as a dye listed in the inactive ingredient section.

Of course, there are other reasons to reduce consumption of sodas and candies as well. Consumption of large amounts of sugary, ultra-processed foods are associated with a myriad of health problems, including diabetes, obesity and heart problems. Try to replace some sodas with water and add fresh fruit and other healthy snacks like nuts, hummus and yogurt to your diet.

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