FDA revokes approval of brominated vegetable oil (BVO); science in action.
This illustrates the need for scientific agencies to keep our foods, medications, and other consumer products safe.
As of July 3, 2024, the FDA no longer permits brominated vegetable oil (BVO) in food products. While many influencers online are trying to suggest this means the FDA can’t be trusted to properly monitor and regulate medications, chemicals, foods, and other products, it actually means the opposite.
There has always been a faction of people who have been opposed to outside expert agencies exerting oversight and regulating the manufacture, safety, quality, and efficacy of products, even since the birth of the FDA in the 1920s.
These individuals are successful because they wage concerted misinformation campaigns geared toward eroding trust in these federal and state agencies: if they can convince you the government and all organizations operated by the government are out to get you, then they can convince you not to trust anything they do or say.
This is a bigger topic of discussion, but I want to use the revocation of BVO as a food additive to illustrate the importance of the FDA and their scientists in reviewing data, conducting studies, evaluating research, and making safety decisions is critical.
Before the FDA, food and drug manufacturing was the Wild West.
We will get into more of this at a later date, but if you recall from my article on dietary supplements, the Food, Drug, and Cosmetic Act of 1938 (FDCA) was created in order to keep people safe.
The FDCA was created in the early years of the FDA to crack down on people selling “magic miracle elixirs” that were filled with pretty much anything and everything, including antifreeze. Yes, literally.
Massengil's Elixir Sulfanilamide, sold in 1937, was a liquid antibiotic (sulfa drug) that contained an untested solvent: diethylene glycol (DEG), which caused 107 deaths.
After this tragedy, because there were no laws regulating what manufacturers could put in their products, the 1938 FDCA required that food, drugs, cosmetics, and medical device manufacturers were required to provide proof of their safety before marketing them, and the FDA (established in 1930), had to approve all of them prior to being sold. This was the first major piece of legislation that granted the FDA regulatory powers, and it was done to prevent further tragedies.
Since then, there have been a variety of amendments, updates, and additional legislation that have clarified, expanded, and modernized the FDA’s regulatory powers. Which brings us to brominated vegetable oil.
Brominated vegetable oil was used since the 1930s in certain beverages
Brominated vegetable oil (BVO) was developed in the 1930s by food scientists and formulations chemists to solve the issue of flavoring oils separating from beverages. Citrus oils are less dense than water, and so when early soft drinks were created, a need arose to find something to keep them suspended in the beverage.
In the 1930s - 1960s, BVO might have been found in drinks like 7UP, Orange Crush, Squirt, early formulations of Gatorade, and others.
Used in these products, BVO acts as an emulsifier. BVO is created by adding bromine to vegetable oils through a chemical reaction with elemental bromine.
In the early days of the FDA, the 1938 FDCA did not include food ingredients. But in 1958, the Food Additives Amendment granted authority to the FDA to regulate food ingredients.
Interestingly, this discussion started pre-FDA with the The Pure Food and Drug Act of 1906, born out of the realization about unsanitary meat processing conditions following the release of Upton Sinclair’s The Jungle. The PFDA prohibited the sale of adulterated or misbranded food and drugs and was the precursor to the FDA.
The Food Additives Amendment allowed the FDA to monitor and regulate food ingredients.
In the early 1960s, BVO was added to the FDA’s GRAS (generally recognized as safe) list. The GRAS list is a stipulation of the 1938 FDCA that states that all food additives are required to be reviewed and approved by the FDA unless the substance is recognized by scientific experts and has been demonstrated to be safe as it is intended to be used in the product.
GRAS items and the data associated with them are summarized in a database, so anyone can review the safety and toxicology data used to make these determinations.
That being said, shortly after BVO was added to the GRAS list, the capabilities of scientific research was expanding rapidly. In the late 1960s, some questions arose regarding the unregulated concentration of BVO that could be used, and in 1970, FDA updated their regulation of BVO to restrict its use in beverages to 15 parts per million (ppm), or 0.0015%.
The studies conducted in animal models that suggested potential risks of BVO consumption were using levels of BVO that were orders of magnitude higher than what humans would be realistically exposed to.
This is a central feature of all regulated substances: the threshold for safety is always set at LEAST 100 - 1,000 times LOWER than the level observed in safety studies to not have an adverse effect.
This level is called the no adverse effect level (NOAEL). The NOAEL is the highest dose across animal studies where no harmful effects are observed. From there, safety factors are applied, because scientists understand that animal models and humans can differ in physiology. These uncertainty factors bring the safety threshold set level down to 100 to 1,000 times lower than that NOAEL.
How the safety threshold relates to NOAEL:
An interspecies factor of 10 is applied to consider differences between non-human animal models and humans.
An intraspecies factor of 10 is applied to consider variability within human populations: for example, certain demographics with differences in metabolism, risk factors, genetics, age, etc.
Depending on the studies used to make these assessments, a third factor of 10 may be applied if the data are less robust than desired - which will further decrease the level of that substance that might be included in a product.
For example, if a NOAEL for a chemical in animal studies was determined to be 100 milligrams per kilogram of body weight per day, and a safety factor of 1,000 was applied, the acceptable daily intake (ADI) for humans would be 1,000 less than that:
So a person weighing 150 lbs (68 kg) would be able to consume 6.8 milligrams of this substance before reaching the ADI.
This is why whenever I discuss “toxic chemicals” I always emphasize that these thresholds are incredibly conservative.
These safety thresholds are especially conservative to ensure that regulatory guidance covers all vulnerable populations: elderly, pregnancy, young children.
The FDA, contrary to what people online would lead you to believe, always operates with safety as first priority.
Unfortunately, many people who spread fear about chemicals, the FDA, and how substances are regulated do not understand any of this, either intentionally or not.
Now, are there flaws or gaps with the FDA? Sure, like with everything. But that isn’t a function of the scientists themselves, rather, political influence and how budgets for federal agencies are allocated. That doesn’t mean we throw out the importance of the FDA and the need for it with that.
FDA is continually reviewing new data: a hallmark of the agency.
So, BVO was regulated at 15 ppm starting in 1970, but that doesn’t mean the FDA just took a nap. Another stipulation in the FDA regulatory authority is that they continue with post-market review of data - this is similar to phase 4 review of FDA-approved medications. This allows them to notice any safety signals when a substance reaches an even larger population, or to modernize regulations as scientific data accrues.
Started in 2014 and progressing through 2020, FDA scientists collaborated with other agencies, including the The National Institute of Environmental Health Sciences (NIEHS) and National Institutes of Health (NIH) to map out additional studies that can be conducted to further quantify any potential risks to human health through BVO exposure.
In 2022, FDA scientists published a study that used Sprague-Dawley rats to assess potential health effects of BVO exposure. They used BVO concentrations of 0% (control), 0.002%, 0.02%, 0.1%, and 0.5% BVO (weight/weight). All of these, aside from the control group, were higher than the regulatory threshold set by FDA for BVO in beverages (0.0015%), but lower than previous studies in animal models: this was designed to assess more “real-world” exposures that humans might be subject to.
The study suggested that some of the bromine present in BVO may be retained in certain tissues in rats, and suggested that the thyroid in particular, might be a target tissue. As such, the FDA proposed an rule to revoke the previously approved 15 ppm BVO in beverages, which is what has now gone into effect.
Do you need to worry that you’ve been exposed to harmful levels of BVO? No.
First, even in these newer studies that suggest a potential risk associated with BVO consumption in rats, the levels fed are still higher than what humans might be realistically exposed to, even if your diet was solely BVO-containing sodas.
Next, remember that animal models are a stand-in for humans, but don’t always adequate represent the physiology of people. Remember the saccharin story? I actually discussed that in my episode of WIRED Tech Support:
The saccharin example also illustrates that the FDA always operates with an abundance of caution toward human health, even when interpreting animal data. If there is a potential safety signal in animals, it will raise a flag for humans, until demonstrated otherwise.
BVO has not been widely used in beverages for a long time.
Even before this recent regulation by the FDA, BVO has been widely replaced by newer emulsifiers, like sucrose acetate isobutyrate (SAIB) or glycerol ester of rosin (GEWR), which serve similar functions as BVO, but have been well-characterized with no indication of safety signals in animals.
There has been no demonstrated evidence of harm among people.
This revocation of approval by the FDA serves as an additional safety feature, to ensure that while BVO is not widely used, that any residual beverage manufacturers transition to newer emulsifiers. Manufacturers that still use BVO are legally required to disclose that on their labels, and they have one year to fully remove and reformulate their products.
Large beverage manufacturers such as PepsiCo and Coca-Cola have already transitioned away from BVO use.
A few that this still applies to are Walmart brand (Great Value) Orangette and Fruit Punch drinks, Keurig Dr Pepper Sun Drop soda, H-E-B Orange Burst Cane Sugar Soda, and Food Lion Diet Orange Soda.
If you have some of these drinks on hand, do you need to throw them away? No, there hasn’t been any indication that you need to do that. There isn’t any data to suggest harms have occurred in people, and these updates factor in the very conservative nature of safety thresholds.
The removal of BVO approval by FDA is science in action.
This latest guidance is science in action: interpret new data, conduct additional studies, and adjust regulations as needed. This should illustrate how seriously scientists and our regulatory agencies take the responsibility of our health and safety, not the other way around.
Without the FDA and the stringent oversight and ongoing monitoring their scientists undertake daily, we would be less healthy and less safe. The Dietary Supplement Health and Education Act of 1994 removed the FDA’s authority from the supplement industry, and you see how well that is playing out.
Thanks for joining in the fight for science!
Thank you for supporting evidence-based science communication. With outbreaks of preventable diseases, refusal of evidence-based medical interventions, propagation of pseudoscience by prominent public “personalities”, it’s needed now more than ever.
Stay skeptical,
Andrea
“ImmunoLogic” is written by Dr. Andrea Love, PhD - immunologist and microbiologist. She works full-time in life sciences biotech and has had a lifelong passion for closing the science literacy gap and combating pseudoscience and health misinformation as far back as her childhood. This newsletter and her science communication on her social media pages are born from that passion. Feel free to follow on Instagram, Threads, Twitter, and Facebook, or support the newsletter by subscribing below: