On the heels of a new California law banning the use of brominated vegetable oil (BVO), potassium bromate, propyl paraben and Red Dye No. 3 as food additives, the FDA has announced its proposal to revoke the regulation authorizing the use of BVO in food. Food companies are currently allowed to use BVO, a vegetable oil that is modified with bromine, in small amounts to keep the citrus flavoring from floating to the top in some beverages.
The FDA announced that it is issuing the proposed rule now because the agency has recent data from studies it conducted that demonstrate adverse health effects in animals at levels more closely approximating real-world human exposure. “Based on these data and remaining unresolved safety questions, the FDA can no longer conclude that the use of BVO in food is safe,” the agency stated in its announcement. The studies, which were conducted in collaboration with the National Institute of Environmental Health Sciences’ Division of Translational Toxicology, showed bioaccumulation of bromine and toxic effects on the thyroid gland.
The FDA has regulated BVO as a food additive since the agency removed it from the codified list of Generally Recognized As Safe or “GRAS” substances in 1970. “We recognize that California recently took steps to ban the use of four food ingredients, including BVO, in that state,” the FDA wrote. “The agency is continuously reviewing and reassessing the safety of a variety of chemicals in food to ensure the science and the law support their safe use in food, including all four ingredients that are part of the recent California law. In fact, the FDA is currently reviewing the color additive regulations authorizing the use of FD&C Red No. 3 in ingested drugs and foods (including dietary supplements) under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which, in relevant part, prohibits the FDA from approving a color additive that is ingested if it causes cancer in animals or humans when ingested. A decision from the FDA is forthcoming.”
The agency also noted that one of the key reasons for the proposed Human Foods Program (HFP) transformation currently underway is to enhance FDA’s review of food chemical safety. The proposed HFP would include the creation of the Office of Food Chemical Safety, Dietary Supplements and Innovation with the goal of developing a faster and more nimble process for evaluating chemicals in the food supply.
Comments about the proposed BVO rule should be submitted by January 17, 2024, using docket number FDA-2023-N-0937.
On October 7, California Governor Gavin Newsom signed California Assembly bill AB 418 into law. The bill, which was authored by Assemblymember Jesse Gabriel (D-Woodland Hills) and co-sponsored by Consumer Reports and the Environmental Working Group (EWG) bans the use of brominated vegetable oil, potassium bromate, propyl paraben and Red Dye No. 3 as additives in food and drink products sold in the state. The chemicals are currently banned in the European Union due to alleged links to serious health problems, including higher risk of cancer, harm to the reproductive system and hyperactivity.
The bill will go into effect on January 1, 2027. Violators face a civil penalty not to exceed $5,000 for a first violation, and not to exceed $10,000 for each subsequent violation.
In a statement following the signing of the bill, Governor Newsom acknowledged concerns relates to the state’s actions as well as his reasons for supporting the legislation, stating:
“Californians trust that the food products they consume are safe. I appreciate the author and stakeholders for working on amendments, which advance our shared public health objectives while maintaining consumer choice. The additives addressed in this bill are already banned in various other countries.
Signing this into law is a positive step forward on these four food additives until the United States Food and Drug Administration (FDA) reviews and establishes national updated safety levels for these additives.
There have been many misconceptions about this bill and its impacts. For example, attached to this message is a bag of the popular candy “Skittles,” which became the face of this proposal. This particular bag of candy comes from the European Union – a place that already bans a number of chemical additives and colorants. This is demonstrable proof that the food industry is capable of maintaining product lines while complying with different public health laws, country-to-country.
Further, this bill’s implementation is delayed until 2027 – significant time for brands to revise their recipes to avoid these harmful chemicals. Californians will still be able to access and enjoy their favorite food products, with greater confidence in the safety of such products.”
California Assembly bill AB 418, authored by Assemblymember Jesse Gabriel (D-Woodland Hills) and co-sponsored by Consumer Reports and the Environmental Working Group (EWG), has passed the state Senate and Assembly is now in the hands of Governor Gavin Newsom. If signed into law, the bill would ban the use of brominated vegetable oil, potassium bromate, propyl paraben and Red Dye No. 3 as additives in food and drink products sold in the state. The chemicals are currently banned in the European Union due to alleged links to serious health problems, including higher risk of cancer, harm to the reproductive system and hyperactivity.
“We are thrilled to move A.B. 418 to Gov. Newsom’s desk. This marks a major step forward in our effort to protect children and families in California from dangerous and toxic chemicals in our food supply,” said Gabriel, chair of the Assembly Committee on Privacy and Consumer Protection. “It’s unacceptable that the U.S. is so far behind the rest of the world when it comes to banning these dangerous additives.
The bill, if signed by Gov. Newsom, will go into effect on January 1, 2027. Violators would face a civil penalty not to exceed $5,000 for a first violation, and not to exceed $10,000 for each subsequent violation.
Some have expressed concern that passage of the bill would create a patchwork of regulations in the country. In an Opinion article, Frank Yiannas, former FDA Deputy Commissioner of Food Policy and Response, urged Newsom to think carefully about the ban, noting that three of the five original ingredients targeted by the California ban are currently under review by FDA. “In the case of brominated vegetable oil (BVO), the FDA has already initiated steps to remove BVO from the U.S. food supply, thereby making the California action unnecessary,” he argued, adding that “a state-by-state patchwork of different, emerging regulatory standards that would weaken our nation’s food system and food safety efforts. Our nation is better when each state can help feed the rest of the states with a uniform standard of safe, available food.”
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