United States, Ingredient Bans

A Pivotal Year for Ingredient Bans

Jan. 13, 2025
California forced the issue, now the FDA appears likely to reconsider additives that for decades have been considered safe, or at least acceptable.

For years, there have been calls for the FDA to ban questionable ingredients and additives in foods and beverages. Last year, in the face of inaction by the FDA, those grumblings became legislation in several states and, in the case of California, two new laws that ban specific ingredients with specific deadlines. All these actions are forcing the FDA into action.

California will ban red dye No. 3, brominated vegetable oil, potassium bromate and propylparaben from all food sales in the state on Jan. 1, 2027. Another bill bans six synthetic food dyes – blue 1, blue 2, green 3, red 40, yellow 5 and yellow 6 – from being used in foods in the state’s public schools in 2028.

Whatever happens in other states or at the federal level, food & beverage processors will have to reformulate and/or find substitutes if they want to serve the fifth largest economy in the world (California). While similar efforts in four other states appear to have stalled, the very introduction of five state bills appears to have motivated the FDA to act or risk looking like state legislatures are better at regulating food safety than the federal agency is.

Or have the country end up with 50 similar but slightly different regulations on food additives.

As food safety consultancy The Acheson Group wrote after the first California bill passed, “We had some serious concerns around who is the leading authority, asking ‘Is it a federal agency charged with keeping current around risks in foods? Or is it a state which has significantly fewer resources and is not charged with protecting public health across the entire country?’ ”

Whatever individual states may lack in scientific resources, they make up for in urgency. Or at least they did in 2023, when representatives in four more states – Illinois, Indiana, New York and Pennsylvania – introduced similar bills to ban questionable ingredients. None became law, whether that’s an indication of lack of support or the expectation that the FDA will take charge. The twin Pennsylvania bills and the New York one appear likely to be revived this year.

“We are entering into a strange unknown concerning nation protections come next month,” says Assemblymember Anna Kelles, who has a Ph.D. in nutritional epidemiology and who introduced the New York bill banning the same four in the California law plus azodicarbonamide, butylated hydroxyanisole and titanium dioxide. “State actions will most likely be more important than ever. The precedent in California definitely helps.”

Two months after the California legislature passed its ban on brominated vegetable oil, the FDA announced its intention to do the same. Nine months later (July 2, 2024) the federal ban was official, with an enforcement date of Aug. 2, 2025.

Feeling the heat, the agency says it has more reviews and reversals up its sleeve. In a Congressional hearing Dec. 5, FDA Deputy Commissioner Jim Jones hinted a ban on red dye No. 3 would be announced “in the next few weeks.”

California started it

The California Food Safety Act (AB-418) started this all, passing back in October of 2023 with an enforcement date of Jan. 1, 2027. The Acheson Group at the time titled a newsletter about it “How a Single State Regulation Can Impact the Entire Nation.”

The law says, “No person or entity can manufacture, sell, deliver, distribute, hold, or offer for sale, in commerce a food product for human consumption that contains brominated vegetable oil, potassium bromate, propylparaben, or red dye 3.” It provides fines up to $5,000 for a first violation and up to $10,000 each for subsequent violations.

The initial bill, proposed in the state senate, also included a ban on titanium dioxide (TiO2), however this was removed in the subsequent assembly bill.

A year later, the California School Food Safety Act was signed into law, prohibiting California public schools from grades 1 to 12 from serving food containing blue 1, blue 2, green 3, red 40, yellow 5 and yellow 6.

“All of these chemicals are prohibited from being added to food sold in the European Union because of the dangers they pose, but are still allowed in the U.S.,” Assemblymember Jesse Gabriel, who introduced both bills, said in a fact sheet.

“Even if the FDA has conducted a thorough review of a proposed food chemical, the agency does not conduct periodic reviews to assess whether old safety determinations remain valid,” Gabriel continued. “As a result, many food chemicals have not been reviewed by the FDA since the 1960s or 1970s. The original evaluations frequently fail to reflect both modern toxicology and modern levels of consumption.”

Illinois copies California

The Illinois Prohibited Food Additives bill (SB2637) was introduced Nov. 7, 2023, by Sen. Willie Preston and got its second and third readings last year. Identical to the California Food Safety Act, it, too, would ban brominated vegetable oil, potassium bromate, propylparaben and red dye 3, also with a Jan. 1, 2027 effective date. Also identical are fines of $5,000 for a first violation, $10,000 for subsequent ones.

Since last February, it’s bounced around committees and been introduced in the state House, where Rep. Anne Stava-Murray is the sponsor. It’s been in the House Rules Committee since May 10. Despite having 26 co-sponsors, half of them in the senate and half in the house, and all Democrats, it appears stalled. Despite requests, no one with Preston or Stava-Murray would say if the bill will be reintroduced.

Indiana: Focus on high-fructose corn syrup

Indiana’s HB1074, “Ban on high fructose corn syrup as food ingredient,” was an odd one in several ways. Its sole target was high-fructose corn syrup, coming in a state that grows miles and miles of corn, practically none of it for human consumption, nearly all for industrial uses. While animal feed and ethanol are the top two applications for the state’s maize, HFCS and other food ingredients are not far behind.

After being introduced by Rep. John Bartlett last January, it was referred to the Indiana House’s Committee on Public Health, where it died.

With the dawn of the new year, old house bills need to be reintroduced, but this one will not. “Thank you for reaching out about Rep. Bartlett's work on high-fructose corn syrup,” an aide responded to us. “At this time, Rep. Bartlett will not be offering legislation but will continue researching the issue and possible solutions.”

New York: The usual suspects plus some

New York Bill A6424A, amended and re-referred to the legislature’s Agriculture Committee last February, would have outlawed azodicarbonamide, brominated vegetable oil, butylated hydroxyanisole, potassium bromate, propylparaben, red 3 and titanium dioxide (although dairy products containing titanium dioxide are exempted.)

It was introduced In April 2023 by Assemblymember Anna Kelles, who has a Ph.D. in nutritional epidemiology. “This bill will be reintroduced and referenced once again to the agriculture committee,” she told us, although there will be a number of changes to it. “We are also looking at including a restriction on food color additives in schools statewide. They are already prohibited in NYC schools as are several of the food additives, so there is precedent here. There are other food additive protections we are exploring. The bill should be live soon.”

Pennsylvania: Twin bills

Two Pennsylvania state representatives introduced House Bills 2116 and 2117, which together would ban red 3, yellow 5 & 6, potassium bromate, brominated vegetable oil and butylated hydroxyanisole (BHA).

“It is not asking too much for consumers to have a reasonable expectation that the foods they are eating are safe. Unfortunately, the lack of action by the U.S. Food and Drug Administration has caused state legislators to take action,” said Rep. Natalie Mihalek, sponsor of HB 2116. “While Pennsylvania House Bills 2116 and 2117 of 2024 have not passed, they will be reintroduced in the upcoming session.”

The FDA reacts

The FDA probably has never been under such pressure to reconsider food additives that for decades have been considered safe. As noted earlier, the agency’s first response was a ban on brominated vegetable oil, a lesser-used ingredient but one targeted in laws or proposals in four of the five states. Red 3 also was in four of the five state bans.

The agency has not had a process to reconsider ingredients once they’ve been approved … no matter how much time has passed and new scientific data has amassed. That’s changing. At a September 2024 public hearing, FDA officials said they’re developing a “systematic process” for conducting post-market assessments of chemicals in food.

This involves ingredients considered generally recognized as safe (GRAS), such as food additives and color additives, as well as food contact substances and naturally occurring contaminants such as lead and arsenic. Indeed, the whole GRAS process is being reconsidered.

Jesse Gabriel, the California assemblymember who introduced the two passed California bans, says, “The [FDA] has increasingly avoided its responsibility to rigorously evaluate proposed food chemicals by allowing food manufacturers to self-certify that a chemical is generally recognized as safe to be used in food. Between 2000 and 2022, manufacturers have been allowed to self-certify almost 99% of the 756 new chemicals used in food.”

“We have not had a robust post-market assessment program here at FDA,” Deputy Commissioner Jones admitted at that September hearing. “This is largely because there's no statutory requirement for FDA's post-market review or safety testing to share that data with the FDA after a chemical is introduced into the market. As such, given our limited resources, the agency has not established a systematic process to ensure that our original determination of safety held up over time.”

“Given our limited resources” comes up a lot when FDA officials discuss their ability to change things and create new programs or processes. Regardless, the agency must (eventually) respond to formal petitions that question the authorization of an ingredient, as is the case with Red 3. But an added wild card this year is the change in leadership that comes with a new presidential administration.

Dr. Robert Califf, current FDA commissioner, almost certainly will be replaced, probably by Dr. Marty Makary, a Johns Hopkins School of Medicine professor. We’ll see if Makary fires Jones, who is in charge of the Human Foods Program. And the nomination of Robert F. Kennedy Jr. as secretary of Health & Human Services, the FDA’s parent agency, while not a certainty, could rewrite the FDA’s whole mission

About the Author

Dave Fusaro | Editor in Chief

Dave Fusaro has served as editor in chief of Food Processing magazine since 2003. Dave has 30 years experience in food & beverage industry journalism and has won several national ASBPE writing awards for his Food Processing stories. Dave has been interviewed on CNN, quoted in national newspapers and he authored a 200-page market research report on the milk industry. Formerly an award-winning newspaper reporter who specialized in business writing, he holds a BA in journalism from Marquette University. Prior to joining Food Processing, Dave was Editor-In-Chief of Dairy Foods and was Managing Editor of Prepared Foods.

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