The food additive rules are changing, and some worries hold up better than others

Key takeaways

• The FDA revoked Red No. 3 in January 2025 under a law that bars colors shown to cause cancer in animals, though the agency sees no evidence of cancer in people¹.
• Companies can still decide on their own that an ingredient is “generally recognized as safe” without telling the FDA; an August 2026 proposal would end that².
• The federal push to remove six petroleum-based dyes rests on voluntary pledges aimed at the end of 2027, and courts have paused parts of new West Virginia and Texas additive laws⁴⁷⁸.
• The strongest evidence of harm involves synthetic dyes and behavior in some children, based on a 2021 California review of 27 clinical trials⁹.
• WHO’s cancer agency called aspartame “possibly carcinogenic” in 2023, yet a 154-pound adult would need more than 9 to 14 diet sodas a day to pass WHO’s safe daily limit¹².

In January 2025, the Food and Drug Administration (FDA) revoked its approval of FD&C Red No. 3, a cherry-red dye used in some candy, frosting and cookies¹. Yet the agency’s own page on the decision says there is no evidence the dye causes cancer in people¹.

So why ban it? Evidence in a 2022 petition showed that high doses caused cancer in male lab rats, through a hormone pathway specific to male rats¹. A 1960 provision called the Delaney Clause bars approval of any color found to cause cancer in people or animals¹. Once the rat data were in, the law made the call.

Food makers have until January 15, 2027, to remove the dye, and products made before then may stay on shelves for a while¹.

That one decision shows how U.S. additive rules work: some choices follow strict legal triggers, while others rest on companies’ own safety conclusions that the FDA may never see.

If you read labels to avoid additives, you now have company in Washington and many statehouses. Below, we look at what changed from 2024 to 2026 and which worries hold up.

Three legal paths let an ingredient into your food

• Food additives. Since the Food Additives Amendment of 1958, a new additive has needed FDA review before it goes on sale².
• GRAS substances. The same law exempted substances that qualified experts generally recognize as safe, or GRAS, for their intended use².
• Color additives. Most colors need FDA approval before use, and approval for one use doesn’t cover others⁵.

Colors come in two kinds. Synthetic ones, such as Yellow 6, are tested by the FDA batch by batch⁵. Colors from plants, animals or minerals skip batch testing, but they must meet the same safety standard⁵.

Who checks that it’s all safe? Often, the companies themselves: the FDA notes that firms are responsible for the safety of the food they sell². When new evidence raises concerns, the FDA can pull an authorization, as it did with BVO and Red No. 3¹³.

The FDA may never have seen hundreds of GRAS ingredients

Today, telling the FDA about a GRAS conclusion is voluntary, so a company can sell an ingredient it has judged GRAS without filing anything². Critics call this the GRAS loophole.

How many ingredients came in this way? No one knows for sure. One estimate put the number at about 1,000 substances as of 2011, out of more than 10,000 additives in use, and the FDA says it can’t verify those figures². By March 2025, its food program had received more than 1,200 voluntary GRAS notices².

On March 10, 2025, Health Secretary Robert F. Kennedy Jr. directed the FDA to explore closing that path². On August 11, 2026, the agency published a proposed rule².

Under the proposal, every company relying on GRAS would have to file a notice with the FDA². Makers of ingredients already in use would get a one-time window to send a shorter version². A company that skipped the notice would push its ingredient toward the front of the FDA’s safety-review line². The agency estimates the rule would cost about $10.5 million to $11.7 million a year, depending on the accounting method².

Public comments are due December 9, 2026². As of mid-October 2026, this is a proposal, not a rule, and the final version could differ.

Washington began pulling ingredients in 2024

Brominated vegetable oil (BVO). In some fruit-flavored drinks, this bromine-modified oil kept the citrus flavoring from separating out³. The FDA stopped calling it GRAS in 1970 but let it stay on an interim basis while studies continued³. Rodent studies run with the National Institutes of Health later found bromine building up in tissues, and at high doses the thyroid took the hit³. The FDA revoked BVO’s authorization in July 2024 and gave companies a year to comply³.

Red no. 3. Revoked in January 2025, with deadlines of January 15, 2027, for food and January 18, 2028, for medicines you swallow¹.

Six more petroleum-based dyes. In April 2025, federal health officials announced a push to phase out Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2 and Green 3⁴. It relies on voluntary company pledges, not a ban⁴. The FDA’s tracker now targets the end of 2027 and lists about 30 companies, with goals running from 2025 to 2028⁴.

Old dyes out, natural colors in. The FDA finalized the removal of Orange B, proposed removing Citrus Red No. 2 and approved five natural colors, including gardenia blue and butterfly pea flower extract⁴.

States moved faster, and courts are sorting it out

California went first. Its AB 418, signed in October 2023, bans making or selling food in the state that contains BVO, potassium bromate, propylparaben or Red No. 3, starting in 2027⁶. Governor Gavin Newsom framed it as a stopgap until the FDA reviews those chemicals⁶.

West Virginia went further in 2025. Its law, HB 2354, banned seven synthetic dyes from school meals as of August 1, 2025, and set a statewide sales ban on those dyes, plus BHA and propylparaben, for 2028⁷.

In December 2025, a federal court blocked the statewide ban, finding the law’s undefined phrase “poisonous or injurious” likely too vague⁷. The school rule still stands⁷.

Texas took a different route. SB 25, signed in June 2025, would require a warning on foods with any of 44 listed ingredients⁸. Its warning, set to start January 1, 2027, would say the ingredient isn’t recommended for eating by authorities in Australia, Canada, the European Union or the United Kingdom⁸.

In February 2026, a federal judge temporarily blocked enforcement in a lawsuit brought by food and beverage industry groups⁸. According to SupplySide Food & Beverage Journal, the court saw serious free-speech problems, pointing to the law’s broad reach and the lack of clear science behind the warning⁸.

So a headline saying an additive is “banned” may describe a law that hasn’t started yet, or one a court has paused.

Dyes and behavior: the strongest case, with limits

The worry dates to 1975, when pediatric allergist Ben Feingold proposed that additives fueled hyperactivity⁹¹⁰.

A 2007 trial in The Lancet gave children mixtures of artificial colors plus the preservative sodium benzoate. Hyperactivity rose in both 3-year-olds and 8- and 9-year-olds, according to a 2025 evidence summary from the Academy of Nutrition and Dietetics¹⁰.

In 2021, California’s Office of Environmental Health Hazard Assessment (OEHHA) reviewed 27 clinical trials. It concluded that synthetic dyes can affect behavior in some children, and that some children are more sensitive than others⁹. By the Academy’s count, 13 of the 25 trials that gave children dyes and watched for changes found statistically significant effects¹⁰. OEHHA also found that federal safe intake levels rest on studies 35 to nearly 70 years old, which couldn’t detect many of these effects, so they may not protect children⁹.

The FDA reads the evidence more cautiously. In 2011, its Food Advisory Committee concluded that a link between certified colors and behavior hadn’t been established⁵. The agency says most children have no bad effects, though some may be sensitive⁵.

These views overlap more than they clash. A 2012 analysis found that parents’ reports tied dyes to more symptoms of attention-deficit/hyperactivity disorder (ADHD), but teacher and observer ratings didn’t confirm it¹⁰. Its authors estimated that about 8% of children with ADHD may have symptoms related to synthetic colors¹⁰.

Two newer worries with early evidence behind them

Titanium dioxide. This white pigment, known in Europe as E171, has been used to whiten foods such as baked goods, sandwich spreads, soups and sauces¹³. In May 2021, the European Food Safety Authority (EFSA) concluded it could no longer vouch for titanium dioxide in food, because a risk of DNA damage couldn’t be ruled out¹³. The European Commission then banned it from food in January 2022, while still allowing it in medicines until safe substitutes are found¹³.

That was a precaution, not proof of harm in people, and the ban doesn’t apply in the United States. Rating: Not enough evidence of harm at food levels, with an open safety question Europe chose not to wait on.

Carboxymethylcellulose (CMC). This synthetic emulsifier is widely used in processed foods¹⁴. A team led by Benoit Chassaing tested it on people in a 2022 study published in Gastroenterology¹⁴. For 11 days, 16 healthy adults ate only food the researchers supplied; seven got 15 grams of CMC mixed in daily, and nine got none¹⁴.

The most striking change turned up in two of the seven. Gut microbes had moved into the inner mucus lining, a zone that is normally free of bacteria¹⁴. Across the CMC group, the bacterial community lost variety, short-chain fatty acids in stool fell, and people reported slightly more belly discomfort after eating¹⁴.

Chassaing’s team thinks the additive’s wide use might play a part in rising rates of chronic inflammatory disease¹⁴. A trial of 16 people over 11 days can’t settle that. Rating: Promising but early. Later articles in this library cover the gut microbiome in depth.

Where additive fears run ahead of the evidence

Aspartame. In July 2023, two World Health Organization groups weighed the same sweetener and reached answers that sound opposed¹². The International Agency for Research on Cancer (IARC) put aspartame in its Group 2B, “possibly carcinogenic to humans,” citing limited human evidence pointing to one kind of liver cancer¹². The Joint FAO/WHO Expert Committee on Food Additives (JECFA) kept its acceptable daily intake where it was: 40 milligrams per kilogram of body weight¹².

The two answers fit together. An IARC label addresses whether something could cause cancer at all, not how much it takes; JECFA’s job is to judge risk at real-world doses¹². To go over JECFA’s limit, a 154-pound adult would have to down more than 9 to 14 cans of diet soda every day, assuming 200 to 300 milligrams of aspartame per can and none from other foods¹².

WHO’s experts still want better, longer studies¹². And the 2025–2030 Dietary Guidelines, released in January 2026, recommend no amount of low-calorie sweeteners such as aspartame, sucralose and acesulfame K¹⁵.

Erythritol. This sugar alcohol, common in sugar-free foods, shows how worry can outpace data. A 2023 study in Nature Medicine measured blood erythritol in nearly 3,000 U.S. and European patients being checked for heart risk¹¹. Those in the top quarter had roughly 1.8 to 2.2 times the risk of heart attack, stroke or death of those in the bottom quarter¹¹. Eight volunteers who drank 30 grams saw blood levels jump about 1,000-fold¹¹.

The FDA’s June 2023 review accepted the study’s math but called the result a link, not proof¹¹. Everyone studied was already at high risk, and diet and kidney function weren’t fully accounted for¹¹. The U.S. samples were drawn from 2001 to 2007, before erythritol was common in food, so the levels likely reflected what the body makes itself¹¹. And the volunteers gulped their 30 grams in two minutes, while real-world intake is likely far lower and spread over a day¹¹.

“Banned in Europe” lists. Rules differ by country, and a federal judge questioned the science behind a Texas warning built on such comparisons⁸. Europe’s caution sometimes deserves a look, as with titanium dioxide, but a foreign ban alone isn’t evidence.

Your additive decoder

Use this table when an ingredient gives you pause. Each rating applies our four-level scale to one specific claim.

Additive	Where you’ll see it	What regulators say	Claim and evidence rating	Practical step
Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2, Green 3	Candy, drinks, cereals, snacks	Still legal; FDA seeks voluntary removal by the end of 20274	“Dyes change some children’s behavior”: Promising but early910	Scan ingredient lists for the color names and pick undyed versions5
Red No. 3	Some candy, frosting, cookies, frozen desserts	Revoked; food deadline January 15, 20271	“It causes cancer in people”: Not enough evidence; banned by law after male-rat results1	Older stock may linger, so check candy and cake decorations1
Brominated vegetable oil	Some fruit-flavored drinks, in the past	Authorization revoked in 20243	“It’s safe to keep using”: Evidence says no, or unsafe, based on thyroid effects in rodents3	Rarely seen now; skip any product that lists it
Titanium dioxide	White coloring in some processed foods	EU banned it from food in 2022 over a DNA-damage concern13	“It harms people at food levels”: Not enough evidence13	If you’d rather avoid it, look for it on ingredient lists
Aspartame	Diet drinks, gum, yogurt, cereals12	IARC: “possibly carcinogenic”; JECFA kept its 40 mg/kg limit (2023)12	“It causes cancer at normal intakes”: Not enough evidence12	Count your daily diet drinks; the Dietary Guidelines advise limiting all such sweeteners15
Erythritol	Sugar-free and keto-style foods	In its 2023 review, the FDA said it had not questioned companies’ GRAS conclusions11	“It raises heart risk”: Not enough evidence; one 2023 study found an association11	With heart or kidney disease, ask your clinician before eating large amounts

Nitrites in cured meats are part of the processed-meat story covered in our protein article.

Reading for additives fits natural-health values

Label readers were early. If you skipped drinks with BVO or candy with Red No. 3, you were years ahead of federal action¹³. The 2025–2030 Dietary Guidelines now advise limiting foods with artificial flavors, petroleum-based dyes and artificial preservatives¹⁵.

Give your own worries the same scrutiny you give food companies. A scary-sounding name isn’t evidence, and a calm one isn’t proof of safety. Ask what studies found, in whom and at what dose.

Try this 30-second additive scan:

1. Start with the food. A short list of ingredients you recognize usually means fewer additives. Our ingredient-list article explains how lists are ranked.
2. Scan for color names such as Red 40 or Yellow 5 if dyes matter to you or your child⁵.
3. Watch for the leavers. Red No. 3 is allowed in food until January 2027 and older stock may linger; BVO should be gone¹³.
4. Read “no artificial colors” closely. The FDA now gives companies more room to use that claim when they color food with naturally derived colors⁴.
5. Keep the bigger picture. Our article on ultra-processed food covers the overall pattern of what you eat.

When to get help. If you think a food color caused a reaction in you or your child, the FDA says you can report it to your local FDA Consumer Complaint Coordinator⁵. For trouble breathing or swelling of the face or throat, call 911.

If you think your child reacts to dyes, keep a simple food and behavior diary and talk with your pediatrician. A dye-free diet shouldn’t replace an ADHD evaluation or treatment.

If avoiding additives starts to bring fear, guilt or a shrinking list of safe foods, call the National Alliance for Eating Disorders helpline at 1-866-662-1235. If you ever think about harming yourself, call or text 988.

Questions readers ask

The bottom line

U.S. additive rules are tightening. BVO’s deadline has passed, Red No. 3’s arrives in January 2027, and a proposal would stop companies from declaring ingredients safe without telling regulators. States are pushing harder, though courts have paused parts of their laws.

The evidence is strongest for synthetic dyes and behavior in some children, with early warning signs for at least one emulsifier. For most other fears, including aspartame and erythritol, the data in people are thin. Reading labels pays off most when it steers you toward whole food, not toward chasing every unfamiliar name.

Related reading

• Why “natural” on a food label guarantees almost nothing
• “Clean” is a marketing category, not a safety standard
• The ingredient list is a ranking, and most people miss it
• The case against ultra-processed food keeps growing, though defining it is harder
• Five lines on the nutrition facts label do most of the work

Sources

1. U.S. Food and Drug Administration. “FD&C Red No. 3.” FDA, content current as of October 5, 2026. fda.gov
2. U.S. Food and Drug Administration. “Substances Generally Recognized as Safe” (proposed rule, Docket FDA-2025-N-3262). Federal Register, August 11, 2026. federalregister.gov
3. U.S. Food and Drug Administration. “Brominated Vegetable Oil (BVO).” FDA, content current as of July 2, 2024. fda.gov
4. U.S. Food and Drug Administration. “Tracking Food Industry Pledges to Remove Petroleum-Based Food Dyes.” FDA, content current as of October 16, 2026. fda.gov
5. U.S. Food and Drug Administration. “How Safe Are Color Additives?” FDA Consumer Update, content current as of July 13, 2023. fda.gov
6. Office of Governor Gavin Newsom. “Assembly Bill 418 Signing Message.” State of California, October 7, 2023. gov.ca.gov
7. National Agricultural Law Center. “Preliminary Injunction Halts Enforcement of West Virginia’s Food Dye Ban.” University of Arkansas System Division of Agriculture, February 2026. nationalaglawcenter.org
8. Hayes D. “Texas’ Bold Food Labeling Law Hits a Legal Roadblock.” SupplySide Food & Beverage Journal, February 27, 2026. supplysidefbj.com
9. California Office of Environmental Health Hazard Assessment. “Health Effects Assessment: Potential Neurobehavioral Effects of Synthetic Food Dyes in Children.” OEHHA, April 2021. oehha.ca.gov
10. Academy of Nutrition and Dietetics. “Nutrition Fact Check: Food Dyes.” eatrightPRO, June 2025. eatrightpro.org
11. U.S. Food and Drug Administration. “An Evaluation of the Article ‘The Artificial Sweetener Erythritol and Cardiovascular Event Risk'” (on Witkowski M, et al., Nature Medicine, 2023). FDA memorandum, June 15, 2023. fda.gov
12. World Health Organization. “Aspartame Hazard and Risk Assessment Results Released.” News release, July 14, 2023. who.int
13. European Commission, Directorate-General for Health and Food Safety. “Goodbye E171: The EU Bans Titanium Dioxide as a Food Additive.” January 18, 2022. ec.europa.eu
14. Chassaing B, Compher C, Bonhomme B, et al., Lewis JD. “Randomized Controlled-Feeding Study of Dietary Emulsifier Carboxymethylcellulose Reveals Detrimental Impacts on the Gut Microbiota and Metabolome.” Gastroenterology, 2022;162(3):743-756. Penn State research portal record. pure.psu.edu
15. U.S. Department of Health and Human Services and U.S. Department of Agriculture. “Dietary Guidelines for Americans, 2025–2030.” RealFood.gov, January 2026. cdn.realfood.gov