HHS, FDA move to ban synthetic ‘poisonous compound’ food colorings and dyes

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Oil-based food colorings will be phased out of American foods as part of the Make America Healthy Again (MAHA) movement under President Donald J. Trump.

Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and Food and Drug Administration (FDA) Commissioner Marty Makary, MD, MPH, announced new regulations marking “a significant milestone” for the MAHA initiative. The ban on food dyes is spurred by concerns about health effects of the additives in products that adults and children eat.

“For too long, some food producers have been feeding Americans petroleum-based chemicals without their knowledge or consent,” Kennedy said in HHS’ news release. “These poisonous compounds offer no nutritional benefit and pose real, measurable dangers to our children’s health and development. That era is coming to an end.

Robert F. Kennedy Jr.
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“We’re restoring gold-standard science, applying common sense, and beginning to earn back the public’s trust,” he said. “And we’re doing it by working with industry to get these toxic dyes out of the foods our families eat every day.”

Days are numbered

There is not an immediate ban. Establishing a new national timeline and standard is the first part of the six-point plan announced April 22.

But days are numbered for at least two dyes — Citrus Red No. 2, used for skins of oranges not intended or used for processing, and Orange B, used to tint casings or surfaces of frankfurters and sausages. Both have been on the books for use since the 1960s, but FDA is starting the process to revoke authorization for them within the coming months.

Martin Makary, MD, MPH
_{© U.S. Food and Drug Administration}

Instead of the synthetic colors, FDA is asking food makers to use natural ingredients like those used in Europe and Canada, Makary said.

“We have a new epidemic of childhood diabetes, obesity, depression, and ADHD,” Makary said, referring to attention deficit hyperactivity disorder. “Given the growing concerns of doctors and parents about the potential role of petroleum-based food dyes, we should not be taking risks and do everything possible to safeguard the health of our children.”

Food dye action

The HHS plan includes:

• Working with food makers to eliminate six remaining synthetic dyes by the end of 2025: FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue No. 2. FD&C is short for the Food, Drug and Cosmetic Act, the law establishing regulatory authority of the FDA.
• Approving at least four new natural color additives in coming weeks, and fast-tracking review of others. It appeared those could be calcium phosphate, Galdieria extract blue, gardenia blue, butterfly pea flower extract.
• Partner with the National Institutes of Health on research about how the substances affect children’s health.
• Requesting food companies remove FD&C Red No. 3 dye sooner than the 2027-2028 deadline. The process to institute that ban began under the administration of President Joe Biden.

‘Disappointing’

Despite stated concerns about health effect of the dyes, the announcement was disappointing, said Peter G. Lurie, MD, MPH, president of the Center for Science in the Public Interest (CSPI). The only real changes are banning Citrus Red 2 and Orange B, which are rarely used, he said in a statement.

Kennedy and Makary “announced no rulemaking of any sort to remove the remaining six numbered dyes,” Lurie’s statement said.

“Instead, we are told that the administration has an unspecified ‘understanding’ with some unspecified fraction of the food industry to eliminate dyes,” Lurie said. “We wish Kennedy and Makary well getting these unnecessary and harmful dyes out of the food supply and hope they succeed. Perhaps the food industry will seek to avoid a vindictive president’s wrath. But history tells us that relying on voluntary food industry compliance has all-too-often proven to be a fool’s errand.”

For years, CSPI has called for a national ban on synthetic food dyes. Its “Chemical Cuisine” guide to food additives is here.

Color me hungry

As of 2023, FDA said color additives are used in foods to:

• Offset color loss due to exposure to light, air, temperature extremes, moisture and storage conditions
• Correct natural variations in color
• Enhance colors that occur naturally
• Provide color to colorless and "fun" foods

The FD&C dyes are “used widely because they impart an intense, uniform color, are less expensive, and blend more easily to create a variety of hues.” Potential health effects have been debated for years.

Red No. 3

The Biden administration took action on FD&C Red No. 3 due to a study with results that the FDA used to conclude the coloring caused cancer in male lab rats, according to KFF. The substance has been barred from cosmetic use since 1990.

This year, the leading researcher on that study, Joseph Borzelleca, told KFF Health News that he stands by the opposite assertion and the dye is not carcinogenic.

“I have no problem with my family — my kids and grandkids — consuming Red 3,” Borzelleca told KFF. “I stand by the conclusions in my paper that this is not a problem for humans.”

Red M&Ms

© Mars

The best known debate involving food colorings may have involved FD&C Red No. 2. It was linked to cancer in a 1971 Russian study, leading to an FDA ban in 1976, according to an article from LiveScience.com. Candymaker Mars has always stated the popular treats M&Ms never used that dye, but the company stopped making red M&Ms for more than 10 years to avoid consumer confusion. Red M&Ms returned in 1987 and the Red M&M serves on the team of cartoon spokescandies for the company.

Exempt from certification

Not all color additives are synthetic or oil-based, and those don’t get the same level of federal review, according to FDA. For example, pigments made from vegetables, minerals or animals may be exempt from certification.

Some examples: annatto extract for yellow color; dehydrated beets for bluish-red to brown; caramel for yellow to tan; beta-carotene for yellow to orange; and grape skin extract for red or purple, according to FDA.