RFK Jr. Sets Sights on Currently Authorized Synthetic Food Dyes

The initial food coloring targets are Citrus Red No. 2 and Orange B, which are to have their FDA authorizations revoked “within the coming months.” Citrus Red No. 2 is only authorized for the coloring of skins of oranges (but not those used to manufacture orange juice or that are otherwise processed), while Orange B, once used on hot dog and sausage skins, has not been used for decades.

The next color additives in FDA’s and HHS’s focus are six more synthetic dyes: 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. The FDA is to work with industry to eliminate them from the food supply by the end of 2026. In addition, the FDA’s currently planned elimination of FD&C Red No. 3 from the food supply by 2027-2028 is to be brought forward. The use of the last six colorants in drugs and cosmetics (the “D&C” in “FD&C”) does not appear to be affected at this time.

The FDA announcement quoted Secretary Kennedy as stating that “some food producers have been feeding Americans petroleum-based chemicals without their knowledge or consent. These poisonous compounds…pose real, measurable dangers to our children’s health and development…We’re restoring gold-standard science, applying common sense, and beginning to earn back the public’s trust. And we’re doing it by working with industry to get these toxic dyes out of foods our families eat every day.”

It is important to note that the FDA previously authorized these substances that are now described as “poisonous” and “toxic.” Although they may be synthesized using starting materials ultimately derived from petroleum, petroleum is the original source for numerous products used everywhere in daily life, including in the food industry. Such products could also be categorized as “petroleum-based.” In assessing potential toxicity, however, science supports evaluating the chemical structure of a substance itself, rather than the original source of its starting material.

According to the FDA announcement, FDA Commissioner Marty Makary’s comments were consistent with the Secretary’s: “The FDA is asking food companies to substitute petrochemical dyes with natural ingredients for American children as they already do in Europe and Canada. We have a new epidemic of childhood diabetes, obesity, depression, and ADHD…. we should not be taking risks and do everything possible to safeguard the health of our children.” Although some studies have suggested a link between certain synthetic colorants and ADHD in some children, the statement appears to be linking by implication, without supporting evidence, synthetic food colorants to a range of childhood maladies that may well have more obvious causes.

With respect to ADHD, a 2007 United Kingdom study investigated the potential effects of certain synthetic food colorants on children’s behavior, primarily increased hyperactivity in some children, and as a result of this study any European Union (EU) food products containing three of the six colorants listed above — specifically Yellow No. 5 (tartrazine, E102), Red No. 40 (Allura Red AC, E129), and Yellow No. 6 (Sunset Yellow FCF, E110)[1] — must be marked with a statement such as “May have an adverse effect on activity and attention in children.”

Nevertheless, these three colorants, along with Blue No. 1 (Brilliant blue FCF, E133) and Blue No. 2 (Indigo carmine, E132), remain approved food colorants in the EU in accordance with Commission Regulation (EU) No. 1129/2011, Annex II Part B.1, although the regulation also specifies the types of food in which each colorant may be used. Only one of the colorants on the FDA’s new hit list, Green No. 3 (Fast Green FCF), is no longer approved in the EU, but in 2017, the Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives concluded that dietary exposure to this colorant presented no health concerns for any age group.

It is worth noting that the California’s Office of Environmental Health Hazard Assessment (OEHHA) conducted a health effects assessment on the same list of six food colorants identified in the FDA announcement, and in April 2021 published its final report linking synthetic food dyes to hyperactivity and other neurobehavioral effects in some children. Subsequently, in 2022, the California Department of Public Health (CDPH) received a petition from the Center for Science in the Public Interest requesting a warning label on any grocery store and restaurant foods and dietary supplements that contained synthetic dyes which would state, “WARNING: Product [or identified restaurant item] contains synthetic food dyes which the State of California has determined can result in hyperactivity and other neurobehavioral problems in some children.”

In September 2024, CDPH denied the petition, stating the following:

CDPH reviewed the studies provided with the petition and conducted our own search of scientific manuscripts. There is a significant body of literature that discusses the uncertainty in the evidence about the adverse effects of synthetic food dye consumption, and there is no scientific consensus on what the adverse effects are, what sensitive subpopulations are affected, and what levels of concern might be.

The FDA/HHS announcement appears to be at odds with CDPH’s review.

The “natural alternatives” identified in the FDA announcement are Galdieria extract blue, gardenia blue, and butterfly pea flower extract, along with calcium phosphate. Galdieria extract blue is a phycocyanin extracted from microalgae. Gardenia blue is derived from an extract of the fruit of the Cape jasmine plant; the extract is hydrolyzed enzymatically, and the intermediate product (genipin) is then reacted with an amino acid. Recent toxicological studies of gardenia blue showed it to be non-genotoxic in vitro, and it demonstrated no reproductive toxicity in rats, although precursor genipin was found to be positive in several genotoxicity tests. Butterfly pea flower extract (yet another blue dye) is commonly consumed as an herbal tea in southeast Asia.

Calcium phosphate is not associated with a color other than white. The term “calcium phosphate” does not really refer to one specific chemical but to a class of inorganic chemicals containing calcium and phosphate ions, sometimes in combination with hydroxide or other ions. Several types of calcium phosphate are used in food, and it is unclear which form is referred to in this announcement, or why it should be considered as a colorant. The Environmental Working Group has classified three forms of calcium phosphate used in food as being of moderate concern, mainly due to an association between dietary phosphates and cardiovascular disease.

In the April 22 announcement, the FDA said it was fast-tracking a review of these “natural alternatives.” Its announcement did not specify any “natural alternatives” for colors other than blue and white, although it hinted at more to come. Indeed, on May 9, the FDA announced the approval of petitions for color additives exempt from certification for three of the four alternatives (all but Gardenia blue). Galdieria blue extract is now approved for use in a variety of products including juices and other beverages, ice cream and other desserts, candy, and yogurt. Butterfly pea flower extract was already approved for similar uses, but its approval has now been expanded to include ready-to-eat cereals, crackers, and a variety of snacks. Calcium phosphate is approved as a white colorant for ready-to-eat chicken products, doughnut sugar, white candy melts, and sugar for coated candies. The three-color additive petitions were filed by the French company Fermentalg, Sensient Colors LLC of St. Louis, Missouri, and Innophos of Cranbury, New Jersey, respectively.

ArentFox Schiff’s Food, Drug, Medical Device & Cosmetic group is carefully tracking these and other issues of interest to the food and beverage industry. Please feel free to reach out to a member of the group or to the ArentFox Schiff attorney who handles your matters for any follow-up.