On February 5, 2026, the U.S. Food and Drug Administration (FDA) issued a letter to the food industry announcing a new enforcement discretion policy for “no artificial colors” labeling claims.1 The agency states that it “does not intend to take enforcement action” against companies using “no artificial colors” or similar claims “on foods intended for human consumption that do not contain any FD&C Act certified colors.”2 Previously, companies were only permitted to use these claims for products that contained no added colors whatsoever, including those derived from natural sources. This initiative is part of the current administration's “Make America Healthy Again” (MAHA) agenda and follows FDA's previously announced plan to work with industry to phase out certified colors from the nation's food supply by the end of 2026.3
Additionally, the agency approved beetroot red as a new color option and expanded the permitted uses of spirulina extract, an existing color additive derived from a natural source. The revised spirulina extract color additive regulation also includes more stringent heavy metals specifications. These approvals follow the recent FDA authorizations for other non-certified colors: calcium phosphate, Galdieria extract blue, gardenia blue, and butterfly pea flower extract (this latter one is an expansion of previously authorized uses).
FDA’s Enforcement Discretion Policy
As brief background, FDA explains in its letter to the food industry that the current definition of “artificial color” does not distinguish between colors that are derived from natural sources and other types of colors additives,4 which “may create challenges to transitioning away from FD&C Act certified colors.”
In its letter, FDA announced that it intends to exercise enforcement discretion as to section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (FFDCA)5 “should a firm use certain voluntary labeling claims on foods intended for human consumption that do not contain any FD&C Act certified colors.” Section 403(a)(1) provides, in relevant part, that a food is deemed misbranded if its labeling is false or misleading. Specifically, FDA states that it does not intend to take enforcement action against companies that use any of the following voluntary labeling claims on foods, provided those foods contain no certified colors:6
- “Made without artificial food colors/colorings”
- “No artificial color/colors/coloring”
- “No added artificial color/colors/coloring”
Importantly, under the enforcement discretion, FDA states that it would not take action over “no artificial colors” or similar claims for products containing either natural or synthetically made colors that are exempt from certification. The enforcement discretion is considered non-binding guidance, but represents the agency’s current thinking on the conditions under which a claim about the absence of artificial colors could be made in a truthful and non-misleading manner.
In announcing the new enforcement discretion policy, FDA also issued a letter to manufacturers reminding them of “their responsibility to ensure color additive safety.” The letter highlights, among other things, that color additive manufacturers should “limit impurities, including heavy metal contaminants, solvent residues, and microbial contaminants” and “take all possible measures to ensure the safety and purity of the color additives they produce.”7
Next Steps
We will continue to monitor FDA’s actions on color additives.
References
1 FDA, FDA Takes New Approach to “No Artificial Colors” Claims (Feb. 5, 2026), https://www.fda.gov/news-events/press-announcements/fda-takes-new-approach-no-artificial-colors-claims.
2 FDA, Letter to the Food Industry on “No Artificial Colors” Labeling Claims” (Feb. 5, 2026), https://www.fda.gov/food/food-chemical-safety/letter-food-industry-no-artificial-colors-labeling-claims.
3 See HL Update, HHS and FDA Announce Plans to Phase Out Certified Colors (Apr. 29, 2025), https://www.hoganlovells.com/en/publications/hhs-and-fda-announce-plans-to-phase-out-certified-colors.
4 See 21 CFR 101.22(a)(4) (“The term artificial color or artificial coloring means any ‘color additive' as defined in § 70.3(f) of this chapter”).
5 21 USC 343(a)(1).
6 FD&C certified colors include Blue Nos. 1 and 2, Green No. 3, Red Nos. 3 and 40, and Yellow Nos. 5 and 6. Note that in January 2025, FDA issued an order revoking the authorization of FD&C Red No. 3 for use in food and ingested drugs by January 15, 2027 and January 18, 2028, respectively.
7 FDA, FDA Reminds Manufacturers of Color Additives Exempt from Certification to Comply with Identity and Purity Requirements (Feb. 5, 2026), https://www.fda.gov/food/food-chemical-safety/fda-reminds-manufacturers-color-additives-exempt-certification-comply-identity-and-purity.
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