FDA to Allow New ‘No Artificial Colors’ Labeling Claims

To clarify this policy shift, the FDA issued a letter to industry stating it intends to exercise enforcement discretion for certain voluntary labeling claims for human foods that do not contain any color additives listed in 21 CFR Part 74 (FD&C certified colors, plus Orange B and Citrus Red No. 2 — two colorants whose authorization is already being revoked). The newly permissible claims are as follows.

• Made without artificial food colors/colorings.

• No artificial color/colors/coloring.

• No added artificial color/colors/coloring.

Until now, such claims were generally limited to products with no added colors of any kind, even if they originated from natural sources. The FDA now recognizes that treating colors from natural sources as “artificial” for claim purposes can confuse consumers and hinder the transition away from synthetic colors. However, ingredient declarations for certification‑exempt color additives listed at 21 CFR Part 73 may continue leveraging the FDA’s existing regulation that such color additives may be declared simply as, for example, “Color Added,” or “Colored with ________” or “_______ color” (the blank to be filled in with the name of the certification‑exempt color additive).

New Alternatives to Synthetic Colorants

The announcement is part of the FDA and US Department of Health and Human Services efforts to transition the food supply away from “petroleum‑based” synthetic colors toward alternatives from natural sources. As part of that effort, the FDA has amended its listing of color additives exempt from certification by adding beetroot red and expanding the permissible uses of spirulina extract. The new authorizations were the result of color additive petitions submitted in 2024 by Phytolon of Israel for beetroot red and on behalf of GNT Group of the Netherlands for spirulina extract. They bring to a total of six naturally occurring or naturally derived food colorants that the FDA has authorized since last May, the previous four being Galdieria extract blue (from microalgae), Gardenia blue (from the fruit of the Cape jasmine plant), butterfly pea flower extract (another blue), and calcium phosphate (a white mineral).

Sources of the Newly Approved Colorants

Beetroot red, a reddish-purple liquid or powder, is formed via fermentation using a strain of the yeast Saccharomyces cerevisiae genetically modified to express the genes for the biosynthesis of betanin, the principal coloring component in the new colorant. Betanin is a betacyanin, a family of pigments. Beetroot red is reported to contain a betacyanin composition similar to that of dehydrated beets, which are already listed as a color additive exempt from certification at 21 CFR §73.40. The specifications for beetroot red include a betanin composition of at least 75% of total betacyanins, and a maximum content of no more than 20% other betacyanins.

Spirulina extract is a blue-colored powder or liquid prepared by water extraction and filtration of the dried biomass of Arthrospira platensis, an edible blue-green cyanobacterium or alga. It is now authorized for use as a color additive in all human foods except for infant formula and meat, poultry, and eggs regulated by the US Department of Agriculture.

Limits

Colors derived from natural sources remain subject to FDA premarket approval via the color additive petition process. There is no generally recognized as safe (GRAS) exception in the definition of a color additive in the FD&C Act, and so the intended use of a new color additive requires FDA approval, even if already considered GRAS for other food uses (as is spirulina extract).

Implications for Food Companies

The development of natural colorants to replace synthetic dyes may be a slow process, since potential replacements must first be identified in nature, then shown to be stable when subjected to manufacturing processes and the conditions of use (e.g., baking) and finally shown to be safe for human consumption and free from contaminants at the proposed levels of use. The natural alternatives are also likely to be significantly more expensive than the synthetic versions they are replacing, and may offer a narrower range of available colors, at least for a while. 

Bottom Line

The FDA will now allow “no artificial colors”-style claims for foods that contain no FD&C-certified colors, while maintaining all other labeling and safety requirements. The policy supports reformulation away from synthetic colors and is accompanied by new or expanded approvals for certification‑exempt, naturally sourced colors, creating opportunities for compliant label updates and product innovation. 

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.