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The U.S. Food and Drug Administration (FDA) has announced a new enforcement approach that allows food companies to make certain "no artificial colors" claims when products do not contain petroleum-based synthetic colors. The agency also approved additional naturally derived color additives to support industry reformulation efforts.
For context, under the applicable regulations, a color derived from a "natural" source is treated as "artificial" if it falls within FDA's definition of a "color additive". A "color additive" is "a food substance such as beet juice [that] is deliberately used as a color, as in pink lemonade". However, "[f]ood ingredients such as cherries, green or red peppers, chocolate, and orange juice which contribute their own natural color when mixed with other foods are not" food additives in those contexts. 21 C.F.R. 70.3(f). Any qualifying "color additive" is defined under 21 C.F.R. 101.22(a)(4) as an "artificial color" and should be identified in one of several ways in the statement of ingredients pursuant to 21 C.F.R. 101.22(k).
However, under FDA's new approach articulated in a letter to industry (here), FDA will refrain from bringing enforcement actions against the following claims when products do not contain petroleum-based synthetic colors, even if they would otherwise meet the definition of a "color additive" provided by the C.F.R.:
- Made without artificial food colors/colorings
- No artificial color/colors/coloring
- No added artificial color/colors/coloring
In making this decision, FDA explained that treating naturally derived colors as "artificial" confused consumers and discouraged adoption of alternative food coloring options. These actions continue to build on FDA's efforts announced in April 2025 to phase out petroleum-based synthetic colors from the U.S. food supply. However, FDA continues to remind manufacturers that they remain responsible for ensuring color additive safety and that food labels must not be "false or misleading in any particular." 21 U.S.C. § 343.
Therefore, companies seeking to make changes based on this FDA guidance remain responsible for complying with other aspects of FDA regulations and should still be mindful about how they position their labeling statements about colors to avoid litigation claims that their labels are "false or misleading."
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