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Letter to the Food Industry on “No Artificial Colors” Labeling Claims

February 5, 2026

Dear Manufacturers:

This letter provides notice that the Food and Drug Administration (FDA) intends to exercise enforcement discretion as to section 403(a)(1) of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C. 343(a)(1))1 should a firm use certain voluntary labeling claims relating to the absence of FD&C Act certified colors in foods intended for human consumption.  

Background

As part of FDA’s efforts to Make America Healthy Again, the agency has worked with industry to phase out certain FD&C Act certified colors and has fast-tracked the approval of several naturally derived alternative colors.2  FDA recognizes that the current definition of “artificial color,”3 which does not distinguish between colors that are derived from natural sources and other color, may create challenges to transitioning away from FD&C Act certified colors.

Enforcement Discretion

FDA intends to exercise enforcement discretion as to section 403(a)(1) of the FD&C Act should a firm use certain voluntary labeling claims on foods intended for human consumption that do not contain any FD&C Act certified colors.4 This means that FDA does not intend to take enforcement action against a firm under section 403(a)(1) of the FD&C Act should the firm make one of the voluntary labeling claims listed below on foods intended for human consumption that do not contain any colors listed in 21 CFR part 74:

  • Made without artificial food colors/colorings
  • No artificial color/colors/coloring
  • No added artificial color/colors/coloring

The scope of this enforcement discretion does not extend to foods that contain FD&C certified colors, listed in 21 CFR part 74.  Firms may continue to make additional labeling claims, so long as they comply with any other applicable requirements and are not false or misleading.5

Conclusion

As described above, FDA does not intend to take enforcement action as to section 403(a)(1) of the FD&C Act against a firm that makes certain voluntary labeling claims on foods intended for human consumption that do not contain any FD&C Act certified colors.  FDA expects manufacturers to comply with all other existing legal requirements.6 Our flexibilities on the use of the term “artificial” when describing the source of colors in the statement of ingredients remain in effect.7

Sincerely,

/S/

Martin A. Makary, M.D., M.P.H.
Commissioner of Food and Drugs

/S/

Kyle A. Diamantas, J.D.
Deputy Commissioner for Human Foods

  1. 1Section 403(a)(1) of the FD&C Act (21 U.S.C 343(a)(1)), in relevant part, states that a food shall be deemed to be misbranded if its labeling is false or misleading.
  2. 2U.S. Food and Drug Administration, “HHS, FDA to Phase Out Petroleum-Based Synthetic Dyes in Nation’s Food Supply,” (April 22, 2025). Available at: https://www.fda.gov/news-events/press-announcements/hhs-fda-phase-out-petroleum-based-synthetic-dyes-nations-food-supply. Accessed December 5, 2025.
  3. 321 CFR 101.22(a)(4), in relevant part, states that the term artificial color or artificial coloring means any color additive.
  4. 4The FD&C Act certified colors are those listed in 21 CFR part 74.
  5. 5Any colors derived from natural sources must still be pre-approved by FDA under FDA’s color additive petition process. See 21 CFR part 71.
  6. 6See, e.g., section 403(k) of the FD&C Act (21 U.S.C. 343(k)).
  7. 7See 21 CFR 101.22(k)(2); see also U.S. Food and Drug Administration, “CPG Sec 587.100 Label Declaration of Certification-Exempt Color Additives” (November 2005) (“FDA . . . will not insist upon the use of the word ‘artificial’ with the declaration of color as an ingredient when the declaration identifies the color by specific common or usual name and by function. Thus, terms such as ‘colored with _____’ or ‘_____ (color) (the blank being filled with the specific color name such as annatto, beet powder, beta carotene, etc.) is considered satisfactory.”). Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-587100-label-declaration-certification-exempt-color-additives.
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