• On February 5, 2026, FDA announced via a letter to food manufacturers that the Agency intends to exercise enforcement discretion regarding certain voluntary claims relating to the absence of certified colors used in foods intended for human consumption.
  • Specifically, FDA does not intend to take enforcement action if the following claims are made on labels or labeling of foods that do not contain colors listed in 21 CFR Part 74:
    • “Made without artificial food colors/colorings”
    • “No artificial color/colors/coloring”
    • “No added artificial color/colors/coloring”
  • This differs from FDA’s prior position in which all color additives, even if derived from natural sources, are considered “artificial,” as described in Compliance Policy Guide Section 587.100 (Label Declaration of Certification-Exempt Color Additives) and Use of the Term Natural on Food Labeling. The new approach is intended to align with FDA’s Make America Healthy Again (MAHA) agenda. According to FDA Commissioner Marty Makary, “calling colors derived from natural sources ‘artificial’ might be confusing for consumers and a hindrance for companies,” so the enforcement discretion will make it “easier for companies to use these colors in the foods our families eat every day.”
  • In addition to the new approach on artificial color claims, FDA announced that the Agency approved two new color additive petitions:
    • The clearance for spirulina extract is being expanded to permit use in foods generally, except for infant formula, certain foods regulated by USDA, and foods subject to a standard of identity unless such use is authorized by the standard. In addition, the specifications for heavy metals are being lowered and a specification for cadmium is being added.
    • Beetroot red will now be permitted for use in foods generally, except for infant formula, certain foods regulated by USDA, and foods subject to a standard of identity unless such use is authorized by the standard
  • Finally, FDA issued an additional letter “reminding manufacturers of their responsibility to ensure color additive safety.”
  • Keller and Heckman will continue to monitor updates related to FDA’s regulation of color additives.