FDA Halts Approval of Beetroot Red and Spirulina Colorings Amid Safety and Labeling Disputes
FDA Halts Approval of Beetroot Red and Spirulina Colorings Amid Safety and Labeling Disputes
March 31, 2026 – The U.S. Food and Drug Administration has put on hold its approval of two natural-source color additives—beetroot red and spirulina extract—following formal objections from consumer and industry groups.
The FDA originally issued final orders on February 6, 2026, allowing expanded use of these colorants without requiring them to be labeled as artificial colors. However, on March 25, the agency indefinitely delayed the effective dates after receiving complaints about safety assessments and labeling claims.
Concerns Over Beetroot Red Made from Engineered Yeast
One of the contested additives is beetroot red, produced using genetically modified yeast. The advocacy group GMO/Toxin Free USA filed an objection, arguing that the dye should not be labeled as "natural" or "no artificial colors" because it is made through synthetic biology.
The group also raised health concerns, noting that residual yeast proteins could remain in the final product, potentially triggering allergic reactions in sensitive individuals. Michael Hansen, a scientist with Consumer Reports, supported this view, calling for more thorough identification of any unintended proteins or compounds introduced during genetic engineering.
The original petition for beetroot red exemption was filed by Phytolon Ltd. in March 2024.
Spirulina Extract Approval Deemed Too Broad
The second additive, spirulina extract, was petitioned by GNT USA, LLC in July 2024. While the FDA approved it for general use in foods (excluding infant formula and certain meat products), critics say the approval is overly broad.
Obelisk Tech Systems Inc., which filed the objection, argued that the FDA failed to analyze the potential contribution of such additives to chronic diseases like obesity, diabetes, and cancer. The National Law Review reported that the complaint also cited regulatory requirement failures.
Hansen noted that the FDA granted blanket approval for spirulina extract at any level consistent with good manufacturing practices, far beyond the original petition's specific requests. Under current regulations, spirulina extract is listed as an exempt-from-certification color additive under 21 CFR §73.530.
GNT USA defended its petition, stating that expanded use was clearly proposed and reviewed through the standard regulatory process.
What Happens Next
The FDA emphasized that the delay does not reverse its safety finding—that both additives pose "reasonable certainty of no harm" under intended conditions. However, the agency must respond to the objections before setting new effective dates. You can track future FDA actions on the FDA Color Additives Status List or search for specific dockets on Regulations.gov.
Critics continue to push for clearer labeling and more rigorous safety reviews, especially for colorants produced through genetic engineering or used across a wide range of food products.
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