The Food and Drug Administration has delayed the effective dates of its final order approving beetroot red and spirulina extract as color additives exempt from certification, following objections filed with the agency.
The beetroot red objection was submitted to FDA by GMO/Toxin Free USA, while Obelisk Tech Systems Inc filed the objection to the approval of spirulina extract.
FDA issued final orders on Feb. 6, amending the color additive regulations, and under its updated guidance did not treat them as artificial colors for labeling purposes. Rather it said it would use enforcement discretion for their use in products with “no artificial colors” claims.
The spirulina extract petition for exemption was originally filed by GNT USA, LLC in July 2024, and the beetroot red extract exemption petition was filed by Phytolon Ltd. in March 2024.
FDA announced an indefinite delay of the effective dates for the two color additives on March 25, stating it will release a new effective date or other administrative action at a later time.
“The delay of the effective date is required by law following the filing of timely objections on the final order,” FDA said. “This announcement does not reflect a change in our determination that there is a reasonable certainty of no harm from the use of this color additive under the conditions of its intended use.”
Beetroot red under the microscope
Critics of the beetroot red approval argue that because the dye is derived from genetically engineered yeast, it is misleading to consumers who might believe the product labeled as natural comes from actual beetroot.
“While the attempt to shift the food industry away from petroleum-based dyes is commendable, replacing one synthetic food dye with another synthetic food dye is not acceptable,” GMO/Toxin Free USA said in its complaint. “Under no circumstance should genetically engineered Synthetic Biology (SynBio) food dyes be allowed to be labeled as ‘natural.’ Further, no products made with SynBio food dyes should be allowed to claim ‘no artificial colors.’”
The complaint also raises concerns about the process integrity used for creating the dye, noting that the “safety profile of this additive is inextricably linked to its production host.”
“Even with high-level purification, there is a risk of residual yeast proteins remaining in the final dye,” the complaint argued. “For individuals with yeast allergies or sensitivities, this poses a direct health risk. Even trace amounts of residual yeast proteins can trigger reactions in sensitive individuals.”
Michael Hansen, senior scientist at Consumer Reports, said genetic engineering, which includes precision fermentation techniques, can leave contaminants during the production process when used to separate the dye from the rest of the cell.
“You should be identifying what all those were, because usually when you do these engineering experiments and you’re creating an additive, if you look really carefully, you can often find in the final product, 15, 20, 30, 40 different proteins, or other things in there,” he said. “Those should all be looked at, because those haven’t been in the food supply before. So, you should be identifying whether any of those raise safety concerns.”
Further study is not all that is needed, according to Hansen.
“They should absolutely let consumers know that is a genetically engineered color or genetically modified. They should not be able to call that ‘not artificial’ or ‘natural,’” he said. “We have done enough surveys to show that people do not consider engineered things to be natural.”
Spirulina extract’s broad approval
Critics also argue that approval of the spirulina extract failed to meet several regulatory requirements, according to The National Law Review.
Obelisk Tech Systems said in its complaint that more study is needed before making spirulina extract exempt from certification.
“The United States faces a documented public health crisis of chronic non-communicable diseases – obesity, type 2 diabetes, cardiovascular disease, neurodevelopmental disorders and certain cancers – in which dietary chemical exposure plays a documented role. The FDA’s expansion of color additive use without adequate chronic disease burden analysis is inconsistent with the HHS Secretary’s §247d emergency preparedness obligations,” Obelisk Tech Systems said in its complaint.
Hansen argued that FDA allowed the spirulina extract “in any product at any level,” which went far beyond the original request for exemption from certification.
“[GNT USA] listed a range of products, and they listed the amounts that they would like,” he said. “But what the FDA did is, in the approval, they just gave a blanket approval that says you could put spirulina extract in anything you want, in any food at any given level, as long as it’s consistent with what’s called GMP, good manufacturing process.”
Hansen speculated that FDA might have made the broad approval by mistake due to mass departures at the agency over the last year.
“After all these people retired and they are hiring new people, maybe they just don’t understand,” he said. “You have to have somebody that really knows the GRAS (Generally Accepted as Safe) system. It seems like a lot of the decisions they’re making are much more by the seat of their pants.”
