Dive Brief:

• The FDA has delayed approval for beetroot red as a natural food dye and the expansion of spirulina extract as it responds to criticism over their safety.
• Advocacy group GMO/Toxin Free USA says the version of beetroot red approved by the FDA is synthetically produced and hasn’t been ruled out as a possible carcinogen. In a separate complaint, Obelisk Tech Systems argues the move to expand uses for spirulina poses heavy metal safety risks.
• The FDA said the delay in effective date “does not change” its determination that the dyes “are safe for their intended uses.” The agency also emphasized it continues to not enforce rules around using the “no artificial colors” label as long as companies avoid petroleum-based dyes.

Dive Insight:

The Trump administration has raced to expand natural dye options after asking food companies to voluntarily remove artificial colors by the end of this year. However, industry players say the agency did not perform important safety assessments when approving these colors, and also raised questions over whether the dyes can truly be considered “natural.”

“The push for ‘sustainable’ colors should not come at the expense of consumer transparency and safety,” GMO/Toxin Free USA wrote in its objections to beetroot red.

Stakeholders say that critical safety checks were overlooked in the approval of beetroot red and spirulina extract, including tests that would ensure the dyes are not carcinogenic and do not expose consumers to heavy metals.

In its petition objecting to spirulina, Obelisk Tech Systems notes the FDA failed to evaluate the dye’s risk against the total dietary heavy metal burden from all food sources, instead looking at the color in isolation. As a result, the agency set acceptable heavy metal thresholds far higher than what is considered safe, the firm argues.

For example, the FDA’s current plan sets acceptable levels of arsenic in spirulina extract at a level 30 times higher than the threshold for apple juice. If the extract were to be used in beverages, exposure “could exceed appropriate risk thresholds for sensitive populations.”

Following Obelisk’s petition, the FDA said it plans to amend its approval for spirulina to lower heavy metal thresholds.

Similar safety concerns were raised in the approval of tech firm Phytolon’s beetroot red, with GMO/Toxin Free USA arguing the company failed to include a long-term safety study in its petition that would rule the dye out as a potential carcinogenic.

Phytolon’s use of beetroot red is also made through fermentation instead of extracting color from beets, which could confuse consumers, GMO/Toxin Free USA said. The group argued Phytolon’s product is a synthetic beetroot red and therefore shouldn’t be considered “natural.”

“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,” the group said.

The objections — and delay by the FDA — underscores the risk for food companies in transitioning to natural dyes. Although the agency signals light enforcement around use of these colors, companies could still remain open to consumer lawsuits and litigation, experts said in a recent Food Dive virtual event.

″[Even though] the FDA is not going to come after you, I can’t emphasize enough that doesn’t mean that you have safe harbor there,” Kevin Kenny, senior advisor at compliance and certification firm FoodChain ID, said during the event.