KANSAS CITY — If its decision to revoke the authorization for food and beverage companies to use Red No. 3 in formulations is indicative, key resources the Food and Drug Administration is devoting to its new Human Foods Program (HFP) are badly misplaced. Judging by the agency’s own assessment of the decision, it is difficult to imagine FDA actions that would do less to make the food supply healthier than the red dye ban announced Jan. 15.

Josh Sosland, editor of Milling & Baking News.
Source: Sosland Publishing Co. 

The FDA established the HFP in September to oversee its programs related to food safety and nutrition. Describing its ambitions for HFP, the agency said, “Our vision is to ensure that food is a source of wellness for all US consumers, and our day-to-day activities are focused at protecting and promoting the health and wellness of all people through science-based approaches to prevent foodborne illness, reduce diet-related chronic disease and ensure chemicals in food are safe.”

HFP’s Office of Food Chemical Safety, Dietary Supplements and Innovation is tasked with ensuring “exposure to chemicals in food is safe.” Included in this group is an Office of Post-Market Assessment, an area the FDA conceded has been a weak spot in the past.

“We have not had a robust post-market assessment program here at FDA,” Jim Jones, the FDA’s deputy commissioner for human foods, said last September. He said the agency had not established a “systematic process” to reaffirm whether an additive was safe.

It would have been hoped that the ban of Red No. 3, which becomes effective as soon as January 2027, would showcase the value of the FDA’s development of a new, enhanced “systematic process,” demonstrating a sound scientific basis for pulling a dangerous chemical from the market.

Instead, in announcing its ban, the FDA strongly asserts evidence that human intake of Red No. 3 is unsafe is completely lacking.

“The way that FD&C Red No. 3 causes cancer in male rats does not occur in humans,” the FDA said. “Relevant exposure levels to FD&C Red No. 3 for humans are typically much lower than those that cause the effects shown in male rats. Studies in other animals and in humans did not show these effects. Claims that the use of FD&C Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information.”

If all evidence suggests Red No. 3 is safe, how did the ban come about?

The FDA’s review of the dye came in response to a 2022 petition from the Center for Science in the Public Interest (CSPI) and other groups. The FDA said the ban was mandated because The Delaney Clause, enacted in 1960, prohibits FDA authorization of a color additive found to induce cancer in humans or animals. High doses of the dye were shown to increase “circulating thyroid stimulating hormone” in rats, activity linked to higher risk of thyroid tumors in rats. In humans, there is no evidence this mechanism is in play. The dye has not been shown to increase “circulating thyroid stimulating hormone” in humans.

“Despite its limited relevance to humans,” the FDA said the cumulative scientific data on the effects of Red No. 3 on rats is compelling and statutorily requires the product be banned for human consumption.

Reacting to public comments submitted in response to the CSPI petition, the FDA dismissed several that contended the Delaney Clause does not apply.

“The language of the Delaney Clause is straightforward,” the FDA said.

With a tidal wave of actions at the state level proposing a wide range of food ingredient bans, it is more important than ever that Congress use its oversight powers to ensure that the FDA is focusing its activities on protecting public health using its scientific expertise and update food safety laws in a way to allow the FDA to use sound science to keep the food supply safe for humans. The alternative is a nightmarish patchwork of state-by-state initiatives if the FDA doesn’t get this process right.