This includes a review of Red Dye 3, which evidence shows is not harmful to humans, but which FDA may be obligated to ban in food and ingestible drugs as proposed by public health advocates due to a legal technicality, top FDA officials added
A “decision should be forthcoming” on a petition filed more than two years ago by the Center for Science in the Public Interest, Environmental Working Group, Consumer Reports and others asking FDA to ban the use of Red Dye 3 in food and digestible drugs, the agency’s Deputy Commission for Human Foods Jim Jones told the Senate Committee on Health, Education, Labor and Pensions.
HELP Committee Chairman Sen. Bernie Sanders, I-Vt., held a hearing Dec. 5 to assess what FDA is doing “to reduce the diabetes and obesity epidemics in America and take on the greed of the food and beverage industry.”
At the wide-ranged hearing, Sen. Tommy Tuberville, R-Ala., asked whether Jones and FDA Commissioner Robert Califf “stand by” the agency’s position that another controversial color additive – Red Dye 40 – is safe for children to ingest.
Jones refrained from commenting on the safety of Red 40 other than to say that FDA concluded it was safe after its most recent review of the additive “over a decade” ago. Califf then redirected the conversation to the agency’s ongoing evaluation of Red Dye 3.
“Even though we don’t believe there is a risk to humans, under the Delaney Clause of the FD&C Act, Red Dye 3, because it is known to cause cancer in laboratory animals, should not be authorized.”
Jim Jones, FDA Deputy Commissioner for Human Foods
Both colors have come under fire in recent years with California banning within the state the sale, distribution and manufacturing of products including Red Dye 3 beginning in 2027. More recently, the state banned Red Dye No. 40, along with several other colors, from food served in the state’s public schools beginning Dec. 31, 2027.
While several other states proposed similar legislation to ban Red Dye 3, the petition filed in November 2022 to revoke the color additive listing of Red Dye 3 under the Federal Food, Drug & Cosmetics Act seeks to expand the ban nationwide.
Jones said FDA is “hopeful that within the next few weeks we will be acting on that petition.”
Safety assessment of Red Dye 3 ‘complicated’ by contradicting animal, human data
Tuberville questioned the agency’s timeline for responding to the petition, and how it could justify continuing to study the additive’s safety in food when in 1990 FDA denied a petition to allow the color in cosmetics and topical drugs due to data associating it with animal carcinogenicity.
Jones acknowledged that Red 3 is “actually known to be cancerous in laboratory animals, rats,” but, he said, “the scientific consensus is that the mechanism of carcinogenicity in rats is not applicable in humans.”
The conundrum for the agency – and the basis of the petition seeking to ban Red 3 in food and digestible drugs – is that the FD&C Act includes a clause that dictates FDA cannot authorize for use any chemical that is shown to be carcinogenic in humans or animals.
“Even though we don’t believe there is a risk to humans, under the Delaney Clause of the FD&C Act, Red Dye 3, because it is known to cause cancer in laboratory animals, should not be authorized,” Jones said.
FDA’s assessment likely will end up in court
While the agency’s decision may appear clear-cut based on this technicality, Califf said the assessment is “complicated” because FDA does not have data showing Red Dye 3 causes cancer in humans, which would make it difficult for a ban – if implemented by FDA – to stand up in court.
“When we do ban something, it will go to court, and if we don’t have the scientific evidence, it will not stand up in court. We will lose in court,” Califf said.
He added that demonstrating whether a substance causes cancer in people requires a large study over a long period of time – which he suggested exceeds FDA’s current resources.
“We have a very small staff that do this based on the budget. We have repeatedly asked for better funding for chemical safety,” he said, pleading, “please look at our request for funding for the people who do this work.”
Jones: US is decades behind Europe, Canada in post-market chemical reviews
Despite resource constraints, Califf stressed that the post-market review of food additives, including colors, is a priority for the agency and one of the reasons he hired Jones to lead the newly reorganized Human Foods Program.”
“I brought Mr. Jones in to head the Human Foods Program because of his history of working on environmental issues,” said Califf, referencing the more the two decades that Jones served as a career employee at the Environmental Protection Agency where he spent most of his time furthering chemical safety. “He is an expert in this.”
As part of the agency’s reorganization, Jones helped oversee the establishment of a post market chemical review office, which is a first step in the agency catching up with its European and Canadian counterparts that he said are several decades ahead of the US in assessing the safety of food additives, several of which they have banned that the US has not.
“The biggest distinction between the US and Europe is that they have been doing post-market review of chemicals now for over 20 years. In the FDA, although we have authorization to do post-market reviews, there is no statutory mandate to do them.”
Even though FDA is not required to evaluate chemicals that have been authorized in the past, “we are going to undertake it,” said Jones.
Echoing Califf’s concerns about budget constraints, Jones added FDA will “definitely struggle with the resources necessary to do that.”
FDA is currently ironing out how it will approach post-market chemical reviews and seeking feedback through Jan. 21 on its proposed two-tier evaluation process.