FDA must test food color additives to improve public trust

First a pop quiz.

What food additive does the Food and Drug Administration deem potentially cancerous if applied to the skin, but is just peachy keen to digest?

Ladies and gentlemen, I give you erythrosine, more commonly known as FD&C Red No. 3, a synthetic food coloring derived from fluorone.

I know what you must be thinking. How is that even possible?

Red No. 3 was approved for use as a food additive in the U.S. in 1907, a year after enactment of the 1906 Pure Food and Drugs Act.

But the law wasn’t really adequate in protecting the public from adulterated and toxic products. The 1906 law was replaced by the Federal Food, Drug and Cosmetic Act of 1938, which increased oversight of food and drugs, and created new regulations for medical devices and cosmetics. A step forward.

A little over five decades later, Red No. 3 appeared on FDA’s radar after a January 1986 National Toxicology Program study showed “equivocal evidence of carcinogenicity for male B6C3F1 mice as indicated by an increased incidence of hepato-cellular adenomas or carcinomas (combined) in the 250 mg/kg group.”

Although the study failed to provide “clear evidence” that Red No. 3 causes cancer, the FDA decided to act on the side of caution and in 1990 banned its use in cosmetics. At that time, the FDA acknowledged eating Red No. 3 might be a health issue and promised — pinky swear — to find an answer.

So what did the FDA’s promised research on human digestion of Red No. 3 show? No one knows because the FDA never got around to doing the study.

And today the public is still inexplicably waiting for FDA to get around to doing some conclusive testing. Thirty-three years and counting. And the Environmental Working Group reports more than 3,200 food products currently on the market contain Red No. 3.

When it comes to food color additives, some states have decided enough is enough. Last month, California became the first state in the nation to ban Red No. 3 as a food additive. In signing Assembly Bill 418, California Gov. Gavin Newsom fired a salvo at FDA:

“The additives addressed in this bill are already banned in various other countries. Signing this into law is a positive step forward on these four food additives until the United States Food and Drug Administration (FDA) reviews and establishes national updated safety levels for these additives.”

Newsom has a right to be frustrated. Pressure on FDA to revisit potential side effects of Red No. 3 and other color additives has been building the last few years. Last February, FDA sought public opinion on a Center for Science in the Public Interest petition seeking repeal of Red No. 3 in foods and ingested drugs.

And a second petition was filed with FDA this past April by the Environmental Defense Fund asking the food color additive titanium dioxide be banned.

Up to now, FDA’s response to the petitions has been fairly muted. Meanwhile, a major food trade organization isn’t happy — not one little bit — that Red No. 3 is out in California effective 2027.

In irony of ironies, Christopher Gindlesperger, National Confectioners Association senior vice president of public affairs and communications, said “We should be relying on the scientific rigor of the FDA in terms of evaluating the safety of food ingredients and additives.”

What? It is FDA inaction and lack of rigor that has created this train wreck in the first place.

This past May, Dr. Robert M. Califf, the commissioner of food and drugs for the FDA, co-authored a blog where he noted the Red No. 3 and titanium dioxide petitions and pledged “to develop new approaches to mine existing data more efficiently and prioritize substances for in-depth review based on risk,” and that FDA is “embarking on a more modernized, systematic reassessment of chemicals with a focus on post-market review.”

Which is only appropriate. It was the FDA broken promises back in 1990 that created this mess. We’ll soon learn if the FDA has learned any lessons on trust. FDA, do what you say you will do.