Revive the precautionary principle

The Right is right to back the FDA's ban on Red Dye No. 3. But there's a better way to manage industry pushback.

Just before leaving office, the Biden administration’s Food and Drug Administration banned future use of Red Dye No. 3 in food products. The rule goes into effect in 2027.

While it is tempting to say candy corn, sports drinks and maraschino cherries will never look the same, they probably will — at least in the short run. Their manufacturers, like the manufacturers of Pop Tarts, Fruit Loops and hundreds of other products, will simply substitute Red Dye No. 40 or some other artificial color that hasn’t yet been banned.

While chemical dyes made from coal tars and petroleum have been inserted into foods for nearly 150 years, their use exploded after World War II as America’s processed food manufacturers embraced the mantra “better living through chemistry.” The dyes are used to make thousands of products visually enticing, especially those aimed at children and young adults.

For decades, progressive groups have sought to limit the use of chemical dyes in the food supply. They cite studies linking some dyes (especially reds and yellows) to cancer, behavioral disorders and allergies.

In 1976, Ralph Nader’s Health Research Group led the charge that forced the FDA to ban Red Dye No. 2. In 2022, the Center for Science in the Public Interest and nearly two dozen other groups petitioned the FDA to ban Red Dye No. 3, citing studies linking its use to increased incidence of thyroid cancer. (Full disclosure: I ran CSPI’s Integrity in Science Project from 2004 to 2009.)

The food industry marshaled its lobbying might to prevent the new ruling without success. Its chance of gaining a reprieve from the new Trump administration appears slim given that Health and Human Services Secretary Robert F. Kennedy Jr. blames food additives for a range of health disorders. Incoming FDA commissioner Martin Makary echoed those sentiments at his confirmation hearing earlier his month. “These are chemicals that the industry insists are safe, a subset of which are concerning,” he said.

Last week, Kennedy called industry executives to a meeting in Washington (attendees included the CEOs of PepsiCo, Kraft Heinz, General Mills, Tyson Foods, W.K. Kellogg and J.M. Smucker) where he made it clear he intends to remove a range of chemical additives from the food supply over the next four years. He called on the companies to act on their own.

Should Trump allow him to follow through (maybe he’s briefly tolerating the barking dog that helps him generate baksheesh and political fealty), this could be a very interesting food fight.

When the science is murky

The science behind regulating industry has always been a contested terrain. This is especially true in food science where human trials are rare and inconclusive, animal studies are merely suggestive, and most studies are conducted by industry-funded scientists.

The Delaney amendment to the Food, Drug and Cosmetics Act, passed in 1960, bans adding anything to food that causes cancer. Yet it took another 16 years before the FDA banned Red Dye No. 2, long-suspected to be a carcinogen.

The move was highly controversial. The FDA botched its own study, the New York Times reported at the time. Among the studies used to justify the ban was one conducted by Soviet scientists and promoted by Allied Chemical, which held a patent on Red Dye No. 40, the likely substitute.

A similar controversy lies behind the recent FDA ban on Red Dye No. 3. The agency cited a 1987 study that showed the additive caused cancer in male rats. But Joseph Borzelleca, the study’s author, whose research was funded by the International Association of Color Manufacturers, concluded that Red Dye No. 3 posed no problem for humans, reported Phil Galewitz of Kaiser Health News in a story published last week by Scientific American.

Borzelleca, now 94 and professor emeritus of pharmacology and toxicology at Virginia Commonwealth University, told Galewitz: “If I thought there was a problem, I would have stated it in the paper. I have no problem with my family — my kids and grandkids — consuming Red 3. I stand by the conclusions in my paper that this is not a problem for humans,” he said.

In 1990, the FDA used the Borzelleca study to ban Red Dye No. 3 in cosmetics, but not food. After the recent FDA decision to impose a food ban, the former deputy commissioner for human foods, Jim Jones, condemned the move, claiming the pathway for the dye causing cancer in rats doesn’t exist in humans. Jones resigned from the FDA in February after the Trump administration gutted his office.

The public interest groups behind the petition to ban Red Dye No. 3 are, of course, ecstatic about the FDA’s action. “At the end of the day, this is an unnecessary additive,” Thomas Galligan, principal scientist for food additives at CSPI, told Galewitz. “It’s a marketing tool for the industry to make foods look more appealing so consumers will buy them. But federal law is clear: No amount of cancer risk is acceptable in foods.”

The new Trump team has a different concern. They believe many food dyes cause hyperactivity in children. California, the bluest state in the nation, banned Red Dye No. 3 in 2023, claiming it triggered hyperactivity after conducting an exhaustive scientific review. The European Union cited similar evidence in its ban. The California evidence report included small studies of children who participated in a randomized clinical trial — a rarity in food research where observational and epidemiological research is most common. Half the study group ate foods with food additives and half ate unadulterated foods.

The major food companies may go along with the Red Dye No. 3 ban. After all, there are several red dye alternatives already on the market. But if Kennedy and Makary move to ban all dyes suspected of causing harm in children, they will undoubtedly trigger massive pushback from both the food and chemical industries, which have billions of dollars in sales at stake.

Trump v. due process

The Trump administration is proving on a daily basis that they have no respect for law, due process or other individual rights (the Supreme Court says the 14th amendment grants corporations the same rights as individuals). Kennedy has already announced he will suspend public participation in much of HHS’s future rule-making, ignoring the Administrative Procedure Act’s requirement that the public (and that includes affected businesses) be allowed to comment, i.e., lobby, on proposed rules.

In addition to its obvious illegality, a diktat ban on food additives would eliminate any public discussion of the science behind the agency’s decision. Companies and their trade association would be denied the right to submit evidence to the FDA or one of its advisory panels. Public interest groups would be similarly excluded.

Industry-funded studies invariably show no harm, whether the rules in question involve food dyes, industrial chemicals, air pollutants, and other products subject to health and safety regulation. Sometimes their studies question the validity of evidence presented by independent scientists or public interest and environmental groups. It is the job of scientists at federal agencies to evaluate the conflicting claims before enacting new regulations.

Since passage of a host of new environmental and safety laws in the early 1970s, industry has created a massive lobbying and research establishment to frustrate agencies’ ability to carry out the mandates in health and safety laws such as the Clean Air, Clean Water, Toxic Substances Control and Occupational Safety and Health acts. As David Michaels, who headed OSHA during the Obama administration, wrote two decades ago in Doubt Is Their Product: How Industry’s Assault on Science Threatens Your Health, industry doesn’t have to prove that their products or your air, water or workplaces are safe, they just have to throw shade on research showing dangers exist. That’s usually enough to paralyze regulators from doing their jobs.

Should Kennedy order a ban on food additives, industry’s well-financed lawyers will undoubtedly challenge him in court. Perhaps his plan is to follow in his boss’ footsteps and ignore any court orders.

The precautionary principle path

If he were smart, he wouldn’t follow the Trump playbook of ignoring the law and the courts. He would take up a cause that progressives lost decades ago when it comes to regulating industry. He would resuscitate the precautionary principle.

The number one tool industries (and their supporters in government) use to frustrate more stringent health and safety rules is cost-benefit analysis, which replaced the precautionary principle as the guide to rule making through an executive order signed by President Bill Clinton on September 30, 1993. It requires every “significant” rule, before promulgation by a government agency, be subject to review by the Office of Management and Budget (OMB). The order established the Office of Information and Regulatory Affairs and charged it with determining whether the benefits of a proposed regulation outweighs its cost to business, the economy and society.

OMB under Trump is being run by Russell Vought, a deregulatory zealot who co-authored the Project 2025 plan to dismantle the federal government, which is now in full flower. He’s not likely to help to Kennedy in his crusade to make America healthy again. This will be especially true when it comes to banning food additives, where the benefit calculations are easily challenged while the costs to industry and the nation’s GDP are easily overstated.

The precautionary principle offers an alternative way of regulating threats to health and safety when both the long-term benefits and risks are in dispute. While its provenance dates back centuries, the precautionary principle in its modern U.S. incarnation dates from a 1998 gathering of environmental activists at Wingspread, the headquarters of the Johnson Foundation in Racine, Wisconsin (classic Frank Lloyd Wright architecture; a must-see stop on any drive from Chicago to Milwaukee). It states:

“When an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically.”

It doesn’t call for ignoring cost-benefit analysis if the calculations are obtainable and reasonable. But in the face of scientific uncertainty, it requires taking anticipatory action to prevent harm. The five tenets of the precautionary principle include looking at the long-term health and environmental benefits of regulation (not just short-term) and using an open, democratic and scientific process for determining when the precautionary principle should be applied.

The Wingspread Conference Center in Racine, WI

The rule-breaking diktats promised by Kennedy violates those principles. “It won’t set a precedent,” said James Goodwin, the policy director for the Center for Progressive Reform, a Washington think tank that has been a long-time proponent of the precautionary principle. “You can always devise some post-hoc rationalization for one action or another. It’s not a precedent because (Kennedy’s threat) is merely an exercise in raw power.

“You’d like to have the precautionary principle grounded on a democratic foundation,” he continued. “If we don’t put some guardrails on use of the precautionary principle, then nothing would be allowed. You have to have built a regulatory system that is truly democratic and responsive to the public. Then you can have confidence that the precautionary principle is being deployed in a way that can be trusted.”

In recent years, environmental activists distraught about the long-term impact of global warming have called for using the precautionary principle to take immediate action to limit carbon emissions.

Neither rising temperature nor its cause is in question. The immediate costs to industries forced to adopt clean energy solutions are predictable and measurable. However, the long-term effects of rising atmospheric carbon — more flooding; more frequent and destructive storms; worse droughts and forest fires — are impossible to quantify with any scientific certainty.

Under the precautionary principle, society should be working to prevent those harms rather than face the possibility of massive economic dislocation, especially since transitioning to clean energy will generate just as much if not more economic activity than the technologies it displaces. (Any wise policy would also include generous help for individuals and communities impacted by new regulations.)

The same principle can be applied to food additives. The immediate cost isn’t trivial. But isn’t there an economic benefit to substituting natural dyes for chemical dyes, if dyeing food is necessary at all? The medical evidence that associates food dyes with behavioral disorders can be easily called into question. But why should we continue to subject children to chemicals that may be contributing to what is a very real and growing problem?