Science
The FDA knew long ago that red dye No. 3 causes cancer. Why did it take so long to ban it?
The Food and Drug Administration said Wednesday that the much-maligned red dye No. 3 will be banned in the United States because it has been shown to cause cancer in animals.
The decision, lauded by consumer advocacy groups, comes a full 25 years after scientists at the agency determined that rats fed large amounts of the artificial color additive were much more likely to develop malignant thyroid tumors than rats who weren’t given the food coloring. They also had an increased incidence of benign tumors and growths that can be precursors to cancer.
Those findings prompted the FDA to declare in 1990 that red dye No. 3 could not be used in cosmetics or drugs applied to the skin. The reason for the decision was clear: A federal law known as the Delaney clause says no color additive can be considered safe if it has been shown to cause cancer in animals or people.
Yet the dye remained a legal food coloring. It’s in the bright red cherries that dress up a bowl of Del Monte’s fruit cocktail. It makes Nesquik’s strawberry milk a pleasing shade of pink. It also colors beef jerky, fruit rolls, candy, ice cream and scores of other processed products.
Now food makers will have two years to reformulate their products without red dye No. 3. Drug companies have three years to remove it from their medicines.
The FDA does not seem to be bothered by the fact that this cancer-causing chemical will linger in the food supply. The agency’s view is that the biological process through which the dye causes cancer in rats doesn’t occur in people.
“We don’t believe there is a risk to humans,” Jim Jones, the FDA’s deputy commissioner for human foods, told members of Congress last month.
In announcing the ban, the agency added that people consume red dye No. 3 at levels far lower than those shown to cause cancer in two studies of rats. A host of other studies in both animals and humans did not show the dye to be cancerous.
Nonetheless, regulators revoked authorization of red dye No. 3 to satisfy a petition demanding that the Delaney clause be enforced.
Starburst-flavored Fruit by the Foot, which contains red dye No. 3. (Christina House / Los Angeles Times)
“Regardless of the truth behind their argument, it doesn’t matter,” said Jensen N. Jose, regulatory counsel for food chemical safety at the Center for Science in the Public Interest, which spearheaded the effort. “Once it’s established that it causes cancer, FDA must prohibit the chemical by law.”
This wasn’t the first case of the FDA banning a food additive it considers safe to comply with the Delaney clause. The situation shows why the federal law is long overdue for a refresh, food safety experts say.
“A lot of people think we need to reform this,” said Diana Winters, deputy director of the Resnick Center for Food Law and Policy at UCLA Law. “It does lead to some absurd results.”
The Delaney clause is part of a 1958 federal law that expanded the FDA’s regulatory authority over newfangled food additives developed during World War II that were making their way into consumer products, Winters said.
Back then, members of Congress were worried about the cancer risks posed by all sorts of man-made compounds. Even small amounts seemed capable of triggering cancerous growths if people encountered them over and over again.
Arthur Flemming, who served as President Eisenhower’s Cabinet secretary for health and welfare, told Congress at the time there was no way for FDA regulators to know whether any exposure level was low enough to be truly safe. Considering the many cancer risks lurking in the environment, he said, the government should “do everything possible to put persons in a position where they will not unnecessarily be adding residues of carcinogens to their diet.”
Signature Select rainbow cups, which contain red dye No. 3.
(Christina House / Los Angeles Times)
The issue was personal for Rep. James Delaney, a Democrat from New York City whose wife was undergoing cancer treatment at the time. He made sure the new law included a zero-tolerance provision for cancer-causing substances, though it said nothing about additives that might cause other kinds of health problems.
“No additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal,” the Delaney clause states. A 1960 amendment governing color additives extended the rule to dyes.
As the years went by, advances in toxicology allowed scientists to expand the list of known cancerous compounds, and to identify them in ever-smaller amounts. Regulators were no longer as clueless as they’d been in Flemming’s day.
In 1986, the FDA tried to take that progress into account as it evaluated the safety of two color additives — orange dye No. 17 and red dye No. 19 — for use in lipsticks, nail polishes, face powders and other cosmetics. The agency acknowledged that both dyes were capable of inducing cancer in laboratory animals. But it argued that the regulatory decision should be guided not by a literal interpretation of an aging law but by the real-world risks to people.
When those color additives were used as intended, those risks were vanishingly small: A panel of scientists from the U.S. Public Health Service determined the lifetime cancer risk posed by the red dye was 1 in 9 million at worst; for the orange dye, it was 1 in 19 billion. In both cases, the possibility of developing cancer was “so trivial as to be effectively no risk,” the panel concluded.
A federal appeals court agreed that the dyes seemed to be safe. In fact, the risks they posed were millions of times lower than the risks of smoking, the judges wrote.
Moreover, the judges noted, forbidding the use of chemicals that carry a minute risk of cancer might prompt manufacturers to use compounds that are more toxic, albeit in noncancerous ways. Substitutions like these would be “a clear loss for safety,” they wrote.
But none of that matters, the court ruled: If a dye or any other chemical is found to cause cancer in animals, the FDA’s only option under the Delaney clause was to forbid its use.
Nestle Nesquik strawberry milk, containing red dye No. 3. (Christina House / Los Angeles Times)
Regulators found themselves in a more absurd situation in 2018 when they were asked to revoke their authorization of a flavoring additive called myrcene.
When the synthetic compound was force-fed to rats at doses of 1 gram per kilogram of body weight for two years, the animals developed kidney cancer and other forms of renal disease. Female mice fed under the same conditions developed liver cancer as well, the FDA said.
But the amount of artificial myrcene consumed by a typical American is 813,000 times lower — around 1.23 micrograms per kilogram of body weight, the agency said.
Moreover, myrcene is a natural component of mangoes, citrus juices, cardamom, and herbs including basil, parsley and wild thyme. The amount of natural myrcene in the food supply is about 16,5000 times greater than its synthetic counterpart, the agency added.
Still, the FDA declared the additive unsafe “as a matter of law” while assuring the public that no one’s health was actually at risk when synthetic myrcene was on the market. It blamed the Delaney clause for the confusion.
In 2020, a group of food industry scientists said the problem goes well beyond confusion. Revoking approval for artificial myrcene “has contributed to the ongoing erosion of trust in regulatory agencies,” they argued in the journal Regulatory Toxicology and Pharmacology. Such decisions promote an irrational fear of chemicals and cause consumers to lose faith in the safety of the U.S. food supply, they wrote.
Red dye No. 3 was approved for use in U.S. food in 1907, when it was known as erythrosine. It won permanent listing as an authorized color additive for foods, supplements and ingested drugs under the name FD&C Red No. 3 in 1969.
Soon after that decision, an industry group called the Toilet Goods Assn. petitioned the FDA to upgrade the dye’s listing for cosmetics and topical drugs from provisional to permanent. The request triggered additional tests in the 1970s and ‘80s, including two long-term feeding studies in rats.
Beginning before birth and for their entire lives, the animals were put on diets that included the red dye at concentrations of 0.1%, 0.5%, 1% or 4%. Compared to male rats that didn’t consume any dye, male rats that ate the most had a significantly higher incidence of tumors — both malignant and benign — as well as abnormal cell growth in the thyroid. No other group had an increased incidence large enough to be considered statistically significant. Among female rats, the incidence of benign tumors was elevated for those on the 1% diet, though not for rats on the 4% diet, as would be expected if the dye were the cause of cancer in these animals.
After consulting with scientists from the National Toxicology Program and the U.S. Public Health Service, the FDA concluded that red dye No. 3 could cause cancer in animals. In 1990, the agency denied the industry group’s request for permanent listing.
That decision applied only to cosmetics and topical drugs, and had no immediate bearing on food products sold in the U.S. At that point, the dye had been permanently listed as an approved food additive for decades. Nothing in those rat studies indicated to the agency that its designation needed to change.
Over the years, the dye has been tested in mice, rats, gerbils, pigs, beagles and humans. An extensive review conducted by the World Health Organization and the Food and Agriculture Organization of the United Nations found “no concerns” about the dye’s ability to trigger cancer, impair fertility or cause developmental problems in people of all ages when consumed in realistic doses.
“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,” the agency said Wednesday.
Frosted sugar cookies from Favorite Day Bakery, containing red dye No. 3.
(Christina House / Los Angeles Times)
Pitting the Delaney clause’s strict legal requirements against advances in cancer research has been a longstanding challenge for the agency, officials said.
“When we ban something, it will go to court,” Dr. Robert Califf, the FDA’s commissioner, told the Senate Health, Education, Labor and Pensions committee last month. “And if we don’t have the scientific evidence that will stand up in court, we will lose in court.”
The elaborate regulatory process for removing an additive from the food supply can certainly result in litigation, said Emily Broad Leib, director of the Center for Health Law and Policy Innovation at Harvard Law School.
“The Delaney clause probably works a lot better at the outset if you’re trying to add a new substance to food,” she said. “Once things are in food, it takes a really long time to remove it.”
The way some people see it, the problem with the Delaney clause isn’t that it forces the FDA to ban food additives that don’t pose a true cancer threat. It’s that the law doesn’t address all the other ways the foods we eat can be hazardous to our health.
“There’s a lot of things in foods naturally that cause cancer, and the Delaney clause doesn’t cover that,” said Alyson Mitchell, a food scientist at UC Davis. “It also does not speak to anything regarding other illnesses, whether it’s kidney dysfunction or ADHD or mental health issues or endocrine imbalances.”
The General Accounting Office (now known as the U.S. Government Accountability Office) raised this issue back in 1981, when it advised Congress to update the Delaney clause to reflect the latest scientific and medical knowledge. It would make sense for the law to apply “ equally to cancer-causing and non-cancer-causing substances,” the GAO said.
Other items that contain red dye No. 3: Del Monte fruit cocktail, Signature Select Jordan almonds, Betty Crocker Suddenly! pasta salad, and Jack Links beef stick and cheese. (Christina House / Los Angeles Times)
California has banned all uses of red dye No. 3 in the Golden State, and prohibited the use of six other dyes in foods served or sold in schools. Scientists who examined the dyes for the California Office of Environmental Health Hazard Assessment determined that “the behavioral factors are more of a concern” than the cancer risk, said Asa Bradman, an expert on exposure assessment and epidemiology at UC Merced and co-author of the comprehensive state report.
The FDA has studied the behavioral risks of color additives and hasn’t found “a clear and causal link,” an FDA spokesperson told The Times. Studies suggest some children with behavioral challenges like ADHD appear to be sensitive to food dyes, and that genetic variants affecting the body’s ability to break down histamine are a likely cause. In the FDA’s view, that doesn’t mean the dyes themselves are “neurotoxic,” the spokesperson said.
If there was convincing evidence that an artificial dye failed to meet FDA’s safety standards, the agency would take action whether the health threats were covered by the Delaney clause or not, the spokesperson added.
Mitchell, who worked on the California report with Bradman, said that because manufacturers have been phasing out red dye No. 3 for more than a decade, it’s not a significant concern for her. She’s more worried about the hyperactivity risk posed by red dye No. 40 because it’s ubiquitous in processed foods, especially those consumed by children.
“I’m grateful for the Delaney clause because I do think it’s been very helpful in trying to protect our food,” Mitchell said. “But it doesn’t go far enough. So much of this needs to be revisited.”
Because of budget cuts, the Los Angeles County Department of Public Health has ended clinical services at seven of its public health clinic sites.
As of Feb. 27, the county is no longer providing services such as vaccinations, sexually transmitted infection testing and treatment, or tuberculosis diagnosis and specialty TB care at the affected locations, according to county officials and a department fact sheet.
The sites losing clinical services are Antelope Valley in Lancaster; the Center for Community Health (Leavy) in San Pedro, Curtis R. Tucker in Inglewood, Hollywood-Wilshire, Pomona, Dr. Ruth Temple in South Los Angeles, and Torrance. Services will continue to be provided by the six remaining public health clinics, and through nearby community clinics.
The changes are the result of about $50 million in funding losses, according to official county statements.
“That pushed us to make the very difficult decision to end clinical services at seven of our sites,” said Dr. Anish Mahajan, chief deputy director of the L.A. County Department of Public Health.
Mahajan said the department selected clinics with relatively lower patient volumes. Over the last month, he said, the department has sent letters to patients about the changes, and referred them to unaffected county clinics, nearby federally qualified health centers or other community providers. According to Mahajan, for tuberculosis patients, particularly those requiring directly observed therapy, public health nurses will continue visiting patients.
Public health clinics form part of the county’s healthcare safety net, serving low-income residents and those with limited access to care. Officials said that about half of the patients the county currently sees across its clinics are uninsured.
Mahajan noted that the clinics were established decades ago, before the Affordable Care Act expanded Medi-Cal coverage and increased the number of federally qualified health centers. He said that as more residents gained access to primary care, utilization at some county-run clinics declined.
“Now that we have a more sophisticated safety net, people often have another place to go for their full range of care,” he said.
Still, the closures have unsettled providers who work closely with local vulnerable populations.
“I hate to see any services that serve our at-risk and homeless community shut down,” said Mark Hood, chief executive of Union Rescue Mission in downtown Los Angeles. “There’s so much need out there, so it always is going to create hardship for the people that actually need the help the most.”
Union Rescue Mission does not receive government funding for its healthcare services, Hood said. The mission’s clinics are open not only to shelter guests, up to 1,000 people nightly, but also to people living on the streets who walk in seeking care.
Its dental clinic alone sees nearly 9,000 patients a year, Hood said.
“We haven’t seen it yet, but I expect in the coming days and weeks we’ll see more people coming through our doors looking for help,” he said. “They’re going to have to find help somewhere.” Hood said women experiencing homelessness are especially vulnerable when preventive care, including sexual and reproductive health services, becomes harder to access.
County officials said staffing impacts so far have been managed through reassignment rather than layoffs. Roughly 200 to 300 positions across the department have been eliminated amid funding cuts, officials said, though many were vacant. About 120 employees whose positions were affected have been reassigned; according to Mahajan, no one has been laid off.
The clinic closures come amid broader fiscal uncertainty. Mahajan said that due to the Trump administration’s “Big Beautiful Bill,” Los Angeles County could lose $2.4 billion over the next several years. That funding, he said, supports clinics, hospitals and community clinic partners now absorbing patients who previously went to the clinics that closed on Feb. 27.
In response, the L.A. County Board of Supervisors has backed a proposed half-cent sales tax measure that would generate hundreds of millions of dollars annually for healthcare and public health services. Voters are expected to consider the measure in June.
Sharon Horton stepped through the door of a sky-blue mobile clinic and onto a Skid Row sidewalk. She wore a yellow knit beanie, gold hoop earrings and the relieved grin of a woman who has finally checked a mammogram off her to-do list.
It had been years since her last breast cancer screening procedure. This one, which took place in City of Hope’s Cancer Prevention and Screening mobile clinic, was faster and easier. The staff was kind. The machine that X-rayed her breast was more comfortable than the cold hard contraption she remembered.
Relatively speaking, of course — it was still a mammogram.
“It’s like, OK, let me go already!” Horton, 68, said with a laugh.
The clinic was parked on South San Pedro Street in front of Union Rescue Mission, the nonprofit shelter where Horton resides. Within a week, City of Hope, a cancer research hospital, would share the results with Horton and Dr. Mary Marfisee, the mission’s family medical services director. If the mammogram detected anything of concern, they’d map out a treatment plan from there.
Naureen Sayani, 47, a resident of Union Rescue Mission, left, discusses her medical history with Adriana Galindo, a medical assistant, before getting a mammogram on last week.
(Kayla Bartkowski / Los Angeles Times)
“It’s very important to take care of your health, and you need to get involved in everything that you can to make your life a better life,” said Horton, who is looking forward to a forthcoming move into Section 8 housing.
Horton was one of the first patients of a new women’s health initiative from UCLA’s Homeless Healthcare Collaborative at Union Rescue Mission. Staffed by third-year UCLA Medical School students and led by Marfisee, a UCLA assistant clinical professor of family medicine, the clinic treats mission residents as well as unhoused people living in the surrounding neighborhood.
The new cancer screening project arrives at a time of dire financial pressures on county public health services.
Citing rising costs and a $50-million reduction in federal, state and local grant and contract income, the Los Angeles County Department of Public Health on Feb. 27 ended services at seven of 13 public clinics that provide vaccines, tests and treatment for sexually transmitted diseases and other services to housed and unhoused county residents.
Although Union Rescue Mission’s own funding comes mainly from private sources and is less imperiled by public cuts, the 135-year-old shelter expects the need for its services to rise, Chief Executive Mark Hood said.
Even as unsheltered homelessness declined for the last two years across Los Angeles County, the unsheltered population on Skid Row — long seen as the epicenter of the region’s homelessness crisis — grew 9% in 2024, the most recent year for which census data are available.
For many local women navigating daily concerns over housing, food and personal safety, “their own health is not a priority,” Marfisee said.
Those whose problems have become too serious to ignore face daunting obstacles to care. Marfisee recalled one patient who came to her with a lump in her breast and no identification.
In order to get a mammogram, Marfisee explained, the woman first needed to obtain a birth certificate, and then a state-issued identification card. Then she needed to enroll in Medi-Cal. After that, clinic staff helped her find a primary care physician who could order the imaging test.
Given the barriers to preventative care, homeless women die from breast cancer at nearly twice the rate of securely housed women, a 2019 study found. Marfisee’s own survey of the mission’s female residents found that nearly 90% were not up to date on recommended cancer screenings like mammograms and pap smears, which detect early cervical cancer.
To address this gap, Marfisee — a dogged patient advocate — reached out to City of Hope. The Duarte-based research and treatment center unveiled in March 2024 its first mobile cancer screening clinic, a moving van-sized clinic on wheels that it deploys to food banks and health centers, as well as to companies offering free mammograms as an employee benefit.
“In true Dr. Mary fashion, she saw the vision,” said Jessica Thies, the mobile screening program’s regional nursing director. After working through some logistical hurdles, the mission and City of Hope secured a date for the van’s first visit.
The next challenge was getting the word out to patients. Marfisee and her students walked through the surrounding neighborhood, went cot to cot in the women’s dorm and held two informational sessions in December and January to answer patients’ questions.
At the sessions, the team walked through the basics of who should get a mammogram (women age 40 or older, those with a family history of breast cancer) and the procedure itself. (“Like a tortilla maker?” one woman asked skeptically after hearing a description of the mammography unit.)
The medical students were able to dispel rumors some women had heard: The test doesn’t damage breast tissue, nor do the X-rays increase cancer risk. Others questioned a mammogram’s value: What good was it knowing they had cancer if they couldn’t get follow-up care?
On this latter point, Marfisee is determined not to let patients fall through the cracks.
Thirteen patients received mammograms at the van’s first visit on Wednesday. Within a week, City of Hope will contact patients with their results and send them to Marfisee and her team. She is already mentally mapping the next steps should any patient have a situation that requires a biopsy or further imaging: working with their case manager at the mission, calling in favors, wrangling with any insurance the patient might have.
“It’ll be a good fight,” Marfisee said, as residents in the adjacent cafeteria carried trays of sloppy joes and burgers to their lunch tables. “But we’ll just keep asking for help and get it done.”
At first glance, it looks like nothing more than a charming Spanish-revival, quintessentially Californian home — but this Pacific Palisades rebuild is constructed like a tank.
Every exterior wall of the steel-framed home is a foot-thick, fire-resistant barricade. The home is connected to a satellite fire monitoring service. Should a fire start in town, sturdy metal shutters descend to cover every window. An exterior sprinkler system can pump 40,000 gallons of water from giant tanks hidden behind the shrubs in the property’s yard. If the cameras and heat sensors around the house detect danger, the system can envelop the home in over 1,000 gallons of fire retardant and hundreds of gallons of fire-suppressing foam.
Palisades resident and architect Ardie Tavangarian is so confident in his design that he even asked the fire department if they could start a controlled fire on the property to test it all out. (They said no.)
Tavangarian built a career designing multimillion-dollar luxury homes in Los Angeles, but after the Palisades fire destroyed 13 of his works — including his family’s home — he found another calling: how to design a house that can handle what the Santa Monica Mountains throw at it. And how to do it quickly and affordably.
Water tanks form part of a backup water supply in a newly built fire-resistant home in Pacific Palisades.
“Nature is so powerful,” he said, sitting on a couch in the new house, which he built for his adult twin daughters. “We are guests living in that environment and expecting, ‘Oh, nature is going to be really kind to me.’ No, it’s not. It does what it’s supposed to do.”
Tavangarian watched the Jan. 1 Lachman fire from his property not far from here; a week later that fire rekindled, grew into the Palisades fire, and burned through his house. But the painful details of the fire — the missteps of the fire department, the empty reservoir — didn’t matter when it came to deciding how to rebuild, he said. The reality is, many fires have burned in these mountains. Many more will.
A sprinkler on the roof is part of a house-wide sprinkler system.
For the architect, who has spent much of his 45-year career designing for luxury, hardening a home against wildfire has brought a new kind of luxury to his homes: peace of mind.
It’s a sentiment that resonates with fire survivors: Tavangarian says he’s received considerable interest from other property owners in the Palisades looking to rebuild their houses.
The metal shutters and advanced outdoor sprinkler system are the flashiest parts of Tavangarian’s home hardening project, and the efficacy of these adaptations is still up for debate. Because the measures have not yet been widely adopted, there are few studies exploring how much or little they protect homes in real-world fires.
Architect Ardie Tavangarian inside the house he designed.
Anecdotal evidence has indicated the effectiveness of sprinklers can vary significantly based on the setup and the conditions during the fire. Extreme wind, for example, can make them less effective. Lab studies have generally found shutters can reduce the risk of windows shattering.
These measures aren’t cheap, either. Sprinkler systems can cost north of $100,000, for example. However, Tavangarian said when all was said and done, the home he built for his daughters cost around $700 per square foot — less than what Palisades residents said they expected to pay, but more than what Altadena residents expected for their rebuilds.
Tavangarian also hopes to see insurers increasingly consider the home-hardening measures property owners take when writing policies, which he said could potentially offset the extra cost in a decade or less. As he explored getting insurance for the new home, one insurer quoted him $80,000 a year. After he convinced the company to visit the property, it lowered the quote to just $13,000, he said.
The house includes metal heat shields that can drop down if a fire approaches.
The home also has essentially all of the other less flashy — but much cheaper and well-proven — home hardening measures recommended by fire professionals: The underside of the roof’s overhang is closed off — a common place embers enter a home. The roof, where burning embers can accumulate, is made of fire-resistant material. The windows, vulnerable to shattering in extreme heat, are made of a toughened glass. There is virtually no vegetation within the first five feet of the home.
When asked if he felt he had compromised on design, comfort or aesthetics for the extra protection — one of the many concerns Californians have with the state’s draft “Zone Zero” requirements that may significantly limit vegetation within five feet of a home — Tavangarian simply said, “You be the judge.”
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