Scientist whose work led FDA to ban food dye says agency overstated risk

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By Phil Galewitz, KFF Health News

When the FDA announced in January, before President Joe Biden’s term ended, that it would ban a dye called red dye No. 3 in food and ingested drugs, the federal agency cited just one 1987 study on rats to support its action.

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The industry-funded study, based on data from two prior studies, was led by a Virginia toxicologist who said then — and still believes today, decades after concerns first arose that the chemical could be carcinogenic — that his research found the petroleum-derived food coloring doesn’t cause cancer in humans.

“If I thought there was a problem, I would have stated it in the paper,” Joseph Borzelleca, 94, a professor emeritus of pharmacology and toxicology at Virginia Commonwealth University, told KFF Health News after the FDA’s announcement. “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.”

Soon after Borzelleca’s paper was published in a scientific journal, Food and Chemical Toxicology, the FDA examined the data his team had collected and reached its own conclusion: that the dye caused cancer in male lab rats. In 1990, the FDA cited the study in banning Red 3 in cosmetics.

In 1992, the FDA said it wanted to revoke approval of Red 3 in food and drugs. But the agency didn’t act at the time, citing a lack of resources.

More than 30 years later, after a renewed push by consumer advocates, the Biden administration announced the ban in its last days in power. The move came just weeks before the Senate confirmed Robert F. Kennedy Jr., President Donald Trump’s nominee to head the Department of Health and Human Services, which oversees the FDA.

Kennedy has been a vocal critic of food additives, including Red 3. On March 10 he met with top food industry executives and told them if they don’t eliminate artificial food dyes from their products, the federal government will force them to do so, Food Fix reported.

Consumer advocacy groups cheered the Red 3 ban, even as the FDA said there is no evidence that the dye is dangerous to people. “Importantly, the way that FD&C Red No. 3 causes cancer in male rats does not occur in humans,” Jim Jones, FDA deputy commissioner for human foods, said in a statement.

Jones resigned from FDA in February, criticizing Trump administration cuts that he said hobbled his office.

The FDA did not respond to a request for comment, but Marty Makary, Trump’s nominee to lead the agency, said at his Senate confirmation hearing on March 6 that he is concerned about whether food additives such as Red 3 harm children.

WASHINGTON, DC – MARCH 06: Dr. Martin Makary, President Donald Trump’s nominee to lead the Food and Drug Administration testifies during his confirmation hearing before the Senate Committee on Health, Education, Labor, and Pensions Committee at the Dirksen Senate Office Building on March 06, 2025 in Washington, DC. Dr. Makary is a cancer surgeon, researcher at Johns Hopkins University, and has also been a Fox News commentator. (Photo by Kayla Bartkowski/Getty Images)

“It did not make sense that red dye No. 3 was banned in cosmetics but allowed in the food supply,” Makary told Sen. Tommy Tuberville, who questioned why the FDA ban doesn’t take effect until 2027.

“We want to kill people for two more years?” the Alabama Republican said. “I would hope that you would, if you’re confirmed, you’d go in and look at it very quickly and say, ‘Why do we want to put our people in harm’s way?’”

The International Association of Color Manufacturers says Red 3 is safe in the tiny levels typically consumed by humans. The dye was approved for use in foods in the U.S. in 1907, and today it’s an ingredient in thousands of products including cereals, candy, beverages, and cake toppings.

Thomas Galligan, principal scientist for food additives and supplements at the Center for Science in the Public Interest, which petitioned the FDA for a ban, said that a federal regulation known as the Delaney Clause prohibits any ingredient that causes cancer in animals from being included in foods. (The publisher of KFF Health News, David Rousseau, is on the CSPI board.)

“At the end of the day, this is an unnecessary additive,” he said. “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.”

Galligan said he was not surprised Borzelleca’s opinion on Red 3 had not changed or that the food dye industry has played down the risk.

In October 2023, California became the first state to ban Red 3 in food starting in 2027, superseding the FDA’s earlier rule allowing small amounts in foods as a color additive. The state legislature acted after a state analysis concluded the dye could cause hyperactivity in children.

The European Union, Australia, and Japan are among the locations that already ban the chemical in foods. The EU’s ban also cites hyperactivity in children. The EU requires food makers to include a warning that food dyes that are still allowed may “have an adverse effect on activity and attention in children.”

The IACM points to research by scientific committees operated by the World Health Organization, including a 2018 review that affirmed the safety of Red 3 in food.

Some food manufacturers have already reformulated products to remove Red 3. In its place they use beet juice; carmine, a dye made from insects; or pigments from foods such as purple sweet potato, radish, and red cabbage.

It isn’t clear how the FDA determined that Red 3 can cause cancer in male rats. Borzelleca’s paper said some rats that were fed Red 3 developed polyps in their thyroid gland but doesn’t mention cancer.

Borzelleca, whose study was funded by the IACM, then known as the Certified Color Manufacturers Association, said he was stunned the FDA banned the dye and used his research to back the move.

“I am surprised all this time has gone by and it’s been safe for human use, and now it’s being pulled from the market due to concerns not supported by the data,” Borzelleca said. “Our study did not find this was a carcinogen.”

His study was a response to the FDA’s requirement in the 1980s for additional long-term feeding studies in rats and mice as a condition for the continued provisional approval of several color additives, including Red 3.

Over decades, Borzelleca published dozens of research papers on the toxicology of food additives, pesticides, and water contaminants. He also served on advisory boards for the tobacco industry and represented cigarette maker R.J. Reynolds in negotiations with the Department of Health and Human Services about cigarette additives, according to a 1984 corporate memo. Borzelleca is a former president of the Society of Toxicology and consulted for the National Academy of Sciences and the World Health Organization.

The commonwealth of Virginia gave him a lifetime achievement award in 2001 for his work helping assess dangers in foods, drugs, and pesticides.

Phil Galewitz: pgalewitz@kff.org@philgalewitz

From France comes a call for Trump’s America to return Lady Liberty. Here’s why it won’t happen

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PARIS (AP) — Hey, America: Give the Statue of Liberty back to France.

So says a French politician who is making headlines in his country for suggesting that the U.S. is no longer worthy of the monument that was a gift from France nearly 140 years ago.

As a member of the European Parliament and co-president of a small left-wing party in France, Raphaël Glucksmann cannot claim to speak for all of his compatriots.

But his assertion in a speech this weekend that some Americans “have chosen to switch to the side of the tyrants” reflects the broad shockwaves that U.S. President Donald Trump’s seismic shifts in foreign and domestic policy are triggering in France and elsewhere in Europe.

“Give us back the Statue of Liberty,” Glucksmann said, speaking Sunday to supporters of his Public Place party, who applauded and whistled.

“It was our gift to you. But apparently you despise her. So she will be happy here with us,” Glucksmann said.

Can France claim it back?

Dream on.

UNESCO, the United Nations’ cultural arm that has the statue on its list of World Heritage treasures, notes that the iconic monument is U.S. government property.

It was initially envisaged as a monumental gesture of French-American friendship to mark the 100th anniversary of the July 4, 1776, Declaration of Independence.

But a war that erupted in 1870 between France and German states led by Prussia diverted the energies of the monument’s designer, French sculptor Frédéric-Auguste Bartholdi.

The gift also took time to be funded, with a decision taken that the French would pay for the statue and Americans would cover the costs of its pedestal.

Transported in 350 pieces from France, the statue was officially unveiled Oct. 28, 1886.

Is France’s government offering asylum to Lady Liberty?

No. French-U.S. relations would have to drop off a cliff before Glucksmann found support from French President Emmanuel Macron’s government.

For the moment, the French president is treading a fine line — trying to work with Trump and temper some of his policy shifts on the one hand but also pushing back hard against some White House decisions, notably Trump’s tariff hikes.

Macron has let his prime minister, François Bayrou, play the role of being a more critical voice. Bayrou tore into the “brutality” that was shown to Ukrainian President Volodymyr Zelenskyy during his White House visit and suggested that Trump’s administration risked handing victory to Russia when it paused military aid to Ukraine.

Glucksmann’s party has been even more critical, posting accusations on its website that Trump is wielding power in an “authoritarian” manner and is “preparing to deliver Ukraine on a silver platter” to Russia.

In his speech, Glucksmann referenced New York poet Emma Lazarus’ words about the statue, the “mighty woman with a torch” who promised a home for the “huddled masses yearning to breathe free.”

“Today, this land is ceasing to be what it was,” Glucksmann said.

Scientists say NIH officials told them to scrub mRNA references on grants

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By Arthur Allen, KFF Health News

National Institutes of Health officials have urged scientists to remove all references to mRNA vaccine technology from their grant applications, two researchers said, in a move that signaled the agency might abandon a promising field of medical research.

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The mRNA technology is under study at the NIH for prevention and treatment of infectious diseases, including flu and AIDS, and also cancer. It was deployed in the development of covid-19 vaccines credited with saving 3 million lives in the U.S. alone — an accomplishment President Donald Trump bragged about in his first term.

A scientist at a biomedical research center in Philadelphia wrote to a colleague, in an email reviewed by KFF Health News, that a project officer at NIH had “flagged our pending grant as having an mRNA vaccine component.”

“It’s still unclear whether mRNA vaccine grants will be canceled,” the scientist added.

NIH officials also told a senior NIH-funded vaccine scientist in New York state, who does not conduct mRNA vaccine research but described its efficacy in previous grant applications, that all references to mRNA vaccines should be scrubbed from future applications.

Scientists relayed their experiences on the condition of anonymity for fear of professional retaliation by the Trump administration.

A senior official at the National Cancer Institute confirmed that NIH acting Director Matthew Memoli sent an email across the NIH instructing that any grants, contracts, or collaborations involving mRNA vaccines be reported up the chain to Health and Human Services Secretary Robert F. Kennedy Jr.’s office and the White House.

Memoli sent a similar message ahead of the agency canceling other research, such as studies of vaccine hesitancy.

Memoli’s email on that topic bluntly stated that NIH was not interested in learning why people shun vaccines or in exploring ways to “improve vaccine interest and commitment.”

The National Cancer Institute official, who also spoke on the condition of anonymity for fear of reprisals, said that “it is reasonable to assume mRNA vaccine work is next.”

The official said a similar memo also went out regarding NIH-funded work in South Africa, which the White House has targeted over false claims that the country’s government is persecuting white people. More recently, another one went out regarding all global research collaborations, the official said.

Spokespeople for the White House, HHS, and the NIH did not respond to requests for comment.

The NIH, whose latest annual budget was $47 billion, is one of the world’s most critical sources of funding for basic biomedical research. Its mission and programs are under unprecedented scrutiny from Trump’s White House and the Department of Government Efficiency, the Elon Musk-led agency created by a Trump executive order that has directed federal agencies to prepare for widespread layoffs.

The NIH is funding at least 130 studies involving the mRNA technology in covid vaccines produced by Pfizer-BioNTech and Moderna that have been administered to billions of people worldwide.

A former government official familiar with internal discussions said that the Trump administration intends to cut some grants for mRNA vaccine research but that the timing is unclear. The person spoke on the condition of anonymity to protect relationships with the administration.

Political conservatives in the U.S. have promulgated conspiracy theories, unsupported by scientific evidence, that the shots and their relatively new technology are dangerous. This has undermined public support for covid vaccinations and mRNA research.

“There will not be any research funded by NIH on mRNA vaccines,” the scientist in New York said in an interview. “MAGA people are convinced that these vaccines have killed and maimed tens of thousands of people. It’s not true, but they believe that.”

Meanwhile, hundreds of other vaccine-related studies are in limbo. Kawsar Talaat, a vaccine researcher at the Bloomberg School of Public Health at Johns Hopkins University, has been waiting since the fall for money needed to recruit subjects for a study of an antidiarrheal vaccine.

“NIH approved our funding,” she said, “and now we’re waiting, and we don’t know if it’s going forward or going to be killed.”

The scientist in Philadelphia signaled that he believes Kennedy, a longtime anti-vaccine activist, is responsible for the NIH’s turn against mRNA research.

“Kennedy’s war on vaccines has started,” the scientist told his colleague.

The scientist in New York said that it was “ridiculous” to remove mRNA language from the grant applications. But “if my grant is rejected for any reason,” the scientist said, “people in my lab will lose their jobs.”

“I’ve worked with some of them for 20 years,” the scientist added. “They have children and families. There is a real climate of fear in academia about this now, especially among vaccine scientists.”

“My grant does not involve a request for funds to conduct mRNA vaccine experiments,” the scientist said, “so my principal concern was to avoid word-search flags that, at minimum, would lead to delays in any funding.”

While tenured research professors at universities generally receive a salary from their institution, the staffers who work in their labs and offices are often paid through NIH grants. The 2023 Nobel Prize in physiology or medicine was given to two scientists for developing mRNA vaccines, through work that relied on pharmaceutical companies and on NIH scientists working under infectious disease specialist Anthony Fauci.

According to Sen. Bill Cassidy, a Louisiana Republican who chairs the chamber’s Health, Education, Labor and Pensions Committee, Kennedy promised during his Senate confirmation process that he would protect “the public health benefit of vaccination” and “work within the current vaccine approval and safety monitoring systems, and not establish parallel systems.”

Cassidy, a physician, had expressed reservations about confirming Kennedy to the HHS post and challenged his anti-vaccine views during a confirmation hearing. He ended up voting for him, he said, because Kennedy had agreed to work closely with Cassidy and his committee.

WASHINGTON, DC – FEBRUARY 13: Robert F. Kennedy Jr. listens as U.S. President Donald Trump speaks before Kennedy is sworn in as Secretary of Health and Human Services in the Oval Office at the White House on February 13, 2025 in Washington, DC. Kennedy, who faced criticism for his past comments on vaccine, was confirmed by the Senate 52 to 48. Former Senate Republican Leader Mitch McConnell (R-KY) was the only Republican to vote against him. (Photo by Andrew Harnik/Getty Images)

However, Kennedy has faced scrutiny in his first weeks in office for his handling of a large measles outbreak among mostly unvaccinated people in Texas that has led to the death of a child, the first U.S. measles death in more than a decade. A patient who tested positive for measles died in New Mexico, but the cause hasn’t been confirmed. Instead of urging vaccination against the disease, an almost surefire way to prevent infection, Kennedy has blamed malnourishment for the outbreak, promoted unproven treatments for measles, and falsely claimed in one Fox News interview that the vaccine is ineffective and even dangerous.

Cassidy did not respond to a request for comment on the NIH’s potential abandonment of mRNA vaccine research.

As part of the Trump administration’s push to examine spending on mRNA vaccines, health officials are reviewing a $590 million contract for bird flu shots that the Biden administration awarded to Moderna, Bloomberg News has reported. Legislation introduced by GOP lawmakers in at least seven states is aimed at banning or limiting mRNA vaccines. In some cases, the measures would hit doctors who give the injections with criminal penalties, fines, and the possible revocation of their licenses.

Stephanie Armour and Céline Gounder contributed to this article.

We’d like to speak with current and former personnel from the Department of Health and Human Services or its component agencies who believe the public should understand the impact of what’s happening within the federal health bureaucracy. Please message KFF Health News on Signal at (415) 519-8778 or get in touch here.

Arthur Allen: aallen@kff.org@ArthurAllen202

Prosecutors say Minnesota man accused of hiding stolen ruby slippers from ‘The Wizard of Oz’ is dead

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A federal judge dismissed the charges Monday against a Minnesota man accused of hiding a stolen pair of ruby slippers that Judy Garland wore in the 1939 musical “The Wizard of Oz” after prosecutors informed the court that he died on Sunday.

Jerry Hal Saliterman, 77, of Crystal, who had been in poor health with lung disease and other ailments, had been scheduled to change his plea to guilty in January but that hearing was postponed indefinitely after he was hospitalized.

FILE – Jerry Hal Saliterman, of Crystal, Minn., is wheeled out of U.S. District Court in St. Paul, Minn., Friday, March 15, 2024, after he made his initial appearance on charges connected to the 2005 theft of a pair of ruby slippers worn by Dorothy in “The Wizard of Oz.” (AP Photo/Steve Karnowski, file)

Federal prosecutor Matthew Greenley notified the court in a one-page motion Monday that Saliterman died Sunday but did not say how or where. U.S. District Judge Patrick Schiltz granted the request and dropped the charges.

Defense attorney John Brink confirmed Monday that his client had died but declined to give details. A spokesman for the U.S. Attorney’s Office in Fargo, North Dakota, which is handling the case, did not immediately return a phone call seeking further information.

According to court filings, Saliterman was hospitalized in early January “for inability to walk and sepsis,” an infection that can be life-threatening. He attended his arraignment three days later via video from what looked like a hospital room. In an update to the court late last month, Brink told the court that his client had been discharged to a hospice facility and that his prognosis was poor. An accompanying letter from his doctor listed severe chronic obstructive pulmonary disease requiring supplemental oxygen and Parkinson’s disease.

Saliterman was in a wheelchair and on oxygen last March when he made his first court appearance. He was charged then with theft of a major artwork and witness tampering for his role in the ruby slippers case.

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The sequined red slippers were stolen in 2005 from the Judy Garland Museum in her hometown of Grand Rapids. Their whereabouts remained a mystery for nearly 13 years until the FBI recovered them in 2018. They fetched a record for movie memorabilia of $32.5 million in December, according to Heritage Auctions. The slippers were one of several pairs Garland wore during the filming. Only three other pairs remain.

Terry Jon Martin, now 78, of Grand Rapids, used a hammer to smash the glass of the museum’s door and display case to steal them. According to his attorney, an old associate with connections to the mob told him the shoes had to be adorned with real jewels to justify their $1 million insured value. But he got rid of the slippers when he learned they were fake, and they ended up with Saliterman. Martin pleaded guilty in 2023 and was sentenced last January to time served because of his poor health.