{"id":4451,"date":"2025-03-17T09:00:00","date_gmt":"2025-03-17T09:00:00","guid":{"rendered":"https:\/\/medical-article.com\/?p=4451"},"modified":"2025-03-17T09:00:00","modified_gmt":"2025-03-17T09:00:00","slug":"scientist-whose-work-led-fda-to-ban-food-dye-says-agency-overstated-risk","status":"publish","type":"post","link":"https:\/\/medical-article.com\/?p=4451","title":{"rendered":"Scientist Whose Work Led FDA To Ban Food Dye Says Agency Overstated Risk"},"content":{"rendered":"

When the FDA announced in January<\/a>, before President Joe Biden\u2019s 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.<\/p>\n

The industry-funded study<\/a>, based on data from two prior studies, was led by a Virginia toxicologist who said then \u2014 and still believes today, decades after concerns first arose that the chemical could be carcinogenic \u2014 that his research found the petroleum-derived food coloring doesn\u2019t cause cancer in humans.<\/p>\n

\u201cIf I thought there was a problem, I would have stated it in the paper,\u201d Joseph Borzelleca<\/a>, 94, a professor emeritus of pharmacology and toxicology at Virginia Commonwealth University, told KFF Health News after the FDA\u2019s announcement. \u201cI have no problem with my family \u2014 my kids and grandkids \u2014 consuming Red 3. I stand by the conclusions in my paper that this is not a problem for humans.\u201d<\/p>\n

Soon after Borzelleca\u2019s 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.<\/p>\n

In 1992, the FDA said it wanted to revoke approval of Red 3 in food and drugs. But the agency didn\u2019t act at the time, citing a lack of resources.<\/p>\n

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\u2019s nominee to head the Department of Health and Human Services, which oversees the FDA.<\/p>\n

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\u2019t eliminate artificial food dyes from their products, the federal government will force them to do so, Food Fix reported<\/a>.<\/p>\n

Consumer advocacy groups cheered the Red 3 ban, even as the FDA said there is no evidence that the dye is dangerous to people. \u201cImportantly, the way that FD&C Red No. 3 causes cancer in male rats does not occur in humans,\u201d Jim Jones<\/a>, FDA deputy commissioner for human foods, said in a statement.<\/p>\n

Jones resigned from FDA in February, criticizing Trump administration cuts<\/a> that he said hobbled his office.<\/p>\n

The FDA did not respond to a request for comment, but Marty Makary, Trump\u2019s 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.<\/p>\n

\u201cIt did not make sense that red dye No. 3 was banned in cosmetics but allowed in the food supply,\u201d Makary told Sen. Tommy Tuberville, who questioned why the FDA ban doesn\u2019t take effect until 2027.<\/p>\n

\u201cWe want to kill people for two more years?\u201d the Alabama Republican said. \u201cI would hope that you would, if you\u2019re confirmed, you\u2019d go in and look at it very quickly and say, \u2018Why do we want to put our people in harm\u2019s way?\u2019\u201d<\/p>\n

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\u2019s an ingredient in thousands of products including cereals, candy, beverages, and cake toppings.<\/p>\n

Thomas Galligan<\/a>, 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.)<\/p>\n

\u201cAt the end of the day, this is an unnecessary additive,\u201d he said. \u201cIt\u2019s 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.\u201d<\/p>\n

Galligan said he was not surprised Borzelleca\u2019s opinion on Red 3 had not changed or that the food dye industry has played down the risk.<\/p>\n

In October 2023, California became the first state to ban Red 3 in food starting in 2027, superseding the FDA\u2019s earlier rule allowing small amounts in foods as a color additive. The state legislature acted after a state analysis<\/a> concluded the dye could cause hyperactivity in children.<\/p>\n

The European Union, Australia, and Japan are among the locations that already ban the chemical in foods. The EU\u2019s ban also cites hyperactivity in children. The EU requires food makers to include a warning that food dyes that are still allowed may \u201chave an adverse effect on activity and attention in children.\u201d<\/p>\n

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

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.<\/p>\n

It isn\u2019t clear how the FDA determined that Red 3 can cause cancer in male rats. Borzelleca\u2019s paper said some rats that were fed Red 3 developed polyps in their thyroid gland but doesn\u2019t mention cancer.<\/p>\n

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.<\/p>\n

\u201cI am surprised all this time has gone by and it\u2019s been safe for human use, and now it\u2019s being pulled from the market due to concerns not supported by the data,\u201d Borzelleca said. \u201cOur study did not find this was a carcinogen.\u201d<\/p>\n

His study was a response to the FDA\u2019s 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.<\/p>\n

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.<\/p>\n

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

KFF Health News<\/a> is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF\u2014an independent source of health policy research, polling, and journalism. Learn more about KFF<\/a>.<\/p>\n

USE OUR CONTENT<\/h3>\n

This story can be republished for free (details<\/a>).<\/p>","protected":false},"excerpt":{"rendered":"

When the FDA announced in January, before President Joe Biden\u2019s 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. The industry-funded study, based on data from two prior studies, was led by…<\/p>\n","protected":false},"author":0,"featured_media":4452,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[],"class_list":["post-4451","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles"],"_links":{"self":[{"href":"https:\/\/medical-article.com\/index.php?rest_route=\/wp\/v2\/posts\/4451"}],"collection":[{"href":"https:\/\/medical-article.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medical-article.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"replies":[{"embeddable":true,"href":"https:\/\/medical-article.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=4451"}],"version-history":[{"count":0,"href":"https:\/\/medical-article.com\/index.php?rest_route=\/wp\/v2\/posts\/4451\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medical-article.com\/index.php?rest_route=\/wp\/v2\/media\/4452"}],"wp:attachment":[{"href":"https:\/\/medical-article.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4451"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medical-article.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=4451"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medical-article.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=4451"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}