FDA Bans Red Dye 3 in Foods, Linking It to Cancer in Rats

Consumer and food safety groups have long urged the agency to revoke the use of this dye and others. The F.D.A. says there still is no evidence it is a human carcinogenic.The Food and Drug Administration on Wednesday banned the use of Red Dye No. 3 in food, beverages and drugs, more than three decades after the synthetic coloring was first found to cause cancer in male laboratory rats.The dye, a petroleum-based additive, has been used to give candy, soda and other products their vibrant cherry red hue. Consumer advocates said the F.D.A.’s decision to revoke the authorization was long overdue, given the agency’s decision in 1990 to ban the chemical for use in cosmetics and topical drugs.Under federal rules, the F.D.A. is prohibited from approving food additives that cause cancer in humans or animals.“This is wonderful news and long overdue,” said Melanie Benesh, vice president for government affairs at the Environmental Working Group, one of several organizations that petitioned the agency to take action on the additive. “Red Dye 3 is the lowest of the low-hanging fruit when it comes to toxic food dyes that the F.D.A. should be addressing.”Beginning in 2027, companies would have to start removing the dye from their products. Imported foods would also have to lose the additive to be sold in the United States.Although the dye is still used in hundreds of products, many companies have been switching to other food colorings, a move that accelerated after California in 2023 became the first state to ban Red 3 along with three other food additives that have been linked to disease. The dye has also been linked to health concerns for children.In announcing the ban, the agency downplayed the risks to humans, saying that researchers had not found similar cancer risks in studies involving animals other than male rats. Claims that the use of Red Dye No. 3 “in food and in ingested drugs puts people at risk are not supported by the available scientific information,” Jim Jones, the F.D.A.’s deputy commissioner for human foods, said in a statement.Sarah Gallo, senior vice president of product policy and federal affairs for the Consumer Brands Association, a trade group, said food and beverage companies would comply with the agency’s decision. “Revoking the authorized use of Red No. 3 is an example of the F.D.A. using its risk and science-based authority to review the safety of products in the marketplace,” she said.First approved for use in food in 1907, Red Dye No. 3 was banned in cosmetics in 1990 by U.S. regulators. At the time, the F.D.A. cited an industry-conducted study that found that the chemical caused thyroid cancer in male rats but estimated that it might cause cancer in fewer than one in 100,000 people. Along with prohibiting the dye in cosmetics, the agency pledged to do the same with food.Artificial dyes and food additives have been a primary target for Robert F. Kennedy Jr., President-elect Donald J. Trump’s pick for health secretary whose confirmation hearings before the Senate are set to begin soon.

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FDA Moves Forward With Last-Minute Push to Cut Nicotine Levels in Cigarettes

In the final days of the Biden administration, the F.D.A. is moving ahead with a proposal to require companies to produce a less addictive product for traditional smokers.The Biden administration unveiled a proposal on Wednesday to cut the level of nicotine in cigarettes, a last-minute push on a plan that could meaningfully cut cancer rates nationwide and extend the lives of millions of cigarette smokers.If finalized, the proposal would require cigarette makers to significantly reduce the levels of nicotine in their products in an effort to make smoking less addictive and less satisfying. Research has suggested that the move would result in fewer people taking up the habit and would help the nation’s roughly 30 million smokers quit or switch to less harmful alternatives like e-cigarettes.The policy is a centerpiece of antismoking initiatives by Dr. Robert Califf, commissioner of the Food and Drug Administration, who has recounted treating cardiology patients ravaged by smoking during his medical career. “It’s the biggest thing I’ve ever seen in terms of societal benefit, cost saving and lives saved, and strokes prevented and cancers prevented,” Dr. Califf said.The policy’s companion effort to ban menthol cigarettes has been set aside indefinitely after vehement opposition from cigarette makers and other opponents, including convenience store retailers.Whether the nicotine reduction plan would survive the incoming administration of President-elect Donald J. Trump is unclear. Mr. Trump has traditionally been industry friendly and opposed to heavily regulating businesses. In addition, he has had the support of tobacco companies, including Reynolds American, which contributed at least $8 million to Mr. Trump’s main super PAC during the presidential campaign. Reynolds has already expressed its opposition to the proposed requirement.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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How a Company Makes Millions Off a Hospital Program Meant to Help the Poor

A private business has helped supercharge a controversial federal drug program. Patients and insurers have been left with big bills.Soon after being diagnosed with metastatic breast cancer, Virginia King sat in an outpatient clinic in Santa Fe, N.M, while a nurse injected her with a powerful drug to slow damage to her spine, where the disease had spread.Even though the drug had a list price of about $2,700, the hospital that owned the cancer center billed Mrs. King’s insurance company $22,700. Her insurer paid $10,000, but the hospital wanted more.She got a bill for over $2,500 — “more than half my take-home salary for a month,” said Mrs. King, 65.She had unknowingly sought care from a hospital that participates in a federal program allowing it to buy drugs at a steep discount and charge patients and insurers a higher amount, keeping the difference.The intention behind the program was for a small number of safety-net providers to have access to affordable drugs and be able to expand their care for needy patients. But instead, the program has exploded: Now, more than half of nonprofit hospitals in the United States take part. While some providers say it has helped keep their doors open, others — especially large nonprofit health systems — have been accused of maximizing payouts and swallowing the profits.The program’s escalation has driven up health care costs for employers, patients and taxpayers, studies show.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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Online Therapy Boom Has Mainly Benefited Privileged Groups, Studies Find

Digital mental health platforms were supposed to expand access for the neediest patients. Researchers say that hasn’t happened.The number of Americans receiving psychotherapy increased by 30 percent during the pandemic, as virtual sessions replaced in-person appointments — but new research dampens the hope that technology will make mental health care more available to the neediest populations.In fact, the researchers found, the shift to teletherapy has exacerbated existing disparities.The increase in psychotherapy has occurred among groups that already enjoyed more access: people in higher-income brackets, living in cities, with steady employment and more education, researchers found in a series of studies, the most recent of which was, published Wednesday in The American Journal of Psychiatry.Among those who have not benefited from the boom, the team found, are children from low-income families, Black children and adolescents, and adults with “serious psychological distress.”“I think that the whole system of care — and maybe the internet delivery is a piece of this — appears to be pivoting away from those in greatest need,” said Dr. Mark Olfson, a professor of psychiatry at Columbia University Irving Medical Center and the lead author of the studies on access to care.“We’re seeing that those with the greatest distress are losing ground, in terms of their likelihood of being treated, and that to me is a very important and disconcerting trend,” he added.It wasn’t supposed to be this way. In the 1990s, teletherapy was championed as a way to reach disadvantaged patients living in remote locations where there were few psychiatrists. A decade later, it was presented as a more accessible alternative to face-to-face sessions, one that could radically lower barriers to care.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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Kate Middleton Is in Cancer Remission. It Doesn’t Always Mean the Illness Is Cured.

While the announcement is good news for the Princess of Wales, cancer experts describe the challenges of a life shadowed by an earlier diagnosis.Princess Catherine, wife of Prince William, reported on Tuesday that her cancer was in remission. But what does it mean to be in remission from cancer?Doctors discovered her cancer unexpectedly last March when she had abdominal surgery. She has not revealed the type kind of cancer she has, nor how advanced it was when it was discovered.But she did say she had chemotherapy, which she said had been completed in September. She told the British news agency PA Media that she had a port, a small device that is implanted under the skin and attached to a catheter that goes into a large vein. It allows medicines like chemotherapy drugs to be delivered directly to veins in the chest, avoiding needle sticks.Catherine told PA Media that chemotherapy was “really tough.”“It is a relief to now be in remission and I remain focused on recovery,” she wrote on Instagram.Her announcement “certainly is good news and is reassuring,” said Dr. Kimmie Ng, associate chief of the division of gastrointestinal oncology at the Dana-Farber Cancer Institute in Boston.But cancer experts like Dr. Ng say that the meaning of remission in a patient can vary.In general, when doctors and patients talk about remission, they mean there is no evidence of cancer in blood tests or scans.The problem is that a complete remission does not mean the cancer is gone. Even when a cancer is “cured” — defined as no evidence of cancer for five years — it may not be vanquished.That makes life emotionally difficult for patients, who have to have frequent visits with oncologists for physical exams, blood tests and imaging.“It’s really scary,” Dr. Ng said. “The amount of uncertainty is very very hard,” she added.But that ongoing surveillance is necessary, despite the toll it takes on patients.“Different cancers have different propensities of returning or not returning,” said Dr. Elena Ratner, a gynecologic oncologist at the Yale Cancer Center.As many as 75 to 80 percent of ovarian cancers, she noted, can come back in an average of 14 to 16 months after a remission, depending on the stage the cancer had reached when it was found and on the cancer’s biology.“Once the cancer returns, it becomes a chronic disease,” Dr. Ratner said. She tells her patients: “You will live with this cancer. You will be on and off chemotherapy for the rest of your life.”Dr. Ratner’s gynecological cancer patients have to come back every three months for CT scans to keep an eye out for evidence that the cancer has returned.“The women live CT scan to CT scan,” she said. “They say that for two and a half months, they have a wonderful life, but then, in time for the next CT scan, the fear returns.”“It costs them — it costs them a lot,” she said.“It’s awful, yet I am amazed every day by their strength,” she said of her patients.

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New Obesity Definition Challenges Current Use of B.M.I.

An international commission made the case for focusing on body fat quantity and the illnesses people experience.Obesity should be assessed in a way that goes beyond the standard measure of body mass index, or B.M.I., according to a new definition of the condition released by an international commission.Its report, published Tuesday in The Lancet Diabetes & Endocrinology journal, makes the case for focusing on how much body fat and what medical complications the person has, not just their weight.If the guidelines are widely adopted, they could change doctors’ perceptions of who needs to be treated for obesity. They could also affect the use of prescription drugs that treat obesity, like Wegovy and Zepbound. The new definition of obesity was endorsed by 76 organizations around the world.The commission proposed that instead of continuing the current use of B.M.I. — as a way to define obesity — it should be a screening tool to determine who should be tested for excess body fat.The commission said that people who had a B.M.I. over 25 and too much fat, but who are otherwise healthy, should pretty much be left alone. They should be monitored and counseled not to gain any more weight and possibly to lose some.Their condition would be called pre-clinical obesity.Other people with any of the 18 medical conditions caused by obesity — 13 for children and adolescents — require medical treatment to improve their health and prevent serious injuries to organs. The conditions include breathlessness, heart failure, hip or knee pain, metabolic abnormalities and poorly functioning organs.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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F.D.A. Proposes New Food Labels to Detail Sugar, Fat and Salt Content

The agency issued designs for front-of-package lists that food companies would be required to include.The Food and Drug Administration on Tuesday proposed requiring new nutrition labels on the front of food and beverage products, a long-awaited move aimed at changing eating habits associated with soaring rates of obesity and diet-related illness that are responsible for a million deaths each year.The new label, a small black-and-white box similar to the Nutrition Facts box on the back of packaged goods, is designed to help consumers quickly understand which products contain excessive amounts of sugar, salt and saturated fat. Those three nutrients are implicated in the nation’s skyrocketing rates of Type 2 diabetes, heart disease and high blood pressure.More than 60 percent of American adults suffer from those three chronic illnesses, which are estimated to account for $4.5 trillion in annual health care costs, according to the F.D.A.In contrast to the mandatory back-of-package Nutrition Facts panels, which list a product’s ingredients, calorie count and serving size, the front-of-package labels would rank the contents of sugar, fat and salt as high, medium or low to indicate whether the amounts exceed or fall short of the recommended daily values set by the F.D.A.“Nearly everyone knows or cares for someone with a chronic disease that is due, in part, to the food we eat,” Dr. Robert Califf, the commissioner of the F.D.A., said in a statement. “It is time we make it easier for consumers to glance, grab and go.”The proposal follows three years of research by agency scientists, who considered the front-of-package labels used by other countries. After reviewing studies on the effectiveness of those labels, the F.D.A. tested prospective designs with focus groups to determine whether the information they conveyed was easy to comprehend.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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