Canned cherries made with red dye #3/Photo credit: Linnea Bullion For The Washington Post via Getty Images
(WASHINGTON) — The U.S. Food and Drug Administration is moving to ban the use of Red No. 3 dye in food products.
The agency said Wednesday it is amending its color additive regulations to no longer allow the use of Red No. 3 in food, beverages and ingested drugs, in response to a 2022 petition from health groups and activists.
FD&C Red No. 3, also known as Red 3, is a synthetic food dye that gives foods and drinks a bright, cherry-red color. It is primarily used in foods such as candy, cakes and cupcakes, cookies, frozen desserts, frosting and icings, and some ingested drugs.
At least two studies have shown that high levels of the food dye were linked to cancer in rats. However, the link between the dye and cancer does not occur in humans, the FDA says.
While studies in other animals and humans did not show this link of cancer, an FDA regulation prohibits the agency to authorize color additive found to induce cancer in humans or animals, pushing the agency to revoke the food dye’s authorization.
Food manufacturers will have until 2027 to reformulate their products while drugmakers will have until 2028.
FDA Commissioner Robert Califf was asked at a Senate hearing in December why the dye had not been banned. He said the FDA hasn’t been given the resources to do the kind of post-market monitoring of substances done in Europe, where it has been largely banned since 1994. The FDA also banned the use of Red 3 in cosmetics in 1990.
“We have repeatedly asked for better funding for chemical safety … Please look at our request for funding for the people who do this work, remember that when we do ban something, it will go to court, and if we don’t have the scientific evidence … we will lose in court,” Califf said at the hearing.
Red 40, another synthetic food dye used to achieve a bright crimson color in condiments and candy, will remain available for use. Some studies have also shown Red 40 is a carcinogen in animals.
Red No. 3 was first approved by the FDA in 1969 and had been reviewed “multiple times” since then, according to the agency.
ABC News’ Kelly McCarthy contributed to this report.
(NEW YORK) — The rates of late-stage breast cancer at diagnosis have risen among women in all racial and ethnic groups, but Black women have been hit the hardest, according to a new study published in the journal Radiology.
The study, which looked at data from 2004 to 2021, found that advanced breast cancer rates have risen among women of all ages, with the sharpest increases in young women aged 20 to 39, and women over 75.
Black women experience advanced diagnoses 55% more often than white women and are more likely to die from the disease, the study found.
While mammography does save lives by catching cancer earlier, fewer than 70% of eligible women are up to date on their screenings, the study found.
This trend is particularly alarming because early detection significantly improves survival. Five-year survival rates drop drastically from 99% for early-stage breast cancer to just 31% when the cancer is more advanced and has already spread to other parts of the body, the study found.
However, disparities persist despite Black women having similar self-reported mammography use rates as white women.
“Black women tend to have more aggressive breast cancers, including a higher rate of triple-negative breast cancers,” study co-author, Edward Hendrick, Ph.D., clinical professor of radiology at the University of Colorado told ABC News. “There may also be differences in how findings are acted upon, reflecting barriers to high-quality care.”
The COVID-19 pandemic made things worse as well, Hendrick noted, with many women skipping or delaying mammograms.
“Volumes at screening sites for the year 2020 were down as much as 90% from 2019 levels,” he said. “These missed screenings contributed to higher rates of advanced breast cancers in 2021 and likely subsequent years.”
The study also pointed to other possible reasons for the uptick in later-stage diagnoses.
“Obesity in post-menopausal women increases breast cancer risk, as does prolonged exposure to estrogen from early periods or late menopause,” explained study co-author, Debra L. Monticciolo, M.D., a professor of radiology at Texas A&M University.
She added that physicians could help by offering a breast cancer risk assessment to their patients starting at age 25. Identifying high-risk women early would help catch cancers sooner, she said.
Despite the concerning statistics, the study suggested that solutions are within reach. Increasing screening rates, expanding healthcare access, and ensuring follow-up care after abnormal mammograms could make a difference.
“Improving equity in care is critical to saving lives,” Monticciolo said. “By prioritizing access to care for all and emphasizing the importance of early detection, we believe this trend of rising late-stage diagnoses can be reversed.”
Late-stage breast cancer diagnoses are not just statistics — they reflect missed opportunities for prevention and early treatment, Hendrick added.
“We could benefit from greater public awareness of the importance of catching breast cancer at its earliest, most curable stages,” he said.
Breast cancer accounts for about one in three new cancer diagnoses in women every year, according to the latest American Cancer Society statistics. More than 40,000 American women die from the disease yearly.
Esther Zusstone, MD, is a radiology resident at NYU Langone, and a member of the ABC News Medical Unit.
(NEW YORK) — If you’re feeling hungover from New Year’s Eve champagne or had one too many boozy eggnogs over the holidays, let January be a fresh start.
Taking the challenge of going dry in January, or Dry January, i.e. having no alcohol for the entire month, is one resolution that might actually make you healthier.
The Dry January campaign was started in 2013 by Alcohol Change U.K., a charity focused on reducing alcohol harm. For the past several years, the initiative has proved popular in the United States and other countries too.
What are the health benefits of Dry January?
While research on how quitting alcohol for a month affects your body is still limited, several studies have shown psychological and health benefits.
Over one dozen staff members at the magazine New Scientist teamed up with researchers at the Institute for Liver and Digestive Health at the University College London Medical School in 2013 to investigate the benefits of Dry January.
The staff members, who all considered themselves “normal” drinkers, underwent baseline testing with blood samples, liver ultrasound scans and questionnaires. For the next five weeks, 10 of them stopped drinking and four drank their normal amounts.
The people who stopped drinking had lower levels of liver fat (which can be a precursor to liver damage), improved blood sugars and lower cholesterol than they did at the beginning of the month. They also reported improved sleep and concentration. In contrast, the four people who kept drinking saw no benefit.
Another study out of the U.K. had nearly 100 participants abstain from drinking alcohol for a month and another nearly 50 participants continue drinking alcohol as normal.
They found that moderate-heavy drinkers who took a break from alcohol had improved insulin resistance, weight, blood pressure, and cancer-related growth factors.
The researchers do warn, however, that the study does not show that a short-term ‘detox’ period is all that is required to ‘refresh’ the liver or achieve other health gains. Abstaining from alcohol for a month is only one part of addressing negative effects from longer-term alcohol consumption.
People who drink excessive amounts of alcohol are at higher risk of death and many medical conditions.
People who drink unhealthy amounts of alcohol are more likely to have high blood pressure, heart disease, liver disease, nerve damage, infections including pneumonia and even certain cancers like breast cancer.
Dr. Fulton Crews, director of the Center for Alcohol Studies at the University of North Carolina at Chapel Hill, said attempting to stop drinking for Dry January is a good opportunity for people to see if they have an actual addiction to alcohol.
“Many people are in denial about their drinking and hazardous drinking, and if they try to stop and are not able to, it really points out to them their weakness,” Crews told ABC News. “If they can’t stop for a month, they would realize that they have a problem.
“Either that or they do it, and they realize it’s not that hard for them,” said Crews, who described Dry January as a “good idea.”
Experts say Dry January may be especially helpful to those who consistently drink over the recommended amount of two drinks per day for men and one drink per day for women.
Excessive drinking includes binge drinking, defined as consuming five or more drinks for men in a single occasion and four or more drinks for women, and heavy drinking, defined as consuming 15 or more drinks per week for men or eight drinks or more for women). A standard drink is 12 ounces of a regular beer, 8 ounces of a malt liquor, 5 ounces of a glass of wine, and 1.5 ounces of a spirit, according to the Centers for Disease Control and Prevention.
For those individuals who drink alcohol within the recommended limits, Crews said he is “not sure there would be any observable benefits.”
“I don’t see any clear potential for a moderate drinking person to stop drinking,” he said.
If you do choose to participate in Dry January, Crews shared his advice for sticking to the program.
“Try to avoid temptation by maybe putting all the alcohol out of the house,” he said.
Does Dry January prompt bigger change for some?
Staying dry for January may also help jump-start people to give up alcohol for longer.
Although most people who participate in Dry January return to drinking, up to 8% stay dry six months later, according to Public Health England and the British Medical Journal.
And those who go back to drinking drink less. A 2015 study conducted in the U.K. and published in the journal Health Psychology found that people who participated in Dry January drank less often, had fewer drinks when they did drink and were drunk less often six months after Dry January was completed.
Dry January participants were also better able to refuse alcoholic drinks. These benefits were even seen in people who did not complete the whole month of Dry January.
It might seem daunting to stop drinking alcohol for a whole month. But a 2020 Alcohol and Alcoholism study found that nearly 70% of people completed the Dry January Challenge in 2019.
If you are concerned about yourself or a loved one, call the Substance Abuse and Mental Health Services Administration’s (SAMSA) confidential, free, 24-hour-a-day, 365-day-a-year helpline at 1-800-662-HELP (4357). For information and resources about alcohol-related problems and health, visit the website of the National Institute of Alcohol Abuse and Alcoholism (NIAAA) HERE.
Editor’s note: This piece was originally published on Jan. 3, 2018.
(NEW YORK) — From a pig kidney transplant to restoring genetic deafness, 2024 was a year full of medical breakthroughs.
The breakthroughs include the discovery of a cause of an autoimmune disease, the development of a “game-changing” drug and potential hope for those experiencing end-stage organ failure.
Here are five of the biggest highlights in medical achievements this year:
Gene therapy restores hearing in children
Children with hereditary deafness regained their hearing thanks to a type of gene therapy, according to the results of a clinical trial published in the medical journal The Lancet in January.
Investigators from Mass Eye and Ear, a specialty hospital in Boston, examined six children who had a form of genetic deafness called DFNB9, which is caused by a gene mutation that interferes with the transmission of sound signals from the ear to the brain.
Gene therapy involved the use of an inactive virus carrying a functioning version of the gene, which was introduced into the inner ears of the six children.
After 26 weeks, five of the six children recovered their hearing and could even conduct “normal conversation.”
“Children with this genetic hearing loss…the only treatment option for them until now is [a] cochlear implant,” Dr. Zheng-Yi Chen, an associate scientist in the Eaton-Peabody Laboratories at Mass Eye and Ear and study co-investigator, told ABC News. “And of course, [a] cochlear implant can help them tremendously, but it’s with its own limitations.”
“But with this gene therapy, the children regain hearing, and they were able to speak. So, in a way, the life is totally transformed,” he continued. “This study really opened up the whole field that, in the future, we’ll be able to develop a treatment for other [types] of genetic hearing loss, for which there is no treatment at all at the moment.”
Groundbreaking animal organ transplant
Surgeons at Massachusetts General Hospital (MGH) conducted the world’s first genetically-edited pig kidney transplant into a living human in March 2024.
During a four-hour procedure, a surgical team connected the pig kidney’s blood vessels and ureter – the duct that carries urine from the kidney to the bladder – with those of 62-year-old Richard Slayman, a man living with end-stage kidney disease.
“For patients with kidney failure, we know that transplantation is the best treatment option, but unfortunately, we face an immense organ shortage,” Dr. Leonardo Riella, medical director of kidney transplantation at MGH, told ABC News. “So, we have over 100,000 patients waiting for a kidney transplant in the U.S., and more than 17 patients die every day on the waiting list.”
“So, the idea here is, how can we overcome this organ shortage barrier? And having kidneys from another species that could be delivered in a timely manner for these patients once they develop kidney failure could be game-changing for the entire field,” he added.
Slayman passed away in May of this year, but there is no evidence it was the result of the transplant, according to MGH.
Riella said over the course of Slayman’s care, much was learned about how to best deliver care when using animal organs for transplants in the hopes of making the treatment more widely available to patients waiting for a new organ.
A cause of lupus discovered
A team at Brigham & Women’s Hospital and Northwestern Medicine said they have discovered a cause of the autoimmune disease lupus and a possible way to reverse it.
Lupus sees the body’s immune system mistakenly attack its own healthy cells and tissues, which can cause inflammation and damage in organs or systems, according to the Centers for Disease Control and Prevention.
In a study, published in the journal Nature in July, researchers compared blood samples from 19 lupus patients to 19 patients without the condition and found imbalances in the types of T-cells lupus patients produce.
T-cells are a certain type of white blood cell that plays a crucial role in the body’s immune response to the disease.
“We’ve identified a fundamental imbalance in the immune responses that patients with lupus make, and we’ve defined specific mediators that can correct this imbalance to dampen the pathologic autoimmune response,” co-corresponding author Dr. Deepak Rao, a rheumatologist at Brigham and Women’s Hospital and co-director of its Center for Cellular Profiling, said in a press release at the time.
1st new class of schizophrenia drug in more than 3 decades
In September, the FDA approved the first new class of drug to treat people with schizophrenia in more than 30 years.
The pill, called Cobenfy – manufactured by Bristol Myers Squibb – combines two drugs, xanomeline and trospium chloride, and is taken twice a day.
Clinical trials showed the combination helped manage schizophrenia symptoms such as hallucinations, delusions and disorganized thinking.
Dr. René Kahn, chair of psychiatry at the Icahn School of Medicine at Mount Sinai, said it took many years to develop the first medications for schizophrenia, which are effective in preventing psychosis and work by blocking dopamine receptors.
“Blocking the dopamine receptor directly or indirectly is very unpleasant. Sometimes for patients, they can have unpleasant side effects. It can decrease their energy, it can make them feel depressed, and it can give them Parkinsonian side effects,” Kahn told ABC News.
He described Cobenfy as “game-changing in the sense that this is the first drug that doesn’t directly – with the emphasis on directly – influence the dopamine system and certainly doesn’t block dopamine receptors. So that’s very important, because it may show that we don’t have to directly block or affect the dopamine system but can do that through a different mechanism.”
Kahn said the next step will be monitoring the drug as it is prescribed to thousands of schizophrenia patients to ensure it works and that side effects are minimal.
1st over-the-counter combo flu and COVID test outside of emergency use
The FDA authorized the first over-the-counter combination COVID-19 and flu test outside of emergency use in October.
The Healgen Rapid Check COVID-19/Flu A&B Antigen Test can be purchased at a pharmacy or other stores without a prescription.
While there are other over-the-counter combination tests currently available, this is the first to be marketed to consumers using the traditional approval pathway outside of a public health emergency, according to the FDA.
