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.
LW, who asked not to show her face, is a 16-year-old transgender teenager challenging Tennessee’s ban on gender-affirming medical treatments that have improved her quality of life. (ABC News)
(WASHINGTON) — Medical treatments for transgender children, endorsed by major American medical associations and safely used for decades, hang in the balance at the U.S. Supreme Court on Wednesday as the Biden administration and three families with transgender teenagers ask the justices to strike down a state law banning some gender-affirming care for kids.
The landmark case — U.S. v. Skrmetti — comes from Tennessee, which is among 26 states that have moved to prohibit administration of puberty-blocking medication and hormone therapy to minors who seek to identify with, or live as, a gender identity inconsistent with his or her sex at birth.
Oral arguments mark the first time the nation’s highest court has openly considered a state law targeting transgender people. It is also the first time an openly transgender litigator, ACLU attorney Chase Strangio, will argue a case in the Supreme Court chamber.
The historic hearing thrusts the justices to the forefront of a cultural debate that has sharply divided the country and tested the limits of science and parental rights.
The outcome of the case could determine access to health care for hundreds of thousands of trans teens and more broadly influence how communities treat transgender people in hospitals, schools and on sports fields.
The government argues that Tennessee’s SB1, which was enacted in March 2023, violates the Constitution’s Equal Protection clause because it discriminates on the basis of sex to decide who can receive otherwise legal medical treatments available to youth.
“Put simply, an adolescent assigned female at birth cannot receive puberty blockers or testosterone to live as a male, but an adolescent assigned male at birth can,” the administration wrote in its brief to the court.
The Tennessee law expressly allows minors who are not transgender to receive gender-affirming treatments to address a “congenital defect, precocious puberty, disease, or physical injury.”
Denying discrimination, the state argues its law is a reasonable regulation of medical treatment based on its purpose, meant to protect children from potential long-term health risks and possible irreversible changes to the body.
The law’s Republican sponsors claim that contradictory scientific evidence and documented regret among some young people who have transitioned both warrant caution in developing standards of care.
The law also cites a “compelling interest in encouraging minors to appreciate their sex, particularly as they undergo puberty” and preventing them from becoming “disdainful of their sex.” The government says the text proves an intent to enforce gender conformity.
Hundreds of Tennessee transgender children were receiving treatments before SB1 was enacted, legislators concluded. It is not known how many suffered alleged harm.
The plaintiffs in the case include 16-year-old LW and her parents Brian and Samantha Williams of Nashville. After several years of successful hormone therapy, LW now has to travel out of state to continue treatments she says have dramatically improved her quality of life.
“I feel normal now,” LW said in an exclusive interview with ABC News last month.
“Our state legislature had made such a big deal out of parents rights during COVID, about masks and vaccines — that that’s for parents to decide these medical decisions for their children,” noted Samantha Williams. “And then, they made this medical decision for our child.”
Nationwide, an estimated 300,000 Americans ages 13 to 17 identify as transgender, according to the Williams Institute at UCLA School of Law. Of those, nearly 100,000 live in states that have banned access to gender-affirming medical treatments for minors.
“It’s a case of enormous significance that presents fundamental questions about the scope of state power to regulate medical care for minors, of the rights of parents to make medical decisions for their children… and the level of scrutiny that courts should apply to laws that discriminate against transgender people in general,” said Deepak Gutpa, a veteran Supreme Court litigator. “This is a major, major constitutional civil rights issue.”
More than 60% of Americans say they oppose law banning certain types of gender-affirming medical treatment for minors, according to Gallup.
Major American medical associations have endorsed the treatments for more than a decade as part of “individually tailored interventions” to support trans kids and affirm their sense of self. Not all transgender children seek medical care to facilitate transition to another sex.
“It needs to be part of a very deliberate process that involves medical specialists, who are expert at doing this, and, again, are following the science,” said Dr. Ben Hoffman, a pediatrician and president of the American Academy of Pediatrics. “It all begins and ends with science. This is not about any sort of agenda.”
Clinical practice guidelines from the American Endocrine Society, based on more than 260 research studies, recommend the use of puberty-delaying medications and waiting until a child reaches adulthood to consider gender-affirming surgery.
The American Academy of Pediatrics says the effects of puberty blockers are not permanent if treatment is discontinued. Many effects of hormone therapy can also be reversed. Long-term risks may include fertility challenges and possible harm to bone density, but the group says those risks require further study.
In contrast to the U.S. medical establishment, several European countries, including the United Kingdom, have reversed course on the use of gender-affirming treatments as a standard-of-care for transgender children, citing insufficient scientific evidence of long-term benefits.
“When you look at the totality of the medical research, to me there is more than enough uncertainty and evidence of bad outcomes for kids who’ve gone through these treatments when they reach the later stages in life,” said Tennessee Senate GOP Leader Jack Johnson.
A federal district court sided with the plaintiffs, temporarily halting enforcement of SB1, but the Sixth Circuit U.S. Court of Appeals reversed. The panel of judges concluded Tennessee had a rational basis for enacting the law.
“Kind of the whole ballgame in the case is the debate about whether there actually is discrimination on the basis of sex,” said Erin Murphy, a Supreme Court litigator and former clerk to Chief Justice John Roberts.
“It’s really not,” Murphy argued. “To say providing testosterone to a biological boy and biological girl is the same thing because testosterone is involved — it’s a different treatment that has different risks.”
David Cole, former legal director of the American Civil Liberties Union, which is representing the Williams family, says the court’s conservative majority will have to confront the legacy of its decision.
“I think there’s no question in 25 years that the court will have recognized that treating people differently because their gender identity is sex discrimination,” Cole said.
“The question is whether the court wants to write a decision will be overturned, you know, in the course of the next 10 years or 15 years,” he said, “or whether it wants to recognize what is going on, which is sex discrimination.”
A decision in the case is expected by the end of June 2025.
Photo by Roberto Pfeil/picture alliance via Getty Images
(NEW YORK) — Semaglutide, a medication widely used for diabetes and weight loss, may offer another unexpected benefit — it could help people drink less alcohol.
A study published in JAMA Psychiatry enrolled 48 adults between ages 21 and 65 who had been diagnosed with alcohol use disorder but were not actively seeking treatment.
Half received semaglutide, a type of GLP-1 receptor agonist, while the other half received no treatment. Over the nine-week trial, participants taking semaglutide started at a dose of 0.25 mg per week, which gradually increased to 1.0 mg in the final week — a much lower dose than what’s typically prescribed for weight loss.
”We found the largest effects for outcomes related to drinking quantity or heavy drinking…[semaglutide] appeared to reduce drinking quantity,” said Christian Hendershot, PhD, the study’s lead author and director of clinical research at the USC Institute for Addiction Science, in an interview with ABC News.
In a controlled lab setting, participants taking semaglutide drank less alcohol. However, outside the lab, their overall drinking days and daily alcohol intake did not change significantly. They did, however, report fewer binge-drinking episodes and reduced alcohol cravings.
Hendershot emphasized that the participants were not actively trying to cut back on drinking or become abstinent, making the drug’s impact particularly interesting.
”The reason why semaglutide may have an effect on addictive behaviors and cravings and may play a role in treating alcohol use disorder is still not entirely clear,” said Dr. Stephanie Widmer, an emergency medicine physician and addiction medicine expert. ”More research needs to be done in order to really get a firm grasp on what the pathophysiology is behind this,” she added.
One possible explanation is that GLP-1 receptor agonists increase feelings of fullness, which could make alcohol less appealing, Hendershot said.
Previous animal studies suggest these medications may also affect the brain’s reward system, reducing the desire for substances like alcohol and nicotine. However, it remains unclear if the same effect holds true in humans.
Interestingly, the medication also appeared to reduce cigarette use in a small group of participants who smoked, hinting at broader effects on addictive behaviors.
”Preclinical studies indicate that GLP-1 receptor agonists reduce not just alcohol intake, but also nicotine self-administration and nicotine-related reward,” Hendershot noted. However, no FDA-approved medications currently exist to treat both alcohol and nicotine dependence.
Another unexpected benefit was that those treated with semaglutide lost 5% of their body weight over the course of the study. While this result is consistent with previous research, Hendershot noted the need to evaluate potential side effects, particularly in individuals with lower BMIs.
The study did have several important limitations. It was small, lasted only nine weeks, and was conducted in a controlled setting that may not fully reflect real-world drinking behaviors.
Additionally, because participants were not actively trying to reduce their alcohol consumption, their motivation—or lack of it—could have influenced the results, Henderson implied.
Still, the findings suggest semaglutide could play a role in reshaping addiction treatment. According to the National Institutes of Health, only three medications are currently FDA-approved to treat alcohol dependence, and many individuals with the condition never receive any treatment.
In 2023, more than 2 million people had alcohol use disorder, yet only about 8% received treatment.
”If semaglutide proves to be a better option than the three FDA-approved drugs that are currently in use, this would be a huge breakthrough for many,” Widmer said.
Dr. Christopher Wachuku is an internal medicine preliminary intern at Lankenau Medical Center and a member of the ABC News Medical Unit.
(NEW YORK) — Heart disease remains the leading cause of death in the United States, according to a new report.
The American Heart Association (AHA) report, published Monday in the journal Circulation, found that 941,652 Americans died from cardiovascular disease in 2022, the most recent year for which data is available. That’s an increase of more than 10,000 from the just over 931,500 reported to have died from cardiovascular disease in 2021.
It also means that a person in the U.S. dies of cardiovascular disease every 34 seconds, or nearly 2,500 people every day, according to the AHA report.
“The stats are pretty sobering from this report,” Dr. Tara Narula, ABC News chief medical correspondent and a board-certified cardiologist, said on ABC’s “Good Morning America” on Monday. “In fact, cardiovascular disease kills more Americans than all forms of cancer and accidents combined.”
Cancer and accidental deaths continue to remain the second and third leading causes of death, respectively, according to the latest data from the Centers for Disease Control and Prevention (CDC).
The AHA report also found racial and ethnicity disparities, with Black Americans having the highest prevalence of cardiovascular disease. Between 2017 and 2020, 59% of non-Hispanic Black females and 58.9% of non-Hispanic Black males had some form of the disease, according to the report.
In addition, the report showed several heart disease risk factors continue to rise, with nearly 47% of American adults having high blood pressure and more than half, 57%, diagnosed with type 2 diabetes or prediabetes.
Additionally, 72% of U.S. adults have an unhealthy weight, with nearly 42% of adults having obesity, which also is a risk factor for developing cardiovascular disease, according to the AHA report.
In an accompanying editorial, Dr. Dhruv Kazi, associate director of the Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology at Beth Israel Deaconess Medical Center In Boston, said risk factors for cardiovascular disease are expected to rise over the next several years.
“Although we have made a lot of progress against cardiovascular disease in the past few decades, there is a lot more work that remains to be done,” Kazi wrote. “If recent trends continue, hypertension and obesity will each affect more than 180million U.S. adults by 2050, whereas the prevalence of diabetes will climb to more than 80 million.”
Overall, cardiovascular-related deaths have begun plateauing after ticking upward during the COVID-19 pandemic, according to the AHA. The report found death rates dropped during the survey period for all 10 leading causes of death except kidney disease, which increased by 1.5%.
The good news is that 80% of cardiovascular disease is preventable, according to Narula. Ways to lower the risk include eating a heart-healthy diet, getting regular exercise, quitting smoking, managing stress, and getting adequate sleep every night.