FDA approves, expands 3 natural color additives after RFK Jr.’s plan to remove artificial food dyes
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(WASHINGTON) — The U.S. Food and Drug Administration (FDA) approved on Friday additional color additives from natural sources in line with the Department of Health and Human Services’ goal to eliminate artificial food dyes.
The agency approved two dyes and expanded approval of a third, meaning it can now be used in a wider range of food products.
“Today we take a major step to Make America Healthy Again,” HHS Secretary Robert F. Kennedy Jr. said in a statement. “For too long, our food system has relied on synthetic, petroleum-based dyes that offer no nutritional value and pose unnecessary health risks. We’re removing these dyes and approving safe, natural alternatives — to protect families and support healthier choices.”
The approved additives include Galdieria extract blue, which is derived from algae; butterfly pea flower extract from the butterfly pea flower; and calcium phosphate, a natural compound containing calcium and phosphorus.
Galdieria extract blue has been approved by the FDA to be used in several products including fruit juices, fruit smoothies, candy, chewing gum, breakfast cereals, popsicles and yogurts.
Butterfly pea flower extract, which is already used to color most of the above, had its use expanded to color ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips, plain corn chips, tortilla chips and multigrain chips.
Calcium phosphate was approved for use in ready-to-eat chicken products, white candy melts, doughnut sugar and sugar for coated candies.
The approvals come after comments from Kennedy about his opposition to artificial dyes, claiming they are harmful and calling for them to be removed from foods and beverages. Under Kennedy, the FDA has sought voluntary commitments from food companies that they will phase out synthetic dyes.
Since then, some U.S. food manufacturers, including Tyson Foods, have said they are working to eliminate artificial food dyes.
Nutritionists and dietitians are divided over whether or not synthetic food dyes are harmful, or the extent to which they are harmful, but all agree they do not have any nutritional value.
FDA Commissioner Dr. Marty Makary told reporters on Friday that he is meeting with the Consumer Brand Association, touting the administration’s efforts to remove dyes from the U.S. food supply.
“On April 22, I said the FDA would soon approve several new color additives and would accelerate our review of others. I’m pleased to report that promises made, have been promises kept,” Makary said in a statement. “FDA staff have been moving quickly to expedite the publication of these decisions, underscoring our serious intent to transition away from petroleum-based dyes in the food supply and provide new colors from natural sources.”
(NEW YORK) — Dr. Kimberly Shriner remembers the first COVID-19 patient who came into Huntington Hospital in Pasadena, California, in March 2020.
He was a 35-year-old man who arrived at the hospital short of breath.
“He went straight to our intensive care unit. We were very suspicious that he had COVID,” Shriner, an infectious disease specialist and the hospital’s medical director of infectious disease and infection prevention, told ABC News.
Testing was minimal at the time, but eventually the results came back and confirmed that he had COVID. The patient was eventually sedated and intubated, and he died 24 hours later. Shriner said the next few patients admitted to the hospital for COVID-19 followed similar trajectories, becoming more and more short of breath before eventually dying of their illness.
“As physicians, we understand death,” Shriner said. “We understand that we can’t save every patient, but when you’re having 100% mortality with your first experience with this thing, it was pretty overwhelming and daunting. That first week [was] particularly surreal.”
Tuesday, March 11, marked five years since the World Health Organization (WHO) declared the global outbreak of COVID-19 to be a pandemic. The U.S. is in a much better situation now, with fewer hospitalizations and deaths — and vaccines to prevent severe illness from COVID, frontline health care workers say.
However, they add that, as Americans become more removed from the early days of COVID, it may be hard to remember what it was like — especially for those who were treating patients.
“Everybody was worried, doctors, nurses,” Dr. Matthew Sims, director of infectious disease research for Corewell Health, a non-profit health care system located in Michigan, told ABC News. “It was absolutely crazy, and I think that people have forgotten. I think people have forgotten the horror of what COVID was like in the beginning and, I mean, it was a horror situation.”
Quickly changing world
Shriner said one of the indicators of how quickly the world was changing was the evolution of her hospital’s meetings about the virus and how to prepare as information was starting to come out of China.
“Meetings were held in a very tiny, little meeting room. Nobody was wearing masks or anything,” she said. “And then as things began to evolve, and we saw it was happening, that the rooms got started getting bigger, and then we started meeting with masks on, and then, eventually, went virtual.”
Shriver recalled that the situation was “very terrifying” on a personal and professional level.
“If we’d known how difficult it was going to be, I think we would have been even more disturbed,” she said.
Sims said it became clear how quickly patients could get infected in March 2020. Not long after the WHO declared a global pandemic, he came on shift that week to be the infectious disease doctor rotating in the hospital.
“We had two confirmed cases admitted at that point. By the end of the week I spent on, we had over 100 confirmed cases admitted,” he told ABC News. “It was absolutely devastating to the hospital, to the health care system as a whole … It was a crazy time.”
The state of hospitals
Both Sims and Shriner said the lack of early testing at the time was a source of frustration. Since routine testing wasn’t available, results often took days — or even weeks — to return.
Additionally, hospital labs often had to confirm results with state departments of health.
Sim said as the hospitals became full, it sometimes became a race against the clock to try and treat patients.
“I remember one of the most devastating cases I saw was a young man, relatively young, young kids at home,” he said. “A little overweight, I think he was a diabetic, but he just got super sick, and we were trying to get remdesivir, which was compassionate use at the time,” referencing an antiviral drug later approved to treat COVID-19.
Sims said the hospital had to call up the company manufacturing the drug, tell them about the patient and then get approval from the U.S. Food and Drug Administration (FDA) to use doses on the patient.
“And we got approval, and then they have to ship it to us,” Sims said. “It was all being shipped as fast as possible, but before it could even get here, that patient got too sick to even use it, and the patient died. A week before, he was home with his kids, his wife, et cetera, in normal state of health, and then, all of a sudden, got this terrible virus and died.”
As it became clear how contagious the virus was, hospital staff were required to always wear masks. Shriner said she still has a scar or imprint on her nose from having to wear a mask for 18 hours a day.
One of things she remembers most was the lack of sound, other than machines, whenever she visited ICUs.
“As the months progressed, we ended up having six different intensive care units because the patients were so sick,” she said. “We had many, many patients that were on ventilators. You’d walk into these areas, and it was just silence. All you heard were the ventilators going and seeing people in full protective gear all the time.”
To handle the influx of patients, both hospitalized and in emergency departments, Shriner said her hospital stopped all non-emergency surgeries to be able to have extra physicians available.
COVID-19 vaccines arrive
On Dec. 11, 2020, the FDA granted Pfizer-BioNTech the first emergency use authorization for a COVID-19 vaccine for those aged 16 and older. Three days later, nurse Sandra Lindsay became the first person to receive a COVID-19 vaccine in the U.S. as distribution began.
Both Shriner and Sims felt a sense of relief that a tool was finally available to help stem the spread of disease.
Shriner said she was the first person in her hospital to receive the COVID-19 vaccine, even though she didn’t want to be.
“I didn’t want to be the first person. I was perfectly fine with letting other people go ahead of me,” she said. “And [the CEO] said to me, ‘You have to be.’ She said, ‘If you don’t get vaccinated, nobody else is going to do it.'”
Shriner said the distribution of the vaccine “was a sign of the way out. It was very hopeful.”
Lessons learned
Both Sims and Shriner say COVID-19 taught health care workers many lessons, including how to share information quickly, how to diligently monitor diseases and how to scale up health care capacity.
Sims said another valuable discovery was better communicating to the public that information during a public health crisis can change rapidly.
One example is that early studies would come out suggesting certain drugs might help treat patients. Eventually additional information would be published proving the opposite.
“We were learning, and we were learning in such a rapid [way], it was hard to communicate,” he said. “I think if we had any failure, it was that in that rapid push to communicate.”
Sims noted how that created some uncertainty.
“We didn’t get the message across enough that some of what we’re learning may be wrong, and we will tell you that as we learn,” Sims said. “We’re going to tell you what we know now that may not be the same thing we know tomorrow.”
Shriner added that stay-at home orders and lockdowns were hard on people and, if another pandemic happens, she is hopeful there would be different decisions on what should be locked down.
“Maybe we don’t have such stringent lockdown rules and isolation rules,” she said. “You know, the outdoor restaurant became a great thing. You know, think of all the home delivery services really took off. And so, a lot of good things came out of it, but they were hard won.”
(WASHINGTON) — On the heels of a new report showing that rates of autism diagnoses have again increased, Health and Human Services Secretary Robert F. Kennedy Jr. said he was determined to find the “environmental exposures” behind the rise and directed the National Institute of Health to launch new studies into “everything” — from mold to obesity — that could potentially be a factor.
Kennedy, who prioritizes autism as one of the chronic illnesses he’s determined to tackle in his aim to “Make America Healthy Again,” ardently pushed back against the explanation that a broadening definition of autism spectrum disorder is a meaningful contributor to more autism diagnoses.
Kennedy said he wanted to “move away” from the idea that “the autism prevalence increases — the relentless increases — are simply artifacts of better diagnoses, better recognition or changing diagnostic criteria.”
“This epidemic denial has become a feature in the mainstream media, and it’s based on an industry canard. And obviously there are people who don’t want us to look at environmental exposures,” Kennedy said, speaking at a press conference at the department headquarters on Wednesday in Washington, D.C.
The report Kennedy mentioned — published Tuesday by the Centers for Disease Control and Prevention — estimated that autism prevalence has increased to 1 in 31 children, which Kennedy called “shocking.”
In 2020, the same report found a prevalence of 1 in 36, and over two decades ago in 2000, the rate was 1 in 150.
Experts in the field agree that the rates of diagnoses are increasing and that environmental factors could be at play — but also say most of the increase can be attributed to the expanding definition of autism, which broadened dramatically in recent decades to include subtler features of the illness, including new descriptors as recently as 2013.
“It’s a fair question” to ask why autism prevalence has increased, Dr. Catherine Lord, a psychologist and autism researcher at UCLA’s David Geffen School of Medicine, told ABC News, but she said that it’s also important to acknowledge how much has changed.
“There’s been a huge shift in terms of awareness of autism, particularly awareness of autism without severe intellectual disability, that really changed even since I entered this field,” said Lord.
Studies also suggest that autism risk is heavily rooted in genetics, by as much as 80%.
Dr. Walter Zahorodny, a clinical psychologist and professor who studies autism at Rutgers University, joined Kennedy at Tuesday’s press conference to emphasize that there has been a “true increase” in cases, something he said he has seen throughout his career in New Jersey — though he acknowledged, unlike Kennedy, a wider variety of possibilities, from environmental exposures to other “risk factors.”
“It is a true increase. There is better awareness of autism, but better awareness of autism cannot be driving disability like autism to increase by 300% in 20 years,” Zahorodny said, referring to studies from New Jersey and the CDC report.
Zahorodny said finding the cause was crucial and lamented a lack of progress to “address this question seriously” over his career.
“I would urge everyone to consider the likelihood that autism, whether we call it an epidemic, tsunami or a surge of autism, is a real thing that we don’t understand, and it must be triggered or caused by environmental or risk factors,” he said.
Kennedy on Tuesday acknowledged that the increase in autism diagnoses could be in part caused by increased awareness, but said that still left a large portion of the jump in diagnoses unaccounted for.
He called it “indefensible” to accept awareness as the main reason, describing high stakes of ruined families and “individual tragedy.”
“Autism destroys families, and more importantly, it destroys our greatest resource, which is our children. These are children who should not be suffering like this,” Kennedy said. “These are kids who will never pay taxes, they’ll never hold a job, they’ll never play baseball, they’ll never write a poem, they’ll never go out on a date. Many of them will never use a toilet unassisted.”
“We have to recognize we are doing this to our children, and we need to put an end to it,” he added.
Not every case is as severe as Kennedy described, however; many people diagnosed with autism live highly functional adult lives. The recent CDC report found fewer than 40% of children diagnosed with autism spectrum disorder were classified as having an intellectual disability, meaning an IQ of less than 70.
Dr. Barry Prizant, an adjunct professor in the department of communicative disorders at the University of Rhode Island and director of the private practice Childhood Communication Services, told ABC News that Kennedy’s comments misrepresent what autism is like for families.
“I am not dismissing the challenges. There are considerable challenges, and a lot of those are barriers to services,” he said. “We’ve been doing a parent retreat weekend for 27 years, where we spend a weekend with 60 parents and family members, and we’re not meeting with family members and parents who say, ‘Autism is just a tragedy and it’s hell in our lives.’ They talk about the positives and the negatives, the joys as well as the challenges.”
Autism Speaks also released a statement on Wednesday, calling Kennedy comments “extremely disappointing and damaging.”
“Autism is not a preventable condition,” the nonprofit autism organization said. “The suggestion that it is—especially when linked to environmental toxins without scientific evidence—contributes to decades-old misinformation and distracts from the real needs of autistic people and their families.”
Kennedy said the NIH, led by Dr. Jay Bhattacharya, a former professor at Stanford University, will soon announce a series of new studies aimed at identifying precisely which environmental toxins are to blame. Kennedy cited mold, food, pesticides, medicines, ultrasounds, and the age and health of parents as possible culprits.
Kennedy qualified that the study would provide “some of the answers” by September, which is a variation — welcomed by experts — from his claim to President Donald Trump last week that “by September, we will know what has caused the autism epidemic.”
However, he also claimed on Tuesday: “We know it’s an environmental exposure.”
Asked by ABC News if he would commit to following the science revealed by the studies, regardless of his current expectations on what’s causing the rise in diagnosis, the secretary said yes.
“We’re going to follow the science no matter what it says,” he said.
Medical experts have been studying the potential causes of autism for decades. Research to date suggests that autism is driven by genetics, and the risk may increase when paired with certain outside factors, such as having children at an older age or exposure to pollutants.
“It’s not simple,” Lord said. “If you look at high-quality publications, the findings are small and, in terms of causes other than the genetics, have been quite hard to replicate. Not meaning they’re wrong, but just that we haven’t quite figured out what they should be.”
HHS or NIH have not provided details about how the new studies will be conducted within the given timeframe, but Kennedy pledged transparency, saying the studies would be conducted in the traditional way of funding to academic institutions through the NIH.
(AUSTIN, Texas) — The measles outbreak in western Texas has now reached 624 cases, with 27 new infections confirmed over the last five days.
Nearly all of the cases are among unvaccinated individuals or among those whose vaccination status is unknown, according to new data published by the Texas Department of State Health Services (DSHS) on Tuesday.
Currently, 10 cases are among residents who have been vaccinated with one dose of the measles, mumps and rubella (MMR) vaccine, while 12 cases are among those vaccinated with two doses.
At least 64 measles patients have been hospitalized so far, according to the DSHS, with the majority of cases presenting in children and teenagers between ages 5 and 17, followed by children ages 4 and under.
Gaines County, which borders New Mexico, remains the epicenter of the outbreak, with 386 cases confirmed so far, DSHS data shows.
This is a developing story. Please check back for updates.