logo
3 natural food dyes approved by FDA

3 natural food dyes approved by FDA

CNN09-05-2025
Sign up for CNN's Eat, But Better: Mediterranean Style. Our eight-part guide shows you a delicious expert-backed eating lifestyle that will boost your health for life.
The US Food and Drug Administration has approved three new color additives from natural sources 'that will expand the palette of available colors from natural sources for manufacturers to safely use in food,' the agency said in a news release.
The three dyes are Galdieria extract blue, butterfly pea flower extract and calcium phosphate.
US Department of Health and Human Services Secretary Robert F. Kennedy Jr. has made phasing out petroleum-based dyes in the nation's food supply one of the priorities in his broader initiative to 'Make America Healthy Again.'
Artificial food dyes are facing new restrictions or bans at both the federal level and in more than half the states. In April, FDA Commissioner Dr. Marty Makary announced the agency would work with the industry to remove and replace the dyes, though the FDA largely hasn't yet made this a requirement for industry.
'For too long, our food system has relied on synthetic, petroleum-based dyes that offer no nutritional value and pose unnecessary health risks,' Kennedy said in a news release. 'We're removing these dyes and approving safe, natural alternatives — to protect families and support healthier choices.'
Galdieria extract blue derives from Galdieria sulphuraria, a type of red algae that carries a water-soluble blue pigment known as C-Phycocyanin and is found in acidic volcanic hot springs and calderas, according to the FDA and Fermentalg, a French chemical company using micro-algae for colorants, foods and supplements.
Fermentalg sought approval for the additive for foods and beverages via a petition it submitted to the FDA in 2021 and has patented a Galdieria sulphuraria extract under the name Everzure.
Galdieria sulphuraria's natural ability to reside in acidic environments lends to its stability in food and beverages, which is something food and beverage manufacturers have been concerned about in the shift to natural alternatives to highly stable artificial dyes.
Butterfly pea extract is a blue color from which manufacturers can create a range of shades including bright blues, intense purples and natural greens, according to the FDA. It's produced from the water extraction of the dried flower petals of the butterfly pea plant, and is already approved for some uses, including sports drinks, fruit drinks, fruit and vegetable juices, alcoholic beverages, candy and ice creams.
Its use is now expanded to also include ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips, plain corn chips, tortilla chips and multigrain chips, the FDA said. The petition that raised this extract for consideration was submitted in February 2024 by the St. Louis-based Sensient Colors, one of the largest global dye-makers.
Calcium phosphate, a mineral compound containing both calcium and phosphorus, provides a white color newly approved for use in ready-to-eat chicken products, white candy melts, doughnut sugar and sugar for coated candies, according to the FDA, whose decision approves a 2023 petition filed by New Jersey-based Innophos Inc., a mineral solutions company.
'The FDA determines whether an additive is safe to use by considering the projected human dietary exposure to the color additive, the additive's toxicological data, and other relevant information, such as published literature,' the agency stated in a news release.
The embrace of natural dyes is due to health concerns around artificial colorants, such as increased risk of cancer and neurobehavioral issues. While some manufacturers acknowledge these concerns, they have also highlighted the challenges involved in an industrywide shift to alternative dyes, which is likely due to both state-level bans and the FDA's requirement that food companies remove red dye No. 3 — banned in January — from foods by January 15, 2027.
'Natural colors can be more expensive from a cost-in-use perspective depending on the raw ingredient being used,' Amy Agallar, vice president of investor relations and treasurer at Sensient, said via email May 2. 'The raw ingredients can vary due to many factors such as availability, time to harvest and color availability from the raw material. The natural color needed to replace a synthetic color can be ten times that of a synthetic product.'
That discrepancy is partly due to some food and beverage products requiring heat processing or acids that affect the stability of natural colors, Agallar added. 'Some natural colors are also not very light stable and this may be needed in the end application.'
Additionally, 'studies show that customers prefer products with color and are more likely to purchase food and beverages with a color that matches the expected flavor,' Agallar said. 'Consumers use the color to identify how a product will taste. Food manufacturers currently use natural color products in about 80% of new colored food and beverages released in the US each year.'
There's little funding for research on artificial food dyes, and even less for the study of emerging alternatives — so it's not yet known whether these new natural dyes could have any effect on human health. But with most natural dyes coming from plants and being used in small quantities, 'it's hard to believe they'd have any effect' on the general population, Dr. Marion Nestle, Paulette Goddard Professor of Nutrition, Food Studies, and Public Health, Emerita, at New York University, told CNN in a previous story.
Sensient has developed its own safety program, Certasure, Agallar said. 'This program ensures that our natural colors are free of pesticides, heavy metals, microbiological contamination, adulteration, and unauthorized solvents.'
Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

More questions about Prasad's return
More questions about Prasad's return

Politico

time16 minutes ago

  • Politico

More questions about Prasad's return

Driving the Day BACK TO CBER — Dr. Vinay Prasad has returned to the FDA's Center for Biologics Evaluation and Research, leaving industry and public health observers puzzled over what happened during his brief absence to account for his reinstatement. The hematologist-oncologist's time away from the agency — equivalent to one Scaramucci (IYKYK) — came after President Donald Trump overruled FDA Commissioner Marty Makary and Health Secretary Robert F. Kennedy Jr. and called for his firing amid conservative backlash to Prasad's past political statements and recent decisions around rare disease drugs. Makary told reporters last week he was trying to bring Prasad back to the FDA. But as of Monday afternoon, the FDA website continued to list the Center for Drug Evaluation and Research's director, George Tidmarsh, as CBER's acting leader. Several key questions remain as Prasad, long known as a firebrand in his own right, returns to White Oak. Here are some outstanding questions we have: How will he approach regulatory decisions for rare disease therapies? It's unclear whether the White House has weighed in on Prasad's earlier actions that sparked worry among patient advocates and industry that he would take a harder line on rare disease drug approvals than his predecessors. Those therapies face more obstacles to market because the pool of people who can vet them via controlled trials is inherently tiny, meaning companies often rely on surrogate endpoints — outcomes that can predict clinical significance — to convey their benefit. Prasad had previously criticized the agency for approving Sarepta's Elevidys for Duchenne muscular dystrophy, arguing it posed questionable benefits given its potential risks and high price tag. Stocks in Sarepta and other CBER-regulated companies fell Monday morning as the markets opened for the first time since Prasad's return was reported. Financial analysts in client notes sent Monday were divided on how bullish industry should be in interpreting his second tour as friendlier than his first. How many hats will he wear? During his first FDA stint, Prasad racked up titles to include chief medical and scientific officer, signifying Makary's faith in him as his right hand. Whether he'll reclaim them remains unclear. What's next for CBER on vaccines? Prasad has already effected one of the biggest changes he sought in U.S. Covid vaccine policy by reorienting FDA approval of future formulations toward high-risk populations, absent new randomized trials showing benefit to young, otherwise healthy individuals. But everyone closely watching Kennedy suspects more changes are coming to the federal government's stewardship of vaccines, and CBER is the checkpoint for which shots reach the market. IT'S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. What should we do this week now that the MAHA report isn't hitting our desks? Send tips to David Lim (dlim@ @davidalim or davidalim.49 on Signal) and Lauren Gardner (lgardner@ @Gardner_LM or gardnerlm.01 on Signal). AROUND THE AGENCIES CDC SHOOTING FALLOUT — HHS Secretary Robert F. Kennedy Jr. visited the agency's Atlanta headquarters Monday to survey the damage from Friday's fatal shooting with newly confirmed CDC Director Susan Monarez. Meanwhile, CDC employees are afraid to return to work after the shooting, three agency staffers told POLITICO's Sophie Gardner. No agency workers were hurt, but a local police officer was shot and killed while responding. 'Even the ones who weren't in lockdown for seven hours and are ridiculously traumatized … [are asking] 'Are our windows bulletproof? And what about the areas without cell reception?'' another staffer said. They were granted anonymity for fear of retribution. Some media outlets have reported that the suspected shooter, 30-year-old Patrick White, believed that the Covid-19 vaccine made him sick. White died at the scene, authorities said. 'I think most of us would very much like the next message we hear from him to begin with 'I hereby resign,'' another employee told POLITICO in a text. 'The secretary is being widely (and accurately) blamed for spreading disinformation about vaccines that helped poison the mind of a disturbed individual.' HHS spokesperson Andrew Nixon said in a statement that Kennedy 'unequivocally condemned the horrific attack and remains fully committed to ensuring the safety and well-being of CDC employees.' What's next: The CDC has extended telework for a week to everyone who works from agency campuses in Atlanta. It's unclear when employees will be expected to return to the agency's Edward R. Roybal campus, which sustained extensive damage. Industry Intel NEW CANCER VAX DATA — IO Biotech's cancer vaccine Cylembio helped slow the progression of disease in advanced melanoma patients who took it in combination with Merck's Keytruda, the company said Monday, but it narrowly missed its window for statistical significance. The investigational shot is designed as an off-the-shelf option targeting both tumor and immune-suppressive cells. IO Biotech said it plans to meet with the FDA this fall to discuss the data and identify a path forward to apply for regulatory approval. The mRNA elephant: Those results came days after HHS Secretary Robert F. Kennedy Jr.'s announcement curtailing federal support for certain messenger RNA vaccine projects — a move that spurred concern among cancer-focused pharma companies and patient advocates, Lauren writes. That's because mRNA technology could transform cancer treatment thanks to its rapid manufacturing process and ability to be customized to instruct a recipient's immune system to attack their unique tumor. Dozens of treatments are being studied or advanced in company pipelines. While Kennedy's decision last week focused on vaccines for respiratory viruses, mRNA boosters say his disdain for the technology raises questions about the FDA's posture toward those therapies for other disease areas — and poses risks that some firms may ultimately decide to avoid by moving operations abroad. They also worry about the lasting impacts of his rhetoric on public acceptance of mRNA-based products, even if they're eventually available for stubborn cancers with few treatment options. HHS response: A spokesperson called the industry's assessment of potential fallout 'false.' Eye on the FDA CAPRICOR HEADS TO FDA — Executives from Capricor Therapeutics will meet with FDA officials this week to discuss the agency's rejection last month of its application for a cell therapy to treat heart issues in people with Duchenne muscular dystrophy, CEO Linda Marbán said Monday during the company's second-quarter earnings call. Capricor wants to resubmit its application — which the company has maintained closely followed earlier agency feedback on its data — based on its existing dataset, Marbán said. The firm may also include information from an ongoing trial, depending on the FDA's responses this week. When asked how Dr. Vinay Prasad's return to the agency affects the company's thinking, Marbán said she's taking an 'old-school' approach. 'We have good clinical data, we have great safety data, we have guidance from the agency in writing as to what they wanted. We provided it,' she said. 'And now, really, I think it's up to them to decide who is best suited within that agency to make the decision of adjudication and all of the factors that go into it.' FDA RELEASES DRUG-QUALITY REPORT — A few interesting nuggets are buried in an annual FDA report on the quality of pharmaceuticals in the U.S. The Center for Drug Evaluation and Research's catalog lists 4,619 global manufacturing sites that make drugs for American patients as of the end of September 2024 — with 41 percent located within the U.S. In fiscal 2024, the agency noted that 62 percent of drug-quality assurance inspections were conducted at foreign sites, the highest mark to date. Increasing the number of foreign inspections has been a top priority of FDA Commissioner Marty Makary. 'This progress in foreign inspections was particularly evident in India and China, where 34% and 28% of sites in the Site Catalog, respectively, were inspected,' the report states. 'By comparison, 24% of the U.S. sites in the Site Catalog were inspected in FY2024.' Pharma Moves Jennifer Tomasello is joining AdvaMed as a senior director of federal government affairs. She previously worked at the FDA as a senior policy adviser in the Center for Devices and Radiological Health. WHAT WE'RE READING The U.S. Postal Service is blocking some shipments of vapes that lack marketing authorization from the FDA, Reuters' Emma Rumney reports. The Guardian's Melody Schreiber reports that Pfizer's Covid-19 vaccine for young children under 5 years old might not have its emergency use authorization renewed for the 2025 fall respiratory season.

Biogen Sees Potential in Combining Alzheimer's and Obesity Drugs
Biogen Sees Potential in Combining Alzheimer's and Obesity Drugs

Bloomberg

time16 minutes ago

  • Bloomberg

Biogen Sees Potential in Combining Alzheimer's and Obesity Drugs

If Novo Nordisk A/S 's wildly popular weight-loss drug succeeds in a highly anticipated trial for Alzheimer's disease, Biogen Inc.'s Chief Executive Officer Chris Viehbacher doesn't see it as a roadblock for his company's medication. Rather, he sees it as an opportunity to potentially combine drugs and create a more potent therapy. 'As we look out over the next five years, we're probably going to see a treatment much like any other complex disease,' he said in an interview with Bloomberg News, meaning there will be 'different mechanisms of action that you need.'

Melanoma can be deadly: What to know about the disease that killed Kelly Clarkson's ex
Melanoma can be deadly: What to know about the disease that killed Kelly Clarkson's ex

Fox News

timean hour ago

  • Fox News

Melanoma can be deadly: What to know about the disease that killed Kelly Clarkson's ex

Days after Kelly Clarkson's ex-husband, Brandon Blackstock, passed away at the age of 48, the cause of his death was revealed. On August 11, it was reported that the talent manager died after a private battle with melanoma, a form of skin cancer. "Brandon Blackstock passed away peacefully at his home in Butte, Montana on August 7 under hospice care surrounded by his family," Silver Bow County Coroner Dan Hollis told Fox News Digital. "It is with great sadness that we share the news that Brandon Blackstock has passed away. Brandon bravely battled cancer for more than three years. He passed away peacefully and was surrounded by family. We thank you for your thoughts and prayers and ask everyone to respect the family's privacy during this very difficult time." The singer, who was married to Blackstock for seven years before their divorce in 2022, reportedly "remained protective" of her ex as he battled cancer for three years. Skin cancer is the most common type of cancer in the U.S. — with one in five Americans developing the disease by the age of 70. Melanoma is the deadliest form of skin cancer, expected to take the lives of more than 8,400 people in the U.S. this year, according to the American Cancer Society. "Melanoma has a significantly higher chance of spreading than basal cell and squamous cell carcinomas, the most common types of skin cancer," said Marcus Monroe, MD, surgeon and investigator with the Huntsman Cancer Institute and associate professor at the University of Utah School of Medicine, previously told Fox News Digital. The chances of melanoma spreading to other locations increases with each stage of cancer. "For the earliest stage, this risk is estimated at less than 5%, increasing for patients with stage 2 disease to a wider range, from 5% at the low end up to 40% to 50% for the most advanced stage 2 patients," said Monroe. In stage 3 patients (those with regional spread either via in-transit metastases or to adjacent lymph nodes), up to 30% to 40% will develop distant metastases, with a 16% to 17% risk of brain metastases, the doctor added. Melanoma is the deadliest form of skin cancer, expected to take the lives of more than 8,400 people in the U.S. this year. The brain and lungs are the most common sites of metastasis for melanoma, experts confirmed. If the patient has lesions that are deep in the skin or involve the lymph nodes, the chance of melanoma spreading is higher — anywhere from 20% to 70%, according to Jose Lutzky, MD, director of cutaneous oncology services at the Sylvester Comprehensive Cancer Center in South Florida. Metastatic melanoma was once considered mostly treatment-resistant because it did not respond to traditional chemotherapy and radiation, noted Dr. Joshua Strauss from Advanced Care Oncology and Hematology Associates of the Atlantic Medical Group in Morristown, New Jersey. "Nowadays, using targeted therapies and immunotherapy survival has been dramatically improved, and there is a possibility of long-term remission with treatment," Strauss previously told Fox News Digital. Lutzky noted that melanoma is almost always curable by surgical removal when it's detected early. "Because of advances in the treatment of melanoma over the last 10 to 15 years, even very advanced melanoma can be cured in up to 50% of cases with modern immunotherapy treatment," he told Fox News Digital. "More recently, cell therapy has been approved to treat those advanced melanomas that do not respond to immunotherapy." To prevent melanoma, it's important to reduce exposure to ultraviolet radiation, especially in people with lightly pigmented skin, Strauss advised. "Sunscreen and sun-protective clothing are critical," he said. The American Academy of Dermatology recommends applying water-resistant sunscreen with broad-spectrum protection against UVA and UVB rays, and SPF 30 or higher, before sun exposure. "Indoor tanning bed use should be avoided because it is known to be associated with increased melanoma risk," Strauss added. High-risk individuals should also have yearly skin checks with a dermatologist. "This includes individuals with a personal history of skin cancer, family history of melanoma, people who take medications that suppress the immune system, and people who are highly sun-sensitive, such as those with red or blond hair, light skin pigmentation, significant freckling and light eye color," the oncologist said. For more Health articles, visit Strauss uses the acronym ABCDE to differentiate between a normal mole and a melanoma. "Moles with Asymmetry, irregular Borders, multiple Colors, Diameter larger than a pencil eraser, and Evolving or changing characteristics require further evaluation," he said. Fox News' Christina Dugan Ramirez contributed reporting.

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store