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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.'
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