
FDA to Phase Out Artificial Dyes: What You Need to Know
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The Food and Drug Administration (FDA) has announced a major policy shift that will affect some of the most colorful snacks on store shelves.
Popular items like Flamin' Hot Cheetos, Skittles, and Mountain Dew Baja Blast will soon be reformulated as the FDA phases out petroleum-based synthetic dyes.
Here's a breakdown of what you need to know:
The FDA plans to eliminate six synthetic dyes from the U.S. food supply by the end of next year.
This includes: Red 40
Yellow 5
Yellow 6
Blue 1
Blue 2
Green 2
Red Dye 3, previously given a longer timeline, is now also expected to be phased out by the end of 2026.
This policy directly affects products that rely on vibrant synthetic colors, including: Flamin' Hot Cheetos
Skittles
Trix Cereal
Mountain Dew Baja Blast
Froot Loops
And many more from brands like PepsiCo, General Mills, Mars, and WK Kellogg.
The FDA recommends that food manufacturers switch to natural coloring options, such as: Watermelon juice
Beet juice
Carrot juice
These alternatives, while often more expensive, are considered safer for long-term health.
FDA Commissioner Marty Makary cited growing evidence linking artificial dyes to hyperactivity in children and other health concerns.
The move follows years of pressure from health advocates and consumer groups.
Though there isn't a strict ban in place, the FDA and food industry have an understanding.
The agency plans to enforce a national timeline and is exploring all available tools to ensure compliance.
U.S. Health Secretary Robert F. Kennedy Jr. is leading the charge, claiming food and drug industry corruption has made Americans less healthy.
He aims to prioritize nutrition over pharmaceuticals.
In past years, companies like Kraft Heinz reformulated products like mac and cheese to use natural dyes.
Others, like General Mills, temporarily switched but reverted due to poor consumer response.
Companies that help food brands reformulate recipes are now in high demand. McCormick has reported an uptick in activity as more manufacturers look to replace synthetic colors and reduce sodium.
While natural colors are generally more costly to produce, Makary claims this shift shouldn't significantly impact consumer prices, pointing to other countries where similar changes have been implemented successfully. Spring 2025 : FDA begins revoking authorization of synthetic dyes
: FDA begins revoking authorization of synthetic dyes End of 2025 : Red Dye 3 phased out
: Red Dye 3 phased out End of 2026 : Remaining six dyes removed from market
: Remaining six dyes removed from market Ongoing: Approval and rollout of natural dye alternatives
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FDA to Phase Out Artificial Dyes: What You Need to Know was originally published on b1057.com
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Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. 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We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements. CONTACTS Investors:Michael WoodPhone: +1 646-597-6983mwood@ Media: Uri Yablonka, Chief Business OfficerPhone: +1 917-284-2911uri@ CELL THERAPEUTICS INC. 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AND SUBSIDIARIES INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED) U.S. dollars in thousands (Except share data) Six months ended Three months ended June 30, June 30, 2025202420252024 UnauditedUnaudited Operating expenses:Research anddevelopment, net$ 2,424$ 1,883$ 1,120$ 922 General and administrative 3,238 3,573 1,453 2,060Operating loss (5,662) (5,456) (2,573) (2,982)Financial income (expense), net (284) 43 (330) 30Gain (loss) on change in fair value of Warrants liability (Note 4) 179 529 - (411)Net loss$ (5,767)$ (5,942)$ (2,903)$ (2,541)Basic and diluted net lossper share from continuing operations$ (0.77)$ (1.35)$ (0.34)$ (0.60)Weighted average numberof shares outstanding usedin computing basic and diluted net loss per share 7,487,495 4,531,801 8,620,400 4,747,699 Logo - View original content to download multimedia: SOURCE BrainStorm Cell Therapeutics Inc.


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4 hours ago
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Whoop there it is: FDA wants to regulate wearable firm's blood pressure tool
Get Starting Point A guide through the most important stories of the morning, delivered Monday through Friday. Enter Email Sign Up But in a response sent Aug. 4, Whoop rejected the FDA's assessment, saying the software didn't meet the definition of a medical device and the company would continue to offer the feature to users. The company, which shared the letter with The Boston Globe, also argued the move went against the goals of the Trump administration. Advertisement 'Seeking to regulate the feature as a medical device also runs counter to the stated policy of the Secretary of the Department of Health and Human Services, Robert F. Kennedy Jr., of 'clearing away regulatory barriers so innovation can thrive,'' Whoop said in the letter. Advertisement Whoop's refusal to comply with the FDA's request is uncommon, legal experts said. The FDA, which oversees the safety of medical devices and pharmaceuticals, is usually the ultimate decider of what comes under its jurisdiction and which devices can be sold to help people manage or treat health conditions. Chris Robertson, a Boston University law professor who teaches FDA law, said any communication from the FDA to a company is typically enough to make the company get in line with federal standards. 'You're playing with fire here,' Robertson said. 'That means that Whoop is taking a real calculated gamble.' Wearable technology sits in a grey area when it comes to regulation. The wearables market, estimated by one market intelligence group to be worth $84 billion in 2024, is rapidly expanding, and companies are racing to add new features that give users unique health measurements. Related : Smart wristbands, watches and rings that assess heart rates don't have to get cleared as medical devices. But Whoop competitors, such as Apple and Fitbit, have sought FDA approval for certain software tools in recent years. The crux of Whoop's argument rests on the 21st Century Cures Act, a 2016 law that exempts wellness software features from the definition of a medical device, so long as those features aren't related to the diagnosis, prevention, or treatment of a disease. Blood Pressure Insights, Whoop said, is only intended to be used as a way to gauge a person's performance, quality of sleep, and stress levels . The FDA, however, has rejected Whoop's characterization of the blood pressure tool. In its letter, the agency said the product qualifies as a medical device because its measurements are 'inherently associated with the diagnosis of a disease or condition,' such as hypertension, or high blood pressure. Advertisement Whoop has registered one of its products with the FDA, securing medical device approval for its Heart Screener tool. That tool measures the heart's electrical activity to alert users to potentially abnormal heart rates and atrial fibrillation, a common type of abnormal heart rhythm. The FDA said it doesn't comment on 'ongoing investigations, compliance matters or enforcement activities except with the company involved.' Related : The confrontation is reminiscent of the clash more than a decade ago between the FDA and the personal genomics platform 23andMe, said health law expert Frances Miller, who also teaches at Boston University. The FDA and 23andMe went back and forth on whether the company's health test — which the company claimed could tell customers their risk of conditions like gallstones, heart disease, or arthritis — constituted a medical device. In 2013, the FDA sent a warning letter to 23andMe much like the one it sent Whoop, and 23andMe ultimately capitulated. But the landscape looks different today, Miller said. The FDA has experienced significant cuts under President Trump, and federal agencies as a whole have lost power. In addition, Kennedy has publicly stated his vision that 'every American is wearing a wearable within four years.' Whether Whoop will win its fight against regulation is unclear, Miller said. 'I could have given you a very confident answer a year and a half ago,' Miller said. 'Not now. They're pushing the envelope.' Marin Wolf can be reached at