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Say Goodbye to Red Dye No. 3 and Hello to FDA-Approved Natural Food Dyes

Say Goodbye to Red Dye No. 3 and Hello to FDA-Approved Natural Food Dyes

CNET13-05-2025

The US Food and Drug Administration officially banned Red dye No. 3, a popular food coloring tied to thyroid cancer, in January of this year. Although the decision marks the beginning of the end for the additive, manufacturers still have time to phase it out of their products. On May 9, the FDA announced the approval of three natural food colors derived from natural sources: red algae, butterfly pea flower and calcium phosphate. Here's everything to know about the synthetic red dye and the newly approved natural dyes.
What is Red No. 3?
Red No. 3 -- also known as FD&C Red No. 3, erythrosine or Red 3 -- is a synthetic dye that is made from petroleum and adds a "bright, cherry-red color" to the products it is added to.
In 1990, the FDA banned Red No. 3 in cosmetics, but no law barred the synthetic dye from being added to numerous types of foods and drinks in the decades that followed.
The FDA cited the Delaney Clause as its reasoning behind the ban, which "prohibits FDA authorization of a food additive or color additive if it has been found to induce cancer in humans or animals."
Although studies did show a link to cancer in laboratory rats, a link between the dye and cancer in humans has not been found.
"While there are studies noting carcinogenicity in male rats, the FDA noted in their announcement that the hormonal mechanism through which the dye caused cancer in rats is specific to the animal and does not occur in humans," Bryan Hitchcock, chief science and technology officer of the Institute of Food Technologists, told CNET.
Hitchcock added that the studies used large amounts of the dye, which is more than what the average human would consume when eating the foods that contain it.
"Studies testing Red No. 3 for human safety have done so at amounts well above the average amount of consumption, as noted by various global regulatory bodies," he says. "The studies referenced by the FDA note that the rats were given roughly 200 times the likely maximum daily consumption of .25 mg/kg of body weight per day."
Foods that contain Red No. 3
Here are 9 common types of foods that contain Red No. 3:
Candy
Cupcakes
Cookies
Frozen desserts
Frostings
Icings
Certain Maraschino cherries
Certain processed meats and meat substitutes
Red No. 3 has previously been banned in other countries, including Australia.Specific items that currently have Red No. 3 on their ingredient list are:
Numerous types of Brach's candy, including Classic Jelly Beans, Spiced Jelly Beans and Conversation Hearts
MorningStar Farms Plant-Based Bacon Strips
Good Humor Strawberry Shortcake Frozen Dessert Bars
Pez candy
According to a list compiled by Drugs.com, some drugs that have Red No. 3 include:
Acetaminophen
Doxycycline Monohydrate
Gabapentin
Vyvanse
The Environmental Working Group has compiled a searchable database of food products that use the now-banned dye. As of April 29, 2025, the site had collected 3,225 products that list Red No. 3 as an ingredient.
When do companies need to remove Red No. 3 from products?
Despite the ban, don't expect to see the Red No. 3 ingredient disappear from ingredient lists too quickly. According to the FDA, companies have a couple of years to remove it from their products.
"Manufacturers who use FD&C Red No. 3 in food and ingested drugs will have until January 15, 2027, or January 18, 2028, respectively, to reformulate their products," the FDA statement reads.
What will replace Red No. 3?
Red Dye No. 3 will soon be replaced by food coloring made from beets and other natural ingredients.
istetiana/Getty Images
Givaudan Sense Colour, a manufacturing company that creates natural food and drink colorings, highlighted three possible alternatives to Red No. 3 -- carmine, which is made from bugs; betacyanins, found in beetroots; and anthocyanins, derived from fruits and vegetables.
California Assembly member Jesse Gabriel told NBC News that although synthetic dyes can be cheaper than other alternatives, he does not believe that the Red No. 3 ban will cause prices of the affected products to change.
"We don't expect the price of any food to increase," he told the outlet.
New natural food dyes approved by the FDA
In May of this year, the FDA approved three natural food dye colors. The first is Galdieria extract blue, which is derived from a species of red algae. According to a press release, this food color has been approved to be added to "nonalcoholic beverages and beverage bases, fruit drinks, fruit smoothies, fruit juices, vegetable juices, dairy-based smoothies, milk shakes and flavored milks, yogurt drinks, milk-based meal replacement and nutritional beverages, breakfast cereal coatings, hard candy, soft candy and chewing gum."
Butterfly pea flower has also been approved to create blues, purples and greens. This popular natural food dye is already used in sports drinks, teas, alcoholic beverages and more. However, the new approval now allows the dye to be used in "ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips (restructured or baked), plain corn chips, tortilla chips and multigrain chips."
Lastly, the mineral, chlorine phosphate, and its white color has been approved for "ready-to-eat chicken products, white candy melts, doughnut sugar and sugar for coated candies," per the release.
Will Red 40 be banned?
The FDA has not yet banned red dye No. 40, but discussions are ongoing. According to a press release from April 22, 2025, the FDA plans to eventually phase out all petroleum-based synthetic dyes, which include Red No. 40.
Are other syntethic food colorings safe?
After the Red No. 3 ban, there are now eight approved color additives (but this may change under the current administration). They are FD&C Blue No. 1, FD&C Blue No. 2, FD&C Green No. 3, Orange B, Citrus Red No. 2, FD&C Red No. 40, FD&C Yellow No. 5 and FD&C Yellow No. 6.
Hitchcock says that so far, studies show that there is not a notable risk to consuming these dyes.
"While science tells us that there is little to no risk in consuming other synthetic dyes, it is important that we continue to monitor and evaluate food ingredient safety," he says. "It is paramount that we continue to invest in more scientific research around the health of our foods to ensure safety and provide peace of mind for consumers."
According to the FDA, the above dyes do not pose the same possible risks as Red No. 3, which is why they are still available for use in the US. But, some studies show possible links between certain dyes and potential health conditions. For example, some studies have linked Red 40 to hyperactivity, according to the Cleveland Clinic, but further studies are still needed to determine a direct link between the dye and the condition.
When asked about the safety of other food dyes, Hitchcock highlighted the need for transparency from the FDA, which he says the agency has been addressing.
"We believe there needs to be a clear framework for post-market review for food additive safety," Hitchcock says. "The FDA is actively working to address this issue as seen in their Development of an Enhanced Systematic Process for the FDA's Post-Market Assessment of Chemicals in Food. IFT believes that the FDA needs to bring forward a post-market assessment of chemical food safety that is transparent, scientifically grounded, constituent informed and timely."
If a drink looks too red to be natural, it probably is.
vlad.plus/Getty Images
Does food coloring have a taste?
Most foods contain food coloring in such small amounts that you won't notice a specific taste. However, some food coloring brands, types or certain colors (like red) may taste slightly bitter if a lot is used.
The bottom line on Red No. 3
Red No. 3 has been fully banned in the US, but will continue to be used in food for the next two years as manufacturers work to change their recipes. However, some manufacturers are making changes much more quickly than that.
In an email to CBS News, Keurig Dr Pepper said that a "new formula" for Yoo-hoo Strawberry Flavored Drink, which is currently made with Red No. 3 to help achieve its color, "will be on shelves before the end of the year."

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Ascletis Announces Phase III Trial of Denifanstat (ASC40), a First-in-Class, Once-Daily Oral FASN Inhibitor for Acne, Meets All Endpoints
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Clascoterone: How the Novel Androgen Receptor Inhibitor Fits Into the Acne Treatment Paradigm. Ann Pharmacother. 2021;55(10):1297-1299. doi:10.1177/1060028021992055. Table 1. Baseline characteristics of Phase III trial of denifanstat Baseline characteristics 50 mg denifanstat, oral, oncedaily (n=240) Placebo, oral, once daily (n=240) Total lesion count 102.2 102.1 Inflammatory lesion count 42.1 43.1 IGA=3 (moderate), % 85.8 85.8 IGA=4 (severe), % 14.2 14.2 Table 2. 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Table 3. Denifanstat compared to other commonly used acne treatments (not head-to-head comparison) Category Denifanstat (n=240) Sarecycline(1) (n=1002) Doxycycline(2) (n=216) Clascoterone cream(3) (n=722) Baseline characteristics Total lesion count 102.2 72.4 71.7 103.6 Inflammatory lesion count 42.1 30.0 33.6 42.7 IGA=3 (moderate), % 85.8 85.2 93.5 82.7 IGA=4 (severe), % 14.2 14.9 6.5 17.3 Efficacy endpoints at week 12 Placebo-adjusted percenttreatment success 18.6 9.4 6.7 11.6 Placebo-adjusted percent reductionfrom baseline in total lesion count 22.0 NA 7.6 11.9 Placebo-adjusted percent reductionfrom baseline in inflammatorylesion count 20.3 15.6 7.3 12.8 Placebo-adjusted percent reduction from baseline in non-inflammatorylesion count 23.0 4.5 NA 11.4 Notes: (1) The sarecycline data represent an analysis of its two Phase III clinical trials, with values expressed as means. The data are from Moore, A., et al., J Drugs Dermatol 2018 Vol. 17 Issue 9 Pages 987-996. 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PR and IR teams+86-181-0650-9129 (China)pr@ ir@ View original content: SOURCE Ascletis Pharma Inc. Sign in to access your portfolio

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Such statements include, but are not limited to, statements about the anticipated closing of the public offering and the expected gross proceeds of the offering, among other things, and other statements containing the words "believes," "anticipates," "plans," "expects," "may," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties related to market conditions and whether the conditions for the closing of the public offering will be satisfied, as well as other risks and uncertainties, as well as other risks and uncertainties set forth in the "Risk Factors" section of the preliminary prospectus supplement filed with the SEC on June 2, 2025, in Trevi's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 filed with the SEC, and in any subsequent filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made except as required by law. Investor Contact Jonathan CarlsonTrevi Therapeutics, Inc.(203) 654 3286carlsonj@ Media Contact Rosalia Scampoli914-815-1465 rscampoli@ View original content to download multimedia: SOURCE Trevi Therapeutics, Inc.

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