FDA bans Red Number 3 dye, proposes nicotine limit
by: Greta Cross
Eric Lagatta
and Ken Alltucker
USA Today
..... The Food and Drug Administration officially banned Red Number 3, an additive use for giving food and drinks a bright, cherry-red color.
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The FDA announced the ban for the dye in food and ingested drugs Wednesday [01/15/2025] while also announcing a proposed rule to make tobacco companies nicotine levels in cigarettes, most cigars and other combustible tobacco products.
..... The removal of Red Number 3 from the list of approved dyes comes in reasons to a color additive petition filed in 2022 by advocates claim the additive is linked to cancer and behavioral problems in children.
..... Manufacturers who use Red Number 3 in food will have until January 14, 2027, to reformulate their products, while those who sue the dye in drugs will have until January 18, 2028, according to the FDA announcement. Food imported in the U.S. will also be required to comply with the new regulations.
..... According to the FDA announce mt, Red Number 3 is commonly used in candy, cakes and cupcakes, frozen desserts, frostings and icing, and certain ingested drugs. According to the Environmental Working Group, more than 3,000 products contain the additive.
..... It was banned from use in cosmetics in the U.S. in 1990 due to evidence that the dye is carcinogenic at high does to lab rats. However, it has remained one of nine synthetic dyes approved for sue in food products. The eight reaming approved dyes include Blue Number 1, Blue Number 2, Green Number 3, Orange B, Red 40, Yellow 5, 6 and citrus Red - all used to give food, drinks and ingested drugs bright colors.
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The color additive petition field in 2022 cited two studies that showed cancer in male lab rats when exposed to high levels of Red Number 3. According to the FDA announcement, the way Red Number 3 causes cancer in male lab rats does not occur in humans, and humans are typically exposed to much lower levels than lab rates. The announcement said studies in other animals and humans did not result in these effects.
..... The proposed rule for tobacco companies doesn't ban nicotine but lowers the amount allowed in cigarettes, tobacco and most cigars to 0.7 millgrams per gram of tobacco - a smaller amount that what;s on the market today and potentially low enough to prevent addiction.
..... But the nicotien, limit doesn't apply to vaping products, nicotine pouches, hookahs or premium cigars.
..... The public can comment on the proposed rule through September 15, [2025] which the agency will consider before next steps, including enactment the nicotine limit. That means the nicotine rule would be administered under President-elect Donald Trump, who has nominate Johns Hopkins surgeon Marty Makary to led the agency that regulates drugs, devices, food and tobacco.
..... The reduction was first proposed under Trump's earlier administration by FDA Commissioner Scott Gottlieb.
..... The FDA said the rule aims to prevent underage smoking and help adults transition form smoking to lower-risk alternatives that would reduce exposure to harmful chemicals. But the agency said no tobacco product is safe and urged children and adults to avoid tobacco products entirely.