Red Dye No. 3 Ban: What You Need to Know
In early 2025, The Food and Drug Administration (FDA) announced that it is revoking its authorization for the use of FD&C Red No. 3, a synthetic food dye, in foods and ingested drugs.
But why did the FDA revoke its authorization? And what does this effective ban on the substance, also referred to as Red Dye No. 3, mean for you and your health?
The Delaney Clause
In 2022, the FDA received a color additive petition requesting that the administration review whether or not the Delaney Clause applied to its authorization of Red Dye No. 3.
The petition cited data including two studies that showed male laboratory rats who were exposed to high levels of Red Dye No. 3 developed cancer due to a rat specific hormonal mechanism.
The Delaney Clause is part of the Colo Additives Amendment to the FD&C Act, and it prohibits the FDA from authorizing food additives or color additives if they are found to induce cancer in humans or animals.
On Jan. 15, 2025, the FDA issued an order revoking its authorization of the dye and manufacturers who used Red Dye No. 3 in food or ingested drugs now have until Jan. 15, 2027, or Jan. 18, 2028, respectively, to reformulate their products.
Impact on Your Health
Red Dye No. 3, when used, is utilized in small amounts. This dye gives foods and drinks a particular color described as bright, cherry red, and it’s most often found in certain candy, cakes, cookies, frostings, icings and ingested drugs.
While the ban may impact foods you enjoy or certain medications you ingest, it is nothing to be alarmed about.
The studies that prompted the ban showed the cancer risk was to laboratory rats and not humans. The FDA stated in its Jan. 15 update that "claims that the use of FD&C Red No. 3 in food and ingested drugs put people at risk are not supported by the available scientific information."
Safety Review of Color Additives
The FDA continuously monitors reports of health issues and concerns that may be related to color additives, and there are many actions the FDA can take to ensure consumer safety.
On top of revoking or amending regulations, the FDA can issue warning letters to manufacturers, detain products, issue import alerts and even seize products found to be unsafe.
If you think you experienced an adverse reaction, including illness or allergic reaction, to a color additive, you can report it to the FDA via its Industry and Consumer Assistance page.
