We are committed to keeping our customers informed about important regulatory changes that impact the food and beverage industry. Recently, the FDA announced a significant update regarding the use of Red No.3 in food products.

The Update

On January 15, 2025, the FDA announced the revocation of authorization for the use of FD&C Red No. 3 (also known as erythrosine) in food and ingested drugs. This decision is based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which prohibits the use of any food or color additive found to induce cancer in humans or animals.

Although studies showed cancer in laboratory male rats exposed to high levels of FD&C Red No. 3, the FDA concluded that these effects were specific to rats and do not pose a risk to humans. However, due to the Delaney Clause, the FDA is required to revoke authorization.

Manufacturers using FD&C Red No. 3 in food products will have until January 15, 2027, to reformulate their products. For ingested drugs, the deadline extends to January 18, 2028. While some countries still allow Red No. 3 (under the name erythrosine), foods and drugs imported to the U.S. will need to comply with these updated regulations.

What This Means for You

At LabelCalc, we understand the challenges that come with regulatory changes. As a manufacturer, this revocation means you will need to remove FD&C Red No. 3 from your products or find suitable alternatives. The FDA’s decision requires all food products containing this dye to be reformulated by January 15, 2027, and ingested drugs by January 18, 2028. It’s essential to begin the reformulation process soon to ensure that your products remain compliant.

You will also need to update your product labels to reflect the removal of FD&C Red No. 3. This is an important step to ensure you meet the latest FDA regulations and avoid disruptions in your product offerings.

Should you have any questions or need assistance with updating your labels, our team is here to help. For more details on the FDA’s revocation of Red No. 3, read the full update here.

About LabelCalc

LabelCalc, a Datacor company, is used by food manufacturers worldwide to generate accurate nutrition facts labels quickly and easily. Our intuitive software gathers all the essential details about ingredients, nutrition facts, serving sizes, and allergens, expertly formatted and compliant with the latest FDA regulations. LabelCalc saves you valuable time and eliminates the hassle of complex calculations by seamlessly handling all the behind-the-scenes work.