US FDA bans Red No. 3: US food industry must reformulate by 2027
Food Business Operators (FBOs) involved in marketing, importing, and manufacturing of food products in the US that contain Red No. 3 will need to reformulate and adapt due to various changes in the US food regulations. Alongside recent Food and Drug Administration (FDA) updates, such as the finalization of allergen guidance and the proposed rule on front-of-pack labeling, the FDA has also announced a ban on the colour additive Red No. 3, which is typically used to give food and beverages their bright red colour.
Ban of Red No. 3
On 15 January, 2025 the FDA revoked the authorization for Red No. 3, prohibiting its use in food products. This decision was based on a petition citing two studies that raised concerns about the colour additive's potential link to cancer. This federal ban follows the 2023 California ban, which prohibited the use of this synthetic colour additive, among others, in the manufacture, sale, and import of products within this state. This ban, mirrors the positions of other markets, including the European Union which has banned the use of this additive since 1994.
Where is Red No. 3 currently used?
Red No. 3 is a synthetic food dye that imparts a bright, cherry-red colour to foods and beverages. According to the FDA, Red No. 3 is not as widely used in food and drugs compared to other certified colours based on publicly available information. However, it has been primarily used in certain food products, such as candy, cakes and cupcakes, cookies, frozen desserts, icing, and some beverages.
What’s happening next?
Food manufacturers currently using this additive in their food products, will need to adapt by 15 January, 2027.
How TSG can help
For comprehensive assistance in navigating the changes and implications of the US recent changes in food regulations or addressing other regulatory requirements in North America or world-wide, please get in touch at [email protected]. Leatherhead’s experienced team of scientists and regulatory experts can support you every step of the way. Leatherhead Food Research Members are kept up to date with changing regulations through the weekly Global Legal Highlights newsletter. To learn more, get in touch with our membership team at [email protected]
