• Firms that use petroleum-based synthetic dyes should review their formulations and business operations with suppliers to determine the feasibility of transition and availability of natural alternatives, and also consider whether new color additive petitions should be submitted to FDA.
• Firms should closely monitor FDA's upcoming guidance on the phase-out plan, including the specific compliance deadline to remove the synthetic dyes, updates food labeling, and guidance for products that were manufactured.

Firms may consider engaging with the FDA and HHS to seek clarifications regarding the transition period. This can be effectively done through trade associations or industry groups, allowing them to collectively advocate for their interests and obtain clarity from the agency on the transition process.

In depth

We are highlighting a few FDA key actions below, along with our quick observations:

• Revoking authorization for two food colorings. Within the coming months, FDA will revoke authorization for two synthetic food colorings — Orange B and Citrus Red No. 2. We would like to note that FDA's current regulations narrowly permit the use of Orange B in coloring the casings or surfaces of frankfurters and sausages, and the use of Citrus Red No. 2 only for coloring the skins of oranges that are not intended or used for processing². Given the limited applications of these two synthetic food colorings, the transition to natural alternatives might be somewhat easier compared to other synthetic dyes.
• Eliminating six synthetic dyes in food uses only. By the end of 2026, FDA will work with the industry to eliminate six remaining synthetic dyes from the food supply — FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue No. 2. Importantly, while some of the listed dyes are authorized for use in multiple FDA-regulated products, the phase-out plan only focuses on their application in food. For example, FDA's current regulations authorize the use of FD&C Yellow No. 5 in foods and drugs, and the use of FD&C Blue No. 2 in foods and medical devices³. Apparently, the FDA phase-out plan would not impact their use in non-food products at the moment.
• Authorizing new natural color additives. FDA is fast-tracking the review of four new natural color additives—calcium phosphate, Galdieria extract blue, gardenia blue, butterfly pea flower extract, and also accelerating the review and approval of other natural alternatives to synthetic food dyes. Please note that the colors of the four new natural additives are white, blue, and purple, which do not fully match the colors of the synthetic dyes being phased out. Additionally, a quick review of the food color additive petitions filed by the relevant parties indicates that these natural additives do not have the same types of applications as the synthetic dyes being phased out.
• Expediting the deadline to remove FD&C Red No. 3. In January 2025, FDA issued a new rule revoking authorization for use of FD&C Red No. 3 in food and ingested drugs. The rule also mandated that 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 phase-out plan now requests that food companies (again, only concerning food applications) remove Red No. 3 sooner than the previously required deadline. However, it remains unclear whether the new deadline means that manufacturers may not use FD&C Red No. 3 in food manufacturing, or more broadly, food products being sold in the marketplace should not contain FD&C Red No. 3 as of the expedited compliance date.