FDA Seeks to Phase Out Synthetic Color Additives

On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced a major initiative to voluntarily phase out “petroleum-based synthetic dyes” (i.e., synthetic color additives) from the U.S. food supply. This FDA initiative is part of the broader trend of increased scrutiny of food and color additive safety at the state and federal levels.

Specifically, HHS and FDA expressed the following goals:

• Establish a national standard and timeline for the food industry to transition from petrochemical-based dyes to natural alternatives.
• Revoke authorization of Citrus Red No. 2 and Orange B in the coming months. These color additives are generally no longer used in the U.S. food supply.
• Eliminate six synthetic color additives through voluntary industry action (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) by the end of 2026.
• Accelerate the removal of FD&C Red No. 3 in food ahead of the previously stated January 15, 2027 deadline through voluntary industry action.
• Authorize four new natural color additives in the coming weeks and expedite the approval of other “natural” color additives. To achieve this goal, FDA plans to fast-track its review of pending color additive petitions for new or additional uses of calcium phosphate, Galdieria extract blue, gardenia blue, and butterfly pea flower extract. FDA also plans to issue guidance and provide regulatory flexibilities to industries for the transition to synthetic color additive alternatives.
• Partner with the National Institutes of Health to conduct comprehensive research on how food additives impact children’s health and development.

While FDA Commissioner Marty Makary emphasized that FDA would like to voluntarily work with the food industry, Secretary Makary also noted that FDA is currently exploring “every tool in the toolbox” to accomplish the above goals.

During the joint HHS-FDA press conference on April 22, 2025, HHS Secretary Robert F. Kennedy, Jr. stated that the threat of a patchwork of state legislation brought the food industry to the table to support FDA’s voluntary phase-out of synthetic color additives. This patchwork has slowly expanded since 2023. For example, in 2023 and 2024, California passed laws regulating color and food additives, including brominated vegetable oil, potassium bromate, propylparaben, FD&C Red No. 3, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, and FD&C Yellow No. 6.

So far in 2025, three additional states have also enacted specific color additive bans with various effective dates beginning this May:

• Virginia’s HB 1910 prohibits public elementary and secondary schools from offering or making available foods that contain FD&C Green No. 3, FD&C Red 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.
• Utah’s HB 402 prohibits public schools from serving foods that contain potassium bromate, propylparaben, FD&C Green No. 3, FD&C Red 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.
• West Virginia’s HB 2354 prohibits the sale of any food products that contain 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.

More than 20 other states are considering similar color additive bans in food. Given this evolving landscape, MoFo is closely monitoring federal and state developments concerning color and food additives and is available to provide legal guidance to clients on potential regulatory, advertising, and class action litigation matters.

Cathie Chen, an associate in our Washington D.C. office, contributed to the writing of this article.