HHS and FDA Announce Phase Out of “Petroleum-Based Synthetic Dyes”
On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced that FDA is taking actions to phase out petroleum-based synthetic dyes from the U.S. food supply. The specific color additives that the agencies intend to eliminate are Blue No. 1, Blue No. 2, Green No. 3, Orange B, Citrus Red No. 2, Red No. 40, Yellow No. 5, and Yellow No. 6. These color additives are currently authorized for direct use in food pursuant to Title 21 Code of Federal Regulations (C.F.R.) Part 74.
With respect to the use of these color additives in food packaging, 21 C.F.R. 178.3279(d) cross references the color additives listed for direct use in food in Part 74, permitting their use as colorants for food-contact polymers. If the color additive listings are revoked, this would also eliminate their authorization for use in packaging, absent another basis for establishing FDA status specifically for the food-contact use.
In the press release concerning the phase out of these petroleum-based synthetic dyes, FDA stated that it is taking the following actions:
- Establishing a national standard and timeline for the food industry to transition from petroleum-based dyes to natural alternatives;
- Initiating the process to revoke authorization for Citrus Red No. 2 and Orange B within the coming months;
- Working with industry to eliminate the remaining six synthetic dyes (Blue No. 1, Blue No. 2, Green No. 3, Red No. 40, Yellow No. 5, Yellow No. 6) from the food supply by the end of 2026;
- Authorizing four new natural color additives in the coming weeks, while accelerating the review and approval of others;
- Partnering with the National Institutes of Health to research how food additives impact children’s health and development; and
- Requesting food companies to remove Red 3 sooner than the previously announced 2027-2028 deadline.
(For information on the removal of Red Dye No. 3, see the packaginglaw.com article, FDA Revokes Red Dye No. 3 Authorizations Based on Delaney Clause, not Safety.)
HHS also held a press event on the announcement. During that event, HHS officials did not discuss the legal basis on which FDA intends to revoke the authorizations for Citrus Red No. 2 and Orange B, i.e., whether the agency has identified a specific concern related to safety, carcinogenicity, or consumer deception under Section 721(b)(4)-(6) of the Federal Food, Drug, and Cosmetic Act.
For the other six synthetic colors, FDA’s announcement states that the agency will be “working with industry to eliminate the remaining six synthetic dyes from the food supply by the end of 2026,” suggesting that these efforts would be undertaken voluntarily by industry.
Reactions to the news from relevant industry associations were generally positive. For example, the National Confectioners Association stated in a release:
We are in firm agreement that science-based evaluation of food additives will help eliminate consumer confusion and rebuild trust in our national food safety system. We follow and will continue to follow regulatory guidance from the authorities in this space, because consumer safety is our chief responsibility and priority.
The Consumer Brands Association stated in a release on the announcement that, while the “ingredients used in America’s food supply have been rigorously studied following an objective science and risk-based evaluation process and have been demonstrated to be safe,” it has asked HHS and FDA “to reestablish themselves as the country’s leading regulatory authority.” Citing confusion over a “state patchwork of differing laws,” the association further stated that it appreciates that “the administration has reasserted their leadership in response to the myriad of state activity in the food regulation space.”