Last week, the U.S. Food and Drug Administration (FDA) issued a proposed rule to revoke the color additive listing for Orange B, a synthetic dye historically used on the casings and surfaces of frankfurters and sausages. This action is part of the broader “Make America Healthy Again” (MAHA) initiative to phase out petroleum-based foods from the American food supply by the end of 2026 and efforts to modernize the agency’s regulations.
Notably, no batches of Orange B have been certified or requested for use since 1978, signaling that the industry has long since abandoned its use. Based on this, FDA tentatively concludes that the color additive listing for Orange B is “outdated and unnecessary”. If finalized, the rule would revoke the authorization entirely, meaning that any use of the color additive in food after its certification lapses and the listing is removed would render the product adulterated under the Federal Food, Drug, and Cosmetic Act (FDCA).
Unlike the recent revocation of the FD&C Red Dye No. 3 listing, the proposed revocation of Orange B is largely administrative in nature, given the apparent absence of any known commercial use in decades.
Public comments on the proposed rule are due on or before October 17, 2025.