The Do or Dye Act amends the Federal Food, Drug, and Cosmetic Act to deem foods containing specific color additives adulterated, with two staggered effective dates. Qualified color additives face a December 31, 2025 deadline to be considered unsafe for use in food, while covered color additives follow a December 31, 2026 deadline.
The bill also defines what counts as a covered color additive and what counts as a substantially similar additive to extend the scope.
At a Glance
What It Does
The bill creates a two-tiered mechanism: first, it deems qualified color additives unsafe for foods and makes foods bearing them adulterated after December 31, 2025; second, it does the same for covered color additives after December 31, 2026. Enforcement relies on existing adulteration provisions in the FD&C Act.
Who It Affects
Food manufacturers, exporters, importers, packagers, and retailers that use or label products with the specified color additives; FDA enforcement personnel and laboratories responsible for determining adulteration.
Why It Matters
It expands regulatory risk around popular food color additives, shaping reformulation decisions and supply chain strategies for compliance and consumer safety.
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What This Bill Actually Does
The Do or Dye Act tightens the regulatory regime around artificial colors in the food supply. It introduces two groups of color additives—qualified and covered.
For qualified color additives, the bill makes them unsafe to use in foods and makes any food bearing them adulterated starting December 31, 2025. For the broader group, the covered color additives, the same rule kicks in one year later on December 31, 2026.
The law also defines what qualifies as a colored additive and what counts as substantially similar to those additives, which broadens the potential reach of the rule. The new framework ties these determinations to the existing definitions of unsafe use and adulteration under the FD&C Act (the same parts that govern how food ingredients are regulated).
Practically, manufacturers will need to review their color palettes, reformulate where needed, and adjust labeling and supply chains to avoid triggering adulteration. Public health and consumer safety objectives underpin the stepwise phaseout, while industry faces the costs of reformulation, testing, and recalls if noncompliant products reach the market.
The Five Things You Need to Know
The bill creates a two-stage schedule: 2025 for qualified color additives, 2026 for covered color additives.
Foods containing any listed color additive become adulterated after the respective effective dates.
The defined lists include specific additives (e.g.
Red 40, Yellow 5, Yellow 6, Green 3, Blue 1, Blue 2) and permit coverage for substantially similar additives.
Qualified color additives include Citrus Red 2 and Orange B, plus substantially similar additives.
“Substantially similar” language broadens scope beyond the named additives, extending compliance risk to closely related colors.
Section-by-Section Breakdown
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Adulteration triggers for qualified color additives
This provision (a) sets the two-phase timetable that converts certain color additives from potentially permitted ingredients to unsafe and adulterating agents in food. Beginning December 31, 2025, a qualified color additive is deemed unsafe for use in or on food, and any food bearing that additive is adulterated under the FD&C Act. The same adulteration standard applies to such foods under section 402(c). The section draws on the existing framework for determining safety and adulteration and anchors the change in current law.
Definition: Covered color additives
This subsection defines covered color additives as the listed additives (Red No. 40, Yellow No. 5, Yellow No. 6, Green No. 3, Blue No. 1, Blue No. 2) and any additive substantially similar to those. The timetable to treat these additives as unsafe follows the 2026 date, expanding the set of additives that can trigger adulteration when used in food.
Definition: Qualified color additives
This subsection defines qualified color additives as Citrus Red No. 2, Orange B, and any additive substantially similar to Citrus Red No. 2 or Orange B. This provides a tighter initial list whose status shifts earlier (2025) relative to the longer list of covered additives, creating a staggered transition for compliance planning.
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Explore Government in Codify Search →Who Benefits and Who Bears the Cost
Every bill creates winners and losers. Here's who stands to gain and who bears the cost.
Who Benefits
- FDA regulators gain a clearer statutory basis to enforce adulteration rules and to direct oversight of color additives in the food supply.
- Consumers and public health advocates gain stronger protection against questionable color additives as foods containing those additives become adulterated after the dates.
- Food manufacturers that already plan reformulations or maintain compliance with stricter color additive standards may experience smoother transitions and reduced market risk.
- Food industry compliance professionals and testing laboratories have a defined timeline and criteria to guide risk assessments and audits.
- Retailers and distributors benefit from an expanded but clearer enforcement signal, aiding recalls and product withdrawals when necessary.
Who Bears the Cost
- Food manufacturers and packagers that rely on restricted color additives incur reformulation, testing, and labeling costs.
- Importers and exporters must verify compliance for products sourced globally, potentially leading to recalls or divestment of noncompliant items.
- Retailers and distributors face costs from recalls, inventory write-downs, and supply-chain adjustments to avoid prohibited additives.
- Regulatory agencies and laboratories incur enforcement and monitoring costs to implement and verify adulteration determinations.
- Small businesses using these additives may bear disproportionate burdens associated with reformulation and supplier changes.
Key Issues
The Core Tension
Should the government accelerate the removal of certain color additives to protect consumers, even if it imposes higher costs on industry and could disrupt supply chains, or should it preserve regulatory predictability at the risk of slower public health protection? The central dilemma is balancing rapid consumer safety improvements against the practical costs and feasibility of reformulation across a diverse food industry.
The Do or Dye Act introduces a phased approach to phasing out certain color additives, but it raises several policy tensions. The use of a “substantially similar” standard creates an expanded regulatory footprint that could sweep in additives beyond the named list, potentially increasing compliance complexity for manufacturers who rely on color additives for product appearance.
The staggered dates help the industry adjust, yet they also create a moving target for labeling, testing, and supply-chain management. Enforcement will hinge on FDA interpretive guidance and how “unsafe” is defined in practice for varying product contexts, including imported foods.
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