Bye-bye, bright dyes: Strategies for responding to FDA’s synthetic food dye phase-out

Plan to phase out synthetic color additives

Petroleum-based synthetic dyes are synthetic color additives derived from crude oil. The dyes are most commonly used in processed food and beverages such as candy, baking decorations, and sports drinks to make the items appear more vibrant or consistent in color. However, these dyes are also used in some supplements, medications, and even medical devices such as contact lenses or nonabsorbable sutures. The FDA has already banned certain additives, including Red No. 3, which must be removed from food items by 2027 – 2028.

This move builds on the FDA’s long-standing regulatory framework for color additives, which places strict requirements and restrictions on the use of color additives in food. The FDA requires most color additives in food to be batch-certified and approved for specific uses under the Food, Drug, and Cosmetic Act, and any unapproved uses are prohibited. All ingredients, including color additives, must be listed on labels. Certified ones must be listed by name, but exempt ones may be listed generically.

Before the recent announcement of the plan to eliminate food dyes from the US food supply, the FDA had only approved eight artificial dyes for human consumption:

• Red No. 40
• Blue No. 1
• Blue No. 2
• Citrus Red No. 2
• Green No. 3
• Orange B
• Yellow No. 5
• Yellow No. 6

As announced on April 22, 2025, the FDA is taking decisive steps to phase out synthetic food dyes, beginning with the revocation of Citrus Red No. 2 and Orange B. This marks the first phase in a broader effort to eliminate six additional dyes, including Red No. 40 and Yellow No. 5, by the end of 2026. The FDA has cited potential health risks and consumer demand for cleaner ingredients. To accelerate the transition, the FDA will fast track approval of natural alternatives, such as butterfly pea flower extract and calcium phosphate, to help manufacturers shift without disruption. The FDA has also called for an early removal of Red No. 3, moving up the original 2027 – 2028 deadline, as concerns over its continued use in food and beverages grow.

Momentum is building across both the private and public sectors to move away from synthetic food dyes. Several leading food and beverage companies have already announced plans to eliminate artificial dyes from all products within the next two years. At the state level, Texas recently passed a law requiring food manufacturers to place warning labels on food containing any one of 44 dyes and additives banned in other countries starting in 2027. Several of these ingredients, including Blue No. 1, Blue No. 2, and Green No. 3, are also on the FDA’s proposed ban list, signaling a broader national effort to restrict synthetic dyes in the US food supply.

FDA draft guidance on replacing color additives in drug products

On May 29, 2025, the FDA announced an expanded effort to reduce synthetic dyes beyond food and beverages, extending its focus to drug products. As part of this initiative, the agency released draft guidance providing recommendations for replacing color additives in approved or marketed drug products. Although this guidance targets pharmaceuticals, it reflects the broader regulatory momentum toward eliminating synthetic dyes across sectors.

This draft guidance recommends that manufacturers comply with the following requirements:

• Manufacturers must verify that selected color additive replacements continue to comply with color additive regulations. Color additives not listed have yet to be deemed safe and therefore may not be used.
• Holders of a new drug application or an abbreviated new drug application must submit changes being effected in 30 days (CBE-30) supplements within 30 days of implementing a color additive replacement. These submissions should include evidence confirming that the replacement does not affect the drug’s effectiveness and that the product continues to meet established quality standards.
• Records documenting the replacement’s sustained effectiveness and overall drug composition should be maintained at the drug manufacturing facility through the product’s expiry date.

Like the FDA and HHS’s plan to phase out petroleum-based synthetic dyes, the draft guidance reflects the Trump administration’s broader push to eliminate artificial additives in favor of natural alternatives, signaling that manufacturers across industries should begin preparing for a future with fewer synthetic ingredients. Key action items include the following:

• Conduct a dye inventory assessment to identify all stock keeping units and formulations containing any of the above-listed FDA-certified synthetic dyes.
• Engage with the food industry association or your own industry group to make your voice heard and learn about other responses in your industry.
• Initiate reformulation planning by evaluating natural color alternatives and considering technical feasibility, supply chain availability, and consumer impact. FDA has already approved petitions for new natural blue and white additives, and more are expected in the near term.
• Ensure that marketing and regulatory teams are prepared to update product labeling to reflect reformulated ingredient lists and comply with FDA disclosure requirements for certified and exempt color additives.
• Evaluate supply chain and cost impacts. Work with suppliers to confirm transition timelines and ensure secure sourcing of compliant natural colorants.

Next steps

The draft guidance for replacing color additives in drug products is open for public comment until July 29, 2025. Companies that manufacture, distribute, or private-label food or drug products containing any of the eight currently approved synthetic dyes should begin compliance planning immediately.

The McDermott difference

McDermott will continue to monitor developments to the plan to phase out petroleum-based synthetic dye in food. For more information on complying with the removal of synthetic dyes, please reach out to the authors of this article or any member of McDermott’s Food, Drug & Medical Device Regulatory Group.