As the FDA targets synthetic dyes in food, will drugs be next?

Synthetic dye phase-out

The FDA and HHS' policy initiative mentions a phased approach to reducing the number of synthetic dyes used in food.

While no enforceable regulations have been issued yet, the agencies announced they would initiate a formal rulemaking process "within the coming months" to revoke the authorized approval of the two following synthetic colorants:

• Citrus Red No. 2. First approved in 1956 to color the green skin of unripe oranges.
• Orange B. First approved in 1966 for use in hotdog and sausage casings only.

The release also noted the FDA would like to work with the food industry to eliminate the following six synthetic dyes for coloring food (FCF) commonly found in food, drugs and cosmetics (FD&C) by the end of next year:

• FD&C Green No. 3. Also known as Fast Green FCF, this colorant has been FDA approved since 1927.
• FD&C Red No. 40. Also known as Allura Red AC, this colorant has been FDA approved since 1971.
• FD&C Yellow No. 5. Also known as Tartrazine, this colorant has been FDA approved for use since 1969.
• FD&C Yellow No. 6. Also known as Sunset Yellow FCF, this colorant has been FDA approved since 1986.
• FD&C Blue No. 1. Also known as Brilliant Blue FCF, this colorant has been FDA approved since 1969.
• FD&C Blue No. 2. Also known as Indigo Carmine, this colorant has been FDA approved since 1931.

Although FD&C Red No. 3 is already scheduled for delisting in food, oral drugs and supplements by 2027–2028, the FDA wants food and drug industries to drop it sooner.

However, none of the agency's requests mentioned in the news release are legally binding, until a formal rule is finalized. Until then, manufacturers are only being encouraged to comply.

Natural alternatives

The FDA also announced it would be authorizing the following four new natural color additives in the coming weeks by expediting the review process and fast-tracking the approval:

• Galdieria extract blue. Derived from the microalga Galdieria sulphuraria, this extract offers a natural blue hue suitable for various food applications and is currently in the final stages of FDA approval.
• Butterfly pea flower extract. Obtained from the Clitoria ternatea plant, this extract produces a pH-sensitive blue-to-purple hue. It has been FDA-approved since 2021 and is widely used in beverages and confections.
• Gardenia blue. Sourced from the fruit of the gardenia plant, this pigment yields a vibrant blue color and has been traditionally used in Asian cuisines. The FDA currently has a working group evaluating it.
• Calcium phosphate. While primarily recognized as a mineral supplement, certain forms of this compound are generally recognized as safe by the FDA and can function as color stabilizers or whitening agents in food and beverages.

International restrictions

The FDA said it is partnering with the NIH to expand research into the developmental and behavioral effects of synthetic dyes, especially on children.

"Today, the FDA is asking food companies to substitute petrochemical dyes with natural ingredients for American children, as they already do in Europe and Canada," FDA Commissioner Marty Makary, MD, MPH, said in the press release. "We should not be taking risks when it comes to public health."

For example, FD&C Red No. 3 and Green No. 3 are banned or not permitted in food in both regions. Red No. 40, Yellow No. 5 and Yellow No. 6 are allowed, but in the European Union (EU), they must carry warning labels about potential hyperactivity in children and are subject to usage limits by product type.

Canada also enforces stricter concentration thresholds and mandates label disclosure due to allergen concerns. Blue No. 1 and Blue No. 2 remain authorized in both markets but are governed by maximum daily intake limits and restricted in products intended for infants and young children.

Synthetic dyes in pharmaceuticals

Although the FDA’s policy measures don't directly impact pharmaceutical products, this initiative could lay the groundwork for broader regulatory changes. For instance, synthetic dyes like those being phased out of the food supply aren’t limited to cereals and candy -- they are also widely used as excipients in drug formulations, providing color to tablets, capsules and suspensions.

These additives appear in a broad range of medications, including Advil, Viagra, Adderall, Sertraline, Prednisone, Cephalexin, various children’s cold and allergy treatments and even prenatal vitamins.

Pharmaceutical companies frequently use synthetic dyes for visual appeal, branding and product consistency. They also can be used to distinguish different dosages or formulations. While these ingredients are considered inactive, their use in chronic medications and pediatric products could become a point of contention if public pressure and research findings continue to mount.

Notably, the FDA has already taken a step in this direction. In 2022, the agency moved to ban FD&C Red No. 3 in food, ingested drugs and oral supplements, citing long-standing toxicology data linking the dye to cancer in animal studies. While topical drugs and cosmetics are still permitted to contain Red No. 3, the dual-category ban marked a significant policy shift, and one that may signal future action on other synthetic dyes.

Should payers or policymakers view petroleum-based excipients as outdated or harmful, products containing them could face formulary challenges, especially in pediatric or consumer-sensitive categories.

Commercial strategy considerations

Although there is no immediate regulatory obligation for drugmakers to reformulate, the commercial implications could have a larger impact than expected. Reformulation costs, labeling updates and new compliance submissions could introduce significant financial and timeline risks, especially for products targeting pediatric populations or global markets.

In a sector increasingly shaped by health-conscious consumers and tightening international regulations, excipient transparency could become a market differentiator.

This is particularly relevant for biopharma firms with global operations. The EU and Canada have already imposed tighter restrictions on many of the same dyes the FDA is now targeting in the food sector.

With these international precedents in place, multinational drugmakers could soon face pressure to harmonize formulations across markets to avoid dual manufacturing streams.

What's next?

For now, the phase-out is limited to the food sector. But as public health policy sharpens its focus on additive safety, especially in vulnerable populations, drug makers should prepare for shifting attention.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.