As a kid, the more colorful the food was, the better it looked. Bright red candies? Instant favorite. Neon cereal? Say no more.

But as health-conscious adults, we’ve learned to be a little more skeptical, especially of foods that look too vibrant (😂).

Turns out, we’re not alone in that thinking.

The U.S. Food and Drug Administration (FDA) has proposed a ban on Red Dye No. 3 in food and dietary supplements, citing potential health risks.

Red Dye No. 3 (also known as FD&C Red No. 3 or erythrosine) has been used for decades to give products a bright pink-red hue.  

From your favorite breakfast cereals and candies to nutritional supplements and even throat lozenges, you’ll find it in everything.

But that’s about to change.

For brands, it’s a full-scale update to formulas, labels, and compliance protocols.

If you're part of a packaging or regulatory team, here's what you need to know and how to stay ahead of this change.

A little bit more about the announcement

In January 2025, the FDA proposed revoking its approval of Red Dye No. 3 in food and dietary supplements. While the dye has been banned in cosmetics since 1990 due to evidence it caused cancer in lab animals, it remained legal in foods and ingestible products until now—a loophole that advocacy groups have long challenged.

The FDA’s decision is based on scientific research and growing consumer pressure. Studies have linked Red Dye No. 3 to tumors in rats and raised concerns about hyperactivity and behavioral issues in children. With safer alternatives available, the FDA concluded the risk is no longer justifiable.

A grace period will be provided for companies to comply, but once finalized, any product containing Red Dye No. 3 in violation of the rule will be considered misbranded under the Federal Food, Drug, and Cosmetic Act.

What changes for your team

The current scenario now? A product that’s been on the market for years now requiring a complete update both in formulation and packaging just to stay compliant with the new regulation.

So, this ban sets off a chain reaction of urgent tasks for packaging, labeling, and regulatory teams, spanning multiple SKUs, departments, and markets:

1. Identify products that contain Red Dye No. 3

Begin with a portfolio-wide audit to flag every product containing Red Dye No. 3. This means looking into:

• Ingredient lists of packaging.

• Design files that use the red dye in callouts, flavor visuals, or marketing text.

• Internal formulation databases.

This step often reveals hidden overlaps across SKUs or older SKUs that weren’t updated during reformulations.

2. Update ingredient declarations and artwork

Once you confirm the dye has been removed from a product, the next step is updating its packaging artwork:

• Ingredient panels must reflect the reformulation.

• Front-of-pack claims like “Contains artificial colors” or “Colors added” may need to change.

• Marketing copy referencing color or appearance may also require edits.

Even seemingly minor text or layout changes must be edited accurately, especially when they involve crucial compliance elements.

3. Check regulatory statements and allergen declarations

Many brands include optional or required regulatory statements on-pack, such as:

• “Contains FD&C Red No. 3”

• “Contains artificial color additives”

These declarations will need to be reviewed and removed or revised. Additionally, check for allergen implications tied to colorants or flavoring systems that were altered during reformulation.

4. Coordinate changes across SKUs

It’s rarely a single product. If Red Dye No. 3 was used in a cherry-flavored supplement, it’s likely also in your strawberry, watermelon, or berry variants. Coordinating updates across dozens of SKUs can be time-consuming and risky if not managed systematically.
You’ll need to:

• Track which variants share the same design template or master artwork.

• Ensure consistency across flavors, pack sizes, and regional variants.

• Avoid version mismatches or skipped files during the rollout.

And what if you fail to comply

Ignoring or delaying these changes could lead to:

1. Product recalls

If products with Red Dye No. 3 are still sold after the ban takes effect, they may be subject to mandatory recalls, often costly, logistically complex, and damaging to brand trust.

Also read: Top reasons for FDA recalls and how to avoid them

2. Serious legal actions or hefty fines

The FDA may issue warning letters, seize non-compliant goods, or impose civil penalties. Even unintentional violations (like an outdated label slipping through) can trigger legal action.

3. Loss of consumer trust

In today’s transparency-driven marketplace, consumers expect brands to prioritize safety and stay compliant. If your product is flagged for containing a banned ingredient, it could permanently affect your brand reputation.

4. Retailer rejections or delistings

Large retailers, especially those with strict clean-label policies, may refuse to stock or delist non-compliant products even before the FDA steps in.

How you can deal with the ban

Here’s a practical roadmap for managing the transition hassle-free:

1. Audit your entire product portfolio

Don’t rely on memory or partial spreadsheets. Build a full inventory of products that use Red Dye No. 3. Collaborate with R&D and regulatory teams to confirm which SKUs are affected and which reformulations are underway.

2. Engage your formulation, legal, and packaging teams early

This isn’t just a packaging problem. Legal teams need to interpret the FDA ruling and grace period. R&D must confirm if the dye has been removed. And packaging teams need to update and route artwork across functions. Early cross-functional coordination prevents delays and missteps.

3. Create a packaging update workflow

You’ll need a clear workflow to:

• Assign copy changes.

• Manage stakeholder feedback.

• Route updated designs for legal and regulatory review.

• Approve and release final artwork for print.

Without a centralized workflow, it’s easy to lose track of versions or miss final deadlines.

4. Document every change

Maintain version history, reviewer comments, and final approvals as part of your audit trail. If you're ever being questioned by regulators or need to prove due diligence, this documentation will protect you.

How Artwork Flow helps

Artwork Flow is an artwork management software built to help packaging teams like yours stay organized, move faster, and stay compliant without burning out everyone. Here’s how we can carry you throughout this transition:  

1. Search and identify affected artwork

Use smart tagging and advanced search filters in Artwork Flow to locate artwork files that mention “Red Dye No. 3” or have red colored food images or callouts. Whether you're filtering by product type, colors, or region, the AI-powered platform helps you to quickly identify the desired artwork, and you can prioritize every affected SKU, saving hours of manual effort. No more digging through folders manually.

2. Route updates to the right stakeholders

Updating a label means coordinating across multiple departments such as marketing, legal, regulatory, design, and QA. Artwork Flow simplifies this with automated workflows that route files to the right people at the right time. Reviewers get notified, deadlines are tracked, and no approval slips through the cracks. It's a smoother, more transparent process from start to finish.

3. Run AI-powered label checks

With our smart compliance tool, create custom rulebooks and run them against your labels to catch banned ingredients, and outdated images and product names before files go to print. This reduces back-and-forth and helps you stay compliant, especially when updating large SKU sets.  

4. Maintain version history and audit trails

With regulatory updates, documentation is critical. Artwork Flow automatically logs every artwork version, changes, comments, and approvals. So, if you're ever audited by the FDA or asked to show when a change was made and who signed off, everything’s organized and easy to access. It also gives your team clarity and peace of mind (sudden surprises are no fun here).

Conclusion

The FDA’s proposed ban on Red Dye No. 3 is a clear signal that safety standards are tightening, and that packaging teams must move fast to keep up. Whether you manage 5 SKUs or 500, ensuring your product labels are accurate, compliant, and up to date is critical to protecting both consumers and your brand.

With a platform like Artwork Flow, you can accelerate the packaging updating process across departments and stay ahead of major regulatory shifts like these. Book a demo to save your product (and brand).

‍