The Color of Compliance

When Voluntary Isn’t Exactly Optional

If your company makes, markets, manufactures food, beverages, or supplements, you’ve likely noticed that color is having a moment.

Under the MAHA banner, Robert F. Kennedy Jr. and the U.S. Food and Drug Administration have set their sights on “petroleum-based synthetic dyes.” Yes, the usual suspects remain perfectly lawful and fully approved for use. But in Washington, D.C., sometimes the most powerful regulatory tool isn’t a ban—it’s a raised eyebrow.

The colors in question include:

FD&C Red No. 40
FD&C Yellow No. 5
FD&C Yellow No. 6
FD&C Blue No. 1
FD&C Blue No. 2
FD&C Green No. 3

Still legal. Still listed. Not rescinded.

But rather than endure the long, evidence-heavy slog of rulemaking to revoke approvals, FDA has chosen a more subtle path: “encouragement.” In regulatory dialect, that can translate to strategic inevitability.

The Great Color Migration: From Refinery to Fermentation

To grease the skids of transition, FDA has been fast-tracking alternative color additives. In 2025, four were approved. And in early 2026, two more joined the party.

Beetroot Red

FDA recently approved a new additive commonly referred to as beetroot red—produced via fermentation of a genetically engineered yeast strain that expresses genes responsible for synthesizing betanin (the compound behind that ruby-purple hue).

Approved uses? Broadly in foods—except:

Infant formula
Foods with established standards of identity
Certain USDA-regulated products

In short: welcome to the label, but read the fine print.

Spirulina Levels Up

Spirulina extract—already known for its vibrant blue-green appeal—received expanded approval for use in nearly all foods (again, excluding infant formula and certain USDA-regulated categories).

The message is clear: the bench of “nature-derived” replacements is getting deeper.

Swapping petroleum-based dyes for so-called “nature-derived” alternatives is not a plug-and-play exercise. These substitutes rarely deliver identical hues and are often far more reactive to pH, heat, light, and other formulation variables. As a result, regulated businesses need to look at real reformulation including pilot batches, shelf-life tests, packaging tweaks and taste checks.

This isn’t just a regulatory issue—it’s a supply chain, R&D, QA, and marketing issue.

The Labeling Plot Twist: “No Artificial Colors”

Now for the legal nuance that could have some interesting consequences.

Historically, FDA’s position has been blunt: there is no such thing as a “natural color.” If it’s a color additive, it’s artificial. Therefore, “no artificial colors” meant no added color additives at all.

Under Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (misbranding), labeling a product with added color as “no artificial colors” would typically be… problematic.

But FDA has now announced it does not intend to take enforcement action against companies that use “no artificial colors” (or similar language) so long as the product contains no FD&C colors listed in 21 C.F.R. Part 74. Although FDA plans to exercise discretion, it remains to be seen how—or if—this will influence private misbranding lawsuits.

What Regulated Industry Should Be Considering (Now)

If you’re in a regulated sector, there are several areas to consider:

Enforcement Discretion ≠ Litigation Immunity

FDA may decline to enforce, however, Plaintiffs’ lawyers are not so restrained.

Class action risk remains very real. The agency’s position could complicate private litigation—but it doesn’t eliminate it. Your risk assessment should include:

Consumer class action exposure
State-law misbranding claims
Competitor challenges

Reformulation Is a Regulatory Event

Ingredient swaps trigger:

Updated ingredient statements
Potential allergen analysis
Specification revisions
Stability testing
Supplier qualification
Re-evaluation of standards of identity, as applicable

Supply Chain Due Diligence Is About to Matter More

For certified FD&C dyes, FDA batch-tests for purity and impurities.

For nature-derived colors, the burden shifts more squarely to you and your supplier to ensure compliance with identity and purity specifications. That means:

Robust supplier audits
Certificates of analysis
Impurity screening protocols
Documentation ready for inspection

Marketing Shouldn’t Get Ahead of Legal

If your brand team is excited about splashing “NO ARTIFICIAL COLORS!” across the front panel, it is important to assess regulatory and legal teams early to evaluate:

Substantiation files
Consumer perception risk
Consistency with historical FDA guidance
Insurance coverage for labeling claims

Enforcement discretion today does not guarantee policy stability tomorrow.

Watch the Political Weather

These developments are policy-driven. A change in administration priorities—or leadership posture—can alter enforcement tone quickly, and strategic flexibility is key.

The Bottom Line

The dyes remain legal. No approvals have been rescinded.

But the policy current is unmistakable: petroleum-derived colorants are being gently escorted toward the exit, while “nature-derived” alternatives are being ushered in.

For industry, this is less about what is lawful today and more about what is sustainable tomorrow—legally, commercially, and reputationally.

For more information on FDA color additive compliance, or FDA regulatory compliance or enforcement, please contact info@garg-law.com.