Enforcement Discretion for “No Artificial Colors” Food Labeling Claims

By David Graham

On February 5, 2026, the U.S. Food and Drug Administration (FDA) issued Letter to the Food Industry on “No Artificial Colors” Labeling Claims announcing a revised enforcement policy regarding “no artificial colors” labeling claims. The Agency stated that it will exercise enforcement discretion for certain claims indicating that a product contains “no artificial colors,” even when the product contains colors derived from petroleum-based sources that FDA has long classified as “synthetic” color additives.

The announcement represents a notable shift from FDA’s prior approach. Historically, FDA interpreted “artificial colors” claims narrowly, treating many petroleum-derived color additives as synthetic regardless of their functional similarity to naturally derived colorants. Under the new policy, companies may now have flexibility to make certain “no artificial colors” claims where the product does not contain petroleum-based color additives traditionally associated with artificial dyes.

The Agency framed the policy change as an effort to clarify labeling expectations and improve transparency for consumers. At the same time, the announcement arrives amid heightened public and political attention on artificial dyes and food ingredient labeling. As a result, the change raises both regulatory and litigation considerations for manufacturers evaluating whether to update product labels or marketing claims.

FDA’s Enforcement Discretion Policy

FDA’s February letter explains that the Agency will not object to certain voluntary “no artificial colors” labeling claims when the claim reflects the absence of petroleum-based dyes commonly perceived by consumers as artificial. This approach reflects an apparent shift away from the Agency’s previous position that treated the term “artificial color” as encompassing a broader range of synthetic color additives.

The enforcement discretion policy does not formally amend FDA regulations governing color additives or labeling. Rather, it signals how the Agency intends to prioritize enforcement resources in evaluating labeling claims related to artificial coloring.

Companies should understand what FDA’s announcement does and does not do. The letter signals how the Agency intends to exercise enforcement discretion, but it does not change the underlying statutory prohibition against false or misleading labeling under the Federal Food, Drug, and Cosmetic Act.

As with other FDA enforcement discretion policies, the announcement signals how the Agency intends to prioritize enforcement actions related to labeling claims. It does not define precise criteria for when such claims may be considered misleading under the Federal Food, Drug, and Cosmetic Act (FDCA). Nor does it alter the statutory framework governing false or misleading labeling.

Regulatory and Litigation Implications

For food manufacturers, the policy may create opportunities to revisit labeling strategies. Products previously unable to support “no artificial colors” claims under FDA’s earlier interpretation may now fall within the Agency’s stated enforcement discretion.

At the same time, companies should approach these claims cautiously.

FDA enforcement discretion does not eliminate potential exposure under other legal theories. Private litigation challenging labeling claims remains common in the food sector, particularly in areas involving ingredient characterization or consumer expectations. Plaintiffs’ firms have increasingly targeted “clean label” claims such as “natural,” “non-artificial,” and similar representations. A revised FDA enforcement posture does not necessarily foreclose those claims.

Companies must therefore evaluate labeling changes not only through the lens of FDA enforcement risk but also through broader litigation exposure, including:

• False advertising or deceptive labeling claims under state consumer protection statutes
• Class actions challenging ingredient representations
• Competitor challenges under the Lanham Act
• Parallel regulatory scrutiny from state authorities

Taken together, these risks mean that companies evaluating labeling changes should treat FDA’s announcement as a shift in enforcement posture, not as a definitive interpretation of what claims are legally risk-free.

“It is important to monitor FDA’s changing views of regulation and enforcement as it attempts to enunciate its views on food additives and labeling claims related to new and existing additives.  FDA and state regulators have not developed a unified view of these issues, which makes planning particularly challenging.”
David Graham, Senior Counsel

Political and Policy Context

The announcement has also drawn attention because it intersects with ongoing policy debates surrounding artificial food dyes and ultra-processed foods.

Consumer advocacy groups have urged regulators to restrict synthetic dyes more aggressively, while segments of the food industry have emphasized the safety determinations supporting currently approved color additives. Against that backdrop, some observers have characterized FDA’s announcement as a pragmatic clarification of labeling expectations, while others view it as inconsistent with prior statements suggesting stronger scrutiny of artificial dyes.

At present, it is difficult to determine whether the February policy signals a broader shift in FDA’s regulatory enforcement posture toward food additives or represents a more limited clarification related specifically to labeling claims.

Practical Considerations for Food Manufacturers

Manufacturers considering new or revised “no artificial colors” claims should proceed carefully and evaluate several factors before implementing label changes.

Key considerations include:

• Ingredient analysis: Confirm whether any color additives present could still fall within FDA’s historical definition of synthetic colors.
• Claim substantiation: Ensure the factual basis for labeling claims is well documented and consistent across labeling, advertising, and digital marketing materials.
• Consumer perception risk: Assess whether the claim could create a misleading impression about the nature of ingredients used in the product.
• Litigation exposure: Evaluate potential vulnerability to private labeling lawsuits, particularly in jurisdictions like San Francisco with active consumer class action litigation.
• Regulatory monitoring: Track further FDA guidance or enforcement activity that could clarify the Agency’s interpretation of these claims.

How Gardner Law Can Help

FDA’s February 5 announcement illustrates the complex intersection between regulatory policy, consumer expectations, and litigation risk in modern food labeling. While the Agency’s enforcement discretion may provide new flexibility for manufacturers, it does not eliminate the broader compliance challenges associated with ingredient-related marketing claims.

Gardner Law advises food and life sciences companies on FDA regulatory compliance, enforcement response, and litigation risk management. Our team assists manufacturers in evaluating labeling claims, responding to regulatory scrutiny and enforcement actions, conducting internal investigations, and developing strategies designed to withstand both regulatory review and private litigation.