US FDA Announces Enforcement Discretion for “No Artificial Colors” Claims on Human Food Labels

Details of the Update

The FDA stated that it does not intend to take enforcement action under Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act for specific “no artificial color” claims, provided that foods do not contain any FD&C Act certified colors. This clarification allows companies to make voluntary labeling statements even if products contain colors derived from non-certified sources, which previously limited the use of such claims.

Permitted claims include “made without artificial food colors,” “no artificial color,” and “no added artificial color”, as long as the product is free from FDA-certified synthetic colors. The FDA emphasized that this policy does not change ingredient statement requirements related to the term “artificial”, and firms must continue to comply with all other applicable labeling and food safety regulations. Importantly, claims must not be false or misleading. 

Effective Date

FDA’s enforcement discretion for voluntary “No Artificial Colors” labeling claims is effective as of February 5, 2026.

Feedback Deadline

There is no feedback or public comment deadline associated with this announcement, as it was issued as an FDA enforcement discretion letter rather than a draft guidance or proposed rule.

Why It Matters

This update provides regulatory clarity and flexibility for food manufacturers navigating color-related labeling claims. By supporting a transition toward non-certified color alternatives, the policy aligns with ongoing digital and formulation modernization efforts, reduces compliance uncertainty, and enables clearer consumer communication without introducing new regulatory burdens.

Who This Is Relevant For

This update is particularly relevant for Regulatory Affairs, Quality Assurance, Labeling and Compliance teams, as well as R&D and formulation teams involved in ingredient selection and consumer-facing claims.

Next Steps

Stakeholders should review current product formulations and labeling claims to identify products eligible for the permitted statements. Coordination between regulatory, quality, and labeling teams is essential to ensure continued compliance with ingredient disclosures and all other applicable FDA requirements.

As regulatory expectations around food labeling continue to evolve, having timely visibility into enforcement policies is critical. RegASK is a leading agentic AI regulatory intelligence and workflow orchestration platform that empowers global organizations in highly regulated sectors, including consumer products and life sciences, to proactively navigate complex regulatory landscapes. By combining advanced Agentic AI with experts in the loop, RegASK delivers timely predictive actionable insights and end-to-end automation, helping teams track FDA policy updates, assess labeling impact efficiently, and maintain compliance across markets. Learn more or book a demo now. 

FAQs

What did the FDA announce regarding “No Artificial Colors” claims?

The FDA announced enforcement discretion, stating it does not intend to take enforcement action for certain voluntary “no artificial color” claims when foods do not contain FD&C Act certified colors.

Which color additives are covered under this FDA policy?

The policy applies to foods that are free from FDA-certified colors listed in 21 CFR Part 74.

Does this update change ingredient labeling requirements?

No. The FDA clarified that ingredient statement requirements, including the use of the term “artificial,” remain unchanged.

How can RegASK help companies manage FDA labeling updates like this?

RegASK helps regulatory and compliance teams monitor FDA enforcement policies, assess labeling impact across product portfolios, and streamline cross-functional reviews using AI-driven regulatory intelligence and workflow automation.