Executive Summary
- What’s new: FDA has relaxed its enforcement posture on some “no artificial colors” claims for foods that do not contain certain petroleum-based dyes.
- Why it matters: The policy does not change FDCA or FDA regulations and applies only to FDA enforcement decisions. It does not provide a safe harbor from state regulation or private litigation.
- What to do next: Manufacturers must continue to navigate a fragmented state law landscape, including state-specific disclosure requirements, restrictions on color additives, and evolving legislative and enforcement activity.
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On February 5, 2026, the Food and Drug Administration (FDA) announced a significant shift in its enforcement approach to voluntary labeling claims regarding artificial colors in foods.
The agency stated it will exercise enforcement discretion under Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (FDCA) for claims such as:
- “Made without artificial food colors/colorings.”
- “No artificial color/colors/coloring.”
- “No added artificial color/colors/coloring.”
Discretion will apply provided the food does not contain any certified synthetic (petroleum-based) colors listed in 21 CFR Part 74.
The announcement marks a departure from FDA’s previous policy, which permitted such claims only if a product contained no added color of any kind, whether natural or synthetic. Now, manufacturers may use these claims if their products include naturally derived color additives, such as beetroot red or spirulina extract, both of which recently received FDA approval for expanded use.
FDA stated that the new enforcement policy is intended is to encourage the food industry to transition away from petroleum-based synthetic colors and adopt naturally derived alternatives, aligning with broader public health initiatives. However, this policy change does not alter the statutory misbranding standard under the FDCA or create new binding labeling requirements.
As a result, food manufacturers are left to navigate a complex and evolving regulatory landscape, with significant implications for compliance and litigation risk.
Litigation Risk for Food Manufacturers
While FDA’s move is intended to provide industry flexibility, it may also inadvertently increase litigation risk for food manufacturers. As a practical matter, while FDA may decline to take enforcement action under Section 403(a)(1), manufacturers remain exposed to private litigation and state enforcement actions alleging that “no artificial colors” or similar statements are misleading if the product contains any added color, even if naturally derived.
Plaintiffs’ firms have increasingly targeted “purity” and “natural” claims, and some courts have allowed such claims to proceed where there is a plausible argument that reasonable consumers could be misled. Plaintiffs may attempt to argue that FDA’s decision to exercise enforcement discretion does not reflect a determination that “no artificial colors” claims are nonmisleading, but rather acknowledges that these claims could be considered false or misleading under a strict reading of the law, even if the agency has chosen not to pursue enforcement.
In this context, plaintiffs may argue that this enforcement posture underscores the potential for consumer confusion, particularly where consumers interpret “no artificial colors” claims to mean that no color of any kind has been added, or assume that FDA has somehow endorsed the labeling claim.
State Laws on Food Dyes
The regulatory and enforcement landscape is further complicated by a patchwork of state laws. States such as Texas, Louisiana and West Virginia have enacted or are considering laws that impose their own requirements or outright bans on certain color additives, or require specific warnings for foods containing artificial dyes.
These state laws often have different definitions, disclosure requirements and effective dates, creating a complex compliance environment for manufacturers. FDA’s change in policy does not preempt these state laws, so manufacturers must still comply with all applicable state requirements, which may be more restrictive or require different disclosures than federal policy.
Consumer confusion and reputational risk are also heightened risks under state laws, under the new policy. Allowing “no artificial colors” claims even when products contain added colors from natural sources could appear as misleading to consumers who interpret such claims to mean no added color of any kind, and could lead state attorneys general to bring claims under state consumer protection laws.
This increases the risk of reputational harm, consumer backlash, fines and the potential for additional private litigation. Advocacy groups have already raised concerns that FDA’s approach could allow potentially harmful additives, such as titanium dioxide, to be included in products labeled as having “no artificial colors,” further fueling public skepticism and potential legal challenges.
Compliance Considerations
Given the interplay between federal and state requirements, manufacturers should consider taking a proactive and comprehensive approach to compliance. Manufacturers may want to:
- Monitor state legislative and regulatory developments to identify new or changing requirements.
- Audit product formulations and labels to ensure compliance with both federal and the most stringent applicable state laws.
- Monitor pending litigation affecting color additive disclosures and bans.
- Carefully substantiate labeling claims with robust documentation regarding ingredient sourcing and the nature of color additives used.
- Assess the business risks of operating in certain states that would require state-specific labeling and assess the need for such labeling against the overall business case and consumer demand.
- Develop internal processes to review marketing claims and respond to pre-litigation demands or regulatory inquiries.
In Sum
While FDA’s new enforcement discretion on “no artificial colors” claims may offer greater flexibility from a federal enforcement perspective, it does not provide safe harbor from private litigation or state enforcement actions. In this environment of regulatory ambiguity and state law variability, it may be wise to proceed with caution, ensure claims are fully substantiated, and coordinate closely with legal and regulatory teams.
This memorandum is provided by Skadden, Arps, Slate, Meagher & Flom LLP and its affiliates for educational and informational purposes only and is not intended and should not be construed as legal advice. This memorandum is considered advertising under applicable state laws.