On February 5, the Food and Drug Administration (FDA) announced a major change in how the agency will regulate claims about artificial colors in foods.
In a “Letter to the Food Industry,” the FDA declared that the agency would exercise enforcement discretion under Section 403(a)(1) of the Federal Food, Drug, and Cosmetic (FD&C) Act if a company makes certain voluntary labeling claims about the absence of artificial colors in foods. According to the letter, the FDA does not intend to take enforcement action under the statute based on any of the following labeling claims, as long as the food contains no FD&C Act-certified color:
- “Made without artificial food colors/coloring”;
- “No artificial color/colors/coloring”; and
- “No added artificial color/colors/coloring.”
The FDA described its policy change as part of the Make America Healthy Again initiative and its efforts to encourage manufacturers to eliminate petroleum-based dyes from food products.
Under existing FDA regulations, “artificial color” or “artificial coloring” means any color additive. As a result, claiming that a food is free of artificial colors when in fact the food contains noncertified color additives (such as spirulina extract or beetroot red) has risked enforcement action by the FDA on the ground that the food is misbranded under Section 403(a)(1) due to false or misleading labeling. Under the new policy, the FDA no longer intends to pursue such enforcement actions.
However, the underlying statutory and regulatory provisions under which all color additives have been treated as artificial colors remain intact. Manufacturers likewise will still face risks that state regulators or private plaintiffs will argue that “no artificial color” claims are false or misleading if a product contains a noncertified color additive.
In this way, the FDA’s enforcement discretion policy reduces the risk of federal enforcement but also contributes to a more uncertain regulatory landscape. State regulators and private litigants even may point to the FDA’s letter as evidence that “no artificial color” claims for foods with noncertified color additives are false or misleading, on the theory that a policy of enforcement discretion would be unnecessary if the claims were accurate and not misleading.
Food manufacturers considering labeling changes in light of this new flexibility at the federal level should continue to monitor trends in private litigation and regulatory developments at the state level, and should maintain compliance programs designed to address regulatory and litigation risks wherever their products are sold.