The Food and Drug Administration (FDA) announced on Feb. 5 that the agency will exercise enforcement discretion to allow “no artificial colors” and similar claims if artificial color is added, as long as it is not an FD&C certified color.
This means the FDA doesn’t plan to take enforcement action against firms if they make a voluntary label claim of “no artificial color” to signal the absence of FD&C certified color.
Currently the definition of “artificial color” doesn’t distinguish between colors that are derived from natural sources and other colors. According to the FDA Commissioner, this change to labeling enforcement is intended to facilitate the transition away from FD&C-certified colors.
No mention is made of a plan to revise the law.
Notably, no determination was made on if “no artificial” claims are misleading. The only conclusion was the FDA will not prosecute them under section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (FDCA), the prohibition of false or misleading labeling.
Despite the intention that this policy will provide industry flexibility, it leaves food manufactures to navigate a complex regulatory landscape with significant implications for compliance and litigation risk.
While the FDA may not take enforcement action, 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.
Some 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.
Manufacturers should consider taking a proactive and comprehensive approach to compliance in order to align with both federal and state regulations.
