Fourth Circuit to Review West Virginia Dye Ban Injunction
The Fourth Circuit will decide whether a lower court properly paused enforcement of a West Virginia law banning certain FDA-approved synthetic color additives over concerns the statute is unconstitutionally vague.
The case arises from a 2025 West Virginia law designating seven color additives as “poisonous and injurious” and prohibiting their use in school nutrition programs—including six additives currently approved by FDA for use in food, drugs, or cosmetics.
On December 23, 2025, the Southern District of West Virginia issued a preliminary injunction, agreeing with a color additive trade association that identifying FDA-approved additives as “poisonous and injurious” rendered the law’s requirements unclear.
“[T]he inclusion of a list of FDA-approved color additives muddies the water and creates confusion as to what substances now constitute ‘poisonous and injurious,’” the court wrote. Food additive makers “cannot predict what substances may be considered ‘poisonous and injurious’ when such a slim explanation exists for the named color additives,” leaving the door open for arbitrary enforcement, the opinion continues.
The court further emphasized that, because FDA has not determined six of the seven listed additives to be unsafe, “it is imperative that West Virginia define and, thereby, give necessary notice and guidance as to what constitutes ‘poisonous and injurious.’”
The trade association’s additional claims—that the statute constitutes an unconstitutional bill of attainder and violates the Equal Protection Clause—were rejected. West Virginia officials filed a notice of appeal on January 22, 2026.
Although West Virginia has long barred the sale of adulterated food, including food containing ingredients deemed “poisonous or injurious to health,” it had not previously identified specific substances as meeting that undefined statutory standard.
Contested Additives
The seven color additives named by the statute are FD&C Blue No. 1, FD&C Blue No. 2, FD&C Green No. 3, FD&C Red No. 3, FD&C Red No. 40, FD&C Yellow No. 5, and FD&C Yellow No. 6. FDA has revoked authorization for FD&C Red No. 3 in food and ingested drugs, effective January 2027. Only the six additives that remain FDA-approved are at issue in the litigation.
H.B. 2354 also names two preservatives, butylated hydroxyanisole (BHA) and propylparaben. This month, FDA launched a reassessment of BHA’s safety, publishing a request for information on the use and safety of the substance. BHA is currently listed as generally recognized as safe (GRAS).
The appellants, West Virginia officials from the Department of Health and Bureau for Health, must file their opening brief by March 4. The trade association’s response is due April 3.
The case is International Association of Color Manufacturers v. Singh, No. 26-1085 (4th Cir.), appeal filed January 22, 2026. The underlying case, No. 25-cv-588 (S.D. W. Va.), was filed October 10, 2025.
