Federal Circuit Says Importer's Medical Foods Are 'Medicaments,' Not 'Food Preparations'

At issue are five of Nutricia's branded medical foods -- MSUD Lophlex LQ, Periflex Infant, Periflex Junior, Neocate Junior and Keotcal Liquid -- which the trade court said fall under HTS heading 2106 as food preparations rather than heading 3004 as medicaments (see 2312050028). Central to the dispute is Chapter 30's note 1(a), which says the chapter excludes "[f]oods or beverages (such as dietetic, diabetic or fortified foods, food supplements, tonic beverages and mineral waters), other than nutritional preparations for intravenous administration (section IV)."

CIT centered on note 1(a) in finding Nutricia's products don't fall under heading 3004, ruling that even if some definitions of the term "medicaments' were considered broad enough to encompass what Nutricia describes as "medical food" products, it wouldn't follow that Chapter 30 necessarily includes these products due to note 1(a). The trade court added that note 1(a) created a "general exclusion" covering all "orally" consumed "nutritional preparations" that are foods or beverages as used in note 1(a).

Taranto, writing for the court, first assessed whether Nutricia's goods fit under heading 3004 irrespective of note 1(a), ultimately concluding that they do. In his analysis, the judge leaned on the definition of "medical foods" established in the Federal Food, Drug and Cosmetics Act and the FDA's supplemental definition of this phrase.

In the act, Congress defined "medical food" as a "food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation." The FDA added five characteristics of medical foods to the definition, including that the products be specially formulated for the feeding of a patient, meant for dietary management and meant to be used under medical supervision, among other things.

Taranto found Nutricia's products to meet all of the characteristics of medical foods. The judge said the goods at issue "meet the requirements of heading 3004 that the covered 'medicaments' 'consist[] of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses ... or in forms or packings for retail sale.'" Nutricia's goods are "mixed products that are consumed in measured dosages and are available through retail sale," and they are made, prescribed and marketed for "therapeutic and prophylactic uses," the decision said.

Heading 3004 is a "use" provision, meaning it's limited to goods for "specified uses." Here, the definitions of "medical foods" under the federal Food, Drug and Cosmetics Act "make clear that the medical foods at issue are principally used therapeutically or prophylactically for specific medical conditions under medical supervision," the court said.

Taranto next turned to note 1(a), concluding that the note doesn't exclude Nutricia's goods from heading 3004.

The U.S. argued that note 1(a) "embraces any product used for dietary reasons," even if it qualifies as a "medical food" under the Federal Food, Drug and Cosmetics Act, is only meaningfully used as a medically supervised therapy and isn't a "mere modification of a generally available food item that retains the item's basic commercial character" but a "preparation made out of chemical-level substances."

Nutricia said the note should be limited to "foods generally marketed to consumers and used by many people outside the above-noted context of therapy for specific conditions under medical supervision." Specifically, the note shouldn't cover medical foods "specially formulated out of chemical-level substances rather than a mere modification of an existing food item," the importer urged.

Taranto said Nutricia had the right of it.

The judge started with the government's proposed dictionary definition of the term "dietetic," which says "adapted for use in special diets." As applied to foods, this definition doesn't "clearly help the government," since "adapt" means to "adjust or modify" something preexisting and "modify" generally means to moderately alter something. Thus, the U.S. definition favors Nutricia's position, "given the character of the medical-food products as specially formulated preparations made from chemical-level substances for individuals with specific disorders," since the result isn't "a mere modification of, nor resembles, a preexisting food item," the court said.

Nor does the "overall drafting of note 1(a)" help the U.S., Taranto said. If Congress meant for the note to cover "all foods that contain only nutritional substances," it "had other choices of phrasing," but instead, Congress opted for something more specific, the court held. Thus, the "government’s position runs counter to the surplusage canon of construction," which seeks to give effect to "every clause and word" of a provision.

The government's interpretation of the note also runs afoul of the "association of words canon," which "counsels that a term in a series like this one be given a meaning consistent with its neighboring terms." Here, all the terms other than "dietetic" favor Nutricia's "narrower understanding of note 1(a)’s scope; 'dietetic' should be understood the same way," Taranto said.

Lastly, Taranto looked at the World Customs Organization's Explanatory Note for heading 3004, which says that the heading's provisions don't apply to "foodstuffs or beverages such as dietetic, diabetic or fortified foods, tonic beverages or mineral waters (natural or artificial), which fall to be classified under their own appropriate headings." The note adds that this is "essentially the case as regards food preparations containing only nutritional substances."

The Federal Circuit said nothing in the note "directly deals with medical foods or with the characteristics we have discussed, including the specific formulation and marketing for medically supervised use for specific medical conditions."

In all, the court said "the applicability of heading 3004’s language to medical foods is clear and not even meaningfully contested," while there are "substantial difficulties with concluding that Nutricia’s medical foods come within chapter note 1(a) even when the note is considered alone." Here, "the narrow view of note 1(a) is also supported by the principle favoring an interpretation that achieves consistency with the clearly applicable language of heading 3004," the court held.

(Nutricia North America v. United States, Fed. Cir. # 24-1436, dated 11/17/25; Judges: Sharon Prost, Richard Taranto and Leonard Stark; Attorneys: Amanda Shafer Berman of Crowell & Moring for plaintiff-appellant Nutricia North America; Luke Mathers for defendant-appellee U.S. government)