US Tells CAFC Medical Foods Are Food Preparations, Not Medicaments

The U.S. told the U.S. Court of Appeals for the Federal Circuit on July 19 that importer Nutricia North America's medical foods should be classified as "food preparations" and not "medicaments" (Nutricia North America v. U.S., Fed. Cir. # 24-1436).

Nutricia argued that four of its branded medical foods -- MSUD Lophlex LQ, Periflex Infant, Periflex Junior and Ketocal Liquid -- fit under Harmonized Tariff Schedule heading 3004 as medicaments, while CBP said the proper heading was 2106 as food preparations. The Court of International Trade sided with the government, imposing a 6.4% duty on the goods (see 2312050028).

Responding to Nutricia's claims to the contrary, the government, citing Hippocrates as the "father of Western medicine" who said "let thy food be thy medicine and thy medicine be thy food," said that "even Hippocrates understood the difference between food and medicine," and so does the Harmonized Tariff Schedule.

The central U.S. claim is that Chapter 30's note 1(a) excludes foods, such as "dietetic, diabetic or fortified foods" not intravenously administered from classification under any chapter 30 heading. The government said "food" means "material consisting essentially of protein, carbohydrate, and fat," which covers Nutricia's products.

The imports "consist essentially of proteins (or their constituent amino acids), carbohydrates, fats, vitamins, minerals, and flavorings; provide complete or near-complete nutrition," and are deemed foods by federal laws and regulation, the brief said. Note 1(a)'s inclusion of "dietetic" foods confirms Nutricia's medical foods are excluded from chapter 30, the U.S. argued.

In fact, "Nutritia's own documentation" refers to the products as "dietetic goods," the brief said.

The government said that the imports need only to be "similar" to dietetic foods to be excluded from heading 3004 because note 1(a)'s list of excluded foods is not meant to be exhaustive. Like other dietetic foods, Nutricia's goods "are specially formulated to meet the nutritional needs of people for whom a conventional diet is unsuitable."

In its opening brief, Nutricia argued that the trade court erroneously applied a chapter exclusionary note before finding whether its medical foods were "prima facie classifiable under heading 3004" (see 2405010058). The government said in response that the importer "misunderstands GRI 1," which lays out the "holistic consideration for the terms of the headings 'and any relative section or chapter notes.'" The order of the headings and notes "thus does not matter," the brief said.

Even if the imports meet heading 3004's description of "medicaments," note 1(a) is a "statutory provision of equal footing."

Nutricia additionally said that "medicaments" are defined in heading 3004 as articles made of mixed products for therapeutic use. The government responded that the heading uses the word "medicaments" and not "articles," but even if "medicaments" were broad enough to include "all sorts of articles," the heading can't "be read in a vacuum." Note 1(a) still excludes "non-intravenous 'dietetic' foods like Nutricia's from heading 3004."

In an alternative claim, Nutricia said its goods fit under secondary subheading 9817.00.96 as nontherapeutic "articles" for the "handicapped." Echoing the trade court, the government said nothing in the subheading provides that Congress meant for the scope of the subheading to be "so broad as to cover foods, food supplements, or nutritional substances or ingredients of any type." The U.S. said no "preparations" can be considered articles under the meaning of the subheading, because the term "articles" has "historically been used to distinguish manufactured objects from substances."