Medical Foods for Children Are Medicaments for the Handicapped, Importer Argues at Trade Court

Specialty medical foods designed for infants and toddlers should be classified as medicaments and as duty-free articles for the handicapped rather than foods, Nutricia North America again argued in a Dec. 2 response brief at the Court of International Trade. The brief follows a Oct. 28 motion for summary judgment by DOJ, wherein the government argued that "while therapeutic, Nutricia's products are still foods" (see 2210310054) (Nutricia North America v. United States, CIT # 16-00008).

The dispute stems from a series of entries by Nutricia in 2014 and 2015 and subsequent protests filed with CBP over alleged misclassifications. Five of Nutricia’s medical foods (Periflex Junior, Periflex Infant, MSUD Lophlex, Ketocal and Neocate) are at issue. Nutricia has argued that the products are both designed and prescribed for therapeutic use and specifically not for general use as food. "[H]ealthy children do not consume them (in some cases such consumption would be dangerous)," Nutricia said in its own Aug. 31 motion for judgment (see 2209020043).

Nutricia now argues that because DOJ's preferred classification is a basket provision, it must do more than merely show that the products at issue are foods, it must show that medical foods are in fact not specified elsewhere, which Nutricia says they are not. Within DOJ's arguments the products at issue are foods, it has repeatedly conceded the products are "therapeutic articles used in nutritional therapy," Nutricia said. It argues that language in Harmonized Tariff Schedule Chapter 30 that describes medicaments as “mixed or unmixed products for therapeutic or prophylactic uses” should end any remaining doubt that the products are medicaments.

Further, Nutricia argues that the government incorrectly stated that medicaments "must feature one or more active ingredients" despite neither the HTSUS nor the explanatory notes requiring an active ingredient. Even if such a requirement existed, Nutricia’s products contain "chemically synthesized, medical grade, individual amino acids," which are active ingredients," the company said.