Medical Foods for Children Aren't Medicaments, Government Says

Specialty medical foods designed for infants and toddlers should be classified under Harmonized Tariff Schedule of the U.S. heading 2106 as "food preparations" rather than as "medicaments," DOJ argued in an Oct. 28 motion for summary judgment at the Court of International Trade (Nutricia North America v. U.S., CIT #16-00008).

The dispute stems from a series of imports 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 argued in January that CBP issued Nutricia a binding ruling that classified a series of products used to treat specific conditions under the heading 3004 in 1990. The case was filed in July 2015 after four separate protests seeking reclassification were denied by CBP. Between June 2015 and September 2016, Nutricia filed seven other cases against CBP for alleged misclassification of the same items (see 2201270019).

Nutricia argued in an Aug. 31 motion that its customers are patients suffering from these diseases and were "handicapped," saying that the Americans with Disabilities Act contains a nearly identical definition of "handicapped" to the one in the tariff schedule (see 2209020043).

The case is more straightforward than Nutricia lets on, DOJ said. The plain text of heading 3004 and Note 1(a) to Chapter 30 excludes food and "while therapeutic, Nutricia's products are still foods," DOJ said. In addition, the government argues that because the foods are in fact therapeutic, they are excluded from an alternative classification under subheading 9817.00.96 because U.S. Note 4(b) provides that subheading 9817.00.96 does not cover “... (iii) therapeutic and diagnostic articles ... .” While DOJ said that Congress may have intended to exempt more articles, the "unambiguous text of the statute controls over extratextual considerations."