U.S. Customs and Border Protection has issued a final determination concerning the country of origin of dietary supplement tablets that may be offered to the U.S. government under an undesignated government procurement contract. Any party-at-interest may seek judicial review of this determination by Oct. 4. CBP issues country of origin advisory rulings and final determinations as to whether an article is or would be a product of a designated country or instrumentality for the purposes of granting waivers of certain “Buy American” restrictions in U.S. law or practice for products offered for sale to the U.S. government.
According to CBP, the tablets contain medicinal ingredients sourced from China, India, and the U.S. as well as other ingredients from China, India, Brazil, the U.S., Spain, and Malaysia. The processing of these ingredients into tablet form occurs in the U.S.
CBP states in ruling HQ H299717 that while it has generally held that the processing of pharmaceutical products from bulk form into measured doses does not result in a substantial transformation, it has also held that a substantial transformation does occur when, as here, such processing involves the combination of two or more active ingredients and the resulting combination offers additional medicinal benefits compared to taking each alone.
As a result, CBP concludes that the combining of the various vitamins and minerals at issue into one tablet in the U.S. results in a product that has a name, character, and use distinct from the individual ingredients and that the tablets’ country of origin for government procurement purposes is the U.S.