CLA-2-21:OT:RR:NC:N5:228
Beatrice Golomb
University of California, San Diego School of Medicine
9500 Gilman Drive, MC 0995 La Jolla, CA 92093
RE: The tariff classification of Coenzyme Q10 and a matching placebo from Denmark
Dear Ms. Golomb:
In your letter dated July 14, 2023, you requested a tariff classification ruling.
An ingredients breakdown, a manufacturing flowchart, and a picture of the product labeling accompanied your letter.
The subject merchandise involves the tariff classification of the products, “PharmaNord Bio-Quinone Active CoQ10 GOLD® 100mg,” which will be imported in blister packs (15 pills per blister pack) and a matching placebo. The products are packaged in separate boxes but will be shipped together on the same pallet as a single shipment. PharmaNord Bio-Quinone Active CoQ10 GOLD® and the matching placebo is being imported for use in a clinical trial which is assessing if the products significantly improves symptoms (and function) in veterans with the chronic multisymptomatic condition that is called “Gulf War Illness.”
PharmaNord Bio-Quinone Active CoQ10 GOLD® is said to contain 42 percent soybean oil (bulking agent), 18 percent gelatin (capsule shell), 14 percent Co-enzyme Q10, (ubidecarenone), which functions as the active ingredient, 14 percent mixtures of hydrogenated oils (bulking agents), 8 percent glycerol (humectant), 3 percent purified water (humectant) and trace amounts of d-Tocopherol (antioxidant), and iron oxide (color). The placebo is said to contain 56 percent soybean oil (bulking agent), 18 percent gelatin, (capsule shell), 14 percent mixtures of hydrogenated oils (bulking agents), 8 percent glycerol (humectant), 3 percent purified water (humectant) and trace amounts of d-Tocopherol (antioxidant), and iron oxide (color). The gelatin, glycerol, purified water, and iron oxide are the components that comprise the capsule in both products.
In your letter, you proposed classification for PharmaNord Bio-Quinone Active CoQ10 GOLD® under 2914.69.9000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Ketones and quinones, whether or not with other oxygen function, and their halogenated, sulfonated, nitrated, or nitrosated derivatives: Other,” and the matching placebo pill under 2106.90.9998, HTSUS, which provides for “Food preparations not elsewhere specified or included . . . Other . . . Other . . . Other.” We disagree. With respect to the PharmaNord Bio-Quinone Active CoQ10 GOLD®, based on the ingredient composition, the function of each ingredient, and the method of packaging, the products will be classified elsewhere.
The applicable subheading for the product, “PharmaNord Bio-Quinone Active CoQ10 GOLD® 100mg,” imported in blister packs will be 2106.90.9998, HTSUS, which provides for “Food preparations not elsewhere specified or included . . . Other . . . Other . . . Other.” The general rate of duty will be 6.4 percent ad valorem.
Regarding the classification of the matching placebo, which will be imported in 100 mg capsules, it contains the same ingredients (soybean oil, gelatin, hydrogenated oils and other ingredients) as the CoQ10 GOLD® 100 mg, except it does not contain the Ubiquinone (Co-enzyme Q10). In your letter, you stated the placeboes will be used in an FDA double-blind randomized controlled clinical trial for the treatment of Gulf War Illness. In the condition as imported, the placeboes will not be packaged with the CoQ10 GOLD® 100 mg.
The applicable subheading for the placebos imported in dosage form will be 3006.93.5000, HTSUS, which provides for “Placebos and blinded (or double-blinded) clinical trial kits for a recognized clinical trial, put up in measured doses: Containing ingredients having nutritional value, in which starch or other foodstuff predominates by weight." The general rate of duty will be 6.4 percent ad valorem.
Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided at https://hts.usitc.gov/current.
This merchandise is subject to The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which is regulated by the Food and Drug Administration (FDA). Information on the Bioterrorism Act can be obtained by calling FDA at 301-575-0156, or at the Web site www.fda.gov/oc/bioterrorism/bioact.html.
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact National Import Specialist Timothy Petrulonis at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division