OT:RR:BSTC:CCR HQ H320634 AFM
Matthew A. Bock
Middleton Shrull & Bock, LLC
1375 Broadway
Suite 504
New York, NY 10018
RE: 21 U.S.C. § 863; Drug Paraphernalia; Kappa City Biotech SAS; drug tests
Dear Mr. Bock:
This is in response to your correspondence dated May 6, 2021, in which you requested a prospective ruling in accordance with 19 C.F.R. § 177.2, regarding whether Kappa City Biotech SAS (“Kappa City”) drug tests would be considered “drug paraphernalia” under 21 U.S.C. § 863. Our ruling is set forth below.
FACTS
The subject merchandise consists of the NarcoCheck line of urine, salivary, and forensic (or “substance”) tests by Kappa City, a French biotechnology company. These tests can detect over “200 different psychoactive substances” and are distributed to “testing professionals, including public and private hospitals…law enforcement, and customs services/authorities” as well as the corporate and individual private drug testing market outside the United States. Kappa City has previously imported these products into the United States. Therefore, this ruling will apply only to prospective importations of Kappa City’s NarcoCheck line of urine, salivary, and forensic tests.
Images of Kappa City’s NarcoCheck products as shown on the official PharmaDrugTest website are provided below.
Image A. NarcoCheck Urine Test
Image B. NarcoCheck Saliva Test
Image C. NarcoCheck Cocaine Purity Test
Image D. List of identification and purity tests identifiable in NarcoCheck’s Substances Tests
ISSUE
Whether Kappa City’s urine tests, saliva tests, or substance tests fall within the meaning of drug paraphernalia pursuant to 21 U.S.C. § 863.
LAW AND ANALYSIS
The relevant statute, 21 U.S.C. § 863, provides, in pertinent part:
In general
It is unlawful for any person-
to sell or offer for sale drug paraphernalia;
(2) to use the mails or any other facility of interstate commerce to transport drug paraphernalia; or
to import or export drug paraphernalia.
(d) “Drug paraphernalia” defined
The term “drug paraphernalia” means any equipment, product, or material of any kind which is primarily intended or designed for use in manufacturing, compounding, converting, concealing, producing, processing, preparing, injecting, ingesting, inhaling, or otherwise introducing into the human body a controlled substance, possession of which is unlawful under this subchapter. It includes items primarily intended or designed for use in ingesting, inhaling, or otherwise introducing marijuana, cocaine, hashish, hashish oil, PCP, or amphetamines into the human body, such as –
(1) metal, wooden, acrylic, glass, stone, plastic, or ceramic pipes with or without screens, permanent screens, hashish heads, or punctured metal bowls; (2) water pipes; (3) carburetion tubes and devices;
(4) smoking and carburetion masks;
(5) roach clips . . .;
(6) miniature spoons . . .;
(7) chamber pipes;
(8) carburetor pipes;
(9) electric pipes;
(10) air-driven pipes;
(11) chillums;
(12) bongs;
(13) ice pipes or chillers;
(14) wired cigarette papers; or
(15) cocaine freebase kits.
(e) Matters considered in determination of what constitutes drug
paraphernalia. In determining whether an item constitutes drug
paraphernalia, in addition to all other logically relevant factors,
the following may be considered:
(1) instructions, oral or written, provided with the item concerning its
use;
(2) descriptive materials accompanying the item which explain or depict
its use;
(3) national and local advertising concerning its use;
the manner in which the item is displayed for sale;
whether the owner, or anyone in control of the item, is a legitimate supplier of like or related items to the community, such as a licensed distributor or dealer of tobacco products;
direct or circumstantial evidence of the ratio of sales of the item(s) to the total sales of the business enterprise;
the existence and scope of legitimate uses of the item in the community, and
expert testimony concerning its use.
(f) Exemptions
This section shall not apply to-
(1) any person authorized by local, State or Federal law to
manufacture, possess, or distribute such items; or
any item that, in the normal lawful course of business, is imported, exported, transported, or sold through the mail by any other means, and traditionally intended for use with tobacco products, including any pipe, paper, or accessory.
We have not discovered any authority under 21 U.S.C. § 863 to hold that drug testing kits are drug paraphernalia. The U.S. Supreme Court examined the meaning of “drug paraphernalia” pursuant to 21 U.S.C. § 863 in the matter of Posters ‘N’ Things v. United States, 511 U.S. 513 (1994), and considered the phrases (1) “primarily intended for use” and (2) “designed for use” in such cases. Although the Court was interpreting the text of the former statute, 21 U.S.C. § 857, in 1990 Congress repealed and replaced that section of title 21 with the present statute, 21 U.S.C. § 863. In Posters ‘N’ Things, section 863 is identified as identical with the present statute.
With respect to the first phrase identified above, the Court concluded that “primarily intended for use” is to be understood objectively and refers generally to an item’s likely use. Moreover, the Court noted that this “is a relatively particularized definition, reaching beyond the category of items that are likely to be used with drugs by virtue of their objective features.” Additionally, the Court stated that “items ‘primarily intended’ for use with drugs constitute drug paraphernalia, indicating that it is the likely use of customers generally, not any particular customer, that can render a multiple-use item drug paraphernalia.” Therefore, items having possible multiple uses may constitute drug paraphernalia for purposes of 21 U.S.C. § 863 if the likely use by customers of the seller of the items is for use with illegal drugs.
With respect to the above-mentioned second phrase, “designed for use,” the Court referred to Village of Hoffman Estates et al v. The Flipside, Hoffman Estate, Inc., where the Court stated that it is also to be understood objectively and that it refers to an item’s objective characteristics. “An item is ‘designed for use’…if it ‘is principally used with illegal drugs by virtue of its objective features, i.e., features designed by the manufacturer….The objective characteristics of some items establish that they are designed specifically for use with controlled substances. Such items, including bongs, cocaine freebase kits, and certain kinds of pipes, have no other use besides contrived ones (such as the use of a bong as a flower vase). Items that meet the ‘designed for use’ standard constitute drug paraphernalia irrespective of the knowledge or intent of one who sells or transports them.”
Our determination, set forth below, is based on the information above, our independent research and the application of one of the two aforementioned tests pronounced by the Court as to whether an article falls within the meaning of “drug paraphernalia” pursuant to 21 U.S.C. § 863(d). Specifically, our determination considers whether the subject merchandise is “primarily intended for use,” in the manufacturing, compounding, converting, concealing, producing, processing, preparing, injecting, ingesting, inhaling, or otherwise introducing into the human body a controlled substance. As previously stated, the “primarily intended for use” test considers the stated purpose of multiple-use articles while examining whether the “likely use of customers generally…can render a multiple-use item drug paraphernalia.” Accordingly, our analysis will examine the products’ primary intended use relative to the factors set forth in 21 U.S.C. § 863(e); with particular focus on factors (2), (3), (4), and (7). As will be discussed, and as the evidence reveals, the likely use of Kappa City’s NarcoCheck line of drug tests do not fall within the purview of the factors set forth in 21 U.S.C. § 863(e).
NarcoCheck Tests Do Not Introduce a Controlled Substance into the Human Body
With respect to factor (2) of 21 U.S.C. § 863(e), Kappa City has provided the above exhibits (A-D) which explain how each NarcoCheck test may be used to check for the presence of many substances in a material, or through an individual’s saliva or urine. Similar information is also displayed on the website Kappa City provided (pharmadrugtest.com). These exhibits demonstrate that these items have the legitimate use of deterring the use of drugs and ingestion of harmful additions to drugs.
Corresponding with factor (3) of § 863(e), on its website (pharmadrugtest.com) Kappa City refers to the NarcoCheck tests as “rapid tests for drugs of abuse (cannabis, cocain [sic.] etc.)” and “identification tests for drugs of abuse and suspicious substances.” See below image.
Web Search Results.
Similarly, at another NarcoCheck website, Kappa City states that it distributes these products to “multiple companies around the world whose interest is to manage and prevent the risks related to drugs consumption.” The website lists among its clients “health professionals,” “police forces, armies, customs,” “companies and industries,” and “schools and education.” The legitimate uses that Kappa City attests to for these drug tests in its advertising also weighs in favor of these items not being considered drug paraphernalia.
Under factor (4), Kappa City displays the NarcoCheck tests for sale on its website (pharmadrugtest.com) and cites a variety of clients as described above. The tests are not displayed in a way that encourages the use of drugs or ingestion of drugs into the human body, nor can they be used to prepare drugs for such a purpose. Therefore, this factor also suggests that these tests are not drug paraphernalia.
Factor (7) also demonstrates that these tests are not drug paraphernalia as the pharmadrugtest.com website shows their use by professionals in health, law enforcement, and education, rather than merely for use with individual drug users.
Therefore, under the factors set out in 21 U.S.C. § 863(e), Kappa City’s NarcoCheck line of drug tests should not be considered drug paraphernalia because the primary intended use for the products are not ingestion of drugs into the human body, but rather for testing, an intended use not included in the statute. This implies that the statute did not intend to place limitations on drug testing.
FDA Approval
Kappa City has indicated that these tests have not been approved by the FDA as medical devices or drug tests, but that its facilities are FDA registered. Failure to obtain FDA approval for these devices may introduce a separate legal issue for Kappa City. Therefore, our office recommends Kappa City seek FDA approval for its NarcoCheck line of products prior to importing those products into the United States.
HOLDING
The subject merchandise is not “drug paraphernalia” pursuant to the statutory definition set forth in 21 U.S.C. § 863 and is therefore not prohibited from importation into the United States.
Sincerely,
W. Richmond Beevers Chief, Cargo Security, Carriers and Restricted Merchandise Branch Office of Trade, Regulations and Rulings U.S. Customs and Border Protection