RES-OT:RR:BSTC:CCI H169675 DAC
Mr. Marc A. Hurteau
Area Port Director-Cleveland
Attn: Salvatore Piazza
6747 Engle Road
Middleburg Heights, Ohio 44130
RE: 21 U.S.C. § 863; alleged Drug Paraphernalia; Volcano Vaporizer
Dear Mr. Hurteau:
This is in response to your correspondence dated June 3, 2009, in which you requested internal advice in accordance with 19 CFR § 177.11, regarding the admissibility of the Volcano Vaporizer and the accompanying articles within the commercial sales package. You ask whether the Volcano Vaporizer constitutes prohibited merchandise within the meaning of 21 U.S.C. § 863. Our ruling is set forth below.
FACTS:
The subject merchandise consists of a Volcano Vaporizer. The Volcano Vaporizer is an electromechanical device that is designed to vaporize chemical compounds from plant material or oils by means of heated air. The construction of the device consists of a heating block and an air pump that are housed in a conical shaped base. The device plugs into a standard one hundred twenty volt (120V) outlet and has separate switches for the heating element and the air circulating mechanism. The device comes in two model types, the Digital Volcano vaporizer with a digital display and touch controls and the Classic Volcano vaporizer with a rotary knob that is used to control the temperature. The plant material or oil is dispensed into a filling chamber and placed on top of the device. The user then attaches a balloon and value that serves to capture the vapors for inhalation into the lungs. When the heating element and air circulation device is turned on, hot air passes through the oil or plant material into the balloon. The commercial sales package of the Volcano Vaporizer contains a heating unit, a filling chamber, a valve, a balloon and an herb grinder. The herb grinder consists of three plastic parts approximately two and one quarter inches in diameter. The inside two parts have a series of sharp extrusions arranged so that when the two parts are twisted, the substance inside is shred into finer pieces. The purpose of the herb grinder is to shred material more finely before placing it in the filling chamber. It is claimed that shredding the material into smaller particles allows for more efficient vaporization of herbs. A third plastic piece snaps onto either side of the herb grinder and provides storage space. As part of the commercial sales package for the vaporizer, the presence of the herb grinder is fully compatible with the declared uses of the vaporizer for grinding herbs for aromatherapy or culinary preparation.
Images of complete Volcano Vaporizer kits as shown on the official Storz & Bickel website are provided below: See website: www.storz-bickel.com
Easy Valve Classic Model Solid Valve Classic Model
Easy Valve Digital Model Solid Valve Digital Model
Images of the Classic Volcano Vaporizer commercial sales package are provided below:
The “Storz & Bickel” trademark word mark is registered with the U.S. Patent and Trademark Office for “inhalers and heated inhalers, sold empty for therapeutic use” in International Class of Goods 010 and “hand operated herb grinders” in International Class of Goods 021. On February 4, 2003, Storz & Bickel registered a patent with the USPTO for the Volcano Vaporizer design, US 6,513,524 B1, which is shown below.
In a letter dated August 8, 2007, Bagg Roske & Associates submitted a letter on behalf of their client Storz & Bickel, which stated the Volcano Vaporizer does not fall within the meaning of drug paraphernalia pursuant to 21 U.S.C. § 863 for the following reasons:
The Volcano Vaporizer is not designed for use with controlled substances, but rather eucalyptus, hops, chamomile, lavender, lemon, balm, sage, thyme, aromatherapy, aromatic oils and tobacco;
The operating manual and promotional material does not reference or encourage the use of controlled substances;
Similar articles are being sold and are not categorized as drug paraphernalia;
The manufacturer is considering registration of the Volcano Vaporizer as a medical product with the FDA, as the device has medical benefits;
The Volcano Vaporizer is not similar to traditional drug paraphernalia as the retail price is much higher;
The manufacturer distributes worldwide and has not had any issues with other government entities; and
Storz & Bickel has cooperated with all other government entities regarding unrelated issues.
In a letter dated November 15, 2007, Storz & Bickel submitted additional information that included the following:
A list of Storz & Bickel’s commercial customers;
A list of Stroz & Bickel’s affiliates;
A list of all products offered for sale by Storz & Bickel;
A description of the “Vaporization Industry,” with attachments;
A list of specialized stores carrying Storz & Bickel products; and
Sworn expert testimony on the use of the vaporizer for aromatherapy.
ISSUE:
Whether the subject vaporizers 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:
§ 863. Drug paraphernalia
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.
The submissions on behalf of Storz & Bickel claim that the Volcano Vaporizer does not fall within the meaning of drug paraphernalia in 21 U.S.C. § 863, because the vaporizers are not “designed for use” with controlled substances, but rather eucalyptus, hops, chamomile, lavender, lemon, balm, sage, thyme, aromatherapy, aromatic oils and tobacco. The operating manual provided with each unit provides detailed instructions on how to use the Volcano Vaporizer. See also 21 U.S.C. §863 (e)(1-2). There are three different sets of instructions that address three popular uses for the Volcano Vaporizer. The first set of instructions describes how to use the Volcano Vaporizer for the inhalation of vapor. The second set of instructions describes how to use the Volcano Vaporizer with an oven bag, or heatproof and food safe balloon, which are used in the culinary industry for infusing food with the flavors and aromas of herbs and spices. A third set of instructions describes how to use the Volcano Vaporizer with liquid aromatic oils. To further support this third use, the Volcano Vaporizer kit contains a “liquid pad” to safely vaporize liquids. By placing a drop of liquid oil on such pad, the Vaporizer may be used as a traditional aromatic vaporizer that distributes the essences of aromatic oils into the surrounding air.
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 case. 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. See Crime Control Act of 1990, Pub. L. 101-647, §2401, 104 Stat. 4858. See also, 511 U.S. at 516, n. 5; United States v. Search of Music Marketing, Inc., 212 F.3d 920, 925 (6th Cir. 2000).
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. Posters ‘N’ Things, 511 U.S. 513, 521 (1994). 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.” Id. at 521 n.11. 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.” Id. at 521 n.11. 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., 455 U.S. 489 (1982), where the Court stated that it is also to be understood objectively and that it refers to an item’s objective characteristics. Id at 501. 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 contrived 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. See Village of Hoffman Estates et al v. The Flipside, Hoffman Estate, Inc., 455 U.S. 489, 501 (1982).
The relevant statute, 21 U.S.C. § 863(e), enumerates eight factors which may be considered, in addition to all other logically relevant factors, in determining whether an item constitutes drug paraphernalia. See 21 U.S.C. § 863(e)(1-8). Storz & Bickel has submitted detailed information addressing most of the eight objective factors set forth in 21 U.S.C. § 863(e). We shall now briefly describe the information addressing the additional factors in numerical order. Factor (1) - “instructions, oral or written, provided with the item concerning its use.” Storz & Bickel has provided operating manuals and instructions that accompany the Volcano Vaporizers as set forth above. See 21 U.S.C. § 863(e)(1). Factor (2) – “descriptive materials accompanying the item which explain or depict its use.” The Volcano Vaporizer retail unit includes a “Quick Start Manual” which illustrates how the merchandise is intended to be used. The literature does not name one particular ingredient in their step by step instructions, but simply references to a “substance” being vaporized. Storz & Bickel provided additional descriptive literature published by the manufacturer which neither references nor alludes to the use of the Volcano Vaporizer with illicit substances. The literature does refer to use of the Volcano Vaporizer with “plant material” and “herbs,” and within the overall context of such literature, these words may very well refer to aromatherapy herbs. We note the literature does not refer to illicit substances. See 21 U.S.C. § 863(e)(1-2). Factors (3 and 4) – “(3) national and local advertising concerning its use;” and “(4) the manner in which the item is displayed for sale.” The Storz & Bickel website is the official site of the Volcano Vaporizer. There is no reference to use with illicit substances in conjunction with the Volcano Vaporizer on Storz & Bickel’s website, rather it advertises use with eucalyptus, hops, chamomile, lavender, lemon balm, sage, thyme, cooking techniques, aromatherapy, and aromatic oils. Factors (5 and 6) – “(5) 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;” and “(6) – direct or circumstantial evidence of the ratio of sales of the item(s) to the total sales of the business enterprise.” Based on our independent research and the evidence submitted, Storz & Bickel manufactures one principle item, the Volcano Vaporizer, which represents the total sales of the business enterprise. The Volcano Vaporizer may be ordered from the descriptions and information provided on the Storz & Bickel website. See 21 U.S.C. § 863(e)(5-6). Factor (7) – “the existence and scope of legitimate uses of the item in the community.” An independent search of the internet supports the existence of popular legitimate uses for the Volcano Vaporizer in the commercial community. The Volcano Vaporizer is commonly used with aromatherapy herbs and essential oils for holistic medical benefits and natural remedies, as well as for a method used in modern cooking in the culinary arts called “molecular gastronomy.” The subject Volcano Vaporizer may very well be suitable for such uses as the inhalation of vapor in aromatherapy, for infusing herbs and spices into food in the culinary arts and for the simmering of aromatic oils. See 21 U.S.C. § 863(e)(7). Factor (8) – “expert testimony concerning its use.” Storz & Bickel has submitted statements from technical experts in support of legitimate consumer uses of the Volcano Vaporizer. See 21 U.S.C. § 863(e)(8).
Our determination is based upon all of the information and discussion above and the application of the two 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). The two tests are whether the article is (1) “primarily intended for use,” or, (2) “designed for use” in the manufacturing, compounding, converting, concealing, producing, processing, preparing, injecting, ingesting, inhaling, or otherwise introducing into the human body a controlled substance.
With respect to the “primarily intended for use” test, “it is the likely use of customers generally, not any particular customer, that can render a multiple-use item drug paraphernalia.” Posters ‘N’ Things, supra. The Volcano Vaporizer may be used by customers generally as a device to aid in the inhalation of vapor from legal substances, a device to aid in a method used in modern cooking called “molecular gastronomy,” and as an aromatherapy device for heating and releasing the aromatic compounds in fragrant oils. Because there are multiple popular uses for the Volcano Vaporizer in the vaporization community, the subject vaporizers are not “primarily intended for use” with illegal substances. We find that the information described above is sufficient to show that the primary and/or likely use of the subject vaporizers in the United States is not with illegal controlled substances. Therefore, we find that the subject vaporizers are not primarily intended for use in inhaling an illegal controlled substance (or any of the actions enumerated in 21 U.S.C. § 863(d)). In making this determination, we note that based upon the submissions and literature, there is no reference in the record that the subject vaporizers shall be used with illegal controlled substances. See 21 U.S.C. § 863. Posters ‘N Things v. United States, 511 U.S. 513, 516, 521 (1994).
With respect to the “designed for use” test, the Court in Village of Hoffman Estates, 455 U.S. 489 (1982), stated that 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 contrived use of a bong as a flower vase). Based upon the information provided and the discussion above, we find that the subject vaporizers do not possess objective characteristics which establish that they are designed specifically for use with controlled substances. As stated above, the subject vaporizers may very well have multiple legitimate consumer uses within the vaporization community. Therefore, we determine that the subject vaporizers do not fall within the relevant meaning of “designed for use” in inhaling an illegal controlled substance (or any of the other actions enumerated in 21 U.S.C. § 863(d)). See 21 U.S.C. § 863. Posters ‘N Things v. United States, 511 U.S. 513, 516, 521 (1994). Village of Hoffman Estates et al v. The Flipside, Hoffman Estate, Inc., 455 U.S. 489, 501 (1982).
Accordingly, in light of all of the above, we determine that the subject vaporizers are not “drug paraphernalia” within the meaning of 21 U.S.C. § 863(d). Therefore, they are not prohibited from importation into the United States.
HOLDING:
The subject vaporizers are not considered “drug paraphernalia” within the meaning of 21 U.S.C. § 863(d), and are therefore not prohibited from importation into the United States. If you have any questions regarding this determination, please contact Dean Cantalupo of my staff at (202) 325-0085.
Sincerely,
George Frederick McCray
Supervisory Attorney-Advisor/Chief
Cargo Security, Carriers and Immigration Branch
Office of International Trade, Regulations & Rulings
U.S. Customs and Border Protection