OT:RR:CTF:EMAIN: H330544 PF

Michael R. Smiszek
Braumiller Consulting Group, LLC
5220 Spring Valley Road, Suite 200
Dallas, TX 75254

Re: Request for Reconsideration of NY N330484; Tariff Classification of the Droplette Micro-Infuser and the Droplette Micro-Infuser Kit

Dear Mr. Smiszek

This is in response to your letter submitted on behalf of Droplette, Inc. (“Droplette”) requesting reconsideration of New York Ruling Letter (“NY”) N330484, dated February 8, 2023. NY N330484 involved the classification of a Droplette Micro-Infuser and a retail kit that includes the Droplette Micro-Infuser under the Harmonized Tariff Schedule of the United States (“HTSUS”). Upon review of NY N330484, we have determined the ruling to be correct. We are accordingly affirming the ruling.

NY N330484 provides the following description of the subject merchandise:

The merchandise under consideration is identified as the Droplette Micro-Infuser (DMI) and its DMI Retail Kit.

It is stated that the Droplette Micro-Infuser is a hand-held, rechargeable, battery-operated, electromechanical personal care device. The device transforms various specially formulated skincare ingredients, by releasing single-use capsules made of HDPE (high density polyethylene), into a therapeutic aerosolized “micro-mist.” As a result, ingredients are more deeply transdermally infused into the skin than traditional topical skincare application methods. The Droplette Micro-Infuser is roughly in an oval shape resembling a computer mouse. It consists of a housing, capsule chamber, capsule door, power button, and an indicator light. The device contains an electric motor, PCBs (printed circuit board), etc., inside the housing.

The DMI Retail Kit comprises four discrete items that at the time of import will be packaged in the retail box. Each DMI Kit will include a Droplette Micro-Infuser (including a permanently installed rechargeable lithium-ion battery), a battery charger cradle (to recharge the DMI’s battery wirelessly), an insulated power cable with a wall plug, and a quick start guide.

In use, an HDPE capsule is inserted into the top of the DMI where it is pierced, releasing the therapeutic formulation from inside the capsule that the DMI’s patented technology then transforms into an aerosol micro-mist. When held against the skin, the aerosol micro-mist is infused deeply into the skin, producing the desired therapeutic benefit. Droplette offers several encapsulated therapeutic formulations, which are sold separately.

In NY N330484, CBP classified the subject merchandise in subheading 8509.80.50, HTSUS, which provides for “Electromechanical domestic appliances, with self-contained electric motor, other than vacuum cleaners of heading 8508; parts thereof: Other appliances: Other.” You assert that the classification of the subject merchandise in subheading 8509.80.50, HTSUS, is incorrect and it is properly classified in subheading 9019.20, HTSUS, which provides for “Mechano-therapy appliances; massage apparatus; psychological aptitude-testing apparatus; ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus; parts and accessories thereof: Ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus; parts and accessories thereof.”

In understanding the language of the HTSUS, the Explanatory Notes (“ENs") of the Harmonized Commodity Description and Coding System, which constitute the official interpretation of the HTSUS at the international level, may be utilized. The ENs, although not dispositive or legally binding, provide a commentary on the scope of each heading, and are generally indicative of the proper interpretation of the HTSUS. See T.D. 89-80, 54 Fed. Reg. 35127 (August 23, 1989).

Since Note 1(m) to Section XVI excludes articles of Chapter 90, HTSUS, we first consider whether the subject merchandise is classified in heading 9019. The issue in this case is whether the subject merchandise constitutes an aerosol therapy apparatus.

Clarifying the scope the scope of the legal text, EN 90.19 provides, in pertinent part as follows:

(VI) AEROSOL THERAPY APPARATUS

This is used for the application of a therapeutic agent in the treatment of pulmonary, cutaneous, otorhinolaryngologic, gynaecologic diseases, etc., by the dispersion (nebulisation) in the form of a mist of various medicinal solutions (hormones, vitamins, antibiotics, bronchodilating preparations, essential oils, etc.).

Some of these appliances are of the individual type (nebulisers) designed for connecting to cylinders of oxygen or compressed air, or for fitting to the oxygen tents described in Part (V) above. Others are of the aerosol generator type for doctors’ consulting rooms or hospitals; these consist of a cabinet containing a motorcompressor unit, measuring instruments, the generator proper and various application devices (masks, nasal, buccal, gynaecological, etc., nozzles).  The heading includes aerosol-type hand-sprays for spraying teeth or gums which operate by compressed gas contained in a screw-on cartridge; the action of the medicinal substance used cleans the mouth and treats diseases such as periodontitis.

EN 90.19(VI), supra, indicates that “aerosol therapy apparatus covered by the legal text of heading 9019 are “…used in the application of a therapeutic agent in the treatment of pulmonary, cutaneous, otorhinolaryngologic, gynaecologic diseases, etc., by the dispersion (nebulisation) in the form of a mist of various medicinal solutions (hormones, vitamins, antibiotics, bronchodilating preparations, essential oils, etc.).” This is consistent with the definition of the term “therapeutic” adopted by the Court of International Trade inasmuch as the term mean “…of or relating to the treatment of disease or disorders by remedial agents or methods: curative, medicinal” and “prophylactic” as meaning “preventive; preventing disease . . . an agent that acts to prevent a disease.” Warner-Lambert Co. v. United States, 28 C.I.T. 939, 946 (2004) aff’d 425 F.3d 1381 (Fed. Cir. 2005).

The subject merchandise delivers an aerosolized form of certain agents for cutaneous application. However, it does not deliver a therapeutic or medicinal agent for the purposes of treating a disease. In this regard, anti-aging and care of the skin is not a disease or ailment. Since neither the DMI or DMI kit are used for the application of a therapeutic agent in the treatment of cutaneous diseases by the dispersion in the form a mist of a medicinal solution, they are not classified as an aerosol therapy apparatus in heading 9019, HTSUS.

Similar devices have been classified in other HTSUS headings. See, e.g., NY rulings N133277 (Dec. 16, 2010) (the heated wrinkle device is designed to heat serum and allow for dispensing of the serum for facial application), N277149 (Aug 5, 2016) (the moisturizer/serum dispenser dispenses a customized blend of skin care products that include one day moisturizer, one night moisturizer and three serums), and N315458 (Nov. 17, 2020) (the battery-powered handheld sprayer of skincare cosmetic products such as sunblock, tanner and body lotion. The device uses electrostatically charged droplets applied evenly to the skin of the user).

Heading 8509, HTSUS, provides, in part, for electro-mechanical domestic appliances, with self-contained electric motor. Heading 8509, HTSUS, covers a broad range of electromechanical domestic appliances with self-contained electric motor. Note 4 to Chapter 85, HTSUS, provides, in pertinent part, that:

Heading 8509 covers only the following electromechanical machines of the kind commonly used for domestic purposes:

Floor polishers, food grinders and mixers, and fruit or vegetable juice extractors, of any weight;

Other machines provided the weight of such machines does not exceed 20 kg, exclusive of extra interchangeable parts or detachable auxiliary devices….

In this regard, we note that EN 85.09 provides in relevant part, the following:

This heading covers a number of domestic appliances in which an electric motor is incorporated. The term “domestic appliances” in this heading means appliances normally used in the household.

Based on the submitted information, we find that the subject DMI and the DMI Kit are electromechanical appliances, designed for common domestic use, with a self-contained electric motor. They are handheld devices that weigh below the 20 kg threshold provided in Note 4(b) to Chapter 85. Thus, the DMI and the DMI Kit fall within the scope of heading 8509, HTSUS, as electromechanical domestic appliances.

The subject merchandise is therefore properly classified in heading 8509, is properly classified by application of GRIs 1 (Note 4(b) to Chapter 85) and 6 in heading 8509, HTSUS, specifically in subheading 8509.80.50, HTSUS, as “Electromechanical domestic appliances, with self-contained electric motor, other than vacuum cleaners of heading 8508; parts thereof: Other appliances: Other.” NY N330484, dated February 8, 2023, is hereby affirmed.

Sincerely,

Yuliya A. Gulis, Director
Commercial and Trade Facilitation Division