CLA-2 RR:CR:GC 960697ptl
Mr. Les Tobin
L. Tobin
5 Island Avenue
Miami, FL 33139
RE: Aroma Inhalers; NY 811343, 848883, B88485.
Dear Mr. Tobin:
This is in response to your letter of April 24, 1997, to the
Area Director of Customs, New York, NY, requesting a ruling on
the classification under the Harmonized Tariff Schedule of the
United States (HTSUS), of two types of aromatic inhalers made in
Thailand. Your letter and the samples were forwarded to this
office for a response.
FACTS:
The merchandise consists of two "inhalers." One, referred
to as an "Aroma Fragrance Inhaler" is a base metal canister type
container with a "salt shaker type top" underneath the canister
lid. Inside the container is a bag of herbs which produces the
desired aroma. The herbs are: Citrus-Medical L. Var
Sarcodactylus, Citrus-Chachitensis Hort., Clove-Eugenis
Caryophyllata Tumb, Cinnamomum Japonicumsied, menthol crystals,
camphor crystals and oil of peppermint. The aroma is released by
removing the outer lid of the inhaler. The second article,
referred to as a "Herbal Inhaler," is made of plastic. It
consists of three parts. The bottom segment contains the active
ingredients, which are liquid drops of the oils which produce the
aroma. The center segment is designed to be inserted into the
nostril so the concentrated aroma can be inhaled. The third
segment is a cap which effectively closes the inhaler. The
"Herbal Inhaler" contains menthol, camphor and oils of eucalyptus
and peppermint. Both articles are products of Thailand, where
they are reportedly widely used. While
the aromas may "clear the nasal passages or sinus cavities", you
state that you do not intend to make any claims as to the
product's therapeutic qualities or benefits.
ISSUE:
Are the products classifiable as medicaments of heading
3004, HTSUS, mixtures of odiferous substances of heading 3302,
HTSUS, or toilet preparations of heading 3307, HTSUS?
LAW AND ANALYSIS:
Merchandise is classifiable under the Harmonized Tariff
Schedule of the United States (HTSUS) in accordance with the
General Rules of Interpretation (GRIs). The systematic detail of
the HTSUS is such that virtually all goods are classified by
application of GRI 1, that is, according to the terms of the
headings of the tariff schedule and any relative Section or
Chapter Notes. In the event that the goods cannot be classified
solely on the basis of GRI 1, and if the headings and legal notes
do not otherwise require, the remaining GRIs may then be applied
in order.
In understanding the language of the HTSUS, the Harmonized
Commodity Description and Coding System Explanatory Notes may be
utilized. The Explanatory Notes (ENs), although not dispositive
or legally binding, provide a commentary on the scope of each
heading of the HTSUS, and are generally indicative of the proper
interpretation of these headings. See T.D. 89-80, 54 Fed. Reg.
35127, 35128 (August 23, 1989).
Both versions of the articles under consideration contain a
combination of herbs and/or oils which produce a scent which
identifies the particular product. It is this particular scent,
combined with the use for which the products will be imported,
that presents us with the alternative classifications under
consideration. When using this product, the overwhelming scent
appears to be a combination of camphor and menthol.
The following subheadings are under consideration:
3004 Medicaments (excluding goods of heading 3002, 3005 or
3006) consisting of mixed or unmixed products for
therapeutic or prophylactic uses, put up in measured
doses or in forms or packings for retail sale: * *
*
3004.90.90 Other
Medicaments primarily affecting the eyes,
ears or respiratory system:
3004.90.9075 Cough and cold preparations
Other:
3004.90.9080 Antihistamines
3004.90.9085 Other
3004.90.9090 Other
* * * * *
3302 Mixtures of odoriferous substances and mixtures
(including alcoholic solutions) with a basis of one or
more of these substances, of a kind used as raw
materials in industry; other preparations based on
odiferous substances, of a kind used for the
manufacture of beverages.
* * * * *
3307 Pre-shave, shaving or after-shave preparations,
personal deodorants, bath preparations, depilatories
and other perfumery, cosmetic or toilet preparations,
not elsewhere specified or included; prepared room
deodorizers, whether or not perfumed or having
disinfectant properties:
* * *
3307.90.00 Other
Of the three headings under consideration, one is easily
rejected. The products under consideration are definitely
mixtures of odoriferous substances and the resulting aroma is
rather distinctive. However, in their condition as imported,
they do not fall within heading 3302, HTSUS. Products
classifiable in that heading are mixtures of odoriferous
substances used as raw materials in various industries. These
products are finished products to be sold at retail.
The two remaining headings under consideration cover
products which can fall within the jurisdiction of the U.S. Food
and Drug Administration (FDA) as either a drug
or a cosmetic scent. Therefore, in determining where the
products are properly classified, we look at the treatment
similar articles receive from the FDA. Traditionally, perfumes
and scents have been considered cosmetics by the FDA. The Food,
Drug and Cosmetic Act defines cosmetics as articles to be
introduced into or otherwise applied to the body to cleanse,
beautify, promote attractiveness or alter appearance (21 U.S.C.
321(i)). On the other hand, articles intended for use in the
diagnosis, treatment or prevention of disease, and which are
intended to affect the structure or any function of the body are
usually considered to be drugs (21 U.S.C. 321(g)).
While cosmetics and drugs are both under the FDA's
jurisdiction, the legal requirements applying to them are
different. A claim that a perfume's aroma is good or beneficial,
in general, is a cosmetic claim not requiring FDA approval before
the product is sold. However, if a scent was marketed with the
claim that it was for the treatment or prevention of allergies or
some other symptom, this could be considered a drug claim
requiring premarket approval.
We note that you are calling the particular scent formula
produced by the samples "Chinese." This ruling will apply to
that formulation only. Other formulations are called by such
names as: "Tranquility," "Energize," "Inspiration," and
"Nitecap." Since you have not provided specific information
about the marketing of those products, we cannot suggest a
classification. However, these names suggest that the products
are intended to produce a physical benefit to the user. As such,
the products could be considered medicaments.
In the United States, the scents of camphor and menthol,
either individually or in combination, are often used in and
associated with products which are used for medicinal or hygienic
purposes. However, simply being associated with a use is not
always enough to require that a product be classified as a
medicament. Some claim regarding the therapeutic benefit or use
of the product usually needs to be made. Vicks cream and
ointments which contain camphor, menthol and eucalyptus oil as
active ingredients were classified as medicaments in heading
3004, HTSUS, by
NY Ruling 811343, dated June 29, 1995, because they were labeled
and marketed as products which would relieve nasal and coughing
due to colds. A rabbit-shaped sealed sachet filled with flax
seed, lavender and peppermint called "Thumper" was classified as
a medicament by NY B88485, dated August 25, 1997, because wording
on the label indicated that the product is used to enhance one's
well-being and ease away tension and eyestrain.
You have stated that you do not intend to make any claims
regarding any therapeutic benefits or medicinal properties when
you market these products. However, the two articles differ
significantly in how they function. The "Herbal Inhaler",
is specifically designed so that the herbal ingredients will
either come into direct contact with the user, or will be inhaled
deeply through the product's traditional inhaler end. This use,
combined with the traditionally recognized therapeutic properties
of the ingredients, makes it difficult to distinguish these
inhaler containers from other similarly shaped articles which
contain similar ingredients. We believe that the combination of
factors exhibited by the "Herbal Inhaler" require that we
consider it to be imported and offered for sale and use as a
medicament within the scope of heading 3004, HTSUS.
When we turn to the canister you call an "Aroma Fragrance
Inhaler", we encounter different circumstances and factors. The
canister shaped device is designed so that the user will, at
most, hold the article under the nose while sniffing the aroma.
This positioning and use of the article can be considered
consistent with perfuming or deodorizing products. This does not
suggest a direct application of the product on or into the user's
person. Rather, it is designed to release the aroma into the air
surrounding the user.
Heading 3307, HTSUS, covers cosmetic and toilet preparations
such as: shaving or after-shave preparations, personal
deodorants, and other perfumery, cosmetic or toilet preparations,
not elsewhere specified or included.
The fact that the scents of menthol and camphor are not
usually associated with perfume or cosmetics in the United
States, should not preclude classifying a product with such a
scent in heading 3307. The ENs to Chapter 33 provide that the
heading 3307 applies to products suitable for use as goods of the
heading and which are put up in packages of a kind sold by retail
for such use. The canister is put up in packages of a kind sold
by retail. No attempt is being made to describe the qualities of
its scent as being sweet or light. Use of the term "aroma",
suggests a stronger smell than the term "herbal." The Random
House Dictionary of the English Language lists "aroma" as a
synonym for the word "perfume," but in comments says that "Aroma
is restricted to a somewhat spicy smell." The product does have
a sharp, spicy smell which gives it its distinctiveness.
In NY 848883, dated January 25, 1990, Customs ruled that a
non-aerosol spray used as a room freshener, consisting of
essences of eucalyptus, peppermint, rosemary, pine and clove with
camphor and menthol was classifiable under subheading
3307.49.0000. The canister called an "Aroma Fragrance Inhaler"
is not a spray room freshener, but it has similar components and
is capable of disseminating its scent throughout a room, is
properly classifiable under subheading 3307.90.00.
HOLDING:
The plastic article identified as a "Herbal Inhaler" is
classified in subheading 3004.90.9090, HTSUS, as medicaments
(excluding goods of subheading heading 3002, 3005 or 3006)
consisting of mixed or unmixed products for therapeutic or
prophylactic uses, put up in measured doses or in forms or
packings for retail sale: other; other.
The metal canister, identified as an "Aroma Fragrance
Inhaler" is classified in subheading 3307.90.0000, HTSUS , as
pre-shave, shaving or after-shave preparations, personal
deodorants, bath preparations, depilatories and other perfumery,
cosmetic or toilet preparations, not elsewhere specified or
included; prepared room deodorizers whether or not perfumed or
having disinfectant properties: other.
Sincerely,
John Durant, Director
Commercial Rulings Division