HQ H002847

March 12, 2008

CLA-2 OT:RR:CTF:TCM H002847 ARM

CATEGORY: Classification

TARIFF NO: 2106.90.9998

Lowell De France

Ted L. Rausch Co.

2300 Higgins St. 310

Elk Grove Village, IL 60007

RE: Classification of bulk Hyaluronic Acid 9%; Reconsideration of New
York Ruling Letter R04494, dated August 9, 2006

Dear Mr. De France:

This is in reply to your request, of November 2, 2006, for
reconsideration of New York Ruling Letter (NY) R04494, dated August 9,
2006, regarding the classification, under the Harmonized Tariff Schedule
of the United States (HTSUS), of bulk Hyaluronic Acid 9% for use in soft
gel capsules as a human nutritional supplement. In NY R04494, Customs
and Border Protection ("CBP") classified a mixture of 60-70 percent
maltodextrin, 15-25 percent residue proteins, and 9 percent hyaluronic
acid derived from rooster comb in subheading 2106.90.9998, HTSUS, which
provides for "food preparations not elsewhere specified or
included...other... other...other," at a rate of duty of 6.4 percent ad
valorem. You ask that we consider classification in heading 3003, HTSUS,
which provides for "Medicaments (excluding goods of heading 3002, 3005
or 3006) consisting of two or more constituents which have been mixed
together for therapeutic or prophylactic uses, not put up in measured
doses or in forms or packings for retail sale: . . . " and revoke NY
R04494.

**FACTS:**

> NY R04494 describes the instant merchandise as follows:
>
> The product, rooster comb powder, is manufactured from frozen rooster
> comb that has been cleaned, sterilized, hydrolyzed using enzymes, and
> macerated to separate the hyaluronic acid from the rooster comb.
> Maltodextrin is added to spray dry the acid, resulting in a mixture of
> 60-70 percent maltodextrin, 15-25 percent residue proteins, and 9
> percent hyaluronic acid. It will be imported in bulk and filled into
> soft gel capsules for use as a human nutritional supplement.

We note that Hyaluronic Acid (HA) is a natural high-viscosity
mucopolysaccharide with alternating beta (1-3) glucuronide and beta
(1-4) glucosaminidic bonds. It is found in the umbilical cord, in
vitreous humor, in synovial fluid, in pathologic joints, in group A and
C hemolytic streptococci, and in Wharton\'s jelly. (Merck, 11th ed).

You submit an article titled "Intra-articular hyaluronan treatment for
osteoarthritis." "Intra-articular" treatment refers to injection into a
joint. You also submit a copy of a pamphlet on Injuv®, from Soft-Gel
Technologies, presumably the final oral capsule product the instant
merchandise is used to create. This pamphlet states that "Orally
administered HA is different than injectable HA. The very properties
that make injectable HA so successful, are the same ones that make it
impossible to be absorbed in oral form. . . . In its natural state, the
molecular weight of HA makes it impossible for oral absorption." The
pamphlet goes on to claim that a process has been discovered to reduce
the molecular weight of HA so that it can be absorbed by the intestinal
tract. The pamphlet then discusses the makeup of the epidermis and the
role of HA in keeping the skin from appearing dull and wrinkled. The
pamphlet highlights this claim:

> Injuv® gets absorbed from the inside out. After entering the
> intestinal tract, it moves through the bloodstream to enter the
> extracellular matrix of the skin, from dermis to epidermis. With
> sufficient amounts of HA in the ECM of the skin, the keratinocytes
> survive longer. This survival leads to a more youthful appearance of
> the skin.

The pamphlet concludes with the following statement:

> "Injuv® is the cosmeceutical that moisturizes from the inside out."

**ISSUES:**

Is bulk hyaluronic acid (9%) a medicament?

**LAW AND ANALYSIS:**

Classification under the Harmonized Tariff Schedule of the United States
Annotated (HTSUSA) is made in accordance with the General Rules of
Interpretation (GRI). GRI 1 provides that the classification of goods
shall be determined 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.

When interpreting and implementing the HTSUS, the Explanatory Notes
(ENs) of the Harmonized Commodity Description and Coding System may be
utilized. The ENs, while neither legally binding nor dispositive,
provide a guiding commentary on the scope of each heading, and are
generally indicative of the proper interpretation of the HTSUS.

Customs and Border Protection (CBP) believes the ENs should always be
consulted. See T.D. 89-80, 54 Fed. Reg. 35127, 35128 (August 23, 1989).

The following HTSUS provisions are relevant to the classification of
this product:

2106. Food preparations not elsewhere specified or included:

> \* \* \* \* \*
>
> 3003 Medicaments (excluding goods of heading 3002, 3005 or 3006)
> consisting of two or more constituents which have been mixed together
> for therapeutic or prophylactic uses, not put up in measured doses or
> in forms or packings for retail sale:
>
> \* \* \* \* \*

The ENS to heading 2106 state, in pertinent part, the following:

> **Provided that they are not covered by any other heading of the
> Nomenclature**, this heading covers :
>
> \(A\) Preparations for use, either directly or after processing (such
> as cooking, dissolving or boiling in water, milk, etc.), for human
> consumption.
>
>  \* \* \* \* \*
>
> The heading includes, *inter alia*:
>
> \* \* \* \* \*
>
> (16)  Preparations, often referred to as *food supplements*, based on
> extracts from plants, fruit concentrates, honey, fructose, etc. and
> containing added vitamins and sometimes minute quantities of iron
> compounds. These preparations are often put up in packagings with
> indications that they maintain general health or well‑being. Similar
> preparations, however, intended for the prevention or treatment of
> diseases or ailments are **excluded** (**heading** **30.03** or
> **30.04**).

The ENs to heading 3003 state, in pertinent part, the following:

> This heading covers medicinal preparations for use in the internal or
> external treatment or prevention of human or animal ailments. These
> preparations are obtained by mixing together two or more substances.
> However, if put up in measured doses or in forms or packings for
> retail sale, they fall in **heading 30.04**.
>
>  
>
> The heading includes :
>
> \* \* \* \* \* 
>
> (7)  Medicinal salts obtained by the evaporation of natural mineral
> waters and similar products artificially prepared.
>
> (8)  Concentrated waters from salt sources (such as Kreuznach waters)
> used in therapeutics; mixed salts prepared for medicinal baths
> (sulphurous, iodized, etc., baths), whether or not perfumed.
>
> (9)  Health salts (e.g., a mixture of sodium hydrogencarbonate,
> tartaric acid, magnesium sulphate and sugar) and similar mixed
> effervescing salts used for medicinal purposes.
>
> (10) Camphorated oil, phenolated oil, etc.
>
> \* \* \* \* \*
>
> Moreover, products consisting of a mixture of plants or parts of
> plants or consisting of plants or parts of plants mixed with other
> substances, used for making herbal infusions or herbal "teas" (e.g.,
> those having laxative, purgative, diuretic or carminative properties),
> and claimed to offer relief from ailments or contribute to general
> health and well-being, are also **excluded** from this heading
> (**heading 21.06**).
>
> Further this heading **excludes** food supplements containing vitamins
> or mineral salts which are put up for the purpose of maintaining
> health or well-being but have no indication as to use for the
> prevention or treatment of any disease or ailment. These products
> which are usually in liquid form but may also be put up in powder or
> tablet form, are generally classified in **heading 21.06** or
> **Chapter 22**.
>
> On the other hand, the heading covers preparations in which the
> foodstuff or the beverage merely serves as a support, vehicle or
> sweetening agent for the medicinal substances (e.g., in order to
> facilitate ingestion).

\* \* \* \* \*

The instant merchandise is described by the terms "food preparation" in
that it is a "preparation . . . for human consumption." EN 2106.
Further, it is of the kind of preparation described in EN 2106 (16).
While not derived from plants, the merchandise, once encapsulated, is
known as a dietary supplement and, according to literature submitted
with your letter, " . . . has the potential to help eliminate the
appearance of fine lines and wrinkles, improve the appearance of scars,
and support the quality of the synovial fluid and joint health." These
are general health and well-being claims. No disease or ailment is
identified for which the product is meant to treat or prevent.

However, you state that the recent case on chondroitin sulfate, [Inabata
Specialty Chems. v. United States]{.underline}, 366 F. Supp. 2d 1358,
(Ct. Int'l Trade 2005), supports your position that bulk HA is
classified in heading 3003, HTSUS. The [Inabata]{.underline} case dealt
with the classification of bulk chondroitin sulfate as between heading
3913, HTSUS, which provides for muccopolysaccharides, and heading 3001,
which provides for animal substances for therapeutic or prophylactic
use. The court noted that heading 3001, HTSUS, is a principal use
provision within the meaning of Additional U.S. Rule of Interpretation
1(a) and proceeded to analyze the merchandise under the
[Carborundum]{.underline} factors. The court stated:

> Tariff classification law relies heavily on commercial practice and
> understandings. Tariff classifications are mainly about the
> marketplace. In determining whether a particular item falls within the
> class or kind of merchandise principally used in the manner described
> by a tariff heading, the courts have considered the following factors:
> (1) general physical characteristics; (2) expectations of the ultimate
> purchaser; (3) channels of trade in which the merchandise moves; (4)
> environment of sale; (5) use in the same manner as merchandise which
> defines the class; (6) economic practicality of so using the imported
> merchandise; and (7) recognition in the trade of this use. [Lenox
> Collections v. United States]{.underline}, 19 CIT 345, 347 (1995);
> [United States v. Carborundum Co.]{.underline}, 536 F.2d 373, 377, 63
> C.C.P.A. 98 (C.C.P.A. 1976). By application of these factors to the CS
> at issue, the overwhelming weight of the evidence points to CS
> belonging to the class or kind of merchandise described in HTSUS
> Heading 3001.\
> Id. at 1364.

Like heading 3001, HTSUS, at issue in [Inabata]{.underline}, heading
3003, HTSUS, uses the term "for therapeutic or prophylactic use." The
[Inabata]{.underline} court discussed this term as indicative of a
principal use provision. We will analyze heading 3003, HTSUS, as such.
You indicate that the court states that the term requires only that the
product be prepared, marketed and bought for therapeutic or prophylactic
purposes. *Id.* at 9. According to the literature you submitted, this
imported mixture of 9% sodium hyaluronate, maltodextrin and other
ingredients is prepared, marketed and purchased in order to have " . . .
the potential to help eliminate the appearance of fine lines and
wrinkles, improve the appearance of scars, and support the quality of
the synovial fluid and joint health." Wrinkles and scars are not a
disease or ailment. In fact, the ENs to heading 3304, HTSUS, providing
for skin care products, specifically include the injectable hyaluronic
acid product meant to do exactly this. Thus, sterile pre-filled syringes
containing hyaluronic acid gel for dermal filling are classified in
heading 3304, HTSUS, as "preparations for the care of the skin" in
accordance with the specific inclusion for such products in EN 33.04
(see NY R04609, dated September 5, 2006).

While you submit an article showing that injecting hyaluronic acid into
a joint may help to relieve the pain of osteoarthritis, this only shows
that injectable hyaluronic acid should be classified as a medicament. We
agree. We have classified the injectable form of hyaluronic acid for
similar ailments in heading 3004. In NY H89822, dated April 4, 2002, NY
I81075, dated April 26, 2002, and in NY N004962, dated January 9, 2007,
CBP classified finished hyaluronic acid products packaged for injection
in the treatment of stomatitis, ophthalmic and cataract surgery,
respectively, in heading 3004, HTSUS, which provides for: "Medicaments .
. . consisting of mixed or unmixed products for therapeutic or
prophylactic uses . . . ." But you submit no evidence that the bulk 9%
hyaluronic acid mixture is prepared, marketed, or purchased for the
treatment of arthritis, stomatitis, or ophthalmic and cataract surgery.
Instead, you claim that it "has the potential . . . to improve the
quality of the synovial fluid and joint health." No treatment or
prophylaxis claim is made and it is unlikely that the product is bought
for treatment of any specific disease. Rather, hyaluronic acid, as the
literature states, moisturizes the skin "from the inside out". It does
this by helping epidermal tissues retain water for a limited amount of
time.

You also argue that the extensive listing of included products in EN
3003, including waters and salts, show that the terms "therapeutic and
prophylactic" are meant to be broad and inclusive of substances that are
not necessarily thought of as medicaments. We disagree. The example of
medicinal waters and salts are not dual use products, as is bulk sodium
hyaluronate. The waters and salts listed in the EN are completely
prepared in such a way that their medicinal qualities are apparent. That
is not the case here. The instant hyaluronic acid is prepared for
encapsulization and oral ingestion, but its use is to "moisturize from
the inside out." There is no indication of the ailment or disease it is
meant to cure or prevent. The method of advertising, environment of
sale, expectations of the ultimate purchaser show that the merchandise
is an anti-aging supplement to decrease wrinkles and generally lubricate
joints and the skin.

Lastly, EN 3003 excludes products "put up for the purpose of maintaining
health or well-being but have no indication as to use for the prevention
or treatment of any disease or ailment." You state that hyaluronic acid
is used to treat diseased joints or relieve pain and stiffness
associated with ailments of the joints and thus the\
EN does not exclude the instant merchandise from the heading.
Merchandise is classified as imported. The 9% hyaluronic acid mixture
imported for encapsulation as an ingestable moisturizer is not the same
product as a hyaluronic acid gel prepared for injection into a joint.
Furthermore, we do not take the "no indication" language to mean that
some minor indication for treatment of disease does not exclude a
preparation that is otherwise used for general health and well-being or
anti-aging. For instant, Vitamin C tablets are indicated for the
treatment of rickets and vitamin D and calcium tablets are indicated for
the treatment of osteoporosis, but they are principally used for the
general health and well-being of the person ingesting them. This is also
the case for the instant 9% hyaluronic acid mixture. Hence, for the
reasons set forth above, heading 3003 does not describe the merchandise.

**HOLDING:**

By application of GRI 1, the classification of the subject 9% hyaluronic
acid mixture imported in bulk is in heading 2106, HTSUS, specifically in
subheading 2106.90.9998, HTSUS, which provides for: "Food preparations
not elsewhere specified or included: Other: Other: Other: Other: Other:
Other, Other." The column one general rate of duty is 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 on the World Wide Web at
[www.usitc.gov](http://www.usitc.gov/).

**EFFECT ON OTHER RULINGS:**

NY R04494, dated August 9, 2006, is affirmed.

> Sincerely,

Myles B. Harmon, Director

Commercial and Trade Facilitation Division