CLA-2-30:OT:RR:NC:N3:138
Shivali Puri
Integra LifeSciences Sales LLC
1100 Campus Road
Princeton, NJ 08540
RE: The tariff classification of MEDIHONEY® Calcium Alginate Dressing in retail packings from Canada
Dear Ms. Puri:
In your letter dated May 20, 2025, you requested a tariff classification ruling. The samples submitted will be
retained for reference only.
MEDIHONEY Calcium Alginate Dressing, imported in 3/4" x 12" single pouches, is a sterile absorbent
primary wound dressing made of active Leptospermum honey impregnated into a calcium alginate pad. The
dressing contains 95% active Leptospermum honey indicated for the management of moderately to heavy
exuding wounds such as diabetic foot ulcers; leg ulcers; pressure ulcers/sores; 1st and 2nd degree partial
thickness burns and donor sites; and traumatic and surgical wounds. As the wound exudate is absorbed, the
alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing. In your
letter, you stated the combination of the medical-grade Leptospermum (Manuka) honey with calcium alginate
provides for antimicrobial and healing benefits of Leptospermum honey directly to the wound.
The applicable subheading for the MEDIHONEY Calcium Alginate Dressing in retail packings will be
3005.90.1000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Wadding,
gauze, bandages and similar articles …, impregnated or coated with pharmaceutical substances or put up in
forms or packings for retail sale for medical, surgical, dental or veterinary purposes: Other: Coated or
impregnated with pharmaceutical substances.” The general rate of duty will be free.
Products of Canada as provided by heading 9903.01.10 in Section XXII, Chapter 99, Subchapter III, U.S.
Note 2(j), HTSUS, other than products classifiable under headings 9903.01.11, 9903.01.12, 9903.01.13,
9903.01.14, and 9903.01.15, HTSUS, will be subject to an additional 25 percent ad valorem rate of duty. At
the time of entry, you must report the applicable Chapter 99 heading, i.e. 9903.01.10, in addition to
subheading 3005.90.1000, HTSUS, listed above. Articles that are entered free of duty under the terms of
general note 11 to the HTSUS (U.S.-Mexico-Canada Agreement (USMCA)), including any treatment set
forth in subchapter XXIII of Chapter 98 and subchapter XXII of chapter 99 of the HTSUS, will not be
subject to the additional ad valorem duties provided for in heading 9903.01.10. If your product is entered
duty free as originating under the USMCA, you must report heading 9903.01.14, HTSUS, in addition to
subheading 3005.90.1000, HTSUS.
Effective April 5, 2025, Executive Orders implemented “Reciprocal Tariffs.” All imported merchandise must
be reported with either the Chapter 99 provision under which the reciprocal tariff applies or one of the
Chapter 99 provisions covering exceptions to the reciprocal tariffs. At this time products from all countries
will be subject to an additional 10 percent ad valorem rate of duty. Your product falls within an excepted
subheading. At the time of entry, you must report the Chapter 99 heading applicable to your product
classification, i.e. 9903.01.32, in addition to subheading 3005.90.1000, HTSUS, listed above.
In your submission you requested consideration of a secondary classification under 9817.00.96, HTSUS,
which applies to articles and parts and accessories of articles specifically designed or adapted for the use or
benefit of the permanently or chronically physically or mentally handicapped.
Subheading 9817.00.96, HTSUS, covers: “Articles specially designed or adapted for the use or benefit of the
blind or other physically or mentally handicapped persons; parts and accessories (except parts and
accessories of braces and artificial limb prosthetics) that are specially designed or adapted for use in the
foregoing articles . . . Other.” The term “blind or other physically or mentally handicapped persons” includes
“any person suffering from a permanent or chronic physical or mental impairment which substantially limits
one or more major life activities, such as caring for one’s self, performing manual tasks, walking, seeing,
hearing, speaking, breathing, learning, or working.” U.S. Note 4(a), Subchapter XVII, Chapter 98, HTSUS.
Subheading 9817.00.96, HTSUS, excludes “(i) articles for acute or transient disability; (ii) spectacles,
dentures, and cosmetic articles for individuals not substantially disabled; (iii) therapeutic and diagnostic
articles; or, (iv) medicine or drugs.” U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS. Thus, eligibility
within subheading 9817.00.96, HTSUS, depends on whether the article is “specially designed or adapted for
the use or benefit of the blind or physically and mentally handicapped persons,” and whether it falls within
any of the enumerated exclusions under U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS.
U.S. Customs and Border Protection (“CBP”) and the courts have held that therapeutic articles within the
context of this provision are those articles that heal or cure a condition. See T.D. 92-77, 26 Cust. B. & Dec.
240, 241 (1992); Travenol Laboratories, Inc. v. U.S., 17 CIT 69, (1993). Also, the courts and CBP have
consistently held that therapeutic articles are articles whose purpose is the “complete or partial elimination of
disease.” See Headquarters Ruling Letter (“HQ”) H285358, dated August 6, 2018.
You have suggested that the above MEDIHONEY Calcium Alginate Dressing is eligible for duty-free
treatment under the Nairobi Protocol in subheading 9817.00.96, HTSUS. You claim that the MEDIHONEY
Calcium Alginate Dressing is a specialized wound dressing specifically designed to promote healing in
patients with chronic wounds, particularly those with disabilities and mobility impairments. You further state
it is specifically used for the benefit of the physically handicapped and that individuals with conditions such
as diabetic neuropathy, spinal cord injuries, and vascular disease are at a significantly higher risk of
developing chronic wounds and have impaired wound healing and that the dressing is essential for preventing
severe complications like infections or amputations in patients with chronic conditions that impair wound
healing. Based on the information stated above, the MEDIHONEY Calcium Alginate Dressing is considered
to be a therapeutic article since it prevents infections and contributes to the healing of wounds.
Therefore, the MEDIHONEY Calcium Alginate Dressing is specifically excluded from classification under
subheading 9817.00.96 as “ therapeutic and diagnostic articles.” U.S. Note 4(b)(iii), Subchapter XVII,
Chapter 98, HTSUS. As a result, it is the opinion of this office that a secondary classification will not apply
in subheading 9817.00.96, HTSUS.
The tariffs and additional duties cited above are current as of this ruling’s issuance. 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 at https://hts.usitc.gov/.
The holding set forth above applies only to the specific factual situation and merchandise description as
identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations
(CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the
information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and
complete in every material respect. In the event that the facts are modified in any way, or if the goods do not
conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and
Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2.
Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic
verification by CBP.
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection
Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents
filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact
National Import Specialist Judy Lee at [email protected].
Sincerely,
(for)
Steven A. Mack
Director
National Commodity Specialist Division