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® Gel in retail packings, from Canada
Dear Mr. Puri:
In your letter dated May 20, 2025, you requested a tariff classification ruling. We are retaining the samples
for reference only.
MEDIHONEY Gel wound and burn dressing, imported in 0.5 fl. oz tubes, is a moist dressing made with
100% active Leptospermum honey in combination with gelling agents and contains 80% medical grade
manuka honey by weight. The MEDIHONEY Gel maintains a moist environment conducive to wound
healing and helps aid and support autolytic debridement. It is indicated as a sterile wound and burn dressing
for light to moderately exuding wounds such as diabetic foot ulcers; leg ulcers; pressure ulcers/sores; 1st and
2nd degree burns and donor sites; and traumatic and surgical wounds. The directions for use states to apply
the gel either directly to the wound bed or onto a suitable primary dressing such as an alginate, gauze pad, or
island dressing. Then cover with an appropriate secondary dressing. The medical grade manuka honey is
known for its antimicrobial properties and is used in wound care to combat infections and to promote wound
healing.
The applicable subheading for the MEDIHONEY Gel in retail packings will be 3005.90.5090, Harmonized
Tariff Schedule of the United States (HTSUS), which provides for “Wadding, gauze, bandages and similar
articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical
substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes:
Other: Other: Other.” 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 3005.90.5090, 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 3005.90.5090, 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 3005.90.5090, 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. T hus, 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 an
y 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 Gel is eligible for duty-free treatment under the Nairobi
Protocol in subheading 9817.00.96, HTSUS. You claim that the gel is not a therapeutic article, medicine, or
drug as defined for tariff purposes. You further state that the gel does not fit the definition of a therapeutic
article as that definition implies a pharmacological, metabolic, or immunological action to treat or prevent
disease. You state that the primary function of the gel is to manage the wound environment to facilitate the
body's natural healing processes and while it assists in healing, it does not constitute a drug or medicine. We
disagree. The MEDIHONEY Gel is a therapeutic article that contains a medicinal ingredient (medical grade
manuka honey) and it is specially formulated as a sterile topical gel dressing and applied to various wounds
to promote healing.
Therefore, the MEDIHONEY Gel 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/.
This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health
Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are
administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and
Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by
visiting their website at www.fda.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