OT:RR:CTF:VS H352448 ACH
Lydia C. Pardini
Polsinelli PC
1401 Eye Street NW Ste 800
Washington, DC 20005
RE: Affirmation of NY N351167; Applicability of Subheading 9817.00.96, HTSUS; NeoMed
Enteral Feeding Devices
Dear Ms. Pardini:
This is in response to your request for reconsideration, on behalf of Avanos Medical, Inc.,
dated September 2, 2025, of New York Ruling Letter (“NY”) N351167, dated August 4, 2025,
regarding the eligibility of NeoMed Enteral Feeding Devices (“Feeding Devices”), including the
NeoMed Enteral Feeding Tube (“Tube”), the NeoMed Enteral Feeding Syringe (“Syringe”), and
the NeoMed Enteral Extension Set (“Extension Set”) for subheading 9817.00.96, Harmonized
Tariff Schedule of the United States (“HTSUS”), treatment. For the reasons set forth below, we
affirm NY N351167.
Avanos provided the following information in their request for reconsideration:
The NeoMed line consists of a feeding tube, syringe, and extension set. All of the
components are for feeding-impaired infants with features designed to maintain sterility in
sensitive Neonatal Intensive Care Unit (“NICU”) environments.
The tube is specifically intended for use in newborns who require continuous feedings via
the nasogastric or oral-gastric pathway. This includes specialized, marked tube sections of
various lengths and sizes with a specially designed connector. The connectors come in both
Enteral-Fit-compatible (“ENFit-compatible”) and non-ENFit-compatible forms. While ENFit-
compatible connections offer enhanced safety with features designed to reduce the risk of
misconnections, the non-ENFit compatible connections are also designed to interface with the
related components in the system. The ENFit-compatible connectors are designed to secure with
the syringe. The specialized ENFit-compatible syringe delivers nutrition to the patient’s stomach
through the tube. The tube’s “Instructions for Use” indicate that it is designed to last over 30
days, but a replacement tube may be needed if nasogastric or oral-gastric feeding is required
beyond 30 days either as a result of co-existing chronic conditions or due to other delays in
reaching young infanthood.
The syringe is used as a dispenser, a measuring device, and a fluid transfer device for
essential fluid nutrition to be delivered to the intended patients, enterally. The ENFit-compatible
tips have grooves that allow them to connect to the ENFit connecter on the tube, thus securing
the placement of the syringe. The syringes are available in a variety of volumes as small as 0.5
mL, tailored to the small fluid dosing needs of premature newborns. The NeoMed Enteral
Syringes are available by physician prescription only and are labeled per FDA requirements to be
handled only by licensed healthcare professionals.
The extension set elongates the connection between the tube and the syringe. The
extension sets are designed to connect to a tube. One end of the tube is placed in the patient, and
the other end of the extension set has connectors to allow the syringe to deliver nutrition to the
patient through the tube. Regardless of the connector type, the extension sets are designed to
work with the compatible syringes and tubes.
While the syringe can connect to the tube without the extension set, it is considered an
unsafe practice in the NICU. It is stated that connecting a Syringe directly to the feeding tube
requires opening the incubator and bringing the caregiver’s hands and equipment in direct
contact with the child for prolonged periods of time, which highly increases the risk of
contamination. The extension set allows the feeding connection to be made via a porthole.
In NY N351167, U.S. Customs and Border Protection (“CBP”) determined that the tube,
syringe, and extension set were not eligible for duty free treatment under subheading 9817.00.96,
HTSUS, because these enteral feeding devices for a premature baby were not specially designed
or adapted for the handicapped. NY N351167, which took into account the information above, is
herein incorporated by reference, but additionally the decision noted that the:
NeoMed Enteral Feeding Syringe … is intended to be used in clinical or home care
settings by users ranging from clinicians to laypersons (under the supervision of a
clinician) in all age groups….for the extremely small fluid dosing needs of
premature newborns.
The products described above are placed through the nasal or oral route at the Neonatal
Intensive Care Unit (“NICU”) bedside by trained neonatal clinical staff and are intended
exclusively for neonates who are unable to consume nutrition safely or effectively by mouth.
You claim that the premature, low birthweight neonates are substantially limited or impaired in
the actual physical act of eating, which is a major life activity.
Taking into account information on the March of Dimes’ website (See
https://www.marchofdimes.org/find-support/topics/neonatal-intensive-care-unit-nicu/common-
conditions-treated-nicu (last visited 7/29/2025), specifically a webpage titled “Common
conditions treated in the NICU,” NY N351167 noted the common feeding problems for babies
in the NICU, and the use of tube feeding or IV nutrition. Furthermore, referencing another
2
website, NY N351167 noted that “[e]nteral tube feeding is commonly used in preterm infants to
provide enteral nutrition…. Among methods of nutrition support for preterm infants, enteral tube
feeding via a nasogastric or orogastric tube is commonly used in clinical settings.” See
https://www.sciencedirect.com/science/article/abs/pii/S0020748922000177 (last visited
7/29/2025).
On March 25, 2026, a meeting was held with representatives from Avanos at our
headquarters office to discuss whether the feeding devices were for individuals with acute or
transient disabilities. Avanos contends that “feeding impairments that initially required use of
NeoMed enteral feeding devices often persist into childhood and adulthood,” and that “feeding
impairments beginning at birth and prompting use of NeoMed enteral feeding devices in the
NICU continue beyond the hospital into the post-discharge period, even where NeoMed is used
as part of a broader continuum of feeding interventions rather than as the only strategy
throughout.” Avanos provided the following statistics and information to support their claim:
Children born preterm or with low birth weight are at increased risk for feeding
difficulties: studies have shown that 40–45% of premature babies experience
feeding problems during the first two years of their lives (Gardner & Hagedorn,
1991). Although many infants are able to achieve satisfactory oral feeding by
NICU discharge, Koca (2022) reports that problems with feeding for a notable
portion of these children may continue at school age. Furthermore, rates of
feeding impairment in childhood are also high, with 25% to 40% of typically
developing children (who had been premature babies) and 70% to 80% of
children with developmental delays or chronic medical needs having feeding
problems (Kleinert 2017; Lefton-Greif 2007). Further, these impairments
associated with prematurity can persist into adulthood (Lindström 2007). Each of
these individuals likely relied on the NeoMed enteral feeding system at some
point during their feeding journey.
For infants and young children who do not improve, evaluation for G-tube
placement may occur. As discussed during our meeting, studies show that
gastrostomies often occur when a child is one or two years old. In that sense, the
population that ultimately requires G-tube support necessarily includes a
preceding phase in which NeoMed-type nasogastric feeding support is required, at
a minimum, to bridge the infant to that next stage of care; however, even for
children that do not require a G-tube placement, other oral feeding supports may
still be required to overcome lingering feeding impairments.
These arguments are discussed below.
As NY N351167 provided, 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.” In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (CIT 2017), aff’d, 899 F.3d
1308 (Fed. Cir. 2018), the U.S. Court of International Trade (“CIT”) explained that:
3
The term “specially” is synonymous with “particularly,” which is defined as “to
an extent greater than in other cases or towards others.” Webster’s Third New
International Dictionary 1647, 2186 (unabr. 2002). The dictionary definition for
“designed” is something that is “done, performed, or made with purpose and
intent often despite an appearance of being accidental, spontaneous, or natural.”
Webster’s Third New International Dictionary 612 (unabr. 2002).
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. Based on the language of U.S. Note 4(a), a person suffering from a
permanent or chronic eating impairment is physically handicapped.
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.
Here, the issue is whether the feeding devices are articles for “permanent or chronic”
feeding impairments which are eligible for duty-free treatment under subheading 9817.00.96,
HTSUS, under U.S. Note 4(a), or whether they are articles for an “acute or transient disability”,
and are therefore, excluded under U.S. Note 4(b)(i).
Avanos cites to NY N012277, dated June 27, 2007; NY N351166, dated July 30, 2025;
and Headquarters Ruling Letter (“HQ”) H304676, dated March 26, 2020, as examples of
instances in which feeding tubes and articles designed to be used with feeding tubes were
considered articles for the use of those with chronic or permanent disabilities. NY N102277
addressed a backpack designed for use by those requiring continuous tube feedings. It was
designed to hold an enteral feeding pump, food supply, battery, and tubing. CBP determined that
because the backpack would not be used by someone who was not bedridden, it was relatively
unlikely that it would be used by someone who has an acute or transient disability. In HQ
H304676, CBP determined that clothing designed to be compatible with feeding tubes was not
for a transient or acute disability because of the significant adaptations contained in the clothing,
and that it was highly unlikely that an individual with a transient or acute disability would invest
in these garments. NY N351166 addressed another line of feeding devices produced by Avanos,
the MIC-KEY G Low-Profile Gastronomy (G) Feeding Tube, “for use in patients who require
long-term feeding, are unable to tolerate oral feeding, and require gastric decompression and/or
medication delivery into the stomach.” (Emphasis added.) CBP noted the claim “that the above
feeding tubes and extension set are used primarily for individuals with long-term or permanent
impairments that substantially limit their ability to eat, such as those suffering from neurologic
disorders, prolonged gastrointestinal dysfunctions, and congenital or genetic disorders,” and took
4
note of the specific surgical procedures for placement which would normally not occur in
individuals without significant gastrointestinal impairment.
CBP has also considered and found other articles to be for use by individuals with
permanent or chronic physical impairments. For example, in HQ 556532, dated June 18, 1992,
CBP held that canes were predominately used by permanently or chronically handicapped
individuals, even though individuals with acute disabilities such as sprained ankles could use
them. On the other hand, CBP stated that crutches were predominately used by individuals with
acute or transient disabilities, even though they may be used by individuals with chronic or
permanent disabilities. In HQ H331366, dated March 24, 2025, CBP distinguished between
external defibrillators, used to evaluate and treat an acute or transient disability such as an acute
cardiac event, and articles such as pacemakers/internal defibrillators, designed for chronic
cardiac issues. HQ H331366 stated, “[s]omeone suffering from an irregular heart rhythm or
cardiac event requiring the use of an external defibrillator may go on and live a normal life
thereafter.”
Therefore, CBP must determine whether these feeding devices are used predominately by
individuals with acute or transient disabilities or by individuals with chronic or permanent
disabilities. Oxford Dictionary defines “predominately” as “mostly, mainly.” 1 In order for the
feeding devices not to be for acute or transient disabilities, they must be mostly or mainly used
for chronic or permanent disabilities.
The evidence provided by Avanos shows the probability that infants initially requiring
use of feeding devices will develop permanent or chronic disabilities. However, as with the
defibrillators in HQ H331366, the evidence shows that the feeding devices are designed to deal
with serious, acute feeding difficulties that may or may not become permanent disabilities. Even
though internal defibrillators are “the main treatment for anyone who has survived cardiac
arrest[,]” CBP recognized that the temporary nature of external defibrillation rendered it
ineligible for duty-free treatment under subheading 9817.00.96, HTSUS. 2
The relationship between the NeoMed feeding devices and the MIC-KEY feeding
devices is analogous to the relationship between external and internal defibrillators. Although
both devices perform the same function, one is designed for temporary intervention and the other
is designed for the ongoing management of what has become a chronic disability. Just as
external defibrillators may be used for cardiac arrest that does not result in long term cardiac
disability, the NeoMed feeding devices may be used in cases in which a premature newborn
requires initial feeding assistance but will go on to be discharged from the NICU with the ability
to feed normally.
Although some infants who use the feeding devices will develop chronic feeding issues,
the statistics provided by Avanos do not indicate that a majority of newborns requiring tube
feeding will have severe, chronic feeding disabilities after their stay in the NICU. Avanos states
that 40-45% of premature babies experience feeding problems during the first two years of their
lives, and that 25-40% may continue to have feeding problems in childhood. This is less than a
1
https://www.oxfordlearnersdictionaries.com/us/definition/english/predominately.
2
https://www.mayoclinic.org/tests-procedures/implantable-cardioverter-defibrillators/about/pac-20384692.
5
majority, and there is no indication that these feeding problems are chronic or permanent.
Further, Avanos states that 70-80% of children with developmental delays or chronic medical
needs have feeding problems and that they likely all relied on the NeoMed enteral feeding
system in the NICU. This statistic shows the percentage of children with chronic medical needs
that had feeding problems in infancy instead of showing the percentage of children who had
feeding problems in infancy that then later had chronic medical needs. It does not indicate that
these feeding devices are predominately the first treatment for chronic feeding issues rather than
a short-term intervention for infants who will not require further intubation. Therefore, we find
that these Feeding Devices are not for the use of individuals with chronic or permanent feeding
impairments.
Each of the articles considered in NY N012277, NY N351166, and HQ H304676,
enabled tube-feeding needed in long-term, daily life. In this case, the feeding devices are used
temporarily for newborns in a NICU environment who will then either develop feeding abilities
or require long-term feeding devices. Even Avanos’s website makes a distinction between
neonatal systems (“babies who need enteral feeding short term to grow and thrive”), short-term
feeding systems, and long-term feedings systems such as those addressed in HQ H304676
(“Children & Adults with chronic illnesses/conditions who need enteral feeding for 3-5 years of
life”). 3 (emphasis added.)
For these reasons, the Feeding Devices are not eligible for duty-free treatment under
subheading 9817.00.96, HTSUS. Accordingly, NY N351167 is hereby affirmed on this issue.
Sincerely,
Yuliya A. Gulis, Director
Commercial and Trade Facilitation Division
3
https://avanos.com/our-brands/specialty-nutrition-systems/#LTF.
6