HQ 085776
June 28,1991
CLA-2 CO:R:C:F 085776 JGH
Robert F. Seely, Esq.
Katten Muchin & Zavis
525 West Monroe Street
Suite 1600
Chicago, Illinois 60606-3693
RE: Classification of Peptamen, a complete, nutritional elemental
diet, made in France.
Dear Mr. Seely:
This is in reference to your submissions, as well as the
meetings, held on the reconsideration of the classification of
Peptamen, described as a liquid, isotonic, complete elemental
diet, one of the three nutritional preparations classified as
food preparations not elsewhere specified or included, in
subheading 2106.90.60, Harmonized Tariff Schedules of the United
States (HTSUS). (Headquarters Ruling Letter 082193, dated
February 2, 1989).
FACTS:
The sample of the product submitted is said to contain 20
grams of protein, 63.5 grams of carbohydrate, 19.5 grams of Fat
in 425 grams of water. It is said to be composed of protein,
vitamins and trace elements in 2,000 calories, and described as
a ready-to-use, isotonic, complete, peptide-based, elemental
diet, "Not For Parenteral Use."
Headquarters Ruling Letter 082193, dated February 2, 1989,
covered three liquid nutritional food products: Nutren, Replete
and Peptamen. This reconsideration considers only Peptamen, a
product largely similar to the other two, with the difference
being that it was described as a complete liquid peptide-based
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elemental diet, the protein content being claimed as the
distinguishing feature. In the ruling it was pointed out that in
the pertinent Explanatory Notes preparations that contain only
nutritional substances were considered foodstuffs, in as much as
the major nutritional substances in food are proteins,
carbohydrates, and fats, along with vitamins and mineral salts,
all of which were liberally represented in these preparations.
Therefore it was concluded that the product was a foodstuff in
subheading 2106.90.60, HTSUS, and not a medicament in heading
3004, HTSUS.
ISSUE:
Whether Peptamen is classifiable in subheading 2106.90.60,
HTSUS, as other food preparations not elsewhere specified or
included, or subheading 3004.50.50, HTSUS, for other medicaments
containing vitamins.
LAW AND ANALYSIS:
In your latest submissions you emphasize that Peptamen is an
elemental formula developed exclusively for the critically ill
patient, who suffers from a reduced ability to digest protein,
carbohydrate, fat, vitamins and minerals. You add that it is
indicated for patients suffering from moribound conditions, such
as cancer or other disease entities which result in a
substantially impaired gastrointestinal function. You point out
that Peptamen is used as the sole source of nutrition, so that it
must provide a complete array of nutrients at a level to promote
healing. It is your contention that it is not designed to
maintain general health, but for the person who has an impaired
GI track.
Essentially, it is your position that if the purpose of the
nutritional product is to treat or prevent one or more diseases,
rather than maintain health or general well being, then the
product is classifiable as a medicament in heading 3003 or 3004;
that Peptamen satisfies this test as it functions both as a
nutritional preparation and as a medicament. You submitted in
support of your claim clinical studies illustrative of the use
of Peptamen with patients with various diseases.
As has been previously pointed out, the Explanatory Notes
make clear that food preparations that contain the major
nutritional substances of proteins, carbohydrates and fats, as
well as vitamins and mineral salts, and do not provide an active
ingredient for treatment of a specific ailment or disease entity
are not considered medicaments for the purposes of heading 3003
or 3004, HTSUS, but rather food preparations in heading 2106,
HTSUS.
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In reviewing the literature you submitted on the treatments
for various diseases, it is instructive to note that a common
theme in all of them is that the better nourished the patient,
the more favorable he will respond to specific treatment. A
point made by the article submitted from the Food Drug Cosmetic
Law Journal (Journal),( Vol.44). An example given was the
geriatric patient who is malnourished, and whose symptoms
diminish with proper nutrition. Also it was pointed out that
high risk cancer patients responded better to surgery if given
proper nutritional support.
It can not be denied that apparently the patient's general
condition is improved on the Peptamen regimen. However, the
impression gained from a review of the technical papers
submitted is that it was essential to improve the overall
condition of the patient before specific treatment for the
disease entity could begin. The Journal remarks on the rapid
recovery of post-operative patients in situations where they are
well nourished as opposed to malnourished. Such a benefit is
highlighted in the advertising literature submitted. For
instance, one brochure emphasizes that Peptamen is nutritional
therapy, providing "full strength nutrition from day one" for
patients suffering from sepis, severe burns, trauma, transition,
even HIV+/AIDS. It is not a specific medical treatment for a
specific disease, but is, as one brochure states a "Superior
nutrition for a wide range of stressed patients." Your latest
submissions relate to: 1) a Stanford University Medical Center
study on the part played by a "Defined Formula Diet" in
counteracting malnutrition in treating children with Crohn's
Disease; and 2) a study involving management of HIV-related
weight loss by supplemental feedings of a formula containing whey
peptides and medium chain triglycerides; a program said to be
efficacious in promoting weight gain.
There is no denying that this type of liquid elemental diet
is intended for a special consumer: one who can not tolerate a
normal diet, but it is nonetheless, a well-round, complete diet
(as the manufacturer describes it). They are intended for the
critically ill patient; to improve his overall condition, so that
specific treatment for the particular disease entity may begin,
as headlined by the one brochure, "Because nutrition is critical
for GI therapy..". In other words, before a specific medical
therapy can begin, it is essential that the patient be as well
nourished as possible. However, with the geriatric patient, it
would appear that his main problem is malnutrion, which a
Peptamen diet may assist in overcoming, and often no other
treatment is necessary. As pointed out in the Journal, "the
similarities between medical foods and infant
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formulas are quite striking;" that "Medical foods serve the same
function for patients beyond infancy as infant formulas serve for
infants. Both are life support systems in that they often
provide the sole source of nourishment for their intended
populations." It adds, however, that one serves a generally
healthy population, while, in contrast, the other is for an
unhealthy population. As you are aware the general infant
formulas for the commercial market are not considered
medicaments. It is also instructive to note that the Journal
comments that while the FDA previously considered "medical foods"
as drugs they now classify them in a food status.
The test remains that preparations of proteins,
carbohydrates, fats and minerals used to maintain or increase
health or well-being, and that have no indication as to use for
the prevention or treatment of a specific disease, are not
classifiable in heading 3003 or 3004.
HOLDING:
Peptamen, a complete nutritional liquid diet for the
critically ill patient is classifiable as an other food
preparation in subheading 2106.90.60, HTSUS.
HQRL 082193 is affirmed.
Sincerely,
John Durant, Director
Commercial Rulings Division
6cc A.D., N.Y. Seaport
2cc CIE
hurley library/peh
085776