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HQ 085776

June 28,1991

CLA-2 CO:R:C:F 085776 JGH


TARIFF NO.: 2106.90.60

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).


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
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.


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.


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.

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
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.


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.


John Durant, Director

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