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HQ 089244

May 13, 1991

CLA-2 CO:R:C:F 089244 JGH


TARIFF NO.: 3001.90.000

Lee R. Beck, Ph.D.
Stolle Research & Development Corporation 6990 Cornell Road
Cincinnati, Ohio 45242

RE: Classification of Immune Milk from New Zealand in the Harmonized Tariff Schedule of the United States (HTSUS)

Dear Dr. Beck:

This is in regard to your letter of April 18, 1991, which provided technical information on the nature of immune milk, the subject of our letter to your firm of March 25, 1991 (223053).

The product is referred to as a medical product, produced in New Zealand, and based on skim milk. You state that you desire to import it for use in controlled medical studies.

Since no evidence was provided on the nature of the product in your original classification request, it was assumed that the product was merely a form of skim milk, classifiable as milk and subject to the appropriate quota. However, the data now submitted supports the claim that, while the product has a milk base, it is a biologic and not a food.


The product is made by giving cows a series of intramammary infusions of polyvalent antigens comprising phenol killed bacteria pathogens. Following immunization, blood samples of the cows are taken until the serum antibody titer reaches its highest level, then the milk is collected. The milk is then dried and powdered, a bovine milk immunoglobulin having been produced. Immune milk has been recommended for such diseases as rheumatoid arthritis, gastroenteritis, urinary tract and sinus infections, certain type of allergies, and chronic neurologic conditions (i.e. multiple sclerosis).

In 1980, the Food and Drug Administration issued a Compliance Policy Guide on immune milk (7134.04), in which it was stated that the product was regarded as a biologic drug and subject to the licensing provisions of the Public Health Service Act.


Classification of immune milk under the HTSUS.


Immune milk comprises a natural food product which has been developed to possess anti-inflamatory properties. It is deemed a significant advance in the art of anti-inflammatory pharmacology because it has no adverse side effects. It is based on the discovery that when a cow is brought to a specific state of immunization by means of periodic booster administrations of an antigen or mixture of antigens, it will produce milk which has the highly beneficial property of decreasing inflammatory conditions. The effect is caused by the presence of a factor in the milk, the "anti-inflammatory" factor.

The immune theory in treating bacterial infection is felt to be very specific. Bactericidal antibodies produced against a specific strain of bacteria react only with that strain and have no harmful effects on other types of bacteria. Moreover, antibodies, unlike antibiotics, are natural body products and have no known side effects. This method provides a system for controlling the growth and proliferation of harmful bacterial pathogens; the theory involves the passive immunization by oral ingestion of protective antibodies produced by the cow. A temporary immune protection is provided which is highly specific for those species of bacteria used to produce the antibodies and does no harm to the normal beneficial bacteria that reside in the gut.

Cow's milk provides the preferred source of the antibody product. In general, the levels of immunoglobulins normally present in cow's milk is very low. This method is very specific in that it defines a unique population of antibodies in milk (e.g., IgG type) that react with a known spectrum of bacteria and this reaction results in the beneficial effect, which is treatment and prevention of such diseases as rheumatoid arthritis.

The difference between antibacterial milk and normal cow's milk is to be found in the specificity of antibodies comprising the antibacterial milk. By the specificity of the immunoglobulin is meant the spectrum of bacterial species that the antibodies react with. Antibacterial milk contains no drug additives or any other components which are not natural food products of the cow. One type of immune milk is useful in the control of auto-immune diseases, e.g. lupus erythematosus, which is caused or aggravated by bacterial infections in the gastrointestinal tract.

It is emphasized that the product does not treat the disease, but rather the symptoms of the disease. So that the immune milk is said to be appropriate for use in any disease or injury which exhibits inflamation as a system.

Examples of human disease conditions which may be treated with anti-inflammatory milk include: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tendonitis, acute gouty arthritis, systemic lupus erythematosus, systemic dermatomyositis, acute rheumatic carditis, pemphigus, bullous dermatitis, hepetiformis, severe erythema, multiform exfoliative dermatitis and cirrhosis, seasonal perennial rhinitis, bronchial asthma, contact dermatitis, etopic dermatitis, serum sickness, allergic conjunctivitis, keratitis, herpes zoster, opthalmicus iritis, diffuse uvetis, and choriditus, optic neuritis, and sympathetic opthalmia, symptomatic coidosis, Loeffler's Syndrome, and berylliosis, hemolytic anemia. Also there is believed to be palliative management of neoplastic diseases including: leukemia, lymphomas, tuberculosis, and meningitis.

In the Explanatory Notes to Chapter 4, HTSUS, regarding the definition of milk it is said that it might contain, in addition to natural milk constituents (e.g., milk enriched in vitamins and mineral salts), small quantities of stabilizing agents which serve to maintain the natural consistency of the product during transport, and small quanities of chemicals necessary for processing; and in the dry form, anticaking agents. However, the Notes also emphasize that a milk product that is considered a medicament would not be included.

Chapter 30, HTSUS, covers pharmaceutical products, and the chapter notes specifically state that it does not include food products. Included in heading 3001, HTSUS, are extracts of glands or other organs or of their secretions for organo- therapeutic uses, obtained by solvent extraction, precipitation, coagulation or any other process.

On the basis of the technical evidence submitted, it is concluded that immune milk as described is not a food product, but rather from the processes it undergoes, it has been transformed into a pharmaceutical product used in the treatment of various diseases. Accordingly, if not imported in commercial quantities suitable for sale to the public, but in an amount appropriate for medical research, immune milk, based as it is on a natural secretion, would be classifiable (if not packaged in dosage form) under the provision for other human or animal substances prepared for therapeutic or prophylatic uses, not elsewhere specified or included, in subheading 3001.90.000, HTSUS.


Immune milk, manufactured in the manner described, to be used in clinical research for treatment of various diseases, and not marketed as a food product, is classifiable in subheading 3001.90.000, HTSUS. It is free of duty.


John Durant, Director

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