HQ 089244: Classification of Immune Milk from New Zealand in the Harmonized Tariff Schedule of the United States (HTSUS)

Native CBP ruling rendition. Applicability is fact-specific; modification/revocation relationships and original publisher date are retained. Publisher sentinel year0001 means unknown date, not a historical legal adoption.

                              HQ 089244

                          May 13, 1991


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

CATEGORY: Classification

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.

FACTS:

     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).


                              - 2-

     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.

ISSUE:

     Classification of immune milk under the HTSUS.

LAW AND ANALYSIS:

     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.


                              -3-

     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.

                              - 4 -

     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.


HOLDING:

     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.

                              Sincerely,




                              John Durant, Director
                              Commercial Rulings Division