Download & Memorandum .APR291998

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Date
From
DEPARTMENT
OF HEALTH & HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
Public Health Service
Memorandum
.APR291998
Senior Regulatory Scientist, Regulatory Br~ch, ~s$po~l&o~ams&P.PforcementpolicY
(DPEP), Office of Special Nutritional, HF~-~~
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Subject
75-day Premarket Notification
To
Dockets Management Branch, HFA-305
New Dietary Ingredient:
Firm:
Date Received by FDA:
90-day Date:
~.,
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for New Dietary Ingredient
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Seaprose-s (semi-alkaline protease from Aspergillus
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melleus
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o
General Nutrition Corporation
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April 28, 1998
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.,
July 11, 1998
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In accordance with the requirements of section 413(a)(2) of the Federal Food, Drug, and
Cosmetic Act, the attached 75-day premarket notification for the aforementioned new dietary
ingredient should be placed on public display in docket number95S-0316
after June 28, 1998.
mRobert J. Moore, Ph.D.
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DEPARTMENT
OF HEALTH&
HUMAN
SERVICES
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Public Health Service
Food and Drug Administration
Washington, DC 20204
APR 291998
John P. Troup, Ph.D.
Vice President, Scientific Affairs
General Nutrition Corporation
300 Sixth Avenue
Pittsburgh, Pennsylvania 15222
Dear Dr. Troup:
This is to noti~ you that your submission pursuant to section 4 13(a)(2) of the Federal Food,
Drug, and Cosmetic Act (the Act) dated April 20, 1998, concerning the marketing of a
substance that you assert is a new dietary ingredient (i.e., seaprose-S) was received by the
Food and Drug Administration (FDA) on April 28, 1998. Your submission will be kept
confidential for 90 days from the date of receipt, and after July 11, 1998, your submission
will be placed on public display at Dockets Management Branch (Docket No. 95S-03 16).
Commercial and confidential information in the notification will not be made available to the
public.
Please contact us if you have questions concerning this matter.
Sincerely,
m----j.
Robert J. Moore, Ph.D.
Senior Regulatory Scientist
Division of Programs and Enforcement Policy
Office of Special Nutritional
.
John P. Troup, Ph.D.
Vice President,
%ien[ific Affairs
m
o
qzl%
A@ 20, 1998
Office of Special
Center
Nutritional
for Food Safety
and Applied
Nutrition
Food and Drug Administration
200 C Street
(HFS-450)
Washington,
DC 20204
Pursuant
1994,
to Section
General
Nutrition
PA 15222 wishes
(2) copies
Seap;ose-S
originated
dietary
mg of Seaprose-S
(’(GNC”)
located
from
(Semi-Alkall;e
Aspergillus
Health
at 300
Sixth
and
Education
Avenue,
Act
of
Pittsburgh,
that GNC will market
a new
Proteinase)
a homogeneous
crystalline
.A,cctxdingly,
enclu~ed
please find two
Melleus,
supplement
which
contains
in a tablet
or capsule
which
Seaprose-S,
will consist of fifteen (15)
will be suggested
to be taken two (2)
per day.
Attached
please
that this dietary
the dietary
find the scientific
ingredient,
supplement,
when
Development
(2)
Toxicity
studies
chronic,
toxicology
(3)
Product
stability
(4)
Physiological
P. Troup,
used
is reasonably
(1)
Very truly yours,
John
Supplement
of this notification.
The
times
Corporation
Dietary
to notify the Food and Drug Administration
dietary ingredient,
proteinase
8 of the
studies
under
expected
and manufacturing
(including
and other
the conditions
to be safe.
which
establish
in the labeling
This information
of
includes:
chemistry
absorption
and antigenicity
information
suggested
and excretion,
acute,
subacute,
studies)
data
studies
/“
Ph. D.”
5-5?7/3
Enclosures
General Nutrition Ckporation, 300 Sixth Avenue, Pittsburgh, PA 15222
Tel: (412) 338-8844 Fax: (412) 338-8954
-,
.
SECTION
Development
1- Seaprose-S
and Manufacturing
Chemistry
Backclround
Proteinases,
such as
or semi-alkaline
been
proteinase,
observed
activities
a-chymotrypsin
to exert
serrapeptase
clinically
difficulty
and
expectoration
with respiratory
optimum
Semi-alkaline
of
congestion
and
and so on. Proteinases
of its effectiveness
in “difficulty
as well as “remission
proteinase
of about 30,000.
(SAP) was confirmed
in an experimental
on “remission
of traumatic
1967.
approved
swelling”
used for “improvement
in
of swelling”.
originated
from
It is stable within a range
pH being 8.0 and active center being serine,
proteinase
These
weight
have
and expectoration
mammalian
semi-alkaline
from plants,
microorganisms,
diseases”,
diseases”
crystalline
rne/leus with a molecular
of pH 5.0-9.0,
from
sinusitis,
confirmed
bromelain
anti-swelling
with respiratory
was
is a homogeneous
Aspergi//us
activities
effect
associated
Seaprose-S
swelling,
associated
anti-inflammatory
and pronase
and have been widely
post-traumatic
in expectoration
from animals,
anti-inflammatory,
by an oral administration,
post-operative
having
originated
inflammatory
swelling
swelling
“remission
and anti-swelling
and its clinical effect by an oral route
and inflammation”,
indication,
was published
of its anti-inflammatory
and was approved
of post-operative
as a result of drug re-evaluation
and
(No.11)
in August
post-traumatic
in May 1977 and the
efficacy was confirmed.
h vitro and in vivo studies confirmed
reducing
viscosity,
increasing
expectoration
of its usefulness
through
the
blind
was approved
- bronchitis,
bronchiolitis
indication
with restriction
and
Moreover,
operative
and post-traumatic
confirmed
on March 9, 1995.
..—.
.
.
.
.
.-—.
—.—
bronchial
----
asthma”.
to be re-evaluated
diseases
(SAP should
on February
swelling”
result,
to “difficulty
also
diseases”
an application
in expectoration
bronchiectasia,
On August
1, 1988,
and confirmed
be applied
appointed
and
was confirmed
1978, and in January
for
1980
in the
pulmonary
the
above
on March 9, 1995,
to severe
1, 1990, the indication
was
sputum
with respiratory
on this
tuberculosis,
of
of Seaprose-S
was filed in December
with respect
of Iysing sputum,
elasticity
associated
Based
pulmonary
was appointed
of applicable
above diseases.).
...”..-
study.
indication
disease
oral serving
in expectoration
clinical
has activities
viscosity/dynamic
Moreover,
indications
emphysema,
,,
volume.
of approved
an additional
additional
dynamic
in “difficulty
double
modification
following
reducing
that Seaprose-S
cases of the
of “remission
of post-
to be re-evaluated
and
Analvsis
Seaprose-S
is a semi-alkaline
a proteol~lc
activity. When
proteinase
assayed,
has been listed as a semi-alkaline
of Pharmaceutical
of Searxose-S
originated
it contains
proteinase
from Aspergillus
1900-2500
in Monograph
of the Japanese
Ingredients.
Identification
See the attached
Loss on dry inq
Residue
Assay
on icmition
and has
units per mg. Seaprose-S
Description
w
melleus,
JSPI 1991.
Standards