IA#62-06, REVISED 9/22/92
SUBJECT : Dimethyl Sulfoxide (DMSO)
TYPE OF ALERT: Guidance
PRODUCT : Dimethyl Sulfoxide (DMSO)
PRODUCT CODE : 66V--99
HARMONIZED
CODE : 2953
PROBLEM : New Drug Without an Approved New Drug Application
or Investigational New Drug Application (NDA/IND)
(DNRD)
PAC FOR
COLLECTION : 56008H
COUNTRY : All
MANUFACTURER/
SHIPPER : N/A
MANUFACTURER/
SHIPPER I.D.#: N/A
IMPORTER'S
I.D. # : N/A
CHARGE : "The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears
to be a new drug within the meaning of Section
201(p), without an approved New Drug Application
(NDA) or Investigational New Drug (IND)
Application in effect [Unapproved New Drug,
Section 503(a)]."
RECOMMENDING
OFFICE : Division of Import Operations & Policy (HFC-170)
REASON FOR
ALERT : DMSO is dimethyl sulfoxide, a solvent derived
from wood, which has been the subject of
considerable interest for its potential as a
drug. Testing of DMSO as a drug began in the
early 1960's, but was halted in 1965 after
experiments in animals indicated that it had
adverse effects on the eyes.
Experiments were resumed the following year with
restrictions to assure that patients were
adequately protected. At present, the only human
use for which DMSO has been approved is for
interstitial cystitis, a bladder condition.
Testing of DMSO continues for other purposes,
such as scleroderma, arthritic conditions of
joints, tendinitis, and bursitis. Studies of
DMSO for possible use in mental illness have been
concluded with no evidence that it is effective
for that purpose. No definite conclusions have
yet been drawn about DMSO's usefulness in other
conditions, such a spinal cord injuries and brain
trauma. It has been reported that industrial
grade DMSO, devoid of drug labeling, is being
used for self-treatment of arthritis and other
disease conditions. The industrial grade product
is not of the quality used for drug purposes and
is not made under conditions that are necessary
for the production of human drugs and protection
of users. Side effects associated with its use
include nausea, headache, and skin rash. Further,
since DMSO is a "carrier" chemical, it could
deliver harmful substances into the bloodstream,
if they are present in impure DMSO through use on
the skin. There are no foreign manufactures of
DMSO that hold effective NDA's or IND's.
Review of detention data for FY 90-92, indicated
3 detentions were made in FY 90. Of the 3, 2
were commercial size shipments from Showa
Industry, Shiga, Japan and chemsiche Fabrik,
Zurich, Switzerland.INSTRUCTIONS : Alert local
Customs of our interest in this product. If it
appears that the product is consigned to firms
other than those which might be distributors for
a legitimate use, the product should be detained.
Any questions should be directed to the Center
for Drug Evaluation and Research, Health Fraud
Staff (HFD-304) at (301) 295-8070.
PRIORITIZATION
GUIDANCE : N/A
FOI : No purging required.
KEYWORDS : DMSO, Arthritis, Solvent, Tendinitis, Bursitis,
Dimethyl Sulfoxide
PREPARED BY : Linda A. Wisniowski, DIOP, 301-443-6553.
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