Import Alert 62-06
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 62-06
Published Date: 03/18/2011
Type: DWPE with Surveillance
Import Alert Name:
"Dimethyl Sulfoxide (DMSO)"
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.
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.
Guidance:
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).
Product Description:
Dimethyl Sulfoxide (DMSO)
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 505(a)]."
OASIS charge code - UNAPPROVED
OASIS charge code - UNAPPROVED
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