Import Alert 66-37
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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 # 66-37
Published Date: 12/10/2012
Type: DWPE with Surveillance
Import Alert Name:
"Oxygen Units"
Reason for Alert:
The Food and Drug Administration generally regards oxygen to be a prescription drug. Nevertheless, FDA recognizes that there are many circumstances under which it would be impractical to insist that oxygen be administered only under the supervision of a physician.
Oxygen units may be marketed without a prescription when used for emergency resuscitation and when administered by an individual who is authorized, certified, or licensed by state authorities. Such units must deliver a minimum flow rate of 6 liters of oxygen per minute for a minimum of 15 minutes (90 liters). Labeling for emergency oxygen for OTC use may not contain references to any medical conditions, disorders, or diseases.
Recently, small over the counter oxygen units imported from Japan have appeared on the market. Many of these over the counter units are not suitable for any medical or emergency use and are being promoted for "recreational" use. Most of these units are incapable of supplying an oxygen flow rate of at least 6 liters of Oxygen U.S.P.per minute for at least 15 minutes. These products are regarded as new drugs without approved New Drug Applications.
*** The Center for Drug Evaluation and Research (CDER) was recently made aware of a Japanese manufacturer of sports oxygen units which appear to meet the guidance provided by this alert.
The unit is manufactured by Nippon Tansan Gas Co.Ltd., 32 26, Aoi 3 Chome, Adachi Ku, Tokyo, Japan FEI# 1000251392.***
Oxygen units may be marketed without a prescription when used for emergency resuscitation and when administered by an individual who is authorized, certified, or licensed by state authorities. Such units must deliver a minimum flow rate of 6 liters of oxygen per minute for a minimum of 15 minutes (90 liters). Labeling for emergency oxygen for OTC use may not contain references to any medical conditions, disorders, or diseases.
Recently, small over the counter oxygen units imported from Japan have appeared on the market. Many of these over the counter units are not suitable for any medical or emergency use and are being promoted for "recreational" use. Most of these units are incapable of supplying an oxygen flow rate of at least 6 liters of Oxygen U.S.P.per minute for at least 15 minutes. These products are regarded as new drugs without approved New Drug Applications.
*** The Center for Drug Evaluation and Research (CDER) was recently made aware of a Japanese manufacturer of sports oxygen units which appear to meet the guidance provided by this alert.
The unit is manufactured by Nippon Tansan Gas Co.Ltd., 32 26, Aoi 3 Chome, Adachi Ku, Tokyo, Japan FEI# 1000251392.***
Guidance:
Districts should review all importation of oxygen units and where appropriate may detain such units where one or more of the following conditions are observed:
* The labeling fails to bear the statement, "Caution: Federal law prohibits dispensing without prescription."
* The labeling makes claims indicating that the product can be used for the treatment of a medical disease, disorder, or condition.
* The units are incapable of supplying at least six liters of Oxygen USP per minute for at least 15 minutes.
Districts should contact CDER's Import**s***Export***s*** Branch ***at cderimportsexports@fda.hhs.gov*** if there are additional ***questions***
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science 301-796-6600.
* The labeling fails to bear the statement, "Caution: Federal law prohibits dispensing without prescription."
* The labeling makes claims indicating that the product can be used for the treatment of a medical disease, disorder, or condition.
* The units are incapable of supplying at least six liters of Oxygen USP per minute for at least 15 minutes.
Districts should contact CDER's Import**s***Export***s*** Branch ***at cderimportsexports@fda.hhs.gov*** if there are additional ***questions***
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science 301-796-6600.
Product Description:
Oxygen Units, especially pocket sized containers, small recreational units, etc.
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 pursuant to Section 505(a) and/or the labeling fails to bear the statement:
Caution: Federal law prohibits dispensing without prescription in accordance with Section 503(b)(4)."
OASIS Charge Code - UNAPPROVED
Caution: Federal law prohibits dispensing without prescription in accordance with Section 503(b)(4)."
OASIS Charge Code - UNAPPROVED
Countries
MULTIPLE COUNTRIES (PODS ONLY)
(64 J - - 01) Oxygen (Medicinal Gas)
JAPAN
Nippon Tansan Gas Co., Ltd.
Date Published : 09/10/2009
32-26, Aoi 3-Chome, Adachi-Ku , Tokyo, JAPAN
64 J - - 01 Oxygen (Medicinal Gas)
Date Published: 09/10/2009
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