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I debated as to whether or not to post, as I do not wish to promote any form of fear mongering, where ultimately my decision to post is merely based on my intent to be informative. That being said, the issuing of this FDA Import Alert may or may not be an attempt to achieve an elevated level of enforcement; however, please note this is an update to an earlier FDA alert originally issued Dec 1997, and revised again on 7/30/2010
12/14/2011
Import Alert 95-04
(The following quote is in a condensed version)
Quote:
Import Alert # 95-04
Published Date: 12/14/2011
Import Alert Name:
"Detention Without Physical Examination Of Laser Pointers, Laser Gunsights, Laser Levels, Laser Light Shows, Laser Pointer Key Chains, & Similar Products That Fail To Comply With Applicable Performance Standards And Reporting Requirements."
Reason for Alert: FDA continues to encounter violations with foreign manufactured laser products. ***
Guidance: *** Districts may detain without physical examination (DWPE) all shipments of the same product as was originally found violative such as laser pointers, laser gunsights, laser levels, laser pointer key chains, laser light show projectors, and similar products (covered laser products) from the manufacturers/shippers listed on the attachment to this alert.
In addition, covered laser products are subject to detention if, among other reasons, an examination shows they do not appear to comply with the appropriate standard as follows:
(1) The laser product does not have a permanently attached warning logotype label;
(2) The laser product output exceeds 5 milliwatts;
(3) The laser product fails to contain certification or identification information either on the product or in the instructions for use;
(4) The laser product fails to contain instructions for safe use;
(5) The product class or output information on the laser product's warning logotype label is different from that in the instructions for use; and/or
(6) A product report for the laser product has not been submitted. ***
The companies to which this alert is addressed are listed within the section titled
Quote:
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
The two most familiar are Bob Lasers, and Wicked Lasers (most shocking, not)
Note the additional FDA Consumer Safety Alert below (Last Updated: 03/02/2010):
Consumer Safety Alert: Internet Sales of Laser Products
And this Consumer Hazards Notice (Last Updated 12/08/2011)
Illuminating the Hazards of Powerful Laser Products
Quote:
FDA is working to discourage online sales of illegal lasers and online video demonstrations that describe how to modify a laser pointer to make it more powerful.
________________________________________
12/14/2011
Import Alert 95-04
(The following quote is in a condensed version)
Quote:
Import Alert # 95-04
Published Date: 12/14/2011
Import Alert Name:
"Detention Without Physical Examination Of Laser Pointers, Laser Gunsights, Laser Levels, Laser Light Shows, Laser Pointer Key Chains, & Similar Products That Fail To Comply With Applicable Performance Standards And Reporting Requirements."
Reason for Alert: FDA continues to encounter violations with foreign manufactured laser products. ***
Guidance: *** Districts may detain without physical examination (DWPE) all shipments of the same product as was originally found violative such as laser pointers, laser gunsights, laser levels, laser pointer key chains, laser light show projectors, and similar products (covered laser products) from the manufacturers/shippers listed on the attachment to this alert.
In addition, covered laser products are subject to detention if, among other reasons, an examination shows they do not appear to comply with the appropriate standard as follows:
(1) The laser product does not have a permanently attached warning logotype label;
(2) The laser product output exceeds 5 milliwatts;
(3) The laser product fails to contain certification or identification information either on the product or in the instructions for use;
(4) The laser product fails to contain instructions for safe use;
(5) The product class or output information on the laser product's warning logotype label is different from that in the instructions for use; and/or
(6) A product report for the laser product has not been submitted. ***
The companies to which this alert is addressed are listed within the section titled
Quote:
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
The two most familiar are Bob Lasers, and Wicked Lasers (most shocking, not)
Note the additional FDA Consumer Safety Alert below (Last Updated: 03/02/2010):
Consumer Safety Alert: Internet Sales of Laser Products
And this Consumer Hazards Notice (Last Updated 12/08/2011)
Illuminating the Hazards of Powerful Laser Products
Quote:
FDA is working to discourage online sales of illegal lasers and online video demonstrations that describe how to modify a laser pointer to make it more powerful.
________________________________________
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