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US: FDA updates "Red List" of banned laser importers and products
The U.S. Food and Drug Administration has issued an update to its Import Alert document, also known as the “Red List”. This is a list of importers whose products do not comply with U.S. laser performance standards and/or FDA reporting requirements. Reasons for detaining a product include:
Products which can be Detained Without Physical Examination (DWPE) include laser pointers, laser gunsights, laser pens, laser light show projectors, laser special effects, laser levels, toy guns with lasers, laser pointer key chains, and similar products.
It is unclear what effect the FDA’s import restrictions have on supplies. For example, the well-known company Wicked Lasers is listed multiple times as being banned from importing “All laser products and all products containing lasers.” However, a company representative on December 22 said that Wicked does ship to the U.S. and there should be “no issues getting a laser into the U.S.”
Violating companies are listed as follows.
From the December 20 2011 update to the FDA Red List
- The laser product does not have a permanently attached warning logotype label;
- The laser product output exceeds 5 milliwatts;
- The laser product fails to contain certification or identification information either on the product or in the instructions for use;
- The laser product fails to contain instructions for safe use;
- 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
- A product report for the laser product has not been submitted.
Products which can be Detained Without Physical Examination (DWPE) include laser pointers, laser gunsights, laser pens, laser light show projectors, laser special effects, laser levels, toy guns with lasers, laser pointer key chains, and similar products.
It is unclear what effect the FDA’s import restrictions have on supplies. For example, the well-known company Wicked Lasers is listed multiple times as being banned from importing “All laser products and all products containing lasers.” However, a company representative on December 22 said that Wicked does ship to the U.S. and there should be “no issues getting a laser into the U.S.”
Violating companies are listed as follows.
- Canada: 2 companies shipping from a total of 3 addresses
- China: 51 companies shipping from a total of 57 addresses
- Hong Kong: 9 companies shipping from a total of 9 addresses
- Japan: 1 company shipping from a total of 2 addresses
- Taiwan: 25 companies shipping from a total of 28 addresses
- United Kingdom: 1 company shipping from 1 address
From the December 20 2011 update to the FDA Red List