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US: FDA now recommending aircraft/vehicle caution label

The U.S. Food and Drug Administration is now asking manufacturers of laser pointers and handheld lasers to voluntarily add a Caution label. The following wording is being added to letters sent by FDA’s Center for Devices and Radiological Health (CDRH) in response to a laser pointer/handheld product submission (such as a product report, supplemental report, or annual report):

“CDRH recommends (but does not require) labeling on your product that cautions the purchaser with following or similar language: “CAUTION - LASER LIGHT IS BRIGHT AND BLINDING - DO NOT SHINE AT AIRCRAFT OR VEHICLES AT ANY DISTANCE”.

While FDA can require the familiar labels warning against laser eye and skin hazards, FDA does not have statutory authority to require labels for non-health hazards such as laser distraction or temporary flash blinding. Thus, the agency is only able to recommend -- but not require -- the new aircraft/vehicle caution label.

News of the action came in a December 7 2012 FDA email sent to parties including LaserPointerSafety.com. According to CDRH’s Daniel Hewett, the action applies to all “SLA products.” FDA/CDRH considers that laser pointers and handheld lasers are a subset of such Surveying, Leveling and Alignment laser products. SLA lasers are one of the three laser product uses which FDA can regulate under 21 CFR 1040.10 and 1040.11; the other two are medical and demonstration (education/light show) laser product uses.

From a Dec. 7 2012 FDA email. Thanks to Daniel Hewett for bringing this to our attention.