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US: FDA proposes defacto ban on selling pointers, handhelds above 5 milliwatts
The U.S. Food and Drug Administration on May 5 2014 will announce its intent to limit laser pointers and handheld lasers to be below 5 milliwatts. If adopted, this action would impose a defacto ban in the U.S. on the sale to consumers of portable, battery powered lasers of 5 mW or more. Currently, such lasers are available for sale in the U.S. at powers of up to 3 watts (3000 milliwatts) which is 600 times the proposed FDA limit.
Although the agency did not give a reason, such bans have been imposed in other countries in response to climbing numbers of laser illuminations of aircraft as well as reports of eye injuries caused by higher-powered consumer lasers.
The proposal would not make it illegal to own or responsibly use portable, battery-powered lasers of 5 mW or more. However, manufacturers could not make or sell these into general commerce in the U.S.
The agency will accept comments for 90 days (until August 2 2014) on the new proposal. FDA will then review the comments. Based on whether it believes any objections or suggestions are valid, the agency could put the guidance into effect (thus imposing their new interpretation), could submit a revised proposal, or could withdraw its proposal.
FDA does not have direct authority over battery powered portable lasers. For example, the words “pointer” and “handheld” laser do not appear in U.S. laser regulations 21 CFR 1040.10 and 1040.11.
Therefore, to regulate these lasers, the May 5 draft proposes an extension of the FDA’s existing authority to regulate surveying, leveling and alignment (“SLA”) lasers. In the May 5 proposal, FDA asserts that the existing definition of SLA lasers also can applied to lasers with the following design characteristics:
According to the FDA, these types of lasers would be affected by the new 5 mW limit:
The FDA's proposed 5 mW limit would NOT apply to lasers with the following design characteristics:
From the FDA’s Surveying, Leveling, or Alignment Laser Products - Draft Guidance for Industry and Food and Drug Administration Staff webpage, published online May 2 2014. This webpage includes the procedure for submitting comments to FDA.The FDA’s PDF version of the draft guidance document is here.
Editorial comment from LaserPointerSafety.com: We have previously published our opinion disagreeing with the FDA’s interpretation of “SLA” lasers. The existing regulations are clear on what constitutes “surveying, leveling or alignment” (SLA) lasers. While we understand the FDA’s intent, in our view, they are going about it the wrong way. They are essentially “making it up” by adding characteristics (size, battery power) which are in no way derived from the clear, existing definition of SLA lasers. As support of this position, we have not found any surveying, leveling or alignment lasers which look the same as the majority of laser pointers and handhelds. This topic is discussed in much greater detail on our page describing FDA authority over laser pointers and handheld lasers.
Although the agency did not give a reason, such bans have been imposed in other countries in response to climbing numbers of laser illuminations of aircraft as well as reports of eye injuries caused by higher-powered consumer lasers.
The proposal would not make it illegal to own or responsibly use portable, battery-powered lasers of 5 mW or more. However, manufacturers could not make or sell these into general commerce in the U.S.
The agency will accept comments for 90 days (until August 2 2014) on the new proposal. FDA will then review the comments. Based on whether it believes any objections or suggestions are valid, the agency could put the guidance into effect (thus imposing their new interpretation), could submit a revised proposal, or could withdraw its proposal.
What lasers are covered by the proposed 5 mW limit?
FDA does not have direct authority over battery powered portable lasers. For example, the words “pointer” and “handheld” laser do not appear in U.S. laser regulations 21 CFR 1040.10 and 1040.11.
Therefore, to regulate these lasers, the May 5 draft proposes an extension of the FDA’s existing authority to regulate surveying, leveling and alignment (“SLA”) lasers. In the May 5 proposal, FDA asserts that the existing definition of SLA lasers also can applied to lasers with the following design characteristics:
- Compact size (i.e. small, lightweight)
- Battery power
- Ergonomic design to permit hand-held use
- An aperture in the laser product's protective housing to transmit laser emission into open space
- Portability to permit use in open spaces or in unrestricted environments
- Features that utilize the laser’s straight line emission for surveying, leveling, or alignment
According to the FDA, these types of lasers would be affected by the new 5 mW limit:
- Laser pointers
- Levels
- Tools incorporating laser guides
- Gun sights
- Target designators
- Night vision illuminators
- Visual disruptors
What lasers are NOT covered by the proposed 5 mW limit?
The FDA's proposed 5 mW limit would NOT apply to lasers with the following design characteristics:
- Predictable, stable power input and output
- High quality power supply and/or power conditioning components
- Adjustability of power and wavelength
- Design that facilitates remote actuation
- Non-portability
- Hard wire connection to power mains
From the FDA’s Surveying, Leveling, or Alignment Laser Products - Draft Guidance for Industry and Food and Drug Administration Staff webpage, published online May 2 2014. This webpage includes the procedure for submitting comments to FDA.The FDA’s PDF version of the draft guidance document is here.
Editorial comment from LaserPointerSafety.com: We have previously published our opinion disagreeing with the FDA’s interpretation of “SLA” lasers. The existing regulations are clear on what constitutes “surveying, leveling or alignment” (SLA) lasers. While we understand the FDA’s intent, in our view, they are going about it the wrong way. They are essentially “making it up” by adding characteristics (size, battery power) which are in no way derived from the clear, existing definition of SLA lasers. As support of this position, we have not found any surveying, leveling or alignment lasers which look the same as the majority of laser pointers and handhelds. This topic is discussed in much greater detail on our page describing FDA authority over laser pointers and handheld lasers.