For Event_Horizon and others:
FDA's authority over lasers is set forth in 21 CFR 1040.10 and 1040.11. Over the years, FDA has tried to expand its interpretation of these regulations.
The only reason FDA has gotten away with this is that no one has called them on it. As far as I know, no person or company has seriously challenged FDA's expanding definitions; for example, by suing FDA for exceeding its stated authority and thus impeding commerce.
Could such a lawsuit succeed?
My opinion is that the definition of "pointer" is so entrenched it is not worth fighting. (E.g., FDA saying you can't sell a laser 5 mW or more as a "pointer" or for pointing purposes -- that will probably stay.)
But I believe that the FDA is clearly wrong in trying to stop "amusement" lasers and is especially wrong in trying to regulate handhelds as SLA lasers, based on a clear reading of the English language. More details on this are at http://www.laserpointersafety.com/perspectives/sla/sla.html
If my position is correct, then FDA must permit at the federal level the import and sale of any laser that is properly reported to FDA (e.g., a Laser Product Report, and Form 2877 if required), and that has all the correct labeling and safety features required for its Class. (Also, if the laser is 5 mW or more, it cannot be called a "pointer" or be sold for pointing purposes based on long-standing custom.)
Persons on this thread can get all upset about Big Government, and bemoan the fact that "they're coming for our lasers", etc. But until someone challenges FDA in a significant way, such as by legal action, all these complaints in this little tiny corner of the Internet will be meaningless in actually affecting change.
-- Patrick
PS: The above is my personal opinion. I am not speaking for any organization. Also, there are other important issues such as whether laser pointer sales need to be restricted due to excessive misuse. In this post above, I am simply discussing whether FDA is accurately following the definitions and Congressional grant of authority as listed in 1040.10 and 1040.11.
FDA's authority over lasers is set forth in 21 CFR 1040.10 and 1040.11. Over the years, FDA has tried to expand its interpretation of these regulations.
- They first did it in the late 1980s, to define and regulate "pointers" even though the word "pointer" and the concept of using lasers solely to point are not listed in 1040.10 or 1040.11.
- In 2009 they tried to assert authority over handheld lasers promoted for "amusement", even though that word does not appear in 1040.10 or 1040.11, and has a different meaning than "entertainment" which they can regulate.
- Recently they seem to be asserting that any handheld laser falls into the SLA category when for many, many reasons they absolutely do not. For example, lasers used professionally for surveying, leveling and alignment do not look like handheld lasers unless there is also a special holder; without the holder it is not possible to do useful surveying, leveling or alignment. Also, the word "handheld" is not defined anywhere in 1040.10 or 1040.11, so it is not a defining element of being an SLA laser. Finally, just because a laser emits a straight line does not mean it is "defining" a straight line; otherwise, almost ALL lasers would be SLA lasers and this is clearly not the intent of 1040.10 and 1040.11
The only reason FDA has gotten away with this is that no one has called them on it. As far as I know, no person or company has seriously challenged FDA's expanding definitions; for example, by suing FDA for exceeding its stated authority and thus impeding commerce.
Could such a lawsuit succeed?
My opinion is that the definition of "pointer" is so entrenched it is not worth fighting. (E.g., FDA saying you can't sell a laser 5 mW or more as a "pointer" or for pointing purposes -- that will probably stay.)
But I believe that the FDA is clearly wrong in trying to stop "amusement" lasers and is especially wrong in trying to regulate handhelds as SLA lasers, based on a clear reading of the English language. More details on this are at http://www.laserpointersafety.com/perspectives/sla/sla.html
If my position is correct, then FDA must permit at the federal level the import and sale of any laser that is properly reported to FDA (e.g., a Laser Product Report, and Form 2877 if required), and that has all the correct labeling and safety features required for its Class. (Also, if the laser is 5 mW or more, it cannot be called a "pointer" or be sold for pointing purposes based on long-standing custom.)
Persons on this thread can get all upset about Big Government, and bemoan the fact that "they're coming for our lasers", etc. But until someone challenges FDA in a significant way, such as by legal action, all these complaints in this little tiny corner of the Internet will be meaningless in actually affecting change.
-- Patrick
PS: The above is my personal opinion. I am not speaking for any organization. Also, there are other important issues such as whether laser pointer sales need to be restricted due to excessive misuse. In this post above, I am simply discussing whether FDA is accurately following the definitions and Congressional grant of authority as listed in 1040.10 and 1040.11.
